1221: Biden Reset

Being Unstuck in Time in Slaughterhouse Five by Kurt Vonnegut The concept of being "unstuck in time" refers to a person living from one moment in life to another instead of the day-to-day one we live today. The main character of Kurt Vonnegut's Slaughterhouse-Five, Billy Pilgrim, does just that. He travels through the time line of his life experiencing moments of it in no particular order. In a flash, time travel for Billy happens with no warning to where he will turn up next.

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Sun, 01 Mar 2020 00:39

''Guaranteed, the next Democrat president is going to be impeached on day 3 in office because people we elect are shit heels, pretty much all of them!" '--

@adamcurry #noagenda 1215

View details · I know that many non-Democrats here in South Carolina voted in the Democratic primary in order to skew results. Many I know voted for Biden; I voted for Klobuchar. Just something I thought you might like to consider when looking at Saturday's results

View conversation · @ blueninja Replying to @adamcurry @noagendaquotes nope .. i learned that you didnt even have to declare or reveal your party on the ballot when I talk to the board of elections to get my absentee ballot. I am technically a libertarian myself and was told it didn't matter nor would it change my affiliation in future elections.

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Sun, 01 Mar 2020 00:45

From Ballotpedia

A primary election is an election used either to narrow the field of candidates for a given elective office or to determine the nominees for political parties in advance of a general election. Primary elections can take several different forms. In a partisan primary, voters select a candidate to be a political party's nominee for a given office in the corresponding general election. Nonpartisan primaries are used to narrow the field of candidates for nonpartisan offices in advance of a general election. The terms of participation (e.g., whether only registered party members can vote in a party's primary) in primary elections can vary by jurisdiction, political party, and the office or offices up for election. The methods employed to determine the outcome of the primary (e.g., plurality systems, majority systems, top-two systems, etc.) can also vary by jurisdiction.

HIGHLIGHTS

As South Carolina does not provide for registration by party, primaries in the state are open, meaning any voter can participate in any one party's primary.

Winners in primary contests in South Carolina are determined by majority vote. If no candidate wins a majority, a runoff election is held two weeks following the primary.

See the sections below for general information on the use of primary elections in the United States and specific information on the types of primaries held in South Carolina:

Background: This section outlines the different types of primary election participation models used in the United States, including open primaries, closed primaries, semi-closed primaries, and top-two primaries. This section also details the various methods employed to determine the outcomes of primary elections. Primary election systems used in South Carolina: This section details the primary election systems employed in South Carolina, including primaries for congressional and state-level offices (e.g., state legislative seats, state executive offices, etc). State legislation: This sections lists state legislation relevant to primary election policy in South Carolina. Background In general, there are two broad criteria by which primary elections can vary from jurisdiction to jurisdiction:

Terms of participation: In jurisdictions that conduct partisan primaries, who can vote in a party's primary? Is participation limited to registered party members, or can other eligible voters (such as unaffiliated voters or voters belonging to other parties) participate? In general, there are three basic types of primary election participation models: open primaries, closed primaries, and semi-closed primaries. Methods for determining the election's outcome: What share of the total votes cast does a candidate have to receive in order to advance to the general election? Methods for determining primary election outcomes include plurality voting systems, majority voting systems, and top-two primaries. For more complete information on these criteria, click "[Show more]" below.

Show moreTerms of participation The terms of participation in primary elections vary from jurisdiction to jurisdiction (and, sometimes, within a jurisdiction; different political parties may enforce different participation criteria). In general, there are three basic primary election participation models used in the United States:

Open primaries: An open primary is any primary election in which a voter either does not have to formally affiliate with a political party in order to vote in its primary or can declare his or her affiliation with a party at the polls on the day of the primary even if the voter was previously affiliated with a different party.[1][2] Closed primaries: A closed primary is any primary election in which a voter must affiliate formally with a political party in advance in order to participate in that party's primary.[1][2] Semi-closed primaries: A semi-closed primary is one in which previously unaffiliated voters can participate in the primary of their choosing. Voters who previously affiliated with a political party who did not change their affiliations in advance cannot vote in another party's primary.[1][2]Methods for determining the election's outcome Methods for tallying votes to determine a primary election's outcome include the following:

Plurality voting system: In plurality systems, the candidate who wins the largest share of the vote wins the election. The candidate need not win an outright majority to be elected. These systems are sometimes referred to as first-past-the-post or winner-take-all.[3][4] Majority voting system: In majority systems, a candidate must win more than 50 percent of the vote in order to win the election. In the event that no candidate wins an outright majority, a runoff election is held between the top two vote-getters. For this reason, majority systems are sometimes referred to as two-round systems. Ranked-choice voting is a specific type of majority voting system that may also be used in primary elections.[3][4] Top-two primaries: A top-two primary is one in which all candidates are listed on the same primary election ballot; the top two vote-getters, regardless of their partisan affiliations, advance to the general election. Consequently, it is possible that two candidates belonging to the same political party could win in a top-two primary and face off in the general election. A top-two primary should not be confused with a blanket primary. In a blanket primary, all candidates are listed on the same primary ballot; the top vote-getter from each party participating in the primary advances to the general election.[2][5][6]Primary election systems used in South Carolina Congressional and state-level elections In 22 states, at least one political party utilizes open primaries to nominate partisan candidates for congressional and state-level (e.g. state legislators, governors, etc.) offices. In 15 states, at least one party utilizes closed primaries to nominate partisan candidates for these offices. In 14 states, at least one party utilizes semi-closed primaries. In two (California and Washington), top-two primaries are utilized.[7]

As South Carolina does not provide for registration by party, party primaries are open. Voters may choose which party's ballot they wish to vote on in the primary, but may only vote in one party's primary. Winners in primary contests are determined by majority vote. If no candidate wins a majority, a runoff election is held two weeks following the primary.[1][2][8]

The table below lists South Carolina offices for which parties must conduct primary elections to nominate their candidates.

State legislation and ballot measures Primary systems legislation The following is a list of recent primary election systems bills that have been introduced in or passed by the South Carolina state legislature. To learn more about each of these bills, click the bill title. This information is provided by BillTrack50 and LegiScan.

Note: Due to the nature of the sorting process used to generate this list, some results may not be relevant to the topic. If no bills are displayed below, no legislation pertaining to this topic has been introduced in the legislature recently.

Primary systems ballot measures See also: Elections and campaigns on the ballot and List of South Carolina ballot measuresSince 2017, Ballotpedia has tracked no ballot measures relating to primary elections in South Carolina.

See also Electoral systems in South Carolina Voting in South Carolina Primary electionExternal links National Conference of State Legislatures, "State Primary Election Types" FairVote, "Primaries" '†‘ 1.0 1.1 1.2 1.3 FairVote, "Who Can Vote in Congressional Primaries," accessed August 17, 2017 '†‘ 2.0 2.1 2.2 2.3 2.4 National Conference of State Legislatures, "State Primary Election Types," July 21, 2016 '†‘ 3.0 3.1 FairVote, "Electoral Systems," accessed July 7, 2017 '†‘ 4.0 4.1 Georgetown University, "Electoral Systems," accessed July 7, 2017 '†‘ USLegal.com, "Blanket Primary Law and Legal Definition," accessed January 13, 2016 '†‘ Encyclopedia Brittanica, "Primary Election," accessed January 13, 2016 '†‘ Louisiana utilizes a two-round electoral system in which the names of all eligible candidates are printed on the general election ballot. If a candidate wins more than 50 percent of the vote in the general election, he or she is elected. If no candidate wins an outright majority in the general election, a runoff election is held between the top two vote-getters. This system is sometimes referred to as a jungle primary or majority electoral system. In Nebraska's nonpartisan state legislature employs a top-two primary system in which the top two vote-getters in the primary face off in the general election. '†‘ South Carolina Statehouse, "SECTION 7-17-600. No candidate shall be declared nominated in first primary without majority vote," accessed September 2, 2017 Ballotpedia About Editorial Tech

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Thu, 27 Feb 2020 15:04

Show caption Senator Elizabeth Warren is joined by musician John Legend at a campaign Get Out the Vote event in Orangeburg, South Carolina, on Wednesday. Photograph: Brian Snyder/Reuters

Elizabeth WarrenThe senator has an A-list pitchman but still faces an uphill task with South Carolina's majority black Democratic voters

Elizabeth Warren has been making a last-ditch effort to woo black voters away from former vice-president Joe Biden ahead of the South Carolina primary vote on Saturday.

'Unity, unity, unity': Pelosi insists Democrats will support nominee amid Sanders surge '' live Singer John Legend headlined three events for the Massachusetts senator on Wednesday, including in key African American communities. Legend is an especially appealing surrogate to young voters in South Carolina and to African Americans, and his stump speech aligned closely with hers.

''She supports creating a commission on reparations for the descendants of enslaved people,'' Legend told the crowd in Orangeburg on Wednesday, before directly contrasting her with her rivals for the Democratic presidential nomination.

''Unlike [former New York] Mayor [Mike] Bloomberg, she knows that housing discrimination through redlining has been a national tragedy,'' he said, referring to the decades-long practice of US banks denying mortgages to people, mostly people of color in urban areas, preventing them from buying a house or getting a loan to renovate.

''Her housing plan creates a first of its kind program to help first-time home buyers living in formerly redlined areas buy a home and start building the kind of wealth that government-sponsored discrimination denied their parents and grandparents for decades.''

Warren faces yet another daunting political contestin South Carolina, the first state in the deep south to cast its vote in the primary race, where African American voters form a majority of the electorate. In the 2016 presidential election, 24% of national Democratic primary voters were black.

The vote comes just days before Super Tuesday on 3 March, when the candidates will be vying for more than a third of the available delegates that are key to securing the nomination '' a high-stakes day that has the potential to propel one candidate to solid frontrunner status and see others drop out.

Thus far, Warren has not won or achieved the runner-up spot in any of the early state primary contests. Her best showing so far was in Iowa, where she ended up trailing the former South Bend mayor Pete Buttigieg and Vermont senator Bernie Sanders, respectively. In New Hampshire, a neighbor state to Warren's Massachusetts, Warren placed a distant fourth, behind fellow New Englander Sanders, and the Minnesota senator Amy Klobuchar. In Nevada, Warren once again ended up in fourth place.

Biden has long courted voters in the black community, touting his record as vice-president to America's first African American head of state, Barack Obama. But Warren is hoping that support from prominent black surrogates and some changes to her campaign will help her rank among the top-end candidates in South Carolina.

In addition to Legend, Black Womxn For, a group advocating for ''intentional meeting spaces for Black Women and gender-nonconforming community leaders and activists'' have been among the black surrogates who have held events for Warren throughout South Carolina.

John Legend stumps for Elizabeth Warren in Charleston. Photograph: Patrick Semansky/AP Warren has spent much of the election race enjoying top-tier status without any association to Super Pacs or high-dollar fundraisers, instead favoring individual donors.

But just days before the South Carolina Democratic primary, the situation is different. There's now a Super Pac, which Warren has at least declined to disavow. Warren allies, at the same time, have begun hosting more traditional fundraisers for her rather than the small-dollar, grassroots-only approach that her campaign proudly touted as its only source of fuel for months.

Warren has also been increasingly warning voters about corporate corruption and economic inequality, especially by attacking billionaire Bloomberg, who has been spending hundreds of millions of dollars to run for president. She's criticized billionaires as part of her arguments for increasing taxes on the wealthy.

''Now, you may have heard there's some billionaires who don't like this,'' Warren said during a campaign stop at South Carolina State University, a Historically Black College and University, in Orangeburg. ''Some of them go on TV and cry. So sad.

''Some of them run for president,'' Warren continued, joking ''they're discovering it's harder than they thought.''

Lines like that still please her crowds. At the Orangeburg event the immediate response was deep laughter from the audience.

But it's unclear whether Warren's efforts will succeed in South Carolina.

''I think her John Legend events are good. I don't think that is going to translate into significant African American votes or young votes,'' said Clay Middleton, a South Carolina Democratic National Committee member, who highlighted that Warren had not spent a lot of time in the state until now.

''She has not, in my opinion, had a large organizing staff. Her events that she has done, her public events have not been diverse. She has not done much retail politics.''

Warren's campaign has 40 staffers across South Carolina and has 11 offices. Warren's campaign said she has visited the state more than a dozen times for a total of 21 days. The surrogates who have campaigned for her include congresswomen Ayanna Pressley and Deb Haaland, and she has picked up endorsements from local lawmakers including state representatives Kambrell Garvin and Wendy Brawley.

John Legend speaks to Warren supporters at D & B Fried Fish and Barbecue in Orangeburg, South Carolina, on Wednesday. Photograph: Brian Snyder/Reuters Supporters remain enthusiastic but are also realistic about Warren's prospects. At an event in Charleston on Wednesday night Trevin Cooper, a 25-year-old Warren supporter, said he still believed ''that she is the best chance this country has as far as change.

''Unfortunately I think that other candidates, Bernie Sanders in particular, has a stronger base of supporters who are impassioned in what they believe,'' Cooper said.

Asked what he thought of Warren's chances in the primary Cooper said: ''I'm not really sure. I think she has in this state a chance to beat Sanders which I think is her biggest competition but I'm not sure the margin of error '' it could really go either way.''

Another Warren supporter who attended the Charleston event, Jim Wilson, 70, conceded that he saw Warren's chances of winning the state as ''not very good''.

''Because according to the polls Biden has it wrapped up and probably Sanders will come in second,'' Wilson said. ''But I can always be hopeful.''

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Fri, 28 Feb 2020 10:06

Pushes for gun control ''at federal level''

Democratic Presidential candidate Mike Bloomberg made several dubious claims during a CNN townhall on Wednesday night, in an effort to push an extreme gun control agenda he has long sought to implement.

Without citing any specific statistics or studies, Bloomberg, who is surrounded 24/7 by armed guards, claimed that Americans are much more at risk of injury and death if they keep a gun at home.

''You don't want to have guns. If you have a gun in your house you're something like 22 times as likely to get killed with a gun.'' Bloomberg claimed.

''There's domestic violence, there's children playing, there's accidents.'' he added.

Watch:

Despite Bloomberg's claim, a study from his own Johns Hopkins Bloomberg School of Public Health found no ''clear association between firearm restrictions for domestic abusers and reduced fatal mass shootings.''

Bloomberg went on to jump to conclusions regarding a shooting at Molson Coors in Milwaukee, despite the fact that no detailed information about the gunman had been released at the time.

Six dead including shooter in rampage at Milwaukee campus of Molson Coors. Read more: https://t.co/xaGH8rw8Ej https://t.co/AUx1XsLJzp

'-- Journal Sentinel (@journalsentinel) February 27, 2020

Bloomberg demanded that universal background checks should be implemented in all 50 states, but noted that ''it'd be much easier if we could do it at a federal level.''

''I noticed when I was backstage, watching the president, he said 'our prayers should be with the families,' and I'm sympathetic with that, but what he should have said is, 'We're going to do something to have background checks to stop guns being sold to people that shouldn't buy them,''' Bloomberg added.

He further claimed that the Supreme Court has ruled ''reasonable restrictions'' can be placed on Americans' right to keep and bear arms under the Second Amendment.

''The reasonable privileges include things like background checks, so you don't sell guns to minors, people with physiatric problems, or people with criminal records,'' Bloomberg urged, further claiming that ''if you did just that and took just 24 hours to go through the background check, you would make a very big difference in this country.''

Bloomberg was not the only Democrat to immediately push gun control in the wake of the Milwaukee incident, with Nancy Pelosi also calling for Congressional action, despite admitting a lack of any details on the shooting:

We are closely following developments surrounding the shooting in Milwaukee, Wisconsin. Our prayers are with the families who have lost loved ones and the first responders protecting the community. Congress has a duty to them all to take real action to #EndGunViolence.

'-- Nancy Pelosi (@SpeakerPelosi) February 26, 2020

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Thu, 27 Feb 2020 23:50

Interviews with dozens of Democratic Party officials, including 93 superdelegates, found overwhelming opposition to handing Mr. Sanders the nomination if he fell short of a majority of delegates.

Senator Bernie Sanders, who spoke at a campaign rally in Myrtle Beach, S.C., on Wednesday, said that the candidate with the most delegates from primaries should be the party's presidential nominee. Credit... Erin Schaff/The New York Times WASHINGTON '-- House Speaker Nancy Pelosi and Senator Chuck Schumer, the minority leader, hear constant warnings from allies about congressional losses in November if the party nominates Bernie Sanders for president. Democratic House members share their Sanders fears on text-messaging chains. Bill Clinton, in calls with old friends, vents about the party getting wiped out in the general election.

And officials in the national and state parties are increasingly anxious about splintered primaries on Super Tuesday and beyond, where the liberal Mr. Sanders edges out moderate candidates who collectively win more votes.

Dozens of interviews with Democratic establishment leaders this week show that they are not just worried about Mr. Sanders's candidacy, but are also willing to risk intraparty damage to stop his nomination at the national convention in July if they get the chance. Since Mr. Sanders's victory in Nevada's caucuses on Saturday, The Times has interviewed 93 party officials '-- all of them superdelegates, who could have a say on the nominee at the convention '-- and found overwhelming opposition to handing the Vermont senator the nomination if he arrived with the most delegates but fell short of a majority.

Such a situation may result in a brokered convention, a messy political battle the likes of which Democrats have not seen since 1952, when the nominee was Adlai Stevenson.

''We're way, way, way past the day where party leaders can determine an outcome here, but I think there's a vibrant conversation about whether there is anything that can be done,'' said Jim Himes, a Connecticut congressman and superdelegate, who believed the nominee should have a majority of delegates.

From California to the Carolinas, and North Dakota to Ohio, the party leaders say they worry that Mr. Sanders, a democratic socialist with passionate but limited support so far, will lose to President Trump, and drag down moderate House and Senate candidates in swing states with his left-wing agenda of ''Medicare for all'' and free four-year public college.

Mr. Sanders and his advisers insist that the opposite is true '-- that his ideas will generate huge excitement among young and working-class voters, and lead to record turnout. Such hopes have yet to be borne out in nominating contests so far.

Jay Jacobs, the New York State Democratic Party chairman and a superdelegate, echoing many others interviewed, said that superdelegates should choose a nominee they believed had the best chance of defeating Mr. Trump if no candidate wins a majority of delegates during the primaries. Mr. Sanders argued that he should become the nominee at the convention with a plurality of delegates, to reflect the will of voters, and that denying him the nomination would enrage his supporters and split the party for years to come.

''Bernie wants to redefine the rules and just say he just needs a plurality,'' Mr. Jacobs said. ''I don't think we buy that. I don't think the mainstream of the Democratic Party buys that. If he doesn't have a majority, it stands to reason that he may not become the nominee.''

This article is based on interviews with the 93 superdelegates, out of 771 total, as well as party strategists and aides to senior Democrats about the thinking of party leaders. A vast majority of those superdelegates '-- whose ranks include federal elected officials, former presidents and vice presidents and D.N.C. members '-- predicted that no candidate would clinch the nomination during the primaries, and that there would be a brokered convention fight in July to choose a nominee.

In a reflection of the establishment's wariness about Mr. Sanders, only nine of the 93 superdelegates interviewed said that Mr. Sanders should become the nominee purely on the basis of arriving at the convention with a plurality, if he was short of a majority.

''I've had 60 years experience with Democratic delegates '-- I don't think they will do anything like that,'' said former Vice President Walter Mondale, who is a superdelegate. ''They will each do what they want to do, and somehow they will work it out. God knows how.''

As for his own vote, Mr. Mondale, the 1984 Democratic presidential nominee, said, ''I vote for the person I think should be president.''

'I've had 60 years experience with Democratic delegates. I don't think they will do anything like that.''-- Former Vice President Walter Mondale

While there is no widespread public effort underway to undercut Mr. Sanders, arresting his rise has emerged as the dominant topic in many Democratic circles. Some are trying to act well before the convention: Since Mr. Sanders won Nevada's caucuses on Saturday, four donors have approached former Representative Steve Israel of New York to ask if he can suggest someone to run a super PAC aimed at blocking Mr. Sanders. He declined their offer.

''People are worried,'' said former Senator Chris Dodd of Connecticut, a former Democratic National Committee chairman who in October endorsed former Vice President Joseph R. Biden Jr. ''How you can spend four or five months hoping you don't have to put a bumper sticker from that guy on your car.''

That anxiety has led even superdelegates to suggest ideas that sound ripped from the pages of a political drama.

In recent weeks, Democrats have placed a steady stream of calls to Senator Sherrod Brown of Ohio, who opted against running for president nearly a year ago, suggesting that he can emerge as a white knight nominee at a brokered convention '-- in part on the theory that he may carry his home state in a general election.

''If you could get to a convention and pick Sherrod Brown, that would be wonderful, but that's more like a novel,'' Representative Steve Cohen of Tennessee said. ''Donald Trump's presidency is like a horror story, so if you can have a horror story you might as well have a novel.''

Others are urging former President Barack Obama to get involved to broker a truce '-- either among the four moderate candidates or between the Sanders and establishment wings, according to three people familiar with those conversations.

William Owen, a D.N.C. member from Tennessee, suggested that if Mr. Obama was unwilling, his wife, Michelle, could be nominated as vice president, giving the party a figure they could rally behind.

''She's the only person I can think of who can unify the party and help us win,'' he said. ''This election is about saving the American experiment as a republic. It's also about saving the world. This is not an ordinary election.''

People close to Mr. Obama say he has no intention of getting involved in the primary contest, seeing his role as less of a kingmaker than as a unifying figure to help heal party divisions once Democrats settle on a nominee. He also believed that the Democratic Party shouldn't engage in smoke-filled-room politics, arguing that those kinds of deals would have prevented him from capturing the nomination when he ran against Hillary Clinton in 2008.

'This election is about saving the American experiment as a republic.''-- William Owen, a D.N.C. member from Tennessee

Officials at the Democratic National Committee maintain that it is highly improbable to head to the convention without an assured nominee. Historically, superdelegates had always supported the candidate who won the most pledged delegates, which accrue from primary and caucus wins. While those delegates are proportioned based on the results of those elections, they are not legally bound '-- meaning that they are technically free to change their votes as the race progresses.

In recent days, both Mr. Biden and Senator Elizabeth Warren of Massachusetts said that Mr. Sanders should not become the nominee if he arrived at the convention short of a delegate majority. ''Bernie had a big hand in writing these rules,'' Ms. Warren said during a CNN forum on Wednesday night. ''I don't see how he thinks he gets to change them now that he thinks there's an advantage for him.''

Slightly less than 3 percent of delegates have been allocated in the race so far, and Mr. Sanders, of course, can win a majority, making him the nominee. But while Mr. Sanders has demonstrated momentum in the race, winning the most votes in each of the first three contests, he has yet to show that he can expand his coalition enough to set his campaign on a path to capturing the majority of delegates. As a result, some within Mr. Sanders's own campaign foresee a possible brokered convention.

The argument of Mr. Sanders and his allies '-- that a plurality of delegates should be sufficient to clinch the nomination '-- is a different standard than the one laid out in party rules that his team helped draft two years ago. It's also a reversal of their stance in 2016, when Mr. Sanders encouraged superdelegates to support him over Mrs. Clinton, who secured the majority of pledged delegates.

''The will of the people should prevail,'' he said when asked during last week's debate if the candidate with the most pledged delegates should be the Democratic nominee. ''The person who has the most votes should become the nominee.''

Supporters of Mr. Sanders said that blocking him from the nomination if he had the most delegates would repel progressives, and would deliver a second term to Mr. Trump.

''If Bernie gets a plurality and nobody else is even close and the superdelegates weigh in and say, 'We know better than the voters,' I think that will be a big problem,'' said Representative Pramila Jayapal of Washington state, a Sanders supporter who is co-chairwoman of the Congressional Progressive Caucus.

'We don't have to freak out.''-- Jane Kleeb, the Nebraska Democratic chairwoman

Not only would a messy convention fight risk alienating a sizable part of the Democratic base that supports Mr. Sanders, it would also give Republicans ammunition to use in the general election.

''We don't have to freak out,'' said Jane Kleeb, the Nebraska Democratic chairwoman, who helped write Democrats' presidential nominating rules and supported Mr. Sanders in 2016. ''We shouldn't be second-guessing voters. If that's what our party leaders are going to do, you'll see rebellion not just in the presidential race, but in down-ballot races as well.''

Others in the party view Mr. Sanders as such an existential threat that they see stopping him from winning the nomination as less risky than a public convention fight. Many feared that putting Mr. Sanders on the top of the ticket could cost Democrats the political gains of the Trump era, a period when the party won control of the House, took governor's mansions in deep red states and flipped statehouses across the country.

''Bernie seems to have declared war on the Democratic Party '-- and it's caused panic in the House ranks,'' said Representative Josh Gottheimer of New Jersey, a supporter of former Mayor Michael Bloomberg of New York. Private polling of Mr. Gottheimer's northern New Jersey district, for example, shows a double-digit gap in the approval ratings of Mr. Trump and Mr. Sanders.

Representative Veronica Escobar of Texas said that if Mr. Sanders arrived at the convention with 40 percent of the delegates, it wouldn't be enough to convince her to vote for him on the second ballot.

''If 60 percent is not with Bernie Sanders, I think that says something, I really do,'' she said.

Results in the Super Tuesday contests should give Democrats a strong indication of where the nominating contest is headed.

'If 60 percent is not with Bernie Sanders, I think that says something, I really do.''-- Representative Veronica Escobar of Texas

Should Mr. Sanders win big in the 16 states and territories holding primaries and caucuses on Super Tuesday next week, he could be on a path to the 1,991 pledged delegates needed to capture the nomination on the first ballot at the party's convention. But if the Super Tuesday vote is sharply divided among Mr. Sanders and two or more other rivals, the Vermont senator could find himself with more delegates than the competition but not enough to win the nomination outright.

Under the current rules, the convention would then go to a second ballot. On that vote, all 3,979 pledged delegates and 771 superdelegates would be free to vote for any candidate they chose.

That would give Democratic delegates a huge amount of power to determine the nominee, setting off a fierce round of jockeying by the candidates to win over 2,375.5 delegates and superdelegates. (Superdelegates from Democrats Abroad count as half a vote each.)

''It is a mini primary process in the making,'' said Leah Daughtry, who ran the party's 2008 and 2016 conventions. She's been warning Democratic donors about the prospect of a contested convention for nearly a year. ''If you don't have a political operation that will get you through a second ballot then what are you going to do in a general?''

The campaigns are already strategizing about how they will handle a protracted convention battle. Superdelegates, too, are brushing up on the rules: Ms. Pelosi invited House Democrats to a meeting at D.N.C. headquarters on Thursday to review the details of the convention process.

''Whatever the atmosphere is, and I would hope that everyone would say, no matter who the nominee is for president, we wholeheartedly embrace that person,'' she said, in a private caucus meeting on Wednesday morning, according to an aide in the room.

According to a person familiar with the private conversations, Mr. Schumer told people he had so far stayed out of the primary because many members of his caucus were running. He argued that there was one school of thought that you needed to win the base and one that you needed to bring new voters in, and said that he did not yet know which candidate would be able to accomplish those goals.

A number of superdelegates dream of a savior candidate who is not now in the race, perhaps Mr. Brown, or maybe someone who already dropped out the race, like Senator Kamala Harris of California.

Representative Don Beyer of Virginia cast an even wider net, suggesting senators from Virginia and Delaware, along with Ms. Pelosi, as possible nominees.

''At some point you could imagine saying, 'Let's go get Mark Warner, Chris Coons, Nancy Pelosi,''' he said, while preparing to introduce the former Mayor Pete Buttigieg of South Bend, Ind., at a campaign event near his home on Sunday. ''Somebody that could win and we could all get behind and celebrate.''

Stay up to date on primaries and caucuses. Subscribe to ''On Politics,'' and we'll send you a link to our live coverage.

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Thu, 27 Feb 2020 23:54

Former Democratic presidential candidate Hillary Clinton. | Andreas Rentz/Getty Images

Hillary Clinton is starting a podcast.

The former first lady, secretary of State, and 2016 Democratic presidential nominee is planning to launch a new audio program in late spring, just in time for her to have a powerful new megaphone during the 2020 election.

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The yet-to-be-titled show will be co-produced by audio giant iHeartMedia, which produces original content such as Will Ferrell's ''The Ron Burgundy Podcast,'' and, through iHeartRadio, is also a major distributor for the biggest names in conservative talk radio. They include a who's who of right-wing commentators who have pilloried Clinton and her family over the years: Rush Limbaugh, Mark Levin, Glenn Beck, Ben Shapiro, and Sean Hannity. The Joe Rogan Experience, whose host recently endorsed Bernie Sanders, is one one of iHeartRadio's most popular shows.

But it was Clinton's recent experience with two other famous interviewers that influenced the kind of show she wanted to create. Last fall, Clinton and her daughter Chelsea recorded an episode of Conan O'Brien's audio show, ''Conan O'Brien Needs a Friend.'' They were promoting The Book of Gutsy Women, their co-authored collection of stories about women who have inspired them.

Clinton was struck by how different the hourlong conversation with O'Brien was compared with short promotional segments on TV and radio. She had already begun discussions with iHeartMedia, which also distributes O'Brien's show, and she started to think about how the format might allow her to record deeper conversations with newsmakers that listeners could enjoy well after they aired.

''Conan just exudes enthusiasm about this platform and he does these interviews that are really evergreen and the idea with her, in part inspired by that experience, is to do the same thing,'' said a person close to Clinton. ''She wants to try to have a wider-ranging conversation that will be lasting, so you can listen to it in a year or you can listen to it tomorrow and it will be interesting. And then of course she'll do some ranting and raving about news of the day.''

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The other radio personality who influenced the format and style of the new Hillary Clinton show was even more unusual: Howard Stern.

Clinton had avoided Stern for decades when she was in the White House, Senate, Obama administration and as a presidential candidate. She finally agreed to appear on Stern's show late last year during her promotional book tour. It was scheduled to be an hourlong session, but Clinton quickly succumbed to Stern's well-known skills at getting his guests to open up with a mix of flattery, empathy and emotional mirroring.

Stern and Clinton ended up recording for almost 2½ hours, producing Stern's longest interview for a non-musician in the show's history.

Clinton was unfiltered. She joked that she ''likes men'' despite ''what you may have heard,'' discussed how Sen. Lindsey Graham may have suffered a ''brain snatch,'' complained that Bernie Sanders' delayed endorsement in 2016 ''hurt me,'' and recalled that, when she phoned Trump to concede the election, ''he was so shocked he could barely talk.''

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Clinton enjoyed the relaxed environment that Stern creates at his studio, which isn't too brightly lit and where guests sit amid throw pillows on a couch that looks like it was from Stern's college dorm room. ''It was an incredible experience,'' said the person close to Clinton. ''We've been thinking through based on that experience how to create a similar format.''

There is some irony that Clinton has gravitated to doing a podcast. As Stern repeatedly shows, what makes for a great interview is when a subject opens up and offers windows into character, motivation, relationships '-- the very things that Clinton the candidate was often unwilling to do. Her guardedness led critics to regard her as ''inauthentic,'' which arguably harmed her two presidential campaigns.

Clinton's show will feature her in conversation with a brand-name guest, who might be drawn from world leaders and politicians, of course, but also celebrities, authors and perhaps famous chefs. Her team is experimenting with using a Stern-inspired ensemble plucked from the larger universe of Hillaryland to help loosen her up, keep the show conversational, and discuss the day's news, perhaps at the top or bottom of the show. The search is on inside her organization for a Robin Quivers-like sidekick.

Overall the project is guided by the spirit of Clinton's recent media blitz: the Stern podcast, a recent podcast with David Plouffe in which she suggested that Tulsi Gabbard was being groomed by the Russians, and an interview with The Hollywood Reporter to promote a new Hulu documentary series in which she says of Sanders, ''Nobody likes him, nobody wants to work with him, he got nothing done.''

''Stern has a cast of characters,'' said the person close to Clinton. ''So could you have some people on the show in her orbit who are interesting but not necessarily guest-worthy? And then hopefully there's some irreverence involved.'' (Hillary is not the first Clinton with an audio show. Bill and Chelsea Clinton currently both appear on the Clinton Foundation's podcast, Why Am I Telling You This?)

Hillary Clinton wants the main guests to be defined by the theme of her most recent book. The person close to her described the ideal interview for the show as ''a meeting of the minds with people of grit and determination.''

Clinton has brought in two podcast veterans to produce the show, which will be recorded from a studio in Manhattan: Kathleen Russo, executive producer of Tina Brown's ''TBD'' and creator of Alec Baldwin's ''Here's the Thing,'' and Julie Subrin, who also produces for Brown's show. Clinton has already spent some time in the studio, and on Friday, she's recording an interview with an author promoting a book out in the spring. She'll continue interviews over the coming months until there's enough material for a splashy launch.

Another focus of the show for Clinton is to use the podcast to share good news about problems that are actually being solved rather than produce yet another regular conversation strictly about how the world is going to hell.

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But considering the timing of the new show, and Clinton's recent penchant for offering her candid assessment of politics, the show will offer her a big new platform to weigh in on the drama unfolding in the Democratic primaries, including the potentially messy convention in Milwaukee. Clinton could play a role helping build support for an alternative to Bernie Sanders if he doesn't secure the nomination on a first ballot '-- or in helping unite the party if he wins the nomination.

The show also continues the trend of former major political leaders, especially Democrats, becoming media entrepreneurs. After he lost the 2000 election, Al Gore created his own TV network and starred in an important documentary about climate change. Upon leaving office, the Obamas created Higher Ground, a multimedia production company whose first documentary, ''American Factory,'' just won an Oscar. If Trump had lost in 2016, he was reportedly prepared to start his own conservative media organization.

Perhaps it was only a matter of time before Clinton, whose time in office was marked by a deep distrust of the media, hopped onto the other side of the microphone and became the media herself. As her recent blitz of interviews showed, she has an almost unparalleled ability to make news with even a passing comment about major political figures and events. But that power is partly a function of how rarely she speaks, and she may find that it diminishes the more she's in the fray.

Can she keep up the edginess needed for a compelling show? When asked how she's been preparing, the person close to her said, ''She's been listening to a lot of podcasts.''

Marc Caputo contributed to this report.

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Archived Version

Fri, 28 Feb 2020 10:17

A direct commission officer (DCO) is a United States uniformed officer who has received a commission without the typical prerequisites for achieving a commission, such as attending a four-year service academy, a four-year or two-year college ROTC program, or one of the officer candidate school or officer training school programs, the latter OCS/OTS programs typically slightly over three months in length.

Civilians who have special skills that are critical to sustaining military operations, supporting troops, health and scientific study may receive a direct commission upon entering service. These officers usually occupy leadership positions in the following areas: law, science, medicine, pharmacy, dentistry, nurse corps, intelligence, supply-logistics-transportation, engineering, public affairs, chaplain corps, oceanography, merchant marine affairs, and others.

The U.S. Navy, U.S. Air Force and U.S. Coast Guard have more extensive active and reserve component DCO programs than the other two U.S. armed services.

The U.S. Marine Corps does not offer a DCO program anymore; Navy officers provide medical, legal and chaplain services, and chief warrant officers (CWO) and limited duty officers (LDO) serve as occupational field experts.

The U.S. Public Health Service Commissioned Corps and the National Oceanic and Atmospheric Administration Commissioned Officer Corps exclusively use a DCO program to commission their officers.

Depending on the specialization and duty-status of the officer, "DCOs" as they're called, will attend either Officer Indoctrination School (OIS), Officer Development School (ODS), or Direct Commission Officer School (DCO School) which vary from two weeks duration for certain Reserve DCOs to five weeks duration for Active Duty DCOs.

U.S. Army Active and Reserve Direct Commission Officers [ edit ] Active United States Army direct commissions are available in the medical, legal, chaplain corps, and cyber as of November 2017. Each branch will rank the officer candidate upon completion of Basic Officer Leadership Course (BOLC). The United States Army Reserve uses the DCO program to bring specialized skills and backgrounds, and to fill critical shortages in the Army Reserve commissioned officer corps. A majority of the people obtaining direct commissions in the Army Reserve are prior-enlisted personnel. However, there have been instances when qualified civilians were directly commissioned as well. The general requirements for a direct commission in the Army Reserve are: 60 semester hours of college credit; the ability to get and maintain a "secret" clearance; be physically qualified (obtain and pass a medical evaluation); an open slot or "billet" in an Army Reserve unit; three recommendation letters from commissioned field-grade officers; and a recommendation from a direct commissioning board. Once selected, the applicant signs the oath and is sworn in by another commissioned officer. At that point the newly commissioned officer will then need to attend the Basic Officer Leadership Course (BOLC) in their assigned area of concentration (AOC) before becoming fully qualified.

Direct commission officers in the Army Reserve can serve in the same specialities and hold billets as ROTC, OCS, and USMA graduates. Direct commission officers may be promoted to flag officer rank and hold command within their specialty of work.

U.S. Navy Direct Commission Officers [ edit ] The United States Navy has an extensive DCO program. It is important to distinguish between the Navy's active duty component staff corps school, called Officer Development School (ODS), and the Navy's reserve component Direct Commission Officer School (DCO School).

Base Realignment and Closure (BRAC) of 2005 decreed that the Navy Reserve officer DCO School be relocated from Naval Aviation Schools Command at Naval Air Station Pensacola, Florida to Naval Education and Training Center Newport, Rhode Island effective January 2007. As a result of BRAC and other budgetary-driven actions, the U.S. Navy consolidated many of its schools at NETC, Naval Station Newport, Rhode Island.

The Navy is currently considering merging DCO School, Limited Duty Officer School, and Mustang University into one contiguous officer training program'--all located in Newport, Rhode Island. As of January 2007 all Navy Reserve DCO, LDO and CWO Officers attend the same two-week course of instruction in Newport. Active duty ODS, a five-week course, is also located in Newport, as well as Officer Candidate School (OCS), the 12-week program that college graduates wishing to join the U.S. Navy as active duty officers go through.

The U.S. Navy Reserve Direct Commissioning Program allows university-educated professionals, between ages 19 to 35 (or older, in some cases), the opportunity to be appointed as an officer in the Navy Reserve. Most DCOs hold advanced degrees (MAs, MBAs, JDs, MDs, DOs, PharmDs and Ph.Ds.) and/or significant civilian work experience. In recent years, the number of direct commissions offered by the Navy Reserve has increased due to the need for skilled officers to serve as Individual Augmentees (IAs) in Iraq and Afghanistan. The Direct Commissioning Program serves the expanded needs of the Navy in certain officer skill areas listed below in alphabetical order by category:

Unrestricted Line Officer

Special Warfare OfficerRestricted Line Officer (including Special Duty Officer)

Aerospace Engineering Duty Officer (AEDO)NOTE: Unlike AEDOs in the Regular Navy, who must first be qualified Naval Aviators or Naval Flight Officers with at least five years operational flying experience in naval aircraft, direct commission AEDOs in the Navy Reserve are not required to have any military flight experienceAerospace Maintenance Duty Officer (AMDO)Engineering Duty OfficerForeign area officer (Country or Regional Specialists, Non-Intelligence)Human Resources OfficerInformation Professional (typically, personnel have Computer Science degrees and extensive industry experience)Information Warfare Officer (formerly Cryptology Officer)Cyber Warfare EngineerIntelligence OfficerMerchant Marine OfficerMeteorology/Oceanography Officer (METOC)Public Affairs OfficerStaff Corps Officer

Chaplain Corps OfficerMedical Programs (Medical, Dental, Nurse, Pharmacist and Medical Service Corps)Supply Corps Officer (Logistics, Transportation, Supply Management, Customs, Contracting)JAG Corps OfficerCivil Engineer Corps OfficerLimited Duty Officer (Various specialties)

Warrant Officer (Various specialties)

Some skill areas may not have openings each year. Each year, skill area recruiting quotas are promulgated for recruiters to fill. Upon completion of their training regimen, DCOs serve on nearly every type of ship in the fleet and at shore establishments around the globe. Navy DCOs are forward deployed and are currently serving on the ground in Iraq and Afghanistan. They are an integral part of the Navy's role in the War on Terror.

U.S. Coast Guard Direct Commission Officers [ edit ] The United States Coast Guard uses the DCO program to bring specialized skills and backgrounds into the Coast Guard commissioned officer corps. The DCO course is conducted by the Officer Candidate School, located at the United States Coast Guard Academy in New London, Connecticut. Depending on program and background, the course is three, four, or five weeks long.

There are seven Direct Commission Officer programs:

AviationNOTE: Individuals in this category are typically rated/designated military aviators who have previously served on active duty as officers in other branches of the U.S. armed forces. They have transferred to and are being recommissioned as officers in the U.S. Coast Guard in order to serve as Coast Guard Aviators.Engineering (Various disciplines)Environmental ManagementIntelligenceLegalPrior-Trained Military OfficerMaritime Academy Graduate From the U.S. Merchant Marine Academy or a State Merchant Marine AcademySome DCO programs may not have openings each year. While DCOs are expected to fill specific specialty areas, they are not specifically precluded from crossing into other operational or support billets in follow-on assignments.

U.S. Public Health Service (Commissioned Corps) Direct Commission Officers [ edit ] The PHSCC Direct Commissioning Program allows university-educated professionals, between ages 19 to 45 (or older, in some cases), the opportunity to be appointed as an officer in the Public Health Service Commissioned Corps. Most PHSCC DCOs hold advanced degrees (DDSs, DMDs, MSs, MDs, DOs, PharmDs and Ph.Ds.) and significant civilian work experience, and the minimum in many programs is a master's degree from a duly accredited program. One of the fields requiring only a baccalaureate degree is engineering. The Direct Commissioning Program serves the expanded needs of the PHS in certain officer skill areas listed below:

PhysicianDentistNursePharmacistDietitianEngineerEnvironmental health officerHealth services officerScientist/researcherTherapist (includes occupational therapy, physical therapy, registered respiratory therapist, speech-language pathology, and audiology)VeterinarianMedical Technologist National Oceanic and Atmospheric Administration (Commissioned Officer Corps) Direct Commission Officers [ edit ] The NOAA Corps Direct Commissioning Program allows university-educated professionals, between ages 19 to 35 (or older, in some cases), the opportunity to be appointed as an officer in the National Oceanic and Atmospheric Administration Commissioned Officer Corps. Many NOAA Corps DCOs hold advanced degrees (MS, MAs and Ph.Ds.) and significant civilian work experience, though the minimum requirement is a baccalaureate degree. The Direct Commissioning Program serves the expanded needs of the NOAA Corps in certain officer skill areas listed below:

EngineeringMathematicsAny science related to NOAA's missionExternal links [ edit ] U.S. Armyhttp://www.goarmy.com/careers-and-jobs/become-an-officer/how-to-become-an-officer-in-the-army/direct-commission.htmlU.S. Navyhttp://www.navy-reserve.org/Default.aspx?tabid=264 [permanent dead link ] U.S. Coast Guardhttp://www.gocoastguard.com/find-your-fit/officer-opportunities/programs/direct-commission-programsU.S. Public Health Servicehttps://web.archive.org/web/20090506174822/http://www.usphs.gov/

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Archived Version

Sat, 29 Feb 2020 11:49

12 References

Article

The latest threat to global health is the ongoing outbreak of the respiratory disease that was recently given the name Coronavirus Disease 2019 (Covid-19). Covid-19 was recognized in December 2019.1 It was rapidly shown to be caused by a novel coronavirus that is structurally related to the virus that causes severe acute respiratory syndrome (SARS). As in two preceding instances of emergence of coronavirus disease in the past 18 years2 '-- SARS (2002 and 2003) and Middle East respiratory syndrome (MERS) (2012 to the present) '-- the Covid-19 outbreak has posed critical challenges for the public health, research, and medical communities.

In their Journal article, Li and colleagues3 provide a detailed clinical and epidemiologic description of the first 425 cases reported in the epicenter of the outbreak: the city of Wuhan in Hubei province, China. Although this information is critical in informing the appropriate response to this outbreak, as the authors point out, the study faces the limitation associated with reporting in real time the evolution of an emerging pathogen in its earliest stages. Nonetheless, a degree of clarity is emerging from this report. The median age of the patients was 59 years, with higher morbidity and mortality among the elderly and among those with coexisting conditions (similar to the situation with influenza); 56% of the patients were male. Of note, there were no cases in children younger than 15 years of age. Either children are less likely to become infected, which would have important epidemiologic implications, or their symptoms were so mild that their infection escaped detection, which has implications for the size of the denominator of total community infections.

On the basis of a case definition requiring a diagnosis of pneumonia, the currently reported case fatality rate is approximately 2%.4 In another article in the Journal, Guan et al.5 report mortality of 1.4% among 1099 patients with laboratory-confirmed Covid-19; these patients had a wide spectrum of disease severity. If one assumes that the number of asymptomatic or minimally symptomatic cases is several times as high as the number of reported cases, the case fatality rate may be considerably less than 1%. This suggests that the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza (which has a case fatality rate of approximately 0.1%) or a pandemic influenza (similar to those in 1957 and 1968) rather than a disease similar to SARS or MERS, which have had case fatality rates of 9 to 10% and 36%, respectively.2

The efficiency of transmission for any respiratory virus has important implications for containment and mitigation strategies. The current study indicates an estimated basic reproduction number (R0) of 2.2, which means that, on average, each infected person spreads the infection to an additional two persons. As the authors note, until this number falls below 1.0, it is likely that the outbreak will continue to spread. Recent reports of high titers of virus in the oropharynx early in the course of disease arouse concern about increased infectivity during the period of minimal symptoms.6,7

China, the United States, and several other countries have instituted temporary restrictions on travel with an eye toward slowing the spread of this new disease within China and throughout the rest of the world. The United States has seen a dramatic reduction in the number of travelers from China, especially from Hubei province. At least on a temporary basis, such restrictions may have helped slow the spread of the virus: whereas 78,191 laboratory-confirmed cases had been identified in China as of February 26, 2020, a total of 2918 cases had been confirmed in 37 other countries or territories.4 As of February 26, 2020, there had been 14 cases detected in the United States involving travel to China or close contacts with travelers, 3 cases among U.S. citizens repatriated from China, and 42 cases among U.S. passengers repatriated from a cruise ship where the infection had spread.8 However, given the efficiency of transmission as indicated in the current report, we should be prepared for Covid-19 to gain a foothold throughout the world, including in the United States. Community spread in the United States could require a shift from containment to mitigation strategies such as social distancing in order to reduce transmission. Such strategies could include isolating ill persons (including voluntary isolation at home), school closures, and telecommuting where possible.9

A robust research effort is currently under way to develop a vaccine against Covid-19.10 We anticipate that the first candidates will enter phase 1 trials by early spring. Therapy currently consists of supportive care while a variety of investigational approaches are being explored.11 Among these are the antiviral medication lopinavir''ritonavir, interferon-1Ž², the RNA polymerase inhibitor remdesivir, chloroquine, and a variety of traditional Chinese medicine products.11 Once available, intravenous hyperimmune globulin from recovered persons and monoclonal antibodies may be attractive candidates to study in early intervention. Critical to moving the field forward, even in the context of an outbreak, is ensuring that investigational products are evaluated in scientifically and ethically sound studies.12

Every outbreak provides an opportunity to gain important information, some of which is associated with a limited window of opportunity. For example, Li et al. report a mean interval of 9.1 to 12.5 days between the onset of illness and hospitalization. This finding of a delay in the progression to serious disease may be telling us something important about the pathogenesis of this new virus and may provide a unique window of opportunity for intervention. Achieving a better understanding of the pathogenesis of this disease will be invaluable in navigating our responses in this uncharted arena. Furthermore, genomic studies could delineate host factors that predispose persons to acquisition of infection and disease progression.

The Covid-19 outbreak is a stark reminder of the ongoing challenge of emerging and reemerging infectious pathogens and the need for constant surveillance, prompt diagnosis, and robust research to understand the basic biology of new organisms and our susceptibilities to them, as well as to develop effective countermeasures.

Funding and Disclosures

Disclosure forms provided by the authors are available with the full text of this editorial at NEJM.org.

This editorial was published on February 28, 2020, at NEJM.org.

Author Affiliations

From the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (A.S.F., H.C.L.); and the Centers for Disease Control and Prevention, Atlanta (R.R.R.).

Supplementary Material

References (12)

1. Pneumonia of unknown cause '-- China: disease outbreak news. Geneva: World Health Organization, January 5, 2020 (https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/).

2. de Wit E , van Doremalen N , Falzarano D , Munster VJ . SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol 2016 ;14: 523 - 534 .

3. Li Q , Guan X , Wu P , et al. Early transmission dynamics in Wuhan, China, of novel coronavirus''infected pneumonia. N Engl J Med. DOI: 10.1056/NEJMoa2001316.

4. Coronavirus disease 2019 (COVID-19): situation report '-- 36. Geneva: World Health Organization, February 25, 2020 (https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200225-sitrep-36-covid-19.pdf?sfvrsn=2791b4e0_2).

5. Guan W , Ni Z , Hu Y , et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. DOI: 10.1056/NEJMoa2002032.

6. Holshue ML , DeBolt C , Lindquist S , et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. DOI: 10.1056/NEJMoa2001191.

7. Zou L , Ruan F , Huang M , et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med. DOI: 10.1056/NEJMc2001737.

8. Coronavirus disease 2019 (COVID-19) in the U.S. Atlanta: Centers for Disease Control and Prevention, February 26, 2020 (https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html).

9. Fong MW , Gao H , Wong JY , et al. Nonpharmaceutical measures for pandemic influenza in nonhealthcare settings '-- social distancing measures. Emerging Infect Dis 2020 ;26(5) (Epub ahead of print).

10. DRAFT landscape of COVID-19 candidate vaccines '-- 18 February 2020. Geneva: World Health Organization (https://www.who.int/blueprint/priority-diseases/key-action/list-of-candidate-vaccines-developed-against-ncov.pdf).

11. WHO R&D blueprint: informal consultation on prioritization of candidate therapeutic agents for use in novel coronavirus 2019 infection. Geneva: World Health Organization, January 24, 2020 (https://apps.who.int/iris/bitstream/handle/10665/330680/WHO-HEO-RDBlueprint%28nCoV%29-2020.1-eng.pdf).

12. Lane HC , Marston HD , Fauci AS . Conducting clinical trials in outbreak settings: points to consider. Clin Trials 2016 ;13: 92 - 95 .

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Archived Version

Sat, 29 Feb 2020 11:40

An editorial published Friday in the New England Journal of Medicine speculated that the coronavirus currently causing panic in world markets could turn out no worse than ''a severe seasonal influenza'' in terms of mortality.

Citing an analysis of the available data from the outbreak in China, the authors note that there have been zero cases among children younger than 15; and that the fatality rate is 2% at most, and could be ''considerably less than 1%.''

Those who have died have been elderly or were already suffering from another illness '-- as with ordinary flu. The underlying data suggest that the symptoms varies, and fewer than one in six of the cases reported were ''severe.''

The authors note that coronavirus looks to be much less severe than other recent outbreaks of respiratory illnesses:

[T]he overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza (which has a case fatality rate of approximately 0.1%) or a pandemic influenza (similar to those in 1957 and 1968) rather than a disease similar to SARS or MERS, which have had case fatality rates of 9 to 10% and 36%, respectively.

The vast majority of patients recover, and among those who are hospitalized, the median stay thus far is 12 days.

Coronavirus, they note, does spread easily, and the average infected person has infected two other people. That means the U.S. should expect the illness to gain a ''foothold.'' But they note travel restrictions on China (imposed by President Donald Trump over the objections of some critics) ''may have helped slow the spread of the virus.''

Joel B. Pollak is Senior Editor-at-Large at Breitbart News and the host of Breitbart News Sunday on Sirius XM Patriot on Sunday evenings from 7 p.m. to 10 p.m. ET (4 p.m. to 7 p.m. PT). He earned an A.B. in Social Studies and Environmental Science and Public Policy from Harvard College, and a J.D. from Harvard Law School. He is a winner of the 2018 Robert Novak Journalism Alumni Fellowship. He is also the co-author of How Trump Won: The Inside Story of a Revolution, which is available from Regnery. Follow him on Twitter at @joelpollak.

Hey Adam,

I just wanted to pass along a few things Behin told me

about Iran.

Regarding the very low voter turnout for the recent

parliament elections, she says that on social media people were urging people

to sit the election out and not vote, and apparently it worked. The people see

parliament as kind of useless, and that it’s not uncommon for members of

parliament to show up and sleep on the job.

Regarding the kung flu, she says that people are very

worried, and that some people are even demanding that those who died with the

virus not be be buried in cemeteries near their home. Parliament has now been

shut down until further notice. A lot of people are avoiding social functions.

I tell her not to worry, but unfortunately her and her

family are. Anyways, take care and thank you for your courage!

Hans

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Archived Version

Fri, 28 Feb 2020 11:24

The Trump administration's request for $2.5 billion to mitigate the coronavirus pandemic is likely to become an unstoppable legislative vehicle '-- as must-pass legislation that congressional leaders of both parties could use to ram through a reauthorization of the FBI's call detail records program. Such a move would sidestep the House's reform effort and instead push through a clean reauthorization of the program.

The Senate, said a Democrat on the House Judiciary Committee, is ''threatening to put that clean reauthorization into something like coronavirus funding which would make it impossible to defeat if we don't come up with a bill here. Pelosi and Schiff will never allow it to expire.''

''I would say it is still chatter at this point. But it is also chatter that could become their Plan A,'' a Senate Republican aide, who requested anonymity because they are not authorized to speak on the matter, told The Intercept.

Josh Withrow, senior policy analyst at the GOP-leaning libertarian organization Freedom Works, said that he has heard from a number of his sources on Capitol Hill on both sides of the aisle that the coronavirus vehicle is a looming threat. ''It's a real fear,'' he said. ''It obviously seems to have some legs, but I think they'd run into a little bit of a problem with that, because they already have a lot of conservatives questioning the dollar amount and saying, just pass a clean coronavirus.''

The program in question is the ''call detail records'' program, which sets out how the FBI or NSA can obtain phone records stored by telecom providers. Prior to that, the NSA collected phone records in bulk, relying on a secret interpretation of the Patriot Act that a federal appeals court disputed in 2015.

But due to widespread compliance issues and limited intelligence value, the NSA voluntarily shut down the call details records program in 2019, leading many in Congress to question why the Trump administration was seeking to extend the legal basis for a now-defunct program. Civil liberties groups now see the reauthorization fight as a bellwether for whether Congress can bring itself to roll back surveillance authorities even in cases where the intelligence community determines they have limited intelligence value.

On Wednesday, the House Judiciary Committee had been scheduled to meet to vote on the product of closed-door negotiations between Judiciary Committee Chair Jerry Nadler, his counterpart on the intelligence committee Rep. Adam Schiff, Republicans, and the intelligence community.

Rep. Zoe Lofgren, a California Democrat who has been a lead civil liberties reformer on the committee, had said that she would introduce five amendments to the bill. Given that there is bipartisan skepticism of surveillance authority '-- Republicans have become increasingly opposed to it in the wake of the inspector general report into Foreign Intelligence Surveillance Court abuses surrounding the Carter Page case '-- the amendments had a reasonable chance of success, opening the possibility that leadership would push forward with an Intelligence version of the bill and ditch the Judiciary legislation.

With Lofgren's unexpected amendments surfacing, the hearing was canceled at the last minute. If the negotiations looked deadlocked, committee members worried, it upped the chance that the Senate, with the backing of House leaders, would attach the reauthorization to the must-pass coronavirus bill.

''We are trying to work out something and ensure also that the Senate does not push a clean reauthorization. So we needed more time,'' said the Judiciary Committee member, citing the looming coronavirus vehicle.

The negotiations over surveillance reform are also complicated by the fact that congressional House leadership can decide which version of a bill receives a vote on the floor. In January 2018, while members of Congress were considering whether to reauthorize a different NSA surveillance, House leadership advanced a hastily written bill passed by the House Intelligence Committee under Rep. Adam Schiff, which was much more favorable to the intelligence community, over a counterpart authored by the Judiciary Committee.

On surveillance issues, House Speaker Nancy Pelosi and Schiff are much more closely aligned than her and Nadler. Schiff is increasingly being viewed in the House as a potential successor to Pelosi as House Speaker. Pelosi herself was the former top Democrat on the Intelligence Committee.

House skeptics of mass surveillance have good reason to fear that funding to combat the impact of coronavirus may be used to pass this legislation. The last time critics of government overreach attempted to reform the USA Freedom Act '-- which modified the Patriot Act '-- they were denied a standalone vote, when it was instead attached to a must-pass government spending bill. The promise from leadership at the time was that the extension would be short-term, and skeptics would have an opportunity the next time around for reforms. That's now in doubt.

''We have to have a separate vote on something as important as this FISA reauthorization,'' said Rep. Pramila Jayapal, D-Wash., a member of the Judiciary Committee.

One major question mark hanging over the process this time is what type of changes Trump loyalists '-- who were highly critical of the FBI's handling of investigations into Trump associates '-- may demand. Rep. Jim Jordan and Sen. Rand Paul have both signaled a desire for some type of reform, with Paul tweeting that he ''spoke with Trump,'' and that the FISA Court '-- the secret court which approves certain types of surveillance requests from the intelligence community '-- should be ''forbidden from ever spying on or investigating Americans.''

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Archived Version

Source: Reuters: World News

Sun, 01 Mar 2020 06:21

LONDON (Reuters) - Britain is planning for the global coronavirus epidemic to get worse, health minister Matt Hancock said on Sunday, describing the outbreak as a ''very, very significant challenge''.

Prime Minister Boris Johnson will chair a meeting of the government's emergency response committee on Monday, signaling a stepping up of Britain's preparation for the epidemic which began in China, where authorities estimate it has killed almost 3,000 people worldwide.

''We've got a clear strategy for dealing with coronavirus - a very, very significant challenge,'' Hancock told Sky News. ''We're also planning in case this gets worse, much worse.''

If the virus becomes more widespread, the government will look at registering retired health workers to work again, and whether encouraging people to work at home could delay its peak until summer when it can be more easily dealt with.

Britain currently has 23 confirmed coronavirus cases, and Hancock said on Sunday it was still in a containment phase. The issue will become a standing item for all cabinet meetings and there will be more media briefings from health officials.

Johnson wrote in the Sun newspaper that it was right to be concerned about the possible spread of the virus, but said a visit to a British hospital had left him ''100 per cent confident in the medical resilience''

The government is launching a new public information campaign this week, encouraging people to wash their hands for at least 20 seconds, and to do so more often than normal.

Reporting by William James; Editing by Mark Potter

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Archived Version

Sun, 01 Mar 2020 06:02

News

By Jon Levine

February 29, 2020 | 9:15am

Pope Francis Mondadori Portfolio via Getty Im

Pope Francis has canceled a third day of scheduled events to recuperate from an undisclosed illness.

The 83-year-old pontiff will skip two official audiences at the Apostolic Palace. One would have been with a team of bioethicists and another with the Catholic ''Legion of Christ.''

Francis is working from the Vatican's Santa Marta hotel during his recovery, papal officials said, who noted he continues to attend Mass each morning.

The Vatican has not provided any details about his illness, calling it only a ''slight indisposition.''

The pope has not been seen in public since he was caught on camera coughing and blowing his nose during an Ash Wednesday Mass.

His absence '-- the longest sick leave of his papacy '-- comes as coronavirus sweeps Italy. The country has reported 888 cases and at least 21 deaths, according to the latest numbers; Italy is now the most infected nation after China.

Officials at the Centers for Disease Control and Prevention have warned Americans to brace for the disease spreading in the United States and possibly becoming a pandemic.

With Post Wires

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Fri, 28 Feb 2020 10:04

China's central bank says it plans to destroy most of the banknotes collected by hospitals, markets, and buses in some regions hard hit by the new coronavirus. Fan Yifei, deputy governor of the Chinese central bank, said they plan to out pump 600 billion yuan ($85.6 billion) of freshly printed paper currency to replace the bills taken out of circulation. In other areas of the country, the government has ordered banks to remove incoming paper currency from circulation and replace it with the new cash. They have been directed to keep the cash under quarantine for 14 days and disinfect it at high temperatures and with ultraviolet light before returning it to the public.

Read it at South China Morning Post

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Sun, 01 Mar 2020 00:09

This morning, Bloomberg reported that President Donald Trump had filed a revised National Security Presidential Memorandum (NSPM-4) reorganizing the National Security Council. The memo itself is available here and revises the administration's previous memorandum, which was released shortly after Trump took office. News coverage has focused on the memo's removal of the President's Chief Strategist, Steve Bannon, as an invitee of NSC meetings and as a regular attendee of the Principals Committee.

Below is a summary of the relevant provisions of NSPM-4.

Status of the Homeland Security Advisor

Whereas NSPM-2 had given both the National Security Advisor and the Homeland Security Advisor responsibility for ''determining the agenda'' of the National Security Council or Homeland Security Council, NSPM-4 provides this authority to the National Security Advisor alone. The memo allows that the Homeland Security Advisor may determine the agenda for meetings at the ''sole discretion'' of the National Security Advisor.

Likewise, the new structure of the Principals Committee makes clear that the Homeland Security Advisor may only convene and chair the PC at the ''sole discretion'' of the National Security Advisor.

As such, NPSM-4 appears to make the Homeland Security Advisor (a position currently held by Thomas Bossert) subordinate to National Security Advisor Lt. Gen. H.R. McMaster. This seems to return to the NSC structure used in the Obama administration, under which Lisa Monaco served as President Obama's Homeland Security Advisor but was technically under the direction of Susan Rice as National Security Advisor.

Attendees and Invitees to NSC and Principals Committee Meetings

NSPM-4 alters the list of regular attendees and invitees to National Security Council meetings. Previously, the regular attendees consisted of the President, the Vice President, the Secretary of State, the Secretary of the Treasury, the Secretary of Defense, the Attorney General, the Secretary of Energy, the Secretary of Homeland Security, the National Security Advisor and Homeland Security Advisor, and the Representative to the United Nations; the memo also provided that the Director of National Intelligence and the Chairman of the Joint Chiefs of Staff ''shall'' attend NSC meetings. Under NSPM-4, the DNI and JSC Chair are formally included as regular attendees to NSC meetings along with the previous attendees listed. NSPM-4 includes the CIA Director as a regular attendee as well, which NSPM-2 notably failed to do.

NSPM-4 removes the Chief Strategist from the list of invitees to NSC meetings, which now includes only the Chief of Staff, White House Counsel, Deputy Counsel to the President for National Security Affairs, and the Director of the Office of Management and Budget.

The memo makes changes to the Principals Committee by removing the Chief Strategist as a regular attendee and elevating the Chairman of the Joint Chiefs of Staff and the Director of National Intelligence to regular attendee status. Under NSPM-2, the JSC Chairman and the DNI had only been formally pushed to attend ''where issues pertaining to their responsibilities and expertise are to be discussed.'' NSPM-4 restores the Chairman of the JSC and the DNI to their specified attendance under the Obama administration.

Deputies Committee and Policy Coordinating Committees

NSPM-4 provides much the same structure for the Deputies Committee and Policy Coordinating Committees as under the previous NSPM, with virtually no changes.

Bannon's Status

Trump has left some room for flexibility to include Bannon with language which was present in NSPM-2, by saying that an ''[i]nvitation to participate in specific Council meetings shall be extended to those heads of executive departments and agencies, and other senior officials, who are needed to address the issue or issues under consideration.'' So Bannon's change in status is really one of enumeration: the ''Assistant to the President and Chief Strategist'' is no longer listed in as an ''invitee'' explicitly in the text. Bannon's removal from the PC, coupled with the removal of his enumerated invitation to attend NSC meetings in Section A, formally terminates Bannon's role in the decision-making process of the NSC, as both participant and observer.

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Sun, 01 Mar 2020 00:03

Today, President Donald J. Trump announced the formation of the President's Coronavirus Task Force. Members of the Task Force have been meeting on a daily basis since Monday. At today's meeting, which the President chaired, he charged the Task Force with leading the United States Government response to the novel 2019 coronavirus and with keeping him apprised of developments.

The Task Force is led by Secretary of Health and Human Services Alex Azar, and is coordinated through the National Security Council. It is composed of subject matter experts from the White House and several United States Government agencies, and it includes some of the Nation's foremost experts on infectious diseases.

The Task Force will lead the Administration's efforts to monitor, contain, and mitigate the spread of the virus, while ensuring that the American people have the most accurate and up-to-date health and travel information.

The President's top priority is the health and welfare of the American people. That is why, in 2018, President Trump signed the National Biodefense Strategy, which improves speed of action in situations such as this. The Administration, led by the President's Task Force, will continue to work to prevent the spread of the new coronavirus.

The risk of infection for Americans remains low, and all agencies are working aggressively to monitor this continuously evolving situation and to keep the public informed. For more information, please visit CDC.gov.

Members of the President's Coronavirus Task Force:

Secretary Alex Azar, Department of Health and Human Services

Robert O'Brien, Assistant to the President for National Security Affairs

Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health

Deputy Secretary Stephen Biegun, Department of State

Ken Cuccinelli, Acting Deputy Secretary, Department of Homeland Security

Joel Szabat, Acting Under Secretary for Policy, Department of Transportation

Matthew Pottinger, Assistant to the President and Deputy National Security Advisor

Rob Blair, Assistant to the President and Senior Advisor to the Chief of Staff

Joseph Grogan, Assistant to the President and Director of the Domestic Policy Council

Christopher Liddell, Assistant to the President and Deputy Chief of Staff for Policy Coordination

Derek Kan, Executive Associate Director, Office of Management and Budget

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Sun, 01 Mar 2020 00:02

Several of the nation's top health officials are among those sitting on an advisory panel formed by President Trump.

Administration health officials gave the House Energy and Commerce committee an update on preparedness for the potential spread of the coronavirus in the U.S. Credit... T.J. Kirkpatrick for The New York Times President Trump formed a coronavirus task force in late January, and members have been meeting regularly. But as the virus began to spread around the globe and infections were confirmed in the United States, Mr. Trump named Vice President Mike Pence as his point person at the end of February, and more administration officials were added to the panel. Among them are internationally known AIDS experts; a former drug executive; infectious disease doctors; and the former attorney general of Virginia.

DR. DEBORAH L. BIRXThe new coronavirus response coordinator for the White House, Dr. Deborah L. Birx, also holds the rank of ambassador as the State Department's global AIDS director.

An experienced scientist and physician, Dr. Birx will report to Vice President Pence, though White House officials did not specify how her duties will differ from those of Mr. Pence or Alex M. Azar II, the secretary of health and human services who is the chairman of the nation's coronavirus task force.

Nominated by President Obama in 2014 to the State post, Dr. Birx has spent more than three decades working on HIV/AIDS immunology, vaccine research and global health. For the past six years, Dr. Birx, a former Army colonel, has been in charge of the President's Emergency Plan for AIDS Relief and America's participation in the Global Fund to Fight AIDS, Tuberculosis and Malaria. From 2005 to 2014, she also was director of the division for Global HIV/AIDS at the Centers for Disease Control and Prevention.

A biography distributed by the White House said she had ''developed and patented vaccines, including leading one of the most influential HIV vaccine trials in history.''

During her confirmation hearing in 2014, Dr. Birx spoke with admiration of the government's ability to come together to confront a deadly disease that threatened the health and welfare of people around the globe.

''The history of the end of the 20th century will be forever recorded with the emergence of a new and deadly viral plague that challenged us scientifically, socially and politically,'' she told members of the Senate Foreign Relations Committee. ''Fortunately, that history will also record that '-- eventually '-- we faced our own fears of the disease and embraced those infected and affected with the open arms of compassion, creative research and determined solutions.''

Dr. Birx majored in chemistry at Houghton College and received her medical degree from Penn State University's Hershey School of Medicine.

'-- Michael Shear

Alex M. Azar II became secretary of health and human services in January 2018, arriving with a background in government and industry and presenting himself as a problem-solving pragmatist.

Updated Feb. 26, 2020

What is a coronavirus? It is a novel virus named for the crownlike spikes that protrude from its surface. The coronavirus can infect both animals and people and can cause a range of respiratory illnesses from the common cold to more dangerous conditions like Severe Acute Respiratory Syndrome, or SARS. How worried should I be? New outbreaks in Asia, Europe and the Middle East are renewing fears of a global pandemic. The Centers for Disease Control and Prevention warned this week that Americans should brace for the likelihood that the virus will spread to the United States. How do I keep myself and others safe? Washing your hands frequently is the most important thing you can do, along with staying at home when you're sick. What if I'm traveling? The C.D.C. has warned older and at-risk travelers to avoid Japan, Italy and Iran. The agency also has advised against all nonessential travel to South Korea and China. How can I prepare for a possible outbreak? Keep a 30-day supply of essential medicines. Get a flu shot. Have essential household items on hand. Have a support system in place for elderly family members. Where has the virus spread? The virus, which originated in Wuhan, China, has sickened more than 80,000 people in at least 33 countries, including Italy, Iran and South Korea. How contagious is the virus? According to preliminary research, it seems moderately infectious, similar to SARS, and is probably transmitted through sneezes, coughs and contaminated surfaces. Scientists have estimated that each infected person could spread it to somewhere between 1.5 and 3.5 people without effective containment measures. Who is working to contain the virus? World Health Organization officials have been working with officials in China, where growth has slowed. But this week, as confirmed cases spiked on two continents, experts warned that the world was not ready for a major outbreak. He replaced Mr. Trump's initial pick for the job, Tom Price, who had resigned in September 2017 in the face of multiple federal inquiries into his use of private and government planes for travel.

Mr. Azar, a former top executive at Eli Lilly, has navigated a series of high-profile issues since taking the job, from attempting to scale back the Affordable Care Act to overseeing the shelters that have housed the thousands of unaccompanied minors separated from their parents during border crossings or who entered the United States alone. He has also sought to address rising drug prices and public health initiatives such as improving the care of people with chronic kidney disease, although many of those policies have not come to fruition.

And he has clashed with top health officials, including with Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, in a power struggle that required the intervention of the White House.

From 2012 to early 2017, Mr. Azar was president of Lilly USA, a unit of Eli Lilly and Company, a major producer of insulin. That history as a drug company executive came under criticism during his Senate confirmation, when Democrats questioned whether he would take the industry's side on the issue of rising drug prices. Republicans cited that experience as an asset, arguing that it would help him better understand the problems.

Mr. Azar, 52, was a law clerk for Supreme Court Justice Antonin Scalia. He joined the administration of President George W. Bush as general counsel of H.H.S. in 2001 and became deputy secretary four years later. While there, he helped carry out a 2003 law that added a prescription drug benefit to Medicare, one of the most significant changes in the history of the program.

Mr. Azar graduated from Yale Law School and grew up in Maryland, where his father was an ophthalmologist and his mother a registered nurse.

'-- Katie Thomas

DR. ROBERT R. REDFIELDA longtime AIDS researcher, Dr. Robert R. Redfield has served since March 2018 as the director of the Centers for Disease Control and Prevention and administrator of the Agency for Toxic Substances and Disease Registry.

As such, he is the nation's chief public health officer, overseeing government response to crises like the opioid epidemic or Ebola, and has had primary responsibility for supervising the federal response to the coronavirus cases in the United States, reporting to Mr. Azar.

Dr. Redfield has already been the target of criticism for some of the C.D.C.'s decisions '-- including testing protocols that may have missed infections, flawed testing kits for the virus and the repatriation of infected patients from the Diamond Princess cruise ship '-- although it is not clear whether his was the final word on these and related actions.

Before taking his post, Dr. Redfield was a professor at the University of Maryland School of Medicine, where he co-founded the Institute of Human Virology, and served as chief of infectious diseases. The institute provided treatment for H.I.V., the human immunodeficiency virus, to more than 6,000 patients in the Baltimore-Washington area and more than 1 million people in Africa and the Caribbean. Earlier in his research career, Dr. Redfield advocated broad testing for H.I.V. and the screening of military personnel for the virus '-- and faced renewed criticism for those views when he was nominated to the C.D.C. post.

A native of Chicago, Dr. Redfield grew up in Bethesda, Md., where both of his parents worked at the National Institutes of Health. He graduated from Georgetown University and its School of Medicine, and did his residency at Walter Reed Army Medical Center, then continued as a researcher there, focusing on AIDS. He launched the virology institute with Dr. Robert C. Gallo, who developed the blood test for H.I.V. in 1996.

'-- Sheila Kaplan

As head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health since 1984, Dr. Anthony S. Fauci has played a central role in research of disease outbreaks, and the search for cures, since the emergence of HIV/AIDs '-- as he is doing now with the coronavirus.

He testifies regularly to Congress about the threat of emerging diseases and has been one of the most prominent leaders of the government's front line on public health.

Behind the scenes, though, is where Dr. Fauci is considered most influential: He helps shape the decisions about where research should be directed in search of a response or cure. Overall, Dr. Fauci oversees an agency with a budget of $5.9 billion for 2020.

Dr. Fauci grew up in Brooklyn. His father was a pharmacist. attended Holy Cross College and was graduated from Cornell University Medical College in 1966. His life shifted significantly in 1981, when he was working at the N.I.H. and gay men began showing up with devastated immune systems.

Dr. Fauci, while certainly not known in popular culture circles, carries a kind of celebrity status among scientists. That might stem in part from the amount of research money he controls but also because of his ease with communicating deep science both with nuance and accessibility, making him a translator of sorts during times of crisis.

Kenneth T. Cuccinelli II, one of the top immigration officials in the United States, has brought his firebrand approach to Mr. Trump's coronavirus task force.

He leads the United States Citizenship and Immigration Services, the agency overseeing legal immigration, while simultaneously working as acting deputy secretary of the Department of Homeland Security. In nine months, the former attorney general of Virginia has gone from defending Mr. Trump's aggressive immigration policies on Fox News to representing the Homeland Security Department on virus response.

Mr. Cuccinelli coordinates the screening of travelers at airports, and land and maritime ports, and has overseen the monitoring of people who have recently traveled to China or shown signs of illness.

In his short time with the Homeland Security department, Mr. Cuccinelli has irked other agency leaders with his aggressive communication to the public '-- including when he said the sonnet on the Statue of Liberty poem referred to ''people coming from Europe.''

Mr. Cuccinelli was similarly criticized on Monday afternoon when he complained on Twitter that he could not gain access to a Johns Hopkins University map of the spreading coronavirus outbreak.

''I'm sure it's jarring to the public to see a very high ranking federal official sending out an S.O.S. on Twitter,'' said January Contreras, who was a senior adviser to Janet Napolitano, his predecessor at the homeland security agency.

After Senator Chuck Schumer, the Democratic leader from New York, said Mr. Cuccinelli's appointment to the task force showed how ''hollowed out'' federal agencies are, Mr. Cuccinelli pointed the finger at Mr. Schumer for not attending a briefing on the virus.

In an interview with The New York Times earlier this month, Mr. Cuccinelli said he spent much of his time since being appointed to the task force calling hundreds of local politicians to coordinate their responses to the virus.

Born in Edison, N.J., Mr. Cuccinelli was raised in Virginia. He graduated from the University of Virginia with an engineering degree and from George Mason University with a law degree.

'-- Zolan Kanno-Youngs

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Fri, 28 Feb 2020 13:11

A woman walks into a pharmacy to purchase N95 face masks in advance of the potential coronavirus outbreak in the Manhattan borough of New York City, New York, U.S., February 27, 2020. REUTERS/Carlo Allegri

WASHINGTON (Reuters) - The U.S. House of Representatives could vote on an emergency bill aimed at providing funding for the country's coronavirus response as soon as next week, a congressional source said on Friday.

Negotiators were looking at approving between $6 to $8 billion in funding for the response, the source said, significantly higher than the $2.5 billion the White House had requested.

Reporting by Richard Cowan; Writing by Makini Brice; Editing by Lisa Lambert

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Sun, 01 Mar 2020 07:51

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Sun, 01 Mar 2020 07:25

Israel By Dror Halavy

Thursday, February 27, 2020 at 5:04 am | ב' א×'ר ת×(C)"פ

YERUSHALAYIM - Thursday, February 27, 2020 at 5:04 am | ב' א×'ר ת×(C)"פ

A Magen David Adom worker wears protective clothing as a preventive measure against the coronavirus, outside the special emergency call center in Kiryat Ono, on Thursday. (Flash90)A group of researchers in northern Israel said Thursday they had achieved a ''scientific breakthrough'' in treating coronavirus. At a press conference, researchers of the Migal Galilee Research Institute said that the breakthrough had come while they were doing research on coronavirus in birds. A treatment had been discovered which cured the birds infected with coronavirus, and clinical trials at Israel's Volcani Agricultural Research Institute had confirmed the treatment's viability.

The basic coronavirus in birds is very similar in patterns of infection and effect of the virus in humans, and the genetic structure of the virus in both humans and birds is very similar, the researchers said. As a result, the treatment developed for birds could be applicable to humans '' and they believed that an effective treatment could be developed for humans within three months, they said.

David Zigdon, Chief Operating Officer of the Institute, said that ''there is a great need for an immediate solution to human infection of coronavirus, and we have been working to do that nonstop. The solution we are developing against COVID-19 virus has proven effective, and we believe a version for human treatment can be ready within eight to 10 weeks. That would be followed by a 90-day test period to ensure safety. The treatment we developed for birds is given orally, and the treatment we are developing for humans will also be given orally.''

Director of the Institute Professor Dan Levanon said the speed with which the treatment could be used would depend on regulatory approval. ''Under the current conditions in which the disease is causing terrible losses, I believe that state regulators would be very lenient in the various stages that the treatment must pass before it is approved, of course ensuring that it will do no harm via side effects and the like. Under normal conditions, approval of a treatment like this would likely take several years,'' he said.

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Sun, 01 Mar 2020 07:03

Minister Ruth Aceng and other officials from WHO and ministry of health during a presser on Friday (PHOTO/Courtesy).KAMPALA '' The Minister of Health Dr Jane Ruth Aceng revealed that 695 travellers including Ugandans, Chinese and other nationals have been isolated to contain Coronavirus (COVID 19 disease).

''Uganda has no confirmed case of COVID 19 as of 28th February 2020. However, to date, 695 travellers (Chinese, Ugandans and other nationals) travelling back home have been isolated for purposes of follow-up. Of these, 488 are Chinese nationals, 64 are nationals from various countries and 143 are Ugandan citizens travelling from various countries,'' Aceng told reporters on Friday morning.

So far, she said, 280 individuals have completed the 14 days of self-isolation.

To prevent the importation of the virus, the Ministry of Health has enhanced surveillance measures for all travellers from all 47 countries battling COVID 19.

''This means travellers from all the 47 affected countries will be screened and will be isolated.''

The COVID 19 was first declared by China on 31st December 2020 and has now spread to all continents on Earth and over 47 countries are affected.

In Africa, Nigeria, Algeria and Egypt have already reported cases.

The Minister noted that so far samples from 10 persons in Uganda who presented signs and symptoms similar to that of COVID 19 have been tested and all samples tested negative.

She added that screenings at Entebbe International Airport and other entry points such as Busia, Malaba, Elegu and Cyanika have been strengthened with deployment of addition health workers, treatment and infection prevention materials.

''All persons crossing from these points of entry have been screened.''

Aceng says isolation facilities at all regional referral hospitals are being prepared to receive any persons that may present signs and symptoms. The Ministry of Health she said is considering another isolation facility.

''11 ambulances are on standby to transport suspected cases to appropriate level of care.''

In the meantime, the Ministry has developed Dos and Don'ts for the public, that must be followed to avert the virus.

DOs

Wash your hands frequently with soap and water or use an alcohol based hand rub. This will remove the virus if it is in your hands.

Cover your mouth and nose with tissue or a handkerchief when coughing and sneezing.

The handkerchief must be washed by yourself daily and ironed with a hot iron.

Throw away the used tissue immediately into a dustbin or burn it.

Maintain reasonable distance between yourself and someone who is coughing and sneezing. At least one metre apart.

Avoid touching your eyes, nose and mouth at all times.

If you have fever, cough and difficulty in breathing, seek medical care immediately.

People with flu like signs should use the face masks to cover the nose and mouth and stay home in a well ventilated room.

If you are looking after people with signs and symptoms, you are required to use a face mask to cover your nose and mouth.

DON'Ts

Avoid handshake and hugging at all times.

Avoid close contact with people who are visibly sick with flu like symptoms, fever, cough and sneeze.

When sick with flu like symptoms, avoid going to public places, Offices and public gatherings. Remain home in isolation to avoid infecting others.

Don't take self-medication like antibiotics.

Do not spit in public.

Delay travel to countries that are currently with cases of Coronavirus disease.

If you have flu like symptoms, avoid travel.

Although Uganda has no case of COVID 19, Aceng called on people to remain alert and diligently exercise preventive measures to avoid contracting the disease.

Comments

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Fri, 28 Feb 2020 00:00

Studsker''¤¸ðŸ‡ºðŸ‡¸ @ suestud74

3h I don't believe a dang word he says. He could give me names, addresses, phone numbers, their grades from preschool-college and their pastors name...I will never trust that dictator or any word out of his mouth.

View conversation · Fefe Nero @ FiddlerNero

3h With the lack of sanitary conditions in San Francisco and in parts of L.A. there is no wonder this could take hold there... People living on the streets with no hygienic conditions. no rest rooms, no plumbing, no shelter from others who may be contagious, get local politicians.

View conversation ·

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Sat, 29 Feb 2020 00:37

A pet dog has tested positive for the new coronavirus in Hong Kong.

A spokesman for Hong Kong's Agriculture, Fisheries and Conservation Department (AFCD) said in a statement that the dog was tested and that the test showed a ''weak positive'' for the COVID-19 disease, which is a caused by the new virus.

Testing was done after the agency received a referral from the Department of Health about a dog of a patient confirmed to have the new disease. Staff members from the government picked up the dog and collected oral, nasal, and rectal samples.

Protect yourself against fake news. Get real news directly to your phone. Download The Epoch Times app here.

The nasal and oral cavity samples came back with weak positives.

The dog doesn't have any symptoms linked to the new virus, the Hong Kong government said. The dog remains under quarantine at a facility for animals at the Hong Kong Port. No other animals are there at the moment.

''At present, the AFCD does not have evidence that pet animals can be infected with COVID-19 virus or can be a source of infection to people,'' the government said in a statement.

''The Department will conduct close monitoring of the above dog and collect further samples for testing to confirm if the dog has really been infected with the virus or this is a result of environmental contamination of the dog's mouth and nose. Repeated tests will be conducted for the dog and it will only be returned when the test result is negative.''

Dogs wearing masks are seen in a stroller in Shanghai, China on Feb. 19, 2020. (Noel Celis/AFP via Getty Images)

However, a spokesman for the agency said that mammalian pets of patients with confirmed cases of COVID-19 should be quarantined for two weeks.

Pet owners, the government said, should maintain good hygiene, including washing hands after coming into contact with pets.

Coronaviruses mainly circulate among animals but can, in rare cases, jump to humans before spreading from person to person. One virus is called canine respiratory coronavirus. The virus can cause discomfort for up to two weeks, according to the American Veterinary Medical Association. The virus is contracted through contact with contaminated environments, people, or dogs.

The new virus has an unknown origin, although some evidence points to it originating with bats. The virus emerged in China late last year.

Dr. Maria Van Kerkhove, an infectious disease specialist with the World Health Organization (WHO), told reporters in Geneva on Friday that experts with the agency are aware of the report from the Hong Kong government.

WHO is working with scientists in Hong Kong who are testing animals, she said, ''to understand these results and to understand where or if the dog was actually infected or if the dog picked this up from a contaminated surface.''

WHO says on its website that there is ''no evidence'' that so-called companion animals like dogs and cats can become infected or spread the virus that causes COVID-19.

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Sat, 29 Feb 2020 11:07

When Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization (WHO), declared the Wuhan coronavirus a public health emergency of international concern on Thursday, he praised China for taking ''unprecedented'' steps to control the deadly virus. ''I have never seen for myself this kind of mobilization,'' he noted. ''China is actually setting a new standard for outbreak response.''

The epidemic control efforts unfolding today in China'--including placing some 100 million citizens on lockdown, shutting down a national holiday, building enormous quarantine hospitals in days' time, and ramping up 24-hour manufacturing of medical equipment'--are indeed gargantuan. It's impossible to watch them without wondering, ''What would we do? How would my government respond if this virus spread across my country?''

For the United States, the answers are especially worrying because the government has intentionally rendered itself incapable. In 2018, the Trump administration fired the government's entire pandemic response chain of command, including the White House management infrastructure. In numerous phone calls and emails with key agencies across the U.S. government, the only consistent response I encountered was distressed confusion. If the United States still has a clear chain of command for pandemic response, the White House urgently needs to clarify what it is '--not just for the public but for the government itself, which largely finds itself in the dark.

When Ebola broke out in West Africa in 2014, President Barack Obama recognized that responding to the outbreak overseas, while also protecting Americans at home, involved multiple U.S. government departments and agencies, none of which were speaking to one another. Basically, the U.S. pandemic infrastructure was an enormous orchestra full of talented, egotistical players, each jockeying for solos and fame, refusing to rehearse, and demanding higher salaries'--all without a conductor. To bring order and harmony to the chaos, rein in the agency egos, and create a coherent multiagency response overseas and on the homefront, Obama anointed a former vice presidential staffer, Ronald Klain, as a sort of ''epidemic czar'' inside the White House, clearly stipulated the roles and budgets of various agencies, and placed incident commanders in charge in each Ebola-hit country and inside the United States. The orchestra may have still had its off-key instruments, but it played the same tune.

Building on the Ebola experience, the Obama administration set up a permanent epidemic monitoring and command group inside the White House National Security Council (NSC) and another in the Department of Homeland Security (DHS)'--both of which followed the scientific and public health leads of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and the diplomatic advice of the State Department.

On the domestic front, the real business of assuring public health and safety is a local matter, executed by state, county, and city departments that operate under a mosaic of laws and regulations that vary jurisdiction by jurisdiction. Some massive cities, such as New York City or Boston, have large budgets, clear regulations, and epidemic experiences that have left deep benches of medical and public health talent. But much of the United States is less fortunate on the local level, struggling with underfunded agencies, understaffing, and no genuine epidemic experience. Large and small, America's localities rely in times of public health crisis on the federal government.

Bureaucracy matters. Without it, there's nothing to coherently manage an alphabet soup of agencies housed in departments ranging from Defense to Commerce, Homeland Security to Health and Human Services (HHS).

But that's all gone now.

In the spring of 2018, the White House pushed Congress to cut funding for Obama-era disease security programs, proposing to eliminate $252 million in previously committed resources for rebuilding health systems in Ebola-ravaged Liberia, Sierra Leone, and Guinea. Under fire from both sides of the aisle, President Donald Trump dropped the proposal to eliminate Ebola funds a month later. But other White House efforts included reducing $15 billion in national health spending and cutting the global disease-fighting operational budgets of the CDC, NSC, DHS, and HHS. And the government's $30 million Complex Crises Fund was eliminated.

In May 2018, Trump ordered the NSC's entire global health security unit shut down, calling for reassignment of Rear Adm. Timothy Ziemer and dissolution of his team inside the agency. The month before, then-White House National Security Advisor John Bolton pressured Ziemer's DHS counterpart, Tom Bossert, to resign along with his team. Neither the NSC nor DHS epidemic teams have been replaced. The global health section of the CDC was so drastically cut in 2018 that much of its staff was laid off and the number of countries it was working in was reduced from 49 to merely 10. Meanwhile, throughout 2018, the U.S. Agency for International Development and its director, Mark Green, came repeatedly under fire from both the White House and Secretary of State Mike Pompeo. And though Congress has so far managed to block Trump administration plans to cut the U.S. Public Health Service Commissioned Corps by 40 percent, the disease-fighting cadres have steadily eroded as retiring officers go unreplaced.

Public health advocates have been ringing alarm bells to no avail. Klain has been warning for two years that the United States was in grave danger should a pandemic emerge. In 2017 and 2018, the philanthropist billionaire Bill Gates met repeatedly with Bolton and his predecessor, H.R. McMaster, warning that ongoing cuts to the global health disease infrastructure would render the United States vulnerable to, as he put it, the ''significant probability of a large and lethal modern-day pandemic occurring in our lifetimes.'' And an independent, bipartisan panel formed by the Center for Strategic and International Studies concluded that lack of preparedness was so acute in the Trump administration that the ''United States must either pay now and gain protection and security or wait for the next epidemic and pay a much greater price in human and economic costs.''

The next epidemic is now here; we'll soon know the costs imposed by the Trump administration's early negligence and present panic. On Jan. 29, Trump announced the creation of the President's Coronavirus Task Force, an all-male group of a dozen advisors, five from the White House staff. Chaired by Secretary of Health and Human Services Alex Azar, the task force includes men from the CDC, State Department, DHS, the Office of Management and Budget, and the Transportation Department. It's not clear how this task force will function or when it will even convene.

In the absence of a formal structure, the government has resorted to improvisation. In practical terms, the U.S. government's public health effort is led by Daniel Jernigan, the incident commander for the Wuhan coronavirus response at the CDC. Jernigan is responsible for convening meetings of the nation's state health commissioners and briefing CDC Director Robert Redfield and his boss, Azar. Meanwhile, state-level health leaders told me that they have been sharing information with one another and deciding how best to prepare their medical and public health workers without waiting for instructions from federal leadership. The most important federal program for local medical worker and hospital epidemic training, however, will run out of money in May, as Congress has failed to vote on its funding. The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) is the bulwark between hospitals and health departments versus pandemic threats; last year HHS requested $2.58 billion, but Congress did not act.

On Thursday, the CDC confirmed the first human-to-human spread of the Wuhan coronavirus inside the United States, between a husband and wife in Chicago. While the wife acquired her infection traveling in China, she passed the virus to her husband on return to the United States. Though only six Wuhan coronavirus cases have been confirmed in the United States, with no deaths, Nancy Messonnier of the CDC told reporters on Thursday: ''Moving forward, we can expect to see more cases, and more cases mean the potential for more person-to-person spread.''

As the number of coronavirus cases increases, Americans are growing more fearful, which is creating new problems that the government is leaving unaddressed. Surveying the largest drug store chains in New York City on Wednesday, I found that all were sold out of medical face masks and latex gloves, as is Amazon. Searching online for protective masks reveals that dozens of products intended for use to block dust and particles far larger than viruses are garnering brisk sales'--and none available that can actually prevent viral exposure. The surge in mask and glove sales to worried citizens all over the world needs refereeing. Bona fide anti-viral masks should be prioritized to front-line medical and public health staff, and the populace shouldn't be misled into purchasing and wearing products that offer no genuine protection.

Countering misinformation, conspiracy theories, rumormongering, and discriminatory behavior against people believed to be disease spreaders requires thoughtful communication from leadership at the highest levels of government. None is in evidence. Instead, Commerce Secretary Wilbur Ross appeared on Fox Business on Thursday to fan the flames of fear for the sake of hypothetical business opportunities. ''It does give businesses yet another thing to consider when they go through their review of their supply chain,'' Ross said. ''It's another risk factor that people need to take into account. So, I think it will help accelerate the return of jobs to North America, some to the U.S., probably some to Mexico as well.'' Meanwhile, Trump, asked at the recent World Economic Forum gathering in Davos, Switzerland how he intended to respond to the epidemic, said the situation was under control and a world away from the United States.

In a statement released this week, Pompeo sought to calm Americans, saying, ''People should know that there are enormous efforts underway by the United States government to make sure that we do everything we can to protect the American people and to reduce the risk all around the globe.'' But late Thursday night, the secretary'--in clear defiance of WHO's admonishment against restricting travel to and from China'--issued an advisory saying, ''Those currently in China should consider departing.''

In recent days, a handful of policy leaders have been shifted from government positions focused on weapons of mass destruction and bioterrorism to the slowly emerging epidemic response infrastructure, such as Matthew Pottinger, Philip Ferro, and David Wade on the NSC and the bioterrorism expert Anthony Ruggiero. It's not at all clear how they would handle an explosion of coronavirus cases, were such a dreadful thing to occur in the United States. ''The full weight of the US Government is working on this,'' a senior administration official told CNN on Tuesday. ''As with any interagency effort of this scale, the National Security Council works closely with the whole of government to ensure a coordinated and unified effort.''

The last time the U.S. government and its many local and state counterparts faced an explosive pandemic on American soil was 2009, with the spread of H1N1, or swine flu. The then-new Obama administration was still filling key positions across the executive branch when the epidemic emerged that spring, and it struggled to set the proper tone in reaction to what turned out to be an exceptionally contagious, but not unusually virulent, form of influenza. The challenge revealed enormous gaps in America's ability to swiftly manufacture vaccines, stock-outs of face masks and vital hospital supplies, and serious difficulty in keeping ahead of outright lies, conspiracy theories, and rumormongering on cable TV and social media. The much more deadly pandemic test came in 1981, with the arrival of HIV: It did not go well, as history has well established, because homophobia was so pervasive in the country and within government that gay men, rather than the virus killing them, were treated as a national scourge.

Since the great influenza pandemic of 1918, the United States has been spared terrifying epidemics. Americans now are epidemic voyeurs. They watch YouTube videos of China's struggles. They see the government attack its epidemic by building a 1,000-bed quarantine hospital in a single week, lock down cities larger than New York or Los Angeles, ramp up 24/7 manufacture of face masks and protective gear, deploy its armed forces medical corps to treat ailing citizens, send enormous convoys of food and supplies to anxious citizens of Wuhan, and release terrifying, growing tallies daily of its swelling patient populations. They look in horror at panicked lines of masked people waiting to learn if their fevers are caused by the deadly disease, at bodies lying on cold floors in overcrowded hospitals, and at people crying out from behind their masks for help. And they ask, ''What would the United States do? What would the White House do?'' The answers are not reassuring.

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Sat, 29 Feb 2020 11:00

Rep. John Garamendi John Raymond GaramendiNewly released emails reveal officials' panic over loss of credibility after Trump's Dorian claims Overnight Health Care '-- Presented by American Health Care Association '-- Dems 'frustrated' by coronavirus response after briefing | Mulvaney claims press covering outbreak to take Trump down | Pence bolsters task force House Democrat denies he threatened Trump Jr. with 'physical violence' after demand for apology MORE (D-Calif.) on Friday said the director of the National Institute of Allergy and Infectious Diseases was told to "stand down" and not appear on five Sunday morning talk shows to discuss the coronavirus.

Garamendi told MSNBC's Hallie Jackson that Anthony Fauci was scheduled to do all five major Sunday talk shows, but says Fauci canceled the appearances after Vice President Pence took over the administration's response to the disease.

Trump on Wednesday named Pence as the official overseeing the government's response.

"I can repeat what he said, he said, 'I was not muzzled. However, I was to go on the Sunday talk shows five of them. The vice president's office then took over the control of this situation, and told me to stand down, not to do those shows,'" Garamendi said, quoting Fauci.

"Now, you can draw your own conclusions whether he was muzzled or not, but clearly he was scheduled to do Sunday talk shows and he was not to proceed with that," the congressman added.

The claim from Garamendi comes amid pointed criticism from top Democrats, including former Vice President and 2020 presidential candidate Joe Biden Joe BidenTrump surveys South Carolina supporters on preferred Democratic opponent Watch live: Trump holds a rally in South Carolina Biden, Klobuchar to address AIPAC via video MORE , who urged the Trump administration "to let the experts speak" in an interview with CNN on Friday morning.

''You need to let the experts speak,'' former VP @JoeBiden says about the Trump administration's response to coronavirus fears. ''...No one takes the President's word for these things. At a minimum, he exaggerates everything.'' https://t.co/43RdvxhMVw pic.twitter.com/eh8HV74pHO

'-- New Day (@NewDay) February 28, 2020Director of the National Economic Council Larry Kudlow Lawrence (Larry) Alan KudlowMORE told reporters Friday, "No one's being stifled. No one's being told what to say," with Kudlow adding it was more about coordinating the message.

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Sat, 29 Feb 2020 00:43

ATHENS, Greece (AP) '-- Hundreds of refugees and migrants in Turkey have begun heading for the country's land and sea borders with Greece, buoyed by Turkish officials' statements indicating they will not be hindered from crossing the frontier to head into Europe.

The move comes a day after a deadly Syrian airstrike that killed more than 30 Turkish troops in Idlib, Syria, where Turkey has been engaged since 2016.

WHO ARE THE REFUGEES OR MIGRANTS IN TURKEY?

Turkey currently hosts about 3.6 million Syrian refugees. In 2016, it agreed with the European Union to step up efforts to halt the flow of hundreds of thousands of refugees who headed from its shores into Greece in 2015, in return for funds to support the refugees.

Apart from the Syrian refugees registered in Turkey, the country has also been a staging ground and transit point for many people from the Middle East, North Africa and central Asia hoping to head to Europe. Its coastline's proximity to Greek islands, and the country's land border with EU member Greece, have made it one of the preferred routes into the EU for those fleeing war and poverty at home.

REPEATED THREATS

Turkish President Recep Tayyip Erdogan has frequently warned he could open Turkey's borders and allow refugees into Europe '-- a threat often made during periods of tense relations with EU countries.

Last September, he threatened to allow Syrian refugees to leave for western Europe unless a so-called ''safe zone'' was established inside Syria.

''We will be forced to open the gates. We cannot be forced to handle the burden alone,'' he said at the time, accusing the EU of failing to share the burden of caring for those displaced from Syria.

The following month, furious at EU countries describing his military incursion into northern Syria as an invasion, Erdogan again threatened to let Syrian refugees flood Europe.

''Hey, European Union!'' he said. ''Come to your senses. I repeat: Don't call this an invasion, it's not. If you persist, we will open the gates and send 3.6 million refugees your way.''

Erdogan's threats have not been solely about refugees. In November, angered by an EU decision to impose sanctions on Turkey over its drilling for gas in the Mediterranean off the ethnically divided island nation of Cyprus, he warned he could send Europe Islamic State group prisoners held in Turkey.

''You should revise your stance toward Turkey, which at the moment holds so many IS members in prison and at the same time controls those in Syria,'' he said. ''These gates will open and these IS members who have started to be sent to you will continue to be sent. Then you can take care of your own problem.''

PEOPLE HEAD TO THE BORDER

On Friday, a day after the airstrike that killed Turkish troops in Syria, Turkey appeared to be ready to make good on its threat to open the gates.

The country is ''no longer able to hold refugees,'' said Omer Celik, a spokesman for Erdogan's ruling party.

Turkey's foreign ministry spokesman, Hami Aksoy, warned that the movement of refugees and migrants westward could continue if the situation in Idlib deteriorates.

''Some asylum-seekers and migrants in our country, worried about developments, have begun to move toward our western borders,'' he said. ''If the situation worsens, this risk will continue to increase.''

Hundreds of refugees were headed to Greece's land border, where an estimated 450 people crossed into no-man's land at the Kastanies crossing and were stopped at the Greek border. Greek police used tear gas and flash grenades briefly to move them back, and temporarily shut down the crossing.

Hundreds more were reportedly heading to the Turkish coast, from where at least two dinghies arrived on the Greek island of Lesbos Friday.

WORRIED NEIGHBORS

The developments have alarmed Greece, which is already struggling to cope with tens of thousands of migrants and refugees stuck on its islands, with often several hundred new arrivals daily. Tension has been increasing on the islands, where locals have reacted with often-violent demonstrations to government plans to build new migrant detention facilities.

Greek Prime Minister Kyriakos Mitsotakis spoke by phone with German Chancellor Angela Merkel about the situation and the increased flows of people towards Greece's borders, which are also the EU's external borders.

Neighboring Bulgaria was also increasing security on its border with Turkey to counter a possible migrant influx.

Prime Minister Boyko Borissov said army units, border police and the national guard had been urgently deployed to the border. ''There is a real threat'' of a new migrant wave from Turkey, he said. ''We have data about a lot of crowding.''

At the height of the migration crisis in 2015, thousands of people were reaching Greek islands each day from the Turkish coast and then heading through the Balkans toward more prosperous EU countries. Scores died when their unseaworthy boats sank or capsized during the short but perilous crossing. More than a million people crossed through Greece and the Balkans.

(C) 2020 AP

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Sat, 29 Feb 2020 08:39

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Sat, 29 Feb 2020 12:26

Syrian Minister of Petroleum and Mineral Resources Ali Ghanem says foreign-sponsored Takfiri militants have launched a drone strike against a gas field and a number of energy facilities in the country's central province of Homs, causing fire and material damage.

Ghanem in a statement carried by Syria's official news agency SANA said unmanned aerial vehicles targeted al-Rayyan gas field, the Ebla gas plant, the South Central region gas factory and the Homs refinery early on Wednesday.

He added that maintenance workers embarked on fixing the damage after fire was extinguished.

The Ebla gas plant provides local power plants with approximately 2.5 million cubic meters of gas per day.

The refinery in Homs is one of Syria's two main refineries, covering most domestic demand for diesel, heating fuel, gasoline and other products.

Back on December 21 last year, the Syrian Ministry of Petroleum and Mineral Resources announced in a statement that terrorists had targeted the oil refinery in Homs, located more than located 160 kilometers (100 miles) north of the capital Damascus, and the two gas facilities '' one south of the city and one in the desert to its east.

The ministry added that several production units were damaged as a result.

Erdogan: Turkey will not allow Syrian govt. forces to advance in Idlib

Meanwhile, Turkish President Recep Tayyip Erdogan said his country's military forces will not allow government troops to gain territory in Syria's northwestern province of Idlib.

He added that the attack on Turkish forces, which killed seven soldiers and a civilian on Sunday night, is a clear violation of the Sochi deal.

''Of course there will be costs of such actions for the (Syrian) regime. We have already said that we will do whatever is necessary from now on,'' Erdogan told reporters on a flight back from Ukraine on Tuesday.

The Turkish president noted that Russia has been informed about the latest developments in Syria, and that Ankara cannot tolerate any more conflict in Idlib nor a new influx of refugee.

On Monday, Syria's pro-government and Arabic-language daily al-Watan reported that Turkey had sent a convoy of armored vehicles to Syria's Idlib province in order to block the advance of the Syrian army towards the town of Saraqib.

The paper added that Turkish military is strengthening observation posts on the outskirts of Saraqib and is installing one more post on the Kfar Amim-Abu al Duhur line.

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Sat, 29 Feb 2020 12:24

Steven Sahiounie, political commentator

Tensions between Damascus and Ankara have never been higher over the past nine years. Turkey's President Tayyip Erdogan threatened on February 5, to declare war on Syria if the Syrian Arab Army (SAA) does not withdraw from the territory liberated from terrorists in Idlib province.

''The attack on our soldiers the day before yesterday was a turning point in Syria for Turkey,'' he said, referring to seven Turkish soldiers killed on February 4. Four Turkish military convoys were trying to establish a new control point in Jobas but retreated after the Syrian forces captured the town and attacked them.

On February 6, the SAA attacked a terrorist position in the suburbs of Saraqeb, and the Turkish military defended the terrorist position through the use of heavy artillery; however, this clash between SAA and Turkish forces resulted in the SAA advancing into Saraqeb.

Erdogan and Turkish position

''We hope that the process of the regime pulling back behind our observation posts is completed in the month of February,'' Erdogan told members of his AK Party. ''If the regime does not pull back during this time, Turkey will have to do this job itself. We are determined to continue our operations to ensure the safety of our country, our nation and our brothers in Idlib,'' he warned while adding the Turkish military would carry out air and ground operations in Idlib, when necessary.

A source in the Syrian Ministry of Foreign Affairs and Expatriates told the Syrian Arab News Agency on February 5, that Erdogan lied when he claimed that his troops entered northern Aleppo as a part of the 1998 Adana agreement.

''Syria stresses that the Adana agreement requires coordination with the Syrian government as it is an agreement between two countries, therefore Erdogan, according to the requirements of the agreement, cannot act separately,'' the source said, adding ''the Adana agreement to ensure border security between the two countries is indeed aimed at combating terrorism, but what Erdogan is doing is protecting his tools, the terrorist groups, which he provided and still has with various forms of support.''

On February 4, three Turkish convoys entered Syrian territories from Kafr Lusain crossing, bringing the number of vehicles brought in from February 2 to 400. Five other convoys have entered since then and headed to Idlib and Aleppo. Turkish forces, which invaded Idlib in 2017, have repeatedly tried to prevent the Syrian forces from recovering Syrian territory.

Russian position

The Russian Defense Ministry stated that the Turkish troops were hit because of their failure to communicate with the Russian military, as per agreement.

The Russian Reconciliation Center for Syria has called upon armed groups to abandon terrorism and seek a peaceful settlement, which Russia can guarantee by laying down their arms.

President Vladimir Putin spoke by phone with Erdogan after the Turkish soldiers were killed, along with one civilian contractor. Erdogan stressed that Turkey would continue to use its right of self-defense against similar attacks, according to a statement by the Turkish Communications Directorate.

Putin and Erdogan have a relationship based on shared interests in energy, economics, and security. Neither of them will likely allow Idlib to destroy their ties, even though their interests in Syria diverge. Russia is the deal-maker in Syria, and we saw Putin in shuttle diplomacy flying to Damascus last month, and then he flew on to Istanbul.

US position

Secretary of State Mike Pompeo condemned the attack by Syria on the Turkish soldiers. He declared the US ''fully supports Turkey's justified self-defense actions. '' Pompeo said the assault on al-Qaeda held Idlib is 'unjustifiable', and supports the Turkish position of keeping Saraqeb in the terrorist's hands.

Pompeo further said that the US considers Syria's attempt to take towns from al-Qaeda 'unjustifiable and ruthless assaults.' This is in keeping with US policy in Syria to support Radical Islamic terrorist groups enough that they can continue to attack the Syrian government forces. From the first day of the Syrian conflict, 'regime change' has been the only US foreign policy.

The Facebook page of the US Embassy in Damascus, an institution no longer existing in Syria, posted a statement by Pompeo and changed its cover image to ''IDLIB''.

Who is in control of Idlib today?

Saraqeb, and the rest of Idlib province which has not been liberated, is a well-known stronghold of al-Qaeda-linked groups like Hayat Tahrir al-Sham (HTS) and the Turkistan Islamic Party (TIP). These groups are Turkish supported jihadists, and although HTS is a new name, it was formerly Jibhat al Nusra, which was the Al Qaeda affiliate in Syria. TIP is sponsored by Erdogan personally, and are the Chinese Uyghurs who he imported from China specifically to create an Islamic state in Syria.

The United Nations estimates that as many as 3 million civilians may be trapped in the area ruled by jihadists, who have oppressed the civilians who have no recourse but to try and survive under Radical Islam, which is not a religion or a sect, but a political ideology.

The Syrian Arab Army advances

The SAA has made consistent advances in Idlib province, and this has caused Turkey and the US to panic. The SAA has taken village after village, and now stand poised to clear the highway linking Latakia to Aleppo (M4), as well as the highway linking Aleppo to Damascus (M5). Ground troops and airstrikes have been utilized to achieve its goal to liberate all Syrian territories, and are 8 kilometers away from the city of Idlib.

The underwater pipeline attacked

In June 2019, sabotage attacks damaged five underwater pipelines off the Mediterranean coastal town of Banias, south of Latakia. On February 3, explosives damaged the underwater pipelines once again, which are used to pump oil into one of Syria's two petroleum refineries. No group has claimed responsibility, which leads experts to assume this was a state-sponsored attack and not a terrorist group. Syria's oil minister, Ali Ghanem, said that divers planted the underwater charges in the pipeline which sits 3 kilometers off-shore and at a depth of 23 meters undersea. ''The aim of the attack is to cease (oil) imports into Syria,'' said Ghanem.

Underwater divers, using sophisticated underwater charges, and in such depths lend credence to the assumption of a well trained sophisticated team from a foreign country. These are the very pipelines used to pump in the oil from the Iranian ship that had been detained by the UK at the best of the US last summer.

The Homs oil and gas facilities attacked, again

Drones were used in a sophisticated and synchronized attack on three Syrian oil and gas facilities on February 4, which hit the Al-Rayyan Natural Gas Station, the Ebla Gas Laboratory, and the Homs Refinery. Once again, these attacks have not been claimed by any group. Firefighters battled blazes caused by the explosions triggered by the drones attack. All three facilities are in central Homs province. Syrian civilians have been suffering from lack of gasoline, cooking gas, heating oil, and electricity, all of which are caused by US-EU sanctions which prevent Syria from importing petroleum and gas products. The US and UK have seized an Iranian tanker at sea who might deliver fuel to the Syrian civilians. This US-UK policy has been designed to make the civilians suffer, which has resulted in Syrians leaving as economic migrants, which Germany has been tasked to support.

The city of Homs and the surrounding areas have been under control of the Syrian government since 2017, and there are no terrorist groups present. Besides underwater diving specialists and underwater explosive specialists, there are also expensive and sophisticated drones in use, apparently by foreign countries seeking to increase the suffering and deprivations of the Syrian civilians.

Before 2011, Syria exported around half of the 350,000 barrels of oil is produced per day; however, production now has plummeted to around 24,000 barrels a day, which is a fraction of domestic needs. Thusly, there exists a vital need to import petroleum and gas products. The largest oil field is now in the hands of the US Army, and President Trump is openly proud of stealing the Syrian oil.

Last month, near-simultaneous attacks carried out by drones hit three oil and gas installations in central Syria, while in December the attacks targeted the oil refinery in Homs.

The end game

The liberation of Idlib province approaches and the proxy war will likely be settled in backroom negotiations, and not on the battlefield.

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Sat, 29 Feb 2020 12:20

Idlib, Syria. Map: Wikimedia CommonsFuel and cooking gas are in very short supply in the parts of Syria controlled by the Assad regime. Yet in Idlib, the last rebel-held pocket of the country and currently the target of an intense military offensive, these and other essentials are not only available, but affordable. This is thanks to a company named Watad Petroleum.

But who or what is Watad? If suspicions are true, Watad '' about which little is known '' represents yet another way in which Hayat Tahrir al-Sham (HTS), an organization labeled a terrorist group by much of the world, is strengthening its grip on Idlib.

Life in this province of northwestern Syria has, without a doubt, been made easier by Watad's presence. But with no information available publicly about who owns or runs it, there is a persistent suspicion about it.

The first that anyone had heard of Watad was in January last year, when it was granted a monopoly over the fuel market in greater Idlib, with exclusive rights to import oil and gas from Turkey and to regulate their sale, price and distribution. Ostensibly, the deal, which also eliminated any domestic competition, was struck with Idlib's Salvation Government, but in reality it was with HTS, the de facto power in that area.

Before then, people in Idlib were reliant on motor fuel and gas transported from government-controlled areas and on crude oil brought in from northeastern Syria, which is now controlled by the Kurdish-led Syrian Democratic Forces. But economic sanctions and the Turkish-led offensive to capture the predominantly Kurdish region of Afrin led to those supply lines being severed. Enter Watad Petroleum.

Some reports say the company was founded in Idlib in 2017, while others maintain it was established in early 2018 by a group of Syrian businessmen living in Turkey. What is certain is that the mysterious Watad Petroleum has become a key player in Greater Idlib.

After the Afrin offensive, according to multiple sources, Turkish suppliers began importing fuel, mainly from Ukraine, via an unidentified company and transporting it into Syria via the Bab al-Hawa border crossing, which HTS controls. Once in Syria, the fuel becomes the responsibility of Watad.

Although Watad is often described as a privately owned oil supplier, in the absence of more detailed information, the common assumption is that it is partly owned by or directly affiliated with [Islamist group] HTS

Under the terms of the January 2018 agreement, Watad regulates every aspect of the domestic fuel and gas market, from oil refining to setting prices, which are updated and published daily. Watad has also taken over the processing of most of the crude oil produced in northeastern Syria, having elbowed aside the unregulated makeshift local refineries, whose record on safety and environmental health was dubious, to say the least. The result is guaranteed availability of essential commodities in Idlib, and at affordable prices.

Clearly, this has been of great benefit to the community. But when a new company rises so rapidly to gain sole control over such an essential '' not to mention highly profitable '' market, questions are bound to be asked.

Although Watad is often described as a privately owned oil supplier, in the absence of more detailed information, the common assumption is that it is partly owned by or directly affiliated with HTS. Those who subscribe to this belief point to Watad's close cooperation with the Salvation Government, which is itself closely connected to HTS. Watad relies on Salvation Government forces to ensure the smooth running of its operations.

While this could explain why HTS is willing to use its authority and resources to help Watad, it is, nevertheless, not conclusive evidence. The possibility remains that the two have merely come up with an arrangement that benefits each of them financially, but does not involve direct affiliation. After all, political and ideological differences have never prevented Syrian businessmen from brokering deals with all parties throughout the conflict in their country. And if Watad indeed is tied to HTS, why would Turkey agree to Watad holding the monopoly over fuel imported through its territory?

To answer those questions, we need disclosure, clarity and transparency. We need to know who owns Watad, what deals the company has made and with whom.

As long as the political and military dynamics remain unchanged in Greater Idlib, Watad's dominance in the fuel market is likely to remain unchallenged. Having readily available, affordable fuel may be helpful to those living there but the flip side is that if HTS is indeed substantially involved in Watad, then this is more evidence of the group's influence and grip over the area, which could mean that ultimately, the people of Idlib may end up paying a far higher price than they think.

This article was provided to Asia Times by Syndication Bureau, which holds copyright.

Haid Haid is a research fellow at the International Center for the Study of Radicalization at King's College London. He is also a consulting research fellow of Chatham House's Middle East and North Africa program.More by Haid Haid

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Sat, 29 Feb 2020 12:14

The Syrian army's ongoing military operation in the northwestern province of Idlib has resulted in a number of strategic gains for President Bashar al-Assad's government. On Jan. 28, the Syrian army recaptured Maaret al-Numan, a strategic town south of the city of Idlib, from rebel and terrorist groups. The achievement was seen as an important step to regain full control over the M5 highway that connects Damascus with Aleppo. As has been the case with the previous rounds of the Syrian army's operations in Idlib, the recent advances were made possible by Russian air support for the Syrian forces. However, what has been new this time is the active presence of Iranian and Iranian-backed forces on the battlefield that has been reported.

The British newspaper The Daily Telegraph published a report Jan. 26 containing leaked radio communications from Iran-backed Afghan fighters known as the Fatemiyoun Division showing their involvement in the ongoing battles in Idlib. The newspaper said the estimated number of Fatemiyoun forces in Idlib is between 400 and 800. Earlier in January, there were media reports, citing Turkish intelligence, that several Iran-backed groups in Syria had been deployed to the Idlib and Aleppo fronts. On Jan. 27, US Secretary of State Mike Pompeo criticized ''the combined forces of Russia, the Iranian regime, Hezbollah, and the Assad regime'' for conducting a massive assault on Idlib and western Aleppo.

Despite its persistent military and political support for the Assad government, the Islamic Republic had refrained from getting involved in the previous rounds of the Syrian army's operations in the country's northwest. As such, Tehran's decision to assist the Assad government in its current military campaign in Idlib could be considered an important development.

If we are to discuss the reasons behind Iran's change of course regarding Idlib, first we should take into account the situation that emerged after the Jan. 3 assassination of Iranian Quds Force commander Maj. Gen. Qasem Soleimani by the United States. Removing Soleimani, the mastermind behind the Islamic Republic's regional strategy, resulted in speculation that Iran would start to lose influence in Syria. Such a possibility appeared to cause concern even for Assad, who quickly decided to dispatch his intelligence chief Ali Mamlouk to Tehran to talk with Iranian officials about their ''coordination during the next stage.''

As such, Iran's recent involvement in Idlib could be seen as both trying to send a message to its rivals that its power and influence in Syria have remained intact, and reassuring Assad that he can still count on Tehran's support where and when needed. This reassurance effort was also evident when the Fars news agency '-- affiliated with Iran's Islamic Revolutionary Guard Corps (IRGC) '-- published a report Jan. 26 underlining the role of the Quds Force in preventing the collapse of the Assad regime since the early stages of the Syrian uprising. This was the first time a semi-official Iranian news agency had written about the role of the IRGC's Quds Force in Syria before the rise of the Islamic State (IS) in 2013.

Another factor contributing to a change of Iran's viewpoint toward Idlib could be the changing priorities of Turkey in Syria and the region. At least since the US withdrawal from the nuclear deal with Iran in May 2018, a major reason behind Tehran's hesitation to get directly involved in the Syrian government's military moves in the northwest was its concern not to lose Ankara as a partner in circumventing the revived US sanctions. Turkey has been opposing the Syrian government's military campaign in Idlib, supporting most of the rebel groups stationed in the area.

However, there have been growing signs recently that Turkey is shifting the main focus of its regional policy from Syria to Libya, with hundreds of Turkish-backed rebels being deployed from Syria to the North African country to assist the Government of National Accord, which is struggling against an insurgency led by Gen. Khalifa Hifter. Meanwhile '-- and for the first time since 2011 '-- Hakan Fidan, the head of Turkey's National Intelligence Organization, met with his Syrian counterpart Ali Mamlouk in Moscow on Jan. 13. The meeting was seen as a possible starting point for a change in Ankara's approach toward Syria. However, the latest clashes between the Syrian and Turkish militaries in Idlib, which resulted in the death of at least six Turkish soldiers, are a sign that Ankara and Damascus are still far from any kind of rapprochement. However, Iran's policy change in Idlib might have been based on the calculation that Turkey is either unwilling or unable to sustain an active presence in that area.

The increasing American and Israeli pressures on Iran in Syria might be another factor affecting Tehran's approach toward Idlib. Over the past several years, Iran's main geographical concentration has been on Syria's southern areas, from Daraa in the southwest to Deir ez-Zor in the southeast. However, with the heightened Israeli strikes against Iranian interests in those areas and with tensions between Tehran and Washington in the region being on the rise after Soleimani's assassination, Iranian officials might have changed their strategic calculations on the makeup of their forces in Syria. In order to make it harder for the Israelis and Americans to target its interests, Iran might have decided to dispatch at least some of its forces to other areas, including Idlib. This way, Iran would also gain more influence on the ground in Syria, creating further obstacles for the Americans and Israelis who want to root out Tehran's presence in Syria.

Iran's involvement in Idlib appears to also have something to do with Iran's grand regional plan following the killing of Soleimani, that is, attempting to expel US forces from the region. As the main concentration of the US forces in Syria is in the areas east of the Euphrates river controlled by the Syrian Democratic Forces, Tehran wants the Syrian government operation in Idlib to be concluded successfully as soon as possible so that the next step in realizing Assad's promise to ''liberate every inch of Syrian territory'' could be started in the east of the Euphrates. Referring to this issue, Ali Akbar Velayati, a top adviser to Iranian Supreme Leader Ayatollah Ali Khamenei, said in a press conference Jan. 30 that ''the Syrian government and its allies from the resistance front will go from Idlib to the eastern Euphrates to expel the Americans.''

All these points would mean that Iran is taking a more geographically dispersed, more offensive posture in Syria in order to adapt itself with the rapidly changing situation in Syria and the whole region. As such, Iran's involvement in Idlib marks an important turning point in its strategy toward the Syrian crisis.

Hamidreza Azizi is an assistant professor of regional studies at Shahid Beheshti University and a member of the scientific board at the Iran and Eurasia Studies Institute (IRAS) in Tehran. On Twitter: @HamidRezaAz

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Sat, 29 Feb 2020 12:09

by Hadi Khodabandeh Loui, Anadalu Agency

ISTANBUL: Following the Arab spring, the historical competition between Iran and Turkey has gained momentum.

While Turkey is supporting grassroots movements in the region within the framework of stable peace and democratization vision, Iran is making use of the lack of authority by reorganizing proxy powers similar to Hezbollah, utilizing differences between sects, thus creating its own faithful Shiite militia forces.

In this process, the two countries have different visions for the Middle East and created more tension in relations.

Turkey's vision of regional development and integration is pitched against Iran's regional strategy prioritizing geopolitical wins. The most important grounds for this conflict has become Syria.

In terms of the Syrian civil war, Iran has stood against Turkey from the very beginning and placed more than 80 Shiite militias in Syria. Not once reacting to Israel's hundreds of air attacks in the south of the country, Tehran was aggressively against Turkey-backed Syrian National Army on the northern front.

Ignoring Ankara's concerns in the fight against terrorism during Operation Peace Spring, Tehran is now setting its Shiite militias in the field in motion against Turkey, who is actively endeavoring to prevent a humanitarian crisis.

Following Russia's support for Turkey after the July 15 coup attempt, Ankara and Moscow have been in a process of convergence policy.

The two countries have embraced the ''win-win'' approach rather than zero-sum competition in Syria. Instead of conflict, they have now decided to cooperate.

Not having played a role in Ankara-Moscow convergence policies specifically about the issue of Syria, Tehran had to include itself in this process later on. However, despite of all these efforts for collaboration, Russia's and especially Iran's aims in Syria have started to conflict with Turkey's national interests. Upon attacks in Idlib, this conflict is now for the plain eye to see. While at this point Russia shows from time to time that it is open for negotiations if necessary and Assad is not irreplaceable, Iran equates Assad's survival to its own now.

After neutralizing Gen, Qasem Soleimani, who was the creator of the Middle East vision and commander in full power in realizing these strategies in the field, it was estimated that Iran would face a downfall in its activity in Syria and Iraq.

The situation of a Quds Force without Soleimani in Syria brought a lot of anxiety to Damascus and Tehran. In this framework, upon not being able to coordinate operations in Syria and its own forces in the field, Tehran requested for Lebanon Hezbollah to come forward to compensate for Soleimani's absence.

When it comes to Iraq operations of Quds Force, the killing of Abu Mahdi al-Muhandis, which had a heavier impact than that of Soleimani, has left Iran so weak that it had to play its hand by putting forward Muqtada Sadr.

That his plans of ''one million people demonstration'' not meeting his expectations, Iranian Shiite young people's strong opposition and his failure to create his authority over other militia forces have revealed the inadequacy of Sadr. Not finding what it expected with Sadr, Iran requested Lebanon Hezbollah in Iraq to meet Hashd al-Shaabi directly, just as it did in Syria.

According to a Reuters report published Tuesday, Hezbollah official Shaikh Mohammad al Kawtharani met with militia leaders ''to unite them after the death of their strong leaders and the power gap created by that'' and ''to coordinate their political activities.''

It was estimated that the Quds Force would increase its activities in Afghanistan due to the lack of coordination they experienced in Syria and Iraq.

The new commander Ismail Qaani, appointed to the force after Soleimani, has spent most of its military career in Afghanistan and Iran's eastern hinterland. Upon losing its power on the western front, the Quds Force was expected to put a power play in Afghanistan, of which Qaani was previously responsible, but this did not happen.

By cooperating with the U.S. against the Taliban in some instances during the U.S. occupation of Afghanistan, Tehran had made a new move and started defining the Taliban as ''Afghan mujahideen.'' However, it is observed that the Taliban does not have the same motivation against Iran. Although Tehran tried to sabotage the U.S.-Taliban peace negotiations, there was still some progress as a result. The Taliban only played its ''cooperation with Iran'' card to gain concessions in its negotiations with the U.S.

In the next 40 days following Soleimani's death, Moscow and Damasus' charge on Idlib created an important grounds for the Quds Force to put on a power show against Iran, who had now lost its previous efficiency in nearly all positions. There was a situation of mutual need among Tehran, Moscow and Damascus.

Providing the Damascus regime immediate air support, Russia is aware of the fact that regime forces will not be able to succeed against opposition forces in Idlib and only if Iran's highly-motivated Shiite militias take the leading front will they have a chance to succeed.

Russian attempts to move forward to Idlib have failed in the past two years and their aims were not met. Regime forces capturing Khan Shaykhun in August 2019 was only possible following the new agreement between Russia and Iran, dispatching Iran-backed militias to the region.

Although Iran moves within the sphere enabled by Moscow in Idlib, Russia's aims do not correlate with Iran's priorities outside of the northern fronts. Having the Syrian airfield security under control, Russia leaves Iran alone in the field in the face of air attacks frequently carried out by Israel on the Syria-Iraq border.

Allowing Israel's attacks in a very subtle manner, Russia did not allow Iran to place air defense systems in the region to block Iraq and Lebanon militias and Revolutionary Guard personnel from being targeted by Israel jets.

Lastly, although demonstrating its power under the protective umbrella of Russia on the Idlib front, Iran's coordination in the field is remarkable.

According to voice recordings published by the U.K. Daily Telegraph, Iran's supply and maintenance support for Fatimiyyun brigades, consisting of Afghan Shiites in the region, is now insufficient. According to stories shared by Shiite militias on social media, 12 Shiite militias, most of whom are of Pakistani origin, were killed in Khan Tuman region Feb 4. According to statements by the militia, recently there are ''surprising mistakes and inadequacy'' in the coordination of forces in the field and supply deliveries. Again with their words, the most important problem as of now is war engineering units to ''remain inactive in creating defense fortification'' in the occupied zones. This situation provides hints about the coordination problems of the Quds Force.

Although Tehran endeavors to put a power play on the stage in the short run, that Quds Force has weakened in terms of command and coordination will render it difficult for Iran to continue its active influence in Syria.

About Author: Hadi Khodabandeh Loui is a researcher in IRAM (Iran Research Center), focusing on Shiite geopolitics, Iran's defense strategies, and Gulf security

Translated by Firdevs BulutOpinions expressed in this article are the author's own and do not necessarily reflect the editorial policy of Anadolu Agency.Anadolu Agency website contains only a portion of the news stories offered to subscribers in the AA News Broadcasting System (HAS), and in summarized form. Source: Anadalu Agency

DISCLOSURES: All content herein is owned by author exclusively. Expressed opinions are NOT necessarily the views of VT, authors, affiliates, advertisers, sponsors, partners or technicians. Some content may be satirical in nature. All images within are full responsibility of author and NOT VT.

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Sat, 29 Feb 2020 12:06

TEHRAN, February 29. /TASS/. A political solution remains the only possible way to end the Syria crisis, Turkish President Recep Tayyip Erdogan said on Saturday in a phone call with Iranian President Hassan Rouhani.

"Erdogan named political dialogue as the only solution to Syrian problems," the Iranian presidential press office said.

According to the press office, the Turkish president pointed out that "the talks [within the Astana format] have yielded meaningful results and they should be continued for the sake of a stable peace [in Syria].".

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Source: Signs of the Times

Sun, 01 Mar 2020 06:18

(C) AFP Turkey says up to 30,000 could cross into the EU in the coming days

Turkish President Recep Tayyip Erdogan said Saturday that his country's borders with Europe were open, as thousands of migrants gathered

at the frontier with Greece.

Migrants played a cat-and-mouse game with Greek border patrols throughout the night and into Saturday, with some cutting holes in the fence only to be turned back by tear gas and stun grenades. Greek authorities also fired tear gas to repulse attempts by the crowd to push through the border.

The move by Turkey to open its border, first announced Thursday, was seen in Greece as a deliberate attempt to pressure European countries. It comes as tensions ratcheted up between Turkey and Syria. More than 55 Turkish troops have been killed since Turkey began sending further reinforcements into areas of northwest Syria under the control of rebels, which are backed by Turkey.

"We will not close the gates to refugees," Erdogan said in a speech in Istanbul. "The European Union has to keep its promises."

If Erdogan really has opened the border, it would be a dramatic departure from Turkey's current policy. Under a 2016 deal, Turkey agreed to stem the tide of refugees to Europe in return for financial aid. It has since protested that the EU has failed to honour the agreement.

Erdogan was speaking for the first time since 33 Turkish soldiers were killed in air strikes in northwest Syria on Thursday, the largest single loss of life for Turkish forces since their country became involved in Syria in 2016.

The Turkish troop deaths led officials to declare Turkey would not impede migrants seeking to enter Europe.Turkey currently hosts more than 3.5 million Syrian refugees, and many fleeing war and poverty in Asia, Africa, and the Middle East use it as a staging post and transit point to reach Europe, usually through neighbouring Greece.

On Saturday, small groups managed to get across into Greece clandestinely. The vast majority were from Afghanistan, and most were men, although there were also some families with young children. They took shelter during the night in abandoned buildings or small chapels in the Greek countryside before starting to walk towards northern Greece.

Erdogan has frequently threatened to "open the gates" and allow refugees and migrants to head to Europe unless more international support was provided, particularly at times of tension with European countries.

Thursday's deaths were the most serious escalation between Turkish and Russian-backed Syrian forces. The development has raised the prospect of an all-out war with millions of Syrian civilians trapped in the middle.

Syrian government forces have been on a weeks-long offensive into Idlib province, the country's last rebel stronghold, which borders Turkey. Thousands of Turkish soldiers are deployed inside rebel-controlled areas of Idlib province, which is dominated by al-Qaeda-linked militants.

The Idlib offensive has pushed nearly 950,000 displaced civilians toward the Syrian-Turkish border amid cold winter weather.

"We learnt the border was open and we headed there. But we saw it was closed, and we found a hole in the fence and went through it," said Ali Nikad, a 17-year-old Iranian who made it into Greece overnight with a group of friends.

Nikad said he had spent two months in Turkey but couldn't make ends meet, and was hoping to find his uncle who was already in Greece.

Many of those who made it across the land border were seen being arrested and driven away in white vans.

A police officer told The Associated Press there was pressure along the 200-kilometre (125-mile) land border from migrants trying to force their way through overnight, and groups were being constantly repulsed. The officer spoke on condition of anonymity as he was not authorized to speak on the record.

Others were making their way to Greek islands in dinghies from the nearby Turkish coast.

Greece and Bulgaria increased security at their borders with Turkey. In Athens, Greek Prime Minister Kyriakos Mitsotakis convened an emergency meeting of top cabinet, military and coast guard officials Saturday morning on the issue.

(C) AFP Greece says it stopped 4,000 attempts to enter its border

In Syria, Turkey's Defense Ministry said one of its soldiers was killed and two were injured by Syrian government shelling, the latest fatality after the deadly airstrike that killed 33 earlier this week.

The announcement late Friday also said Turkish forces hit Syrian government targets and a number of Syrian troops were "neutralized".

It remained unclear whether Syrian or Russian jets carried out the airstrike, but Russia denied its aircraft were responsible.

Erdogan had given the Syrian government until the end of the month to pull back from areas captured in Idlib, threatening large-scale military action if they didn't. But any large scale Turkish military action risks more loss of life among Turkish soldiers. He had kept unusually silent since the 33 deaths.

NATO envoys held emergency talks Friday at the request of Turkey, a NATO member. While urging de-escalation in Idlib, NATO offered no further assistance.

Erdogan and Russian President Vladimir Putin spoke by telephone Friday and discussed implementing agreements in Idlib, the Kremlin said. Fahrettin Altun, Erdogan's director of communications, said they had agreed to meet "as soon as possible."

Erdogan also spoke with other world leaders, including President Donald Trump and German Chancellor Angela Merkel.

U.N. Secretary-General Antonio Guterres called for an immediate cease-fire in Idlib. He warned that "without urgent action, the risk of even greater escalation grows by the hour, and as always, civilians are paying the gravest price."

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Source: Sputnik News - World News, Breaking News & Top Stories

Sun, 01 Mar 2020 06:36

World06:23 GMT 01.03.2020(updated 06:33 GMT 01.03.2020) Get short URL

On Saturday, President Donald Trump welcomed the signing of a peace agreement between the US and the Taliban that envisages a timetable for the withdrawal of some 13,000 troops from Afghanistan.

Former National Security Adviser John Bolton has lashed out at a US-Taliban peace deal which he claimed poses an ''unacceptable risk to America's civilian population''.

''This is an Obama-style deal. Legitimising Taliban sends the wrong signal to ISIS [Daesh*] and al-Qaeda* terrorists, and to America's enemies generally,'' Bolton tweeted on Saturday, referring to US President Donald Trump's predecessor Barack Obama.Signing this agreement with Taliban is an unacceptable risk to America's civilian population. This is an Obama-style deal. Legitimizing Taliban sends the wrong signal to ISIS and al Qaeda terrorists, and to America's enemies generally.

'-- John Bolton (@AmbJohnBolton) February 29, 2020Trump's ally Lindsey Graham, for his part, signalled his readiness to ''support any reasonable effort to negotiate an end to the war in Afghanistan'', but added that ''any peace agreement must be sustainable, honourable and include protections for the American homeland against international terrorist organisations that are alive and well in Afghanistan''.

''I am very suspect of the Taliban ever accepting the Afghan constitution and honouring the rights of religious minorities and women. Time will tell if reconciliation in Afghanistan can be accomplished with honour and security, but after more than 18 years of war, it is time to try,'' the Republican Senator underscored.Trump, in turn, responded to Bolton's critical remarks during the Saturday press conference by saying that the former National Security Adviser had ''had his chance'', which he had never used.

''He was here for a year. He could have done something better - I was all ears, and he wasn't able to do that,'' Trump said.

Commenting on the US-Taliban deal, which stipulates the pull-out of about 13,000 American troops from Afghanistan, POTUS pledged that his administration would redeploy its military to the South Asian nation "if bad things happen".

He also vowed that he would personally meet with Taliban leaders "in the not-so-distant future", predicting that the forthcoming talks between the Afghan sides would be successful as "everyone is tired of war", amid concerns that the negotiations would be more complicated than the initial deal.US, Taliban Sign Bilateral Peace DealThe remarks came after the US and the Taliban inked a landmark bilateral peace agreement in the Qatari capital of Doha earlier on Saturday, a document that envisages a phased troop withdrawal from Afghanistan.

The US forces are due to be slimmed down to 8,600 within the first 135 days of the deal's announcement, while allied and coalition forces will be scaled down proportionately.

(C) AP Photo / Rahmat Gul

U.S. forces and Afghan commando are seen in the Achin district, Afghanistan. (File)

Under the agreement, up to 5,000 Taliban prisoners will be released from prisons by 10 March, the first day of intra-Afghan talks, while the remaining prisoners will be freed within the next three months. The Taliban commits that its released prisoners will not pose a threat to the security of the US and its allies.

The deal obliges the US to seek economic cooperation for reconstruction with the new post-settlement Afghan Islamic government and avoid intervening in its internal affairs.

In return, the Taliban will take steps to prevent terrorist groups, such as al-Qaeda, from using Afghan soil to threaten the security of the US and its allies.

*Daesh (ISIS/ISIL/Islamic State), al-Qaeda, terrorist groups banned in Russia and a number of other countries

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Sat, 29 Feb 2020 10:00

42754 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1141 [Docket No. FDA''2019''N''3065] RIN 0910''AI39 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking. DATES: Submit either electronic or written comments on the proposed rule by October 15, 2019. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 15, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: ' Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. ' If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/ paper submission and in the manner detailed (see ''Written/Paper Submissions'' and ''Instructions.'') Written/Paper Submissions Submit written/paper submissions as follows: ' Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA''305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. ' For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ''Instructions.'' Instructions: All submissions received must include the Docket No. FDA'' 2019''N''3065 for ''Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ''Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. ' Confidential Submissions'--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ''THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ''confidential.'' Any information marked as ''confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.gpo.gov/ fdsys/pkg/FR-2015-9-18/pdf/2015- 23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ''Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) in the following ways: ' Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202''395''7285, or email to oira_ submission@omb.eop.gov. All comments should be identified with the title, ''Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.'' FOR FURTHER INFORMATION CONTACT: Courtney Smith or Daniel Gittleson, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993''0002, 877''287''1373, email: AskCTPRegulations@fda.hhs.gov. With regard to the information collection: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A''12M, 11601 Landsdown St., VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42755 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs, Benefits, and Informational Effects Table of Abbreviations/Commonly Used Acronyms in This Document II. Background A. Need for the Regulation B. History of the Rulemaking C. Incorporation by Reference III. Legal Authority IV. Cigarette Use in the United States and the Resulting Health Consequences A. Smoking Prevalence and Initiation in the United States B. Negative Health Consequences of Smoking V. Data Concerning Cigarette Health Warnings A. The Current 1984 Surgeon General's Warnings Are Inadequate B. Cigarette Health Warnings That Are Noticeable, Lead to Learning, and Increase Knowledge Will Promote Public Understanding About the Negative Health Consequences of Smoking VI. FDA's Process for Developing and Testing the Proposed Cigarette Health Warnings A. Review of the Negative Health Consequences of Cigarette Smoking B. Developing Revised Textual Warning Statements C. FDA's Consumer Research Study on Revised Textual Warning Statements D. Developing and Testing Images Depicting the Negative Health Consequences of Smoking To Accompany the Textual Warning Statements E. FDA's Consumer Research Study on New Cigarette Health Warnings VII. FDA's Proposed Required Warnings A. FDA's Proposed Required Warnings VIII. First Amendment Considerations IX. Description of the Proposed Rule A. General Provisions (Proposed Subpart A) B. Required Warnings for Cigarette Packages and Advertisements (Proposed § 1141.10) C. Misbranding of Cigarettes (Proposed § 1141.12) X. Proposed Effective Dates XI. Severability and Other Considerations XII. Preliminary Economic Analysis of Impacts XIII. Analysis of Environmental Impact XIV. Paperwork Reduction Act of 1995 XV. Federalism XVI. Consultation and Coordination With Indian Tribal Governments XVII. References I. Executive Summary A. Purpose of the Proposed Rule This proposed rule would establish new required cigarette health warnings for cigarette packages and advertisements. These new cigarette health warnings would consist of textual warning statements accompanied by color graphics depicting the negative health consequences of cigarette smoking. The new cigarette health warnings, once finalized, would appear prominently on cigarette packages and in cigarette advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Cigarette smoking remains the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year. Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined. In developing this proposed rule, FDA determined that the public holds misperceptions about the health risks caused by smoking and that warning statements focused on less- known health consequences of smoking paired with concordant color graphics would promote greater public understanding of the risks associated with cigarette smoking, especially given that the existing Surgeon General's warnings currently used in the United States have been shown to go unnoticed and be ''invisible.'' For the reasons discussed in the preamble to this proposed rule, FDA has determined that the proposed new cigarette health warnings will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking. B. Summary of the Major Provisions of the Proposed Rule This proposed rule would establish new required warnings to appear on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the FCLAA to require each cigarette package and advertisement to bear one of the new required warnings. These new cigarette health warnings would consist of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. As required under the FCLAA, the new cigarette health warnings, once finalized, would appear prominently on cigarette packages and in cigarette advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. In addition, as required under the FCLAA, the proposed rule would establish marketing requirements that would include the random display and distribution of the required warnings for cigarette packages and quarterly rotations of the required warnings for cigarette advertisements. A tobacco product manufacturer, distributor, or retailer would be required to submit a plan for the random and equal display and distribution of the required warnings on packages and the quarterly rotation in advertisements for approval by FDA. In addition, the proposed rule would require each tobacco product manufacturer required to randomly and equally display and distribute warnings on packaging or quarterly rotate warnings on advertisements in accordance with an FDA-approved plan, to maintain a copy of the FDA-approved plan, and to make the plan available for inspection and copying by officers and employees of FDA. FDA developed the new cigarette health warnings included in this proposed rule through a science-based, iterative research process. The proposed warnings are intended to promote greater public understanding of the negative health consequences of cigarette smoking. C. Legal Authority This proposed rule is being issued in accordance with sections 201 and 202 of the Tobacco Control Act (Pub. L. 111'' 31), which amend section 4 of the FCLAA (15 U.S.C. 1333). This proposed rule is also being issued based upon FDA's authorities related to misbranded tobacco products under sections 903 (21 U.S.C. 387c); FDA's authorities related to records and reports under section 909 (21 U.S.C. 387i); and FDA's rulemaking and inspection authorities under sections 701 (21 U.S.C. 371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). D. Costs, Benefits, and Informational Effects The proposed new cigarette health warnings would promote greater public understanding of the negative health consequences of cigarette smoking by presenting information about the health risks of smoking to smokers and nonsmokers in a format that helps VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42756 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules people better understand these consequences. Despite the informational effects of this proposed rule, there is a high level of uncertainty around quantitative economic benefits at this time, so we describe them qualitatively. The cost of this proposed rule consists of initial and recurring labeling costs associated with changing cigarette labels to accommodate the new cigarette health warnings, design and operation costs associated with the random and equal display and distribution of required cigarette health warnings for cigarette packages and quarterly rotations of the required warnings for cigarette advertisements, advertising- related costs, and costs associated with government administration and enforcement of the rule. We estimate that, at the mean, the present value of the costs of this proposed rule is about $1.6 billion using a three percent discount rate and roughly $1.2 billion using a seven percent discount rate (2018$). If the information provided by the cigarette health warning on each cigarette package was valued at about $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the proposed rule would equal or exceed the estimated annual costs. TABLE OFABBREVIATIONS/COMMONLY USEDACRONYMS INTHISDOCUMENT Abbreviation/ acronym What it means CDC ............... Centers for Disease Control and Prevention. COPD ............. Chronic Obstructive Pul-monary Disease. D.C. Cir .......... United States Court of Ap-peals for the District of Columbia Circuit. EO .................. Executive Order. EPA ................ Environmental Protection Agency. FCLAA ........... Federal Cigarette Labeling and Advertising Act. FD&C Act ....... Federal Food, Drug, and Cosmetic Act. FDA ................ Food and Drug Administra-tion. FTC ................ Federal Trade Commission. IOM ................ Institute of Medicine. ITC''4 ............. International Tobacco Con-trol Four Country Survey. NARA ............. National Archives and Records Administration. OFR ............... Office of the Federal Reg-ister. OMB ............... Office of Management and Budget. PAD ................ Peripheral arterial disease. PDF ................ Portable document format. PVD ................ Peripheral vascular disease. SES ................ Socioeconomic status. SIDS ............... Sudden infant death syn-drome. TABLE OFABBREVIATIONS/COMMONLY USEDACRONYMS INTHISDOCU-MENT'--Continued Abbreviation/ acronym What it means TCA state-ments. Textual warning statements specified in section 4(1) of the FCLAA. TTB ................ Alcohol and Tobacco Tax and Trade Bureau. WHO .............. World Health Organization. II. Background A. Need for the Regulation To help inform consumers of the potential hazards of cigarette smoking, Congress passed the FCLAA that required that a printed text-only warning appear on cigarette packages (Pub. L. 89''92). The 1965 warning requirement was modified by later amendments to the FCLAA, including the Comprehensive Smoking Education Act of 1984 (Pub. L. 98''474), which extended the warning requirement to cigarette advertising and updated the one warning to four warnings, frequently referred to as the Surgeon General's warnings. The FCLAA has required the inclusion of text-only warnings on cigarette packages and in cigarette advertisements for many years. As discussed in detail in section V.A, there is considerable evidence that the Surgeon General's warnings go largely unnoticed and unconsidered by both smokers and nonsmokers. These warnings, which have not changed in nearly 35 years, have been described as ''invisible'' (Ref. 1) and fail to convey relevant information in an effective way (Ref. 2 at p. 291). The Surgeon General's warnings also do not include any color graphics. In 2009, in enacting the Tobacco Control Act, Congress further amended the FCLAA and directed FDA to issue new cigarette health warnings that would include a graphic component depicting the negative health consequences of smoking to accompany the new textual warnings (section 201 of the Tobacco Control Act). In enacting this legislation, Congress also provided that FDA may adjust the warnings if FDA found that such a change would promote greater public understanding of the risks associated with the use of tobacco products (section 202 of the Tobacco Control Act). Approximately 34.3 million U.S. adults smoke cigarettes (defined as smoking at least 100 cigarettes during their lifetime and now smoking cigarettes every day or some days) and nearly 1.4 million U.S. youth (aged 12'' 17 years) smoke cigarettes (defined as past 30-day use) (Refs. 5 and 6). Results from the 2017 National Survey on Drug Use and Health demonstrate that, on average, each day in the United States, about 2,000 youth under age 18 smoke their first cigarette, and 320 youth become daily cigarette smokers (Ref. 7). The health risks associated with cigarette smoking are significant. Cigarette smoking is the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year (Ref. 8). Smoking causes more deaths each year than human immunodeficiency virus, illegal drug use, alcohol use, motor vehicle injuries, and firearm- related incidents combined (Refs. 9 and 10). Over 16 million Americans alive today live with disease caused by smoking cigarettes (Ref. 8). In addition to lung cancer, heart disease, and chronic obstructive pulmonary disease (COPD), smoking also causes numerous other serious health conditions that are less-known effects of smoking and exposure to secondhand smoke, including many types of cancer, premature birth, low birth weight, sudden infant death syndrome (SIDS), respiratory illnesses, clogged arteries, reduced blood flow, diabetes, rheumatoid arthritis, and vision conditions such as age-related macular degeneration and cataracts (Ref. 8). In developing this proposed rule, FDA carefully examined the scientific literature, including the 2014 Surgeon General's Report (Ref. 8), which identified 11 more health conditions that have been established to have sufficient evidence to infer a causal link to cigarette smoking'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports. Those health conditions examined in the 2014 Surgeon General's Report are in addition to the more than forty unique health consequences already classified in previous Surgeon General's Reports as being caused by smoking and exposure to secondhand smoke. Additional findings in the scientific literature demonstrate that the U.S. public'--including youth and adults, smokers and nonsmokers'--holds misperceptions about the health risks caused by smoking (Refs. 3 and 11''16). Through its review of the scientific literature, as well as the Agency's science-based, iterative research and development process (described in sections V and VI), FDA determined that having warning statements focused on less-known health consequences of smoking accompanied by photorealistic VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42757 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 1For the purposes of discussion throughout this document, FDA uses the term ''cigarette health warnings'' to refer to the required warnings we are proposing. 2Section 201(a) of the Tobacco Control Act amends section 4 of the FCLAA to add a new subsection (d), ''Graphic Label Statements,'' which is codified at 15 U.S.C. 1333(d). Section 202(b) of the Tobacco Control Act amends section 4 of the FCLAA to also add a new subsection (d), ''Change in Required Statements,'' which is also codified at 15 U.S.C. 1333(d). Both provisions of the Tobacco Control Act are correctly codified as ''15 U.S.C. 1333(d).'' images can promote greater public understanding of the risks associated with cigarette smoking, especially given the unnoticed and ''invisible'' 1984 Surgeon General's warnings currently used in the United States (see section V.A). Therefore, consistent with section 4 of the FCLAA (as amended by sections 201 and 202 of the Tobacco Control Act), we are proposing a set of textual warning label statements, to be accompanied by concordant color graphics depicting the negative health consequences of smoking, to appear on cigarette packages and in cigarette advertisements. Specifically, we are proposing to replace part 1141 to Title 21 of the Code of Federal Regulations (21 CFR part 1141), and the new part 1141 would require new cigarette health warnings1on cigarette packages and in cigarette advertisements. These new cigarette health warnings would consist of up to 13 textual warning label statements accompanied by color graphics depicting the negative health consequences of smoking. As required by section 4 of the FCLAA, the new cigarette health warnings would appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. As described in section VII, FDA has determined that the proposed new cigarette health warnings will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking. B. History of the Rulemaking In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued a final rule entitled ''Required Warnings for Cigarette Packages and Advertisements,'' which specified nine images to accompany the nine textual warning statements for cigarettes set out in the Tobacco Control Act. The final rule was challenged in court, and on August 24, 2012, the United States Court of Appeals of the District of Columbia vacated the rule and remanded the matter to the Agency. R.J. Reynolds Tobacco Co. v. Food & Drug Administration, 696 F.3d 1205 (D.C. Cir. 2012), overruled on other grounds by Am. Meat Inst. v. U.S. Dep't of Agric., 760 F.3d 18, 22''23 (D.C. Cir. 2014) (en banc). On December 5, 2012, the Court denied the Government's petition for panel rehearing and rehearing en banc, and the Government decided not to seek further review of the Court's ruling. In a letter to Congress on March 15, 2013, the U.S. Attorney General reported FDA's intention to undertake research to support a new rulemaking consistent with the Tobacco Control Act (Ref. 17). Central to FDA's work since that time has been evaluating how to address the D.C. Circuit's critiques of the prior rule and carefully considering how to develop a research plan and rulemaking process that will provide a robust record for a new cigarette health warnings rule. Through extensive legal, scientific, and regulatory analyses, FDA developed a science-based, iterative research process for developing new cigarette health warnings to put forth in this proposed rule that would advance the Government's substantial interest in promoting greater public understanding of the negative health consequences of smoking. Because these cigarette health warnings, as shown through the robust scientific evidence described in detail in sections VI''VII, are factual and accurate, advance the substantial Government interest in promoting greater public understanding of the negative health consequences of smoking, and are not unduly burdensome, FDA believes the warnings would pass a First Amendment analysis under Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) (or, if applied, Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980)). After reviewing public comments and weighing additional scientific, legal, and policy considerations, FDA intends to finalize some or all of the 13 cigarette health warnings proposed in this rule. C. Incorporation by Reference FDA is proposing to incorporate by reference certain material entitled ''Required Cigarette Health Warnings.'' We have included an electronic portable document format (PDF) file, containing the proposed required warnings, as a reference in the docket (Ref. 18). Any final rule would provide information on how to obtain the final electronic, layered design files for each required warning, as well as technical specifications to help regulated entities appropriately select, crop, and scale the warnings to ensure the required warnings are accurately reproduced across various sizes and shapes of cigarette packages and cigarette advertisements. FDA would also provide instructions for how to access this material (e.g., via download through FDA's website or a file transfer protocol website). Any material incorporated by reference must meet the Office of the Federal Register's (OFR) requirements for incorporating material by reference (5 U.S.C 552(a) and 1 CFR part 51). III. Legal Authority The Tobacco Control Act was enacted on June 22, 2009, amending the FD&C Act and providing FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act amends section 4 of the FCLAA to require that nine new health warning statements appear on cigarette packages and in cigarette advertisements and directs FDA to ''issue regulations that require color graphics depicting the negative health consequences of smoking'' to accompany the nine new health warning statements. Under section 201 of the Tobacco Control Act, FDA may adjust the type size, text, and format of the cigarette health warnings as FDA determines appropriate so that both the color graphics and the accompanying textual warning label statements are clear, conspicuous, and legible and appear within the specified area (15 U.S.C. 1333(d)). Section 202(b) of the Tobacco Control Act also amends section 4 of the FCLAA to add a new subsection2that permits FDA to, after providing notice and an opportunity for the public to comment, adjust the format, type size, color graphics, and text of any of the label requirements, or establish the format, type size, and text of any other disclosures required under the FD&C Act, if such a change would promote greater public understanding of the risks associated with the use of tobacco products. Such adjustments, including adjustments to the text of some of the warning statements and to the number of proposed required warnings, are included as part of this proposed rule. These requirements are supplemented by the FD&C Act's misbranding provisions, which require that product labeling and advertising include required warnings. For example, a tobacco product is deemed misbranded under section 903(a)(1) or (a)(7)(A) of the FD&C Act if its labeling or advertising is false or misleading in any VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42758 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules particular. Under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), in determining whether labeling or advertising is misleading, FDA considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Similarly, under section 903(a)(8)(B) of the FD&C Act, a tobacco product is deemed misbranded unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter, which FDA interprets as including packages, a brief statement of, among other things, the relevant warnings. Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act, and sections 704 and 905(g) provide FDA with general inspection authority. Section 909 of the FD&C Act authorizes FDA to require tobacco product manufacturers to establish and maintain records, make reports, and provide such information as the Agency may by regulation reasonably require to ensure that a tobacco product is not adulterated or misbranded and to otherwise protect public health. IV. Cigarette Use in the United States and the Resulting Health Consequences Cigarette smoking is the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year (Ref. 8). Smoking causes more deaths each year than human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, and firearm- related incidents combined (Refs. 9 and 10). In addition to lung cancer, heart disease, and COPD, smoking also causes numerous other serious health conditions, including many types of cancer, premature birth, low birth weight, SIDS, respiratory illnesses, clogged arteries, reduced blood flow, diabetes, rheumatoid arthritis, and vision conditions such as age-related macular degeneration and cataracts (Ref. 8). A. Smoking Prevalence and Initiation in the United States Approximately 34.3 million U.S. adults and nearly 1.4 million U.S. youth (aged 12''17 years) smoke cigarettes (Refs. 5 and 6). Over 16 million Americans alive today live with disease caused by smoking cigarettes (Ref. 8). Results from the 2017 National Survey on Drug Use and Health demonstrate that, on average, each day in the United States, about 2,000 youth under age 18 smoke their first cigarette, and 320 youth become daily cigarette smokers (Ref. 7). Cigarettes remain the most commonly used tobacco product in the United States among adults, and a substantial percentage of U.S. adults are cigarette smokers (Ref. 5). Although cigarette smoking prevalence has generally declined over the past several decades, results from the 2017 National Health Interview Survey indicate that approximately 34.3 million U.S. adults (or 14.0 percent of the U.S. adult population) are current cigarette smokers (Ref. 5). Among these adult smokers, the vast majority'--75 percent, or approximately 25.7 million people'-- smoke every day. Smoking prevalence remains higher than the national average among certain demographic subgroups of the adult population. For example, among adults with differing levels of education, the highest prevalence rates have been observed in adults with lower education levels. Data indicate that 36.8 percent of adults with a General Education Development (GED) certificate and 23.1 percent of adults with less than a high school diploma were current smokers in 2017, compared with 7.1 percent of adults with a college degree and 4.1 percent of adults with a graduate degree (Ref. 5). The National Youth Tobacco Survey is a nationally representative survey of U.S. students attending public and private schools in grades 6 through 12. The 2018 National Youth Tobacco Survey data showed that past 30-day smoking prevalence among high school students was 8.1 percent, representing 1.2 million young people, of which 23.1 percent were frequent smokers (defined as cigarette use on 20 or more of the past 30 days) (Ref. 6). The data also showed that past 30-day prevalence among middle school students was 1.8 percent, representing 200,000 youth, of which 19.7 percent were frequent smokers (Ref. 6). These youth who have smoked in the past 30 days are at particular risk of becoming nicotine dependent through smoking. In one study, 22 percent of 7th grade students who had initiated occasional smoking reported a symptom of nicotine dependence within 4 weeks after starting to smoke at least once per month (Ref. 19). Among 60 students with symptoms of nicotine dependence, 62 percent reported experiencing their first symptom before smoking daily or began smoking daily only upon experiencing their first symptom (Ref. 19). An analysis of the 2012 National Youth Tobacco Survey found that a substantial proportion of adolescents that use tobacco report symptoms of nicotine dependence, even with low levels of use (Ref. 20). Among adolescents who reported only smoking cigarettes, 42.6 percent reported having strong cravings to smoke, a symptom of nicotine dependence, in the past 30 days (Ref. 20). B. Negative Health Consequences of Smoking Cigarette smoking remains the leading cause of preventable disease and death in the United States. The 2014 Surgeon General's Report found that cigarette smoking was responsible for an average of over 480,000 premature deaths in the United States each year from 2005 to 2009, of which almost 440,000 occurred because of active smoking (Ref. 8). The report also found that cigarette smoking was directly responsible for 163,700 deaths from cancer, 160,600 deaths from circulatory conditions, and 113,100 deaths from pulmonary diseases each year. As a consequence of secondhand smoke exposure, there were an additional 7,330 deaths from lung cancer and 33,950 deaths from coronary heart disease annually. Cigarette smoking therefore accounted for 87 percent of deaths from lung cancer, 79 percent of deaths from COPD, and 32 percent of deaths from coronary heart disease in the United States from 2005 to 2009. It has also been estimated that approximately 14 million U.S. adults had serious medical conditions attributable to cigarette smoking in 2009 (Ref. 21). COPD accounted for the largest number of these conditions with an estimated 7.5 million Americans living with this condition because of smoking. Other serious conditions for which smoking-attributable morbidity was estimated included heart attack (2.3 million cases), cancer (1.3 million cases), and stroke (1.2 million cases) (Ref. 21). Because individuals can live for many years with some of these health conditions and, in some cases, smoking-attributable health conditions can develop after a smoker has stopped smoking (e.g., lung cancer) (e.g., Ref. 22), the morbidity burden from cigarette smoking is expected to remain high. Cigarette smoking also causes many other health conditions; however, the link between smoking and these conditions is less known to the public. For example, a meta-analysis found that current smokers are twice as likely as never smokers to have age-related macular degeneration (Ref. 23), a degenerative condition of the tissues of the retina. Current smokers have also been found to have approximately 50 percent higher risk of age-related cataracts than never smokers according to meta-analysis (Ref. 24). Cigarette smokers have an increased risk of VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42759 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules numerous circulatory and metabolic conditions. Another meta-analysis found that smokers have approximately 45 percent higher risk of diabetes than nonsmokers (Ref. 25). It is estimated that 1.8 million Americans have diabetes due to smoking (Ref. 21) and that 9,000 Americans die of diabetes due to smoking each year (Ref. 8). Current smokers are nearly three times as likely as never smokers to have peripheral arterial disease, a condition that can lead to amputation of limbs (Ref. 26). Male smokers have been found to be 40 to 50 percent more likely to have erectile dysfunction due to diminished blood flow than nonsmokers (Refs. 27 and 28). Smokers also have increased risk of many types of cancer, beyond lung cancer. For example, current smokers have been found to have almost four times the risk of bladder cancer as never smokers (Ref. 29), and it has been estimated that smoking is responsible for 5,000 bladder cancer deaths in the United States each year (Ref. 30). Smoking has also been established to cause cancers of the head and neck, such as oral cancer. The American Cancer Society's Cancer Prevention Study II found elevated relative risks (i.e., the risk of the conditions among smokers compared to nonsmokers) for current smoking of 10.9 for males and 5.1 for females for lip, oral cavity, and pharyngeal cancers (i.e., male smokers have 10.9 times higher risk of developing these cancers than male nonsmokers, and female smokers have 5.1 times higher risk of developing these cancers than female nonsmokers) and 14.6 for males and 13.0 for females for laryngeal cancer (Ref. 31). These increased risks result in approximately 4,900 deaths from lip, oral, and pharyngeal cancers and 3,000 deaths from laryngeal cancer from smoking in the United States each year (Ref. 30). Secondhand smoke exposure also increases disease risks, especially among infants and children. For example, secondhand smoke exposure has been found to be causally linked to stroke, lung cancer, and other disease in adults and lower respiratory illness in children (Ref. 8). Additionally, maternal smoking (i.e., smoking while pregnant) has been found to be associated with low birth weight (Ref. 32) and fetal growth restriction (Ref. 33). The California Environmental Protection Agency (EPA) has estimated that there are 24,500 cases of low birth weight due to maternal exposure to secondhand smoke (referred to as ''environmental tobacco smoke'') in the United States per year (Ref. 34). Other health consequences in children exposed to secondhand smoke include middle ear disease, respiratory symptoms, impaired lung function, lower respiratory illness, and SIDS, and it is estimated that 400 infants die from SIDS due to exposure to secondhand smoke each year (Ref. 8). V. Data Concerning Cigarette Health Warnings A. The Current 1984 Surgeon General's Warnings Are Inadequate As described in this section, cigarette warnings in the United States have not changed in nearly 35 years, and the size and location of the warnings have not changed in more than 50 years. The unchanged content of these health warnings, as well as their small size and lack of an image, severely impairs their ability to convey relevant information about the negative health consequences of cigarette smoking in an effective way (Ref. 2). Research has repeatedly illustrated that the current 1984 warnings used in the United States frequently go unnoticed or fail to convey relevant information regarding health risks (Ref. 4). Moreover, although many members of the U.S. public possess some general knowledge of the harms of smoking, substantial gaps in knowledge remain, and smokers have misinformation regarding cigarettes and the negative health effects of smoking (Refs. 36 and 37). Cigarette packages and advertisements can serve as an important channel for communicating health information to broad audiences that include both smokers and nonsmokers. Daily smokers, who in 2016 averaged 14.1 cigarettes per day, are potentially exposed to the warnings on packages over 5,100 times per year, and, because these packages are not always concealed and are often visible to those other than the person carrying the package, warnings on those packages are potentially viewed by many others, including nonsmokers (Refs. 38 and 40). Smokers and nonsmokers, including adolescents, also are frequently exposed to cigarette advertising appearing in a range of marketing channels, including print and digital media, outdoor locations, and in and around retail establishments where tobacco products are sold (Refs. 42 and 43). The importance of cigarette advertising is reflected in cigarette companies' substantial annual expenditures for cigarette advertising and promotion in the United States, which totaled $1.3 billion in 2017 (not including the price discounts paid to cigarette retailers and wholesalers to help lower the price of cigarettes to consumers) (Ref. 41). Retail displays of cigarette packages and other in-store cigarette advertisements are typically located in areas of a store that are seen by a majority of consumers, such as near the checkout counter, and provide significant opportunities for communicating with smokers and nonsmokers (Refs. 44''47). The inclusion of health warnings on cigarette packages and in advertisements therefore can provide a critical opportunity to help smokers and nonsmokers of all ages better understand the negative health consequences of smoking. Prominent displays of such warnings are more likely to be noticed and to impact learning and knowledge than non- prominent displays (Refs. 3, 4, 39, 48'' 50). The World Health Organization's (WHO) Framework Convention on Tobacco Control has also recommended large pictorial cigarette warnings on tobacco products as a way to increase public awareness about the negative health effects of tobacco use (Ref. 51). Given the extreme risks cigarette smoking poses to the public health, new warnings, as described in detail below and as included in this proposed rule, are critical to promote greater public understanding of the negative health consequences of cigarette smoking. 1. The Current 1984 Surgeon General's Warnings Have Not Changed in Nearly 35 Years In response to the Surgeon General's first major report on smoking and health in 1964, Congress passed the FCLAA to require warning labels on all cigarette packages. The text-only warning was written in small print and located on one of the side panels of each cigarette package. It stated ''CAUTION: Cigarette Smoking May Be Hazardous to Your Health.'' This language appeared on all cigarette packages sold from January 1, 1966, through October 31, 1970. In 1969, Congress passed the Public Health Cigarette Smoking Act (Pub. L. 91''222), which slightly modified the warning statement on cigarette packages, but did not require any warnings in cigarette advertisements. The new warning language, ''Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Health'', appeared on cigarette packages sold in the United States from November 1, 1970, through October 11, 1985. In 1972, the Federal Trade Commission (FTC) issued consent orders requiring six major cigarette manufacturers and distributors to include in all of their cigarette advertisements a clear and conspicuous disclosure of the same warning required to be on packages (Ref. 35). VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42760 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 3Slightly different health warnings were required on outdoor billboard advertisements. In 1981, the FTC issued a report to Congress that concluded that the cigarette health warnings had little effect on public awareness and attitudes toward smoking. The FTC report stated that the existing warning likely was ineffective because it: (1) Was overexposed and worn out; (2) lacked novelty; (3) was too abstract; and (4) lacked personal relevance (Ref. 52). Subsequently, Congress again modified cigarette warnings by enacting the Comprehensive Smoking Education Act of 1984 (Pub. L. 98''474), which required the following four rotational health warnings on packages and advertisements:3 ' Surgeon General's Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy. ' Surgeon General's Warning: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health. ' Surgeon General's Warning: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth and Low Birth Weight. ' Surgeon General's Warning: Cigarette Smoke Contains Carbon Monoxide. In addition, the law established the location and format for these warnings and mandated that they be rotated quarterly. Despite an FTC recommendation to change the size and shape of warnings, Congress retained the size and rectangular format of previous warnings (Ref. 218 at pp. 11, 12, 24, and 25; see also Ref. 52). As implemented, for example, this means the Surgeon General's warnings have continued to be printed in small type on one side panel of cigarette packages from October 12, 1985, to the present. Nearly 35 years have passed since these changes and a substantial body of research shows that the current 1984 Surgeon General's warnings do not effectively promote greater public understanding of the negative health consequences of smoking and that there are better approaches to cigarette health warnings. 2. The Current 1984 Surgeon General's Warnings Do Not Effectively Inform the Public Because They Do Not Attract Attention, Are Not Remembered, and Do Not Prompt Thoughts About the Risks of Smoking Pictorial cigarette warnings that increase message processing will aid consumer understanding of the negative health consequences of smoking. Cognitive theories and information processing models describe how information is gathered from the senses and is stored and processed in the brain (Ref. 111). Message processing is important to learning and understanding. Once an individual notices a warning, he or she mentally stores the information found in the warning and gives meaning to that information (Ref. 112). The individual mentally processes the information and builds on it, which helps them better recall and remember the information (Refs. 43 and 113). How much the information is mentally processed, reflected on, and thought about impacts how well the information is learned and understood (Ref. 114). Attracting and maintaining attention is an important step in how communications, such as warning labels, can inform the public (Refs. 53 and 54). Findings from the International Tobacco Control Four Country Survey (ITC''4) found that self-reports of noticing the health warnings on cigarette packages were positively associated with health knowledge among adults across the four countries studied, including the United States (Ref. 3). However, eye-tracking studies, which assess attention to visual stimuli, have documented low levels of attention to the current Surgeon General's warnings in both adults and adolescents, meaning that they do not attract attention (Refs. 55 and 56). One study of adolescents viewing tobacco advertisements found that the average viewing time of the Surgeon General's warnings amounted to only 8 percent of the total advertisement viewing time; nearly half (43.6 percent) of adolescents did not look at the warnings at all; and about one-third (36.7 percent) did not look at the warning long enough to read any of its words (Ref. 55). In that study, adolescents were unable to recall the content of the current Surgeon General's warnings or to correctly recognize the warnings from a list, indicating that the current warnings are likely ineffective among adolescents (Ref. 55). Similarly, a study of middle school students who viewed tobacco advertisements with the Surgeon General's warnings found the total amount of time spent focusing on the warning statement averaged slightly less than one second (Ref. 56). Similar evidence that the Surgeon General's warnings do not attract attention was found with a sample of adult smokers in 2011 who were instructed to look at a tobacco advertisement with a warning for 30 seconds, and of that time participants spent an average of only 2.8 seconds looking at the Surgeon General's warning specifically (Ref. 57). As discussed in the following paragraphs, researchers have also found that the current 1984 Surgeon General's warnings are largely unnoticed and unconsidered by both smokers and nonsmokers. This is in accord with the findings of a major report on tobacco policy in the United States by the Institute of Medicine (IOM) in 2007, which stated that the 1984 warnings on U.S. cigarette packages are both ''unnoticed and stale'' (Ref. 2 at p. 291). Similar conclusions were drawn in a study with a nationally representative sample of middle and high school students in the United States in 2012. Less than half (46.9 percent) of students who saw a cigarette package with the Surgeon General's warning reported seeing the warning ''most of the time'' or ''always'' (Ref. 58). Noticeability of the Surgeon General's warnings is also low for adults. Findings from the ITC''4 published in 2007 found that only 30 percent of U.S. adult smokers noticed the warning ''often'' or ''very often'' (Ref. 4). Even if people notice the warnings, less than 20 percent of smokers in the United States report reading the warning text ''often'' or ''very often'' (Ref. 4). Moreover, additional findings from the ITC''4 found that less than half (46.7 percent) of U.S. respondents considered cigarette packages as a source of information on the negative health effects of smoking compared to 84.3 percent of respondents in Canada, where pictorial health warnings are required (Ref. 3). A study in 2009 found that 60 percent of U.S. adult smokers said they ''never'' or ''rarely'' noticed warnings labels on cigarette packages in the past month (Ref. 59). More recently, an analysis of the Population Assessment of Tobacco and Health Study, an ongoing, nationally representative, longitudinal cohort study of adults and youth in the United States, found that the current health warnings on cigarette packages often go unnoticed (Refs. 60 and 61). In the most recent publicly available data (data collected from late 2016 through the end of 2017), nearly three-quarters (73.5 percent) of the U.S. population, including both youth and adults, indicated they ''never'' or ''rarely'' noticed the health warnings on cigarette packages in the past 30 days (Ref. 61) (data available at https://www.icpsr.umich.edu/icpsrweb/ NAHDAP/studies/36231). Among U.S. youth and adults who have noticed cigarette health warnings in the past 30 days, 52.0 percent of youth and 53.5 percent of adults responded that they ''never'' or ''rarely'' read or looked closely at the warnings in the past 30 VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42761 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules days (i.e., do not attract attention) (Ref. 61). Other data support that adolescents also do not see or read, and do not remember, the current 1984 Surgeon General's warnings on cigarette packages and advertisements. A study of ninth-grade students found that nearly one-third (27.8 percent) reported never seeing warning labels on cigarettes and nearly half (46.1 percent) could not correctly identify the location of the warnings on the package (Ref. 62). Similar data suggest that people also failed to notice or read the current 1984 Surgeon General's warnings prior to the 1999 Master Settlement Agreement, when cigarette advertising was common on outdoor billboards. One study of adults found that drivers could read the entire warning message on only 5 percent of highway billboard advertisements and were only able to fully read the health warning on 18 of the 39 street billboards examined in the study (Ref. 63). All these results indicate that the current warnings are not appropriately conspicuous in advertisements compared to the rest of the advertising message, as discussed in more detail below. Not only do the current Surgeon General's warnings not attract attention, but they also are not remembered'--and remembering is a key component to long-term understanding of the information beyond surface-level noticing of the information presented. Viewing time of U.S. cigarette warnings is positively associated with recall (Refs. 55 and 56). Studies have documented low recall of warning statements for both adults and adolescents. In a study conducted with 13- to 17-year-olds who viewed five tobacco advertisements containing Surgeon General's warnings, only 19 percent were able to recall the general theme of the warning statement (Ref. 55). In another study, only between 20 and 53 percent of high school students could correctly recall each of the four Surgeon General's warnings even when they were provided with the actual wording, and some incorrectly recalled having seen a warning that was not being used at the time (Ref. 62). Similarly, low levels of recall were found in a study with high school students who viewed tobacco advertisements containing Surgeon General's warnings. Although most students (79 percent) reported seeing a warning, very few (15 percent) reported the warning statement's concept and even fewer (6 percent) correctly reported its exact message (Ref. 64). Beyond being noticed and being remembered, additional measures of how well a message helps people understand its contents are to ask whether the message makes them think about the message's substantive information'--showing an even deeper understanding of the information being communicated. These measures, often termed ''cognitive elaboration,'' are well-validated and often used in studies of cigarette health warnings (See, e.g., Refs. 80 and 84). Research demonstrates that the current 1984 Surgeon General's warnings do not prompt thoughts about the risks of smoking, and they are also perceived to be ineffective at making people think about those risks. Less than 40 percent of U.S. adult smokers in the ITC''4 reported that the Surgeon General's warnings make them think about the health risk of smoking, a level that was consistent between 2002 and 2005 (Ref. 4). In a study in Buffalo, NY, 62 percent of adult smokers reported that the Surgeon General's warning labels made them think ''a little'' or ''not at all'' about the health risks of smoking (Ref. 59). Participants in a randomized clinical trial with smokers in California and North Carolina reported that the Surgeon General's warnings made them think about the warning message only a little (an average of 2.3 on a scale of 1 to 5) and made them think about the harms of smoking only somewhat (an average of 2.9 on a scale of 1 to 5) (Ref. 65). That study also found that the Surgeon General's warnings were perceived as not impactful (Ref. 65). Health communication research has found that adolescents also report that the current 1984 U.S. cigarette warnings do not prompt thoughts about the health risks of smoking. Among a nationally representative sample of U.S. middle and high school students who reported seeing a cigarette package, less than one- third (30.4 percent) reported that cigarette warning labels made them think about health risks ''a lot'' (Ref. 58). This proportion is even lower for adolescent current smokers, as only 13.8 percent reported that warnings made them think ''a lot'' about health risks (Ref. 58). 3. There Remain Significant Gaps in Public Understanding About the Negative Health Consequences of Cigarette Smoking Consumers suffer from a pervasive lack of knowledge about and understanding of the negative health consequences of smoking. A nationally representative survey of 1,046 adult smokers found widespread misperceptions regarding cigarettes and the negative health effects of smoking (Refs. 36 and 37). Thirty-three percent of adult smokers in the sample did not know that cigarettes were a proven cause of cancer (Refs. 36 and 37). Additionally, a quarter of the sample did not know that smoking was still dangerous to health even without inhaling (Refs. 36 and 37). Another study of 776 adult and adolescent smokers and nonsmokers asked participants what illnesses are caused by smoking (Ref. 15). Whereas the majority of respondents identified lung cancer as a smoking-related lung disease, only half mentioned emphysema (Ref. 15). A much smaller proportion identified cardiovascular disease (Ref. 15). Very few (3 to 7 percent) named any other smoking- related cancer (besides lung, mouth, throat, or gum cancer), such as pancreatic, cervical, bladder, or kidney cancer (Ref. 15). Very few mentioned negative cardiovascular effects, such as hypertension, atherosclerosis, aneurisms, or stroke, as smoking-related illnesses. In addition, people underestimated the percent of people diagnosed with lung cancer who would die from the condition (Ref. 15). Findings from another study indicate that approximately one-third of U.S. adult smokers believe that cigarettes have not been proven to cause cancer (Ref. 211). Many studies show that the public has limited understanding of other smoking-related health consequences such as impotence (Refs. 3, 12, 13, and 67; U.S. studies); stroke (Refs. 15 and 67; U.S. studies); gangrene (Ref. 12; U.S. study); vision impairment/blindness (Refs. 11, 119, and 201; non-U.S. studies); emphysema and chronic bronchitis (Ref. 11; non-U.S. study); other cancers outside of lung cancer, such as bladder cancer (Refs. 11, 13, 15, and 67; both U.S. and non-U.S. studies); the effects of secondhand smoke on nonsmoker adults and children (Ref. 16; non-U.S. study); and impacts on reproductive health and pregnancy (Refs. 13 and 67; U.S. studies). Studies in the United States have also documented that people are largely unaware of the health risks of smoking specific to women, including infertility (Refs. 13, 14, and 67), osteoporosis, early menopause, spontaneous abortion, ectopic pregnancy, and cervical cancer (Ref. 14 and 67). Research findings also show gaps in public understanding of the negative health effects of smoking during pregnancy. For example, one focus group study conducted in four U.S. cities with current smoking women ages 18 to 30 years found that participants had low to moderate awareness of smoking outcomes related to pregnancy (Ref. 68). These findings suggest that the public does not VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42762 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules understand the complete range of illnesses caused by smoking, indicating gaps in public understanding of the negative health consequences of smoking. B. Cigarette Health Warnings That Are Noticeable, Lead to Learning, and Increase Knowledge Will Promote Public Understanding About the Negative Health Consequences of Smoking To understand a message, individuals must first attend to the message (i.e., notice and be made aware of the message), and then they must process the information in the message (i.e., acquire knowledge of and learn that information) (Ref. 70). When introduced in other countries, pictorial cigarette warnings have been shown to increase understanding of the negative health consequences of smoking (Refs. 3, 4, 39, and 48). The following section describes studies that demonstrate how pictorial cigarette warnings promote greater public understanding about the health consequences of smoking as they: (1) Increase the noticeability of the warning's messages; (2) increase knowledge and learning of the negative health consequences of smoking; and (3) benefit subpopulations that have disparities in knowledge about the negative health consequences of smoking. These studies incorporate measures that evaluate the impact of tobacco health warnings on understanding, many of which were drawn from the WHO's International Agency for Research on Cancer handbook on the methods for evaluating tobacco control policies (Ref. 71). 1. Cigarette Health Warnings That Are Noticeable Will Lead to Increased Attention to the Warning Message To promote understanding of the content of a warning message, individuals must first notice the warning and must be made aware of the information contained in that warning (Refs. 53 and 54). In the scientific literature on consumer warnings, features that increase the noticeability of the warning label (also known as vivid features, such as images) increase the likelihood that people will see and pay attention to the warning message (Refs. 73 and 74). Physical features (e.g., use of pictures or color) that make a message more noticeable increase attraction and attention to the message (Ref. 75). A meta-analysis found that warnings, not specific to cigarette warnings, that include such features were more likely to attract attention than warnings without these features (Ref. 76). One experiment among a sample of U.S. adult smokers and middle school students found that participants who viewed pictorial cigarette warnings with full color spent more time looking at the warning compared to participants who either viewed black and white pictorial warnings or text-only warnings (Ref. 77). Communication theory and research explain the message characteristics that impact how an individual is exposed to, attends to, comprehends, and understands the content of the message (Refs. 43, 78, and 79). Messaging that includes vivid features (e.g., images) increases attention to as well as cognitive elaboration (or thinking about) and processing of the message, which leads to increased message comprehension (Ref. 80). Messages that include vivid features, such as images, are easier to imagine and are more engaging compared to messages that do not include vivid features. An online experiment with 2,156 adults that examined varying levels and combinations of vivid features (i.e., testimonial images, identifying information, nontestimonial explanatory statements, testimonial explanatory statements, and contextual information) found that increasing the number of vivid features of cigarette warnings increased engagement with the message (Ref. 81). a. Pictorial cigarette warnings increase attention to warning messages, which leads to increased understanding of the negative health consequences of smoking. Research supports the role of pictorial cigarette warnings in increasing attention to and noticeability of warnings about the harms of smoking. More noticeable pictorial cigarette warnings are more effective in communicating the harms of smoking compared to text-only cigarette warnings in other countries as well as in experimental studies conducted in the United States (Refs. 3, 49, 50, 82, and 83). Pictorial cigarette warnings result in higher noticeability of and attention to the warning message compared to text-only cigarette warnings (Refs. 4, 48, 72, 77, 82''94). One study using data from ITC-Canada and ITC-Mexico assessed smokers' reactions to cigarette health warnings (Ref. 48). During the study period, Mexico had text-only cigarette warnings while Canada had pictorial cigarette warnings. Compared to adult smokers in Mexico, Canadian adult smokers reported greater levels of noticing the warning label and thinking about the harms of smoking. Another ITC study assessed noticing warnings in a sample of Chinese and Malaysian adult smokers (Ref. 83). After introduction of the new Malaysian pictorial cigarette warnings in 2009, there was a significant increase in the percentage of smokers who reported noticing the health warnings often or very often (54.4 percent pre- implementation compared to 67 percent post-implementation) (Ref. 83). Another study in the United States surveyed a sample of adolescents who had a parent, guardian, or other household member who participated in a randomized controlled trial in which a single pictorial or text-only warning was displayed on the parent's cigarette package for 4 weeks (Ref. 94). The pictorial cigarette warnings drew greater attention among adolescents in the study, and adolescents more accurately recalled the pictorial cigarette warning. In addition, the pictorial cigarette warning was recognized from a list of warnings more than the text-only cigarette warning. Studies demonstrate that increasing notice of and attention to the information in a cigarette health warning promotes understanding of the message. Data from the ITC''4 showed that noticing health warnings on cigarette packages was associated with increased knowledge about the health consequences of smoking (Ref. 3). Smokers who reported noticing the cigarette health warnings were more likely to report believing that smoking causes the specific health consequences contained in the warnings, compared to those who did not notice the warnings. Once individuals notice and attend to the warning, they are able to store and process the information in the warning that can be recalled later; these processes contribute to engagement with the message and lead to understanding. The important role of attention in message storing and processing is well supported by research (see, e.g., Ref. 54). For example, a study with smokers found that the frequency of noticing a cigarette health warning was associated with frequency of thinking about the dangers of smoking (Ref. 95). In addition, studies conducted in the United States with youth and adults have shown that longer time spent looking at a cigarette health warning was associated with greater recall of the information found on the warning (Refs. 56, 57, and 217), indicating that attention to a cigarette health warning leads to storing of the warning content and later recall of that information. b. 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42763 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules warning as well as aiding comprehension and understanding of the information contained in the message warning. In a United States- based experimental study, repeated viewing of warning labels is associated with increased recognition and memory of the content of the label (Ref. 96). Research on recorded eye movement during reading of a warning label provides support for the link between reading and comprehension of the warning (Ref. 97). Measures of viewing duration (e.g., how long the eyes are fixed on specific words in the warning) are associated with how much participants are processing and can later recall that information (Refs. 56, 97, and 98). Many studies support the finding that cigarette health warnings with vivid features (e.g., images) are read and looked at more closely compared to those without these features (Refs. 83, 86, 92; non-U.S. studies). One study of U.S. adult smokers showed that viewing a pictorial cigarette warning led to higher reported reading or looking closely at the warning, label memory and recall, and perceived label credibility compared to text-only cigarette warnings (Ref. 85). Another study of U.S. adult smokers showed that participants who had a pictorial cigarette warning put on their packs reported looking at the label more often and correctly recalled the label's contents more often than those with packs that had a text-only warning on them (Ref. 99). A study in Australia found that students reported more frequent reading and attending to the pictorial cigarette warnings after they were introduced, as compared to when text-only warnings were displayed (Ref. 100). 2. Pictorial Cigarette Warnings Can Address Gaps in Public Understanding About the Negative Health Consequences of Smoking a. Pictorial cigarette warnings increase knowledge and accurate health beliefs by addressing gaps in public understanding about the negative health consequences of smoking. Pictorial cigarette warnings increase consumer knowledge of the harmful effects of smoking, which promotes greater public understanding of the negative health consequences of smoking. Numerous non-U.S. studies support the role of pictorial cigarette warnings in promoting knowledge gains in cigarette-related health risks after implementation of those warnings (Refs. 3, 39, 48, 49, 100, 102''107, 202, and 203). One review examined health warning messages on tobacco products and concluded that health warnings increased correct knowledge about the negative health effects caused by smoking (Ref. 39). That review concluded that pictorial cigarette warnings are significantly more likely to draw attention, result in greater processing, and improve memory of the health warning (Ref. 39). Summarizing these effects among smokers, the National Cancer Institute concluded in its Tobacco Control Monograph 21 that large pictorial health warnings on tobacco packages are effective in increasing smokers' knowledge (Ref. 66). Visual depictions of smoking-related disease in pictorial cigarette warnings help address gaps in public understanding of the negative health consequences of smoking by providing new information beyond what is in the text of the warnings through reinforcing and helping to depict and explain the health effect described in the text (Ref. 101; see also Ref. 39 at p. 330). Many studies have shown that exposure to pictorial cigarette warnings promotes knowledge of the negative health effects of smoking (Refs. 3, 48, and 102''107). For example, a study using data from ITC-Canada and ITC-Mexico assessed smokers' reactions to cigarette health warnings (Ref. 48). During the study period, Mexico had text-only cigarette warnings while Canada had pictorial cigarette warnings. Compared to smokers in Mexico, Canadian smokers had higher levels of knowledge about smoking-related health outcomes, such as stroke, impotence, and mouth cancer. Another study using ITC''4 data showed that Canadian smokers were almost three times more likely than non- Canadian smokers to accurately believe that smoking causes impotence; during the time of the study, Canada was the only country to require pictorial cigarette warnings and the only country that had a warning about impotence (Ref. 3). Another study surveyed adult male smokers to assess changes in awareness of health risks from smoking after Malaysia implemented new pictorial cigarette warnings (Ref. 102). Findings showed that knowledge of health risks across 13 different health conditions was greater after pictorial cigarette warnings were introduced in Malaysia (Ref. 102). In March 2007, Australia became the first country to implement pictorial cigarette warning on cigarette packages with the message that smoking causes blindness. ITC data from adult smokers were analyzed assessing knowledge that smoking causes blindness (Ref. 103). Findings indicated that Australian smokers were significantly more likely to report that smoking causes blindness compared to smokers in countries where there were no cigarette health warnings about blindness (Canada, the United Kingdom, and the United States) (Ref. 103). After the introduction of the blindness warning, Australian smokers were dramatically more likely than before to report knowing that smoking causes blindness (62 compared to 49 percent) (Ref. 103). Another study assessing smokers' beliefs about the health effects of smoking in South Australian smokers found that, post-implementation of pictorial cigarette warnings, participants reported more health beliefs about smoking-related negative health effects, such as blindness/eye damage, stroke, harm to unborn babies, mouth cancer, throat cancer, blocked arteries, as compared to their health beliefs when previous text-only warnings were required (Ref. 105). Research supports that exposure to pictorial cigarette warnings leads to knowledge gains about the harms of smoking among adolescents, whereas, as discussed earlier, the current 1984 Surgeon General's warnings do not. A report of Canadian warnings indicated that pictorial cigarette warnings improved knowledge of specific negative health effects of smoking among adolescents (e.g., increased knowledge of bladder cancer, impotence in men, mouth cancer, gum or mouth disease, reduced growth in babies during pregnancy, and strokes) (Ref. 108). One study that surveyed Australian students in grades 8 through 12 found increases in the proportion of students who recognized the smoking- related effects of mouth cancer and peripheral vascular disease after the introduction of new pictorial cigarette warnings on those topics (Ref. 100). Another study examined the effects of viewing health warnings on beliefs about the specific negative health effects of smoking among adult smokers and adolescents (aged 16 to 18 years). For both adults and adolescents, exposure to pictorial cigarette warnings that highlighted specific health topics led to increases in correct beliefs about smoking causing the specific health topic in the warning. For some topics (e.g., smoking causes strokes, smoking causes impotence), increases in correct health beliefs were only found in adolescents and not adults (Ref. 106). There are a small number of recent studies conducted in the United States that failed to find an effect of pictorial cigarette warnings on increasing health beliefs about the negative effects of smoking (Refs. 77, 84, 109, and 110). The failure in those studies to find an VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42764 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules association between exposure to pictorial cigarette warnings and increased health beliefs may be partly or fully attributable to the fact that, as previously described, the public already has a high pre-existing level of knowledge of the specific health consequences described in the warnings tested in those studies, some of which included warning statements set forth by Congress in the Tobacco Control Act. For example, a few studies have found increases in knowledge only of less- known conditions (e.g., blindness) but not of more well-known negative health effects (e.g., lung cancer) (Refs. 12 and 105). Notably, the increases in health beliefs from pictorial warnings were greatest for negative health effects that started with lower levels of prior beliefs about that health condition, such as gangrene and stroke (Ref. 12). This suggests that the impact of cigarette warnings on knowledge is greatest for topics that are not well known to the public. In summary, pictorial cigarette warnings that convey the risk of specific negative health effects from smoking can increase beliefs and knowledge about the health consequences of smoking, particularly for negative health effects that are less known. b. Pictorial cigarette warnings increase information processing and learning of new information about the negative health consequences of smoking. Pictorial cigarette warnings that increase message processing will aid consumer understanding of the negative health consequences of smoking. Cognitive theories and information processing models describe how information is gathered from the senses and is stored and processed in the brain (Ref. 111). Message processing is important to learning and understanding. Once an individual notices a warning, he or she mentally stores the information found in the warning and gives meaning to that information (Ref. 112). The individual mentally processes the information and builds on it, which helps them better recall and remember the information (Refs. 43 and 113). How much the information is mentally processed, reflected on, and thought about impacts how well the information is learned and understood (Ref. 114). Health warnings are therefore frequently assessed by looking to how noticeable they are; how well remembered their content is; and how much they prompt individuals to think about their content. i. Pictorial cigarette warnings lead to increased thinking about the harms of smoking. One way to process information found in a health message includes thinking about the message's content. Research (from both U.S. and international studies) has demonstrated that pictorial cigarette warnings lead to increased thinking (i.e., ''cognitive elaboration'') about the content of the warning (Refs. 49, 83, 84, 86, 87, 100, 102, 104, and 115). For example, one study of U.S. adult smokers found that participants who were exposed to pictorial cigarette warnings processed the information in deeper ways, such as thinking about their own health problems (e.g., diabetes) in the context of smoking (Ref. 99). Participants assigned to view pictorial cigarette warnings had more accurate recall and were better able to describe the content of the warning compared to those assigned to view the text-only warnings (Ref. 99). A meta- analysis of experimental studies conducted in twenty countries compared pictorial cigarette warnings to text-only cigarette warnings (Ref. 50). Compared to text-only warnings, pictorial cigarette warnings elicited more thinking about the message content (Ref. 50). Another study had U.S. adolescent and adult participants view one of nine pictorial cigarette warnings (Ref. 116). Exposure to pictorial cigarette warnings caused individuals to think about family members who smoke or how smoking could hurt the health of family members (Ref. 116). ii. Pictorial cigarette warnings lead to exposure to and learning of new information about the negative consequences of smoking to smokers and nonsmokers. Health warnings on cigarette packages can serve as prominent sources of health information for both smokers and nonsmokers (Ref. 2). Daily smokers in the United States, who in 2016 averaged 14.1 cigarettes per day, are potentially exposed to the pictorial cigarette warnings on packages over 5,100 times per year, and, because these packages are not always concealed and are often visible to those other than the person carrying the package, information found on those packages are potentially viewed by many others, including nonsmokers (Refs. 38''40). Indeed, a review of tobacco health warning studies in more than 13 countries, including the United States, concluded that pictorial warnings are an important source of health information for smokers as well as nonsmokers (Ref. 39). Pictorial cigarette warnings have also been shown to be effective in communicating the health consequences of smoking to youth (Refs. 94 and 100). A report prepared for Health Canada showed that approximately 6 years after the introduction of pictorial cigarette warnings in Canada, more than 90 percent of Canadian youth agreed that the pictorial cigarette warnings had provided them with important and accurate information about the negative health effects of smoking cigarettes (Ref. 108). Pictorial cigarette warnings can also serve as effective sources of information for youth with smoking parents. One study interviewed adolescents whose parents received pictorial warnings on their cigarette packages as part of a randomized clinical trial (Ref. 117). When asked about the pictorial cigarette warnings, adolescents described how the warnings caught their attention. While many already reported believing that smoking was dangerous before seeing the warnings, viewing the warnings strengthened and reinforced beliefs about the negative health consequences of smoking. In the health communication scientific literature, messages that are accompanied by images closely linked to the message content (i.e., concordant) are shown to increase the likelihood that consumers will comprehend the message (Ref. 118). Because of this, pictorial cigarette warnings increase understandability and learning of the message. After implementation of Australia's pictorial cigarette warnings, focus group research findings concluded that images depicting the health consequences of smoking provided new information beyond what was contained in the text through providing a visual explanation of the negative health effects noted in the text (Ref. 101). For example, very few participants were aware that smoking caused peripheral vascular disease, and having an image of peripheral vascular disease provided a visual explanation of the effects of the disease, which led to learning of the consequences of smoking (Ref. 101). Studies in other countries have shown that participants tend to rate pictorial cigarette warnings as being more informative than text-only warnings (Refs. 119 and 120). A study with U.S. young adult smokers and nonsmokers evaluated the effect of pictorial cigarette warnings on learning (Ref. 121). Findings showed that participants rated pictorial cigarette warnings higher in increasing personal understanding of the health consequences of smoking and leading to learning new information compared to text-only warnings. c. Pictorial cigarette warnings can increase understanding of the negative health consequences of smoking across diverse populations. 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42765 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules Research has shown that being a member of a group with lower socioeconomic status (SES), as measured by income and education levels, is associated with having lower knowledge of the negative health consequences of smoking; most smokers in the United States are in this group (Refs. 5, 123, and 124). One study found that knowledge about the negative health effects of smoking was lower among older respondents, those with lower educational attainment, and those from racial or ethnic minority groups (Ref. 123). Some subpopulations, such as specific racial or ethnic minority groups (e.g., American Indian/Alaskan Natives), those with a lower level of education, and those experiencing serious psychological distress (Ref. 5), are disproportionately represented in lower SES subgroups, which have lower access to health information and are more likely to smoke cigarettes (Refs. 5, 204, and 205). Having a lower SES is also associated with lower health literacy compared to those with higher SES (Ref. 125). One study compared data from higher and lower income adult smokers who participated in the ITC''4 and found that higher income smokers had 71 percent, 34 percent, and 83 percent higher odds of reporting knowledge that smoking causes heart disease, stroke, and lung cancer, respectively (Ref. 124). However, another study found that, among nonsmoking Canadian adolescents, having less spending money was associated with lower knowledge of the negative health effects of smoking but that disparities in knowledge were not as strong in adolescent smokers as they were in other studies with adults (Ref. 11). In addition, smokers with less education may be less likely to notice and recall health information in cigarette warnings (Refs. 69 and 72). In its 2007 report, the IOM expressed concern about the ability of consumers with less education to recall the information included in text-based messages (Ref. 2). The IOM (Ref. 2) cited a study of Canadian smokers' knowledge about the country's prior warning requirements, which, like the current 1984 Surgeon General's warnings, only contained four textual warning statements. In that study, compared to women with higher educational attainment, comparatively fewer women with lower educational attainment were aware of messages that warn of the harmful effects of smoking on life expectancy, heart disease, or pregnancy (Ref. 69). A study of pregnant women found that those with lower reading levels had less knowledge about the negative health effects of smoking (Ref. 136). Pictorial cigarette warnings are likely to help reduce disparities among disadvantaged groups in consumer understanding about the harms of smoking. One study examined perceptions of pictorial cigarette warnings among low-income adult smokers using in-depth interviews (Ref. 126). Some participants reported that the image in the pictorial cigarette warning influenced their perceptions of smoking-related conditions because they contained new information and portrayed long-term health outcomes (e.g., diminished quality of life, irreparable physical damage, death) (Ref. 126). Research has shown that pictorial cigarette warnings increase understanding of the health consequences of smoking across diverse settings and countries (Refs. 4, 87, 102, 119, and 206''210). These findings demonstrate that pictorial cigarette warnings are effective for diverse populations that differ in cultural, racial, ethnic, and socioeconomic backgrounds. One large study that randomized 3,371 adult smokers to view either pictorial cigarette warnings or text-only warnings found that participants who viewed the pictorial warnings had rated the warnings as being significantly more noticeable and more credible compared to participants who viewed the text-only warnings (Ref. 127). No statistically significant interactions were found between these results and race/ethnicity, education, or income, which suggests that the pictorial warnings had consistently greater noticeability and credibility across all the study subpopulations than the text-only warnings (Ref. 127). Other research suggests that among lower SES groups, pictorial cigarette warnings may lead to stronger effects in noticing the warning and thinking about smoking risks compared to those in higher SES groups because of the added benefits of the information contained in the pictorial warning (Refs. 72 and 206). Collectively, the evidence demonstrates that pictorial cigarette warnings are effective across diverse populations and settings and likely will help reduce disparities found in consumer understanding about the harms of smoking. VI. FDA's Process for Developing and Testing the Proposed Cigarette Health Warnings Findings from the scientific literature indicate that an important first step in promoting public understanding of health risks is to raise public awareness of those risks, particularly if the risks are not commonly known (Refs. 130 and 131) (see section V.B). Measuring whether information is new helps identify opportunities to improve understanding through increased awareness. Additionally, communication science research has found that people are more likely to pay attention to information that is new, and attention plays a vital role in message comprehension and learning (Ref. 128). As described in detail in this section, FDA undertook a science-based, iterative research and development process to consider whether revisions to the textual warning statements specified in section 4(1) of the FCLAA (''TCA statements'') would promote greater public understanding of the risks associated with smoking and then to develop and test paired concordant color graphics to accompany the textual warning statements. As part of this process, FDA examined the nine TCA statements to consider whether to revise those statements to promote greater public understanding of the risks associated with cigarette smoking (see sections VI.A''C), which included a review of the risks associated with cigarette smoking and a focus on negative health effects that are less known, less understood, or about which the public holds misperceptions. After considering this information, FDA developed initial versions of revised textual warning statements (''revised statements''). Based on FDA's careful review of the scientific literature on the health risks associated with cigarette smoking, evaluation of the public's general awareness and knowledge of those health risks, and assessment of the Agency's own consumer research on potential revised warning statements, FDA determined there is sufficient support to propose adjusting some of the text of the TCA statements, as authorized by section 4(d) of the FCLAA (as amended by section 202(b) of the Tobacco Control Act). While developing the revised statements, FDA worked in parallel to develop color graphics, in the form of photorealistic images, depicting the negative health consequences of cigarette smoking to accompany the statements (section 4(d) of the FCLAA; see section VI.D). Once FDA determined there was sufficient support to propose adjusting the text of the required warnings, identified textual warning statements for further testing, and developed photorealistic images to accompany those statements, we paired textual warning statements with concordant images to assess which statement-and-image pairings should be VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42766 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules considered for this proposed rule. FDA selected 16 statement-and-image pairings to test in a final quantitative consumer research study. Results of this study (described in section VI.E), along with FDA's formative research, review of the scientific literature, and internal scientific and public health communications expertise, informed FDA's selection of the 13 cigarette health warnings in this proposed rule. The following subsections describe each of these steps in more detail. The Agency invites comment on the warnings proposed in this rule, including its proposed revisions to the textual warning statements and its proposed photorealistic images. Given the degree of public and stakeholder interest in this area, and the legal complexities involved, FDA also seeks proposals for alternative text and images you believe would advance the Government's interest in promoting greater public understanding of the negative health consequences of smoking. If proposing alternative text and images to those in this proposed rule, please provide scientific information supporting that the alternative text and images would, in fact, promote greater public understanding of the negative health consequences of smoking. Proposals for alternative images should accompany either one of FDA's proposed textual warning statements or an alternative textual warning statement you are proposing. A. Review of the Negative Health Consequences of Cigarette Smoking In determining whether FDA should, as authorized by section 4(d) of the FCLAA, adjust the format, type size, color graphics, and text of any of the label requirements to promote greater public understanding of the risks associated with the use of tobacco products, FDA reviewed the scientific literature as well as available nationally representative data on current consumer knowledge and misperceptions about the health risks of smoking. Despite the current 1984 Surgeon General's warnings on cigarette packages and in cigarette advertisements, the literature demonstrates that substantial proportions of U.S. smokers hold misperceptions about the health risks associated with cigarette smoking, particularly regarding cancer, heart disease, and other health conditions. For more discussion, see section V.A.3 (''There Remain Significant Gaps in Public Understanding About the Negative Health Consequences of Cigarette Smoking''). FDA considered the evidence presented in Surgeon General's Reports to identify all negative health consequences that are causally linked to cigarette smoking and exposure to secondhand smoke, including negative health consequences causally linked to cigarette smoking since the passing of the Tobacco Control Act in 2009. Surgeon General's Reports provide definitive syntheses of the available evidence on smoking and health and use such evidence to reach conclusions on causality that have public health implications (Ref. 8, p. 3). Surgeon General's Reports classify the strength of causal inferences in a four-level hierarchy based upon work of the IOM (now the National Academy of Medicine) and the International Agency for Research on Cancer (IARC) (Refs. 200 and 212): ' Evidence is sufficient to infer a causal relationship. ' Evidence is suggestive but not sufficient to infer a causal relationship. ' Evidence is inadequate to infer the presence or absence of a causal relationship (which encompasses evidence that is sparse, of poor quality, or conflicting). ' Evidence is suggestive of no causal relationship (Refs. 154 at p. 18, 8 at pp. 3, 52, and 53). These standardized determinations consider factors such as the consistency of results; the strength of the association between smoking and specific health effects; specificity; temporality; coherence, plausibility, and analogy; biologic gradient (dose-response evidence); and natural experiments (Ref. 154 at pp. 21''23). The rigor and consistent application of these causal standards has rendered Surgeon General's Reports the preeminent source regarding whether cigarette smoking and exposure to secondhand smoke are causally related to specific negative health consequences. Throughout this proposed rule, and in the context of the word ''cause'' or ''causes'' used in the textual warning statements included therein, FDA relied on the four-level classification provided in the Surgeon General's Reports. Further, the negative health consequences addressed in this proposed rule's warnings are all rated at the highest level, meaning that the proposed warnings' use of ''cause'' and ''causes'' is uniformly based upon the strongest possible level of scientific inference: ''Evidence is sufficient to infer a causal relationship'' (Ref. 8 at p. 3). A causal relationship supported at this level expresses ''[t]he judgment that smoking causes a particular disease'' and ''has immediate implications for prevention of the disease'' (Ref. 154, p. 18). Since the first Surgeon General's Report published in 1964, evidence of the negative health consequences of cigarette smoking and secondhand smoke has expanded dramatically. For example, the 2014 Surgeon General's Report, entitled ''The Health Consequences of Smoking: 50 Years of Progress'' (Ref. 8), presented a robust body of scientific evidence documenting the health consequences from both smoking and exposure to secondhand smoke across a range of diseases and organ systems. In particular, the 2014 Surgeon General's Report added eleven diseases to the long list of diseases causally linked to cigarette smoking: Liver cancer, colorectal cancer, age- related macular degeneration, orofacial clefts from maternal smoking during pregnancy, tuberculosis, stroke (for adults), diabetes, erectile dysfunction, ectopic pregnancy, rheumatoid arthritis, and impaired immune function (Ref. 8, pp. 4''5). The health conditions established to be causally linked to cigarette smoking in the 2014 Surgeon General's Report are in addition to the more than 40 unique health consequences of cigarette smoking and exposure to secondhand smoke determined by earlier studies (Ref. 8). FDA determined that some of the health conditions newly identified in the 2014 Surgeon General's Report represented an opportunity to educate the public about negative health consequences of cigarette smoking that are subject to particularly low awareness and understanding. Historically, the large majority of public health messaging about the health risks associated with cigarette smoking has focused on a small subset of health conditions, notably lung cancer and addiction. The current Surgeon General's warnings for cigarette packages and advertisements, which have not been updated for nearly 35 years despite increasing evidence of additional, serious negative health effects of cigarette smoking, only include warnings on a limited number of health conditions (i.e., lung cancer, heart disease, emphysema, pregnancy complications, and general risks to health) (see section V for additional discussion of the current Surgeon General's warnings). Both U.S. and non- U.S. studies have found that consumers are largely unaware of the negative health consequences of cigarette smoking not mentioned in current warnings as well as more specific information about the negative health effects and their mechanisms (Refs. 3, 11, 13''16, 67, 145, and 213''215). VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42767 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 4FDA developed multiple revised versions of some TCA statements, developed no revised version for others, and also developed statements for which there is no TCA statement focused on that health condition. 5The 15 revised statements FDA refined for further testing did not include revised versions of the following 4 TCA statements: WARNING: Cigarettes are addictive; WARNING: Smoking can kill you; WARNING: Tobacco smoke causes fatal lung disease in nonsmokers; and WARNING: Quitting smoking now greatly reduces serious risks to your health. FDA made this determination based on focus group feedback and findings from the scientific literature suggesting the health conditions described in these 4 statements are better-known health consequences of smoking and that revised statements on these conditions likely would not promote greater public understanding of the negative health consequences of smoking more than either the relevant TCA statements themselves or new statements on different health conditions. Additionally, and as discussed in section V, the current Surgeon General's warnings often go unnoticed and are not effective at informing the public of the health risks associated with cigarette smoking. B. Developing Revised Textual Warning Statements After FDA's initial review of the scientific literature on cigarette smoking-related consumer knowledge and misperceptions, as well as its epidemiological reviews of the causally linked health conditions identified in the recent Surgeon General's Reports and scientific literature, we evaluated whether revising some or all of the TCA statements to focus on negative health effects that are less-known or less understood by consumers would promote greater public understanding of the risks associated with cigarette smoking. FDA developed initial versions of revised statements for further review, testing, and refinement. These initial revised statements were reviewed by FDA internal epidemiological experts to ensure that the health conditions under consideration were causally linked to cigarette smoking or exposure to secondhand smoke, and that these smoking-attributed conditions were not rare. Through a series of 16 qualitative focus groups with adolescent smokers, adolescents at risk for starting smoking, and adult smokers (OMB control number 0910''0674, ''Qualitative Study on Cigarettes and Smoking: Knowledge, Beliefs, and Misperceptions''), FDA gathered additional input on consumers' awareness of the negative health consequences of cigarette smoking and assessed initial consumer responses to 17 revised statements4and the nine TCA statements. These focus groups provided FDA with qualitative feedback on consumers' comprehension of each statement, the believability of the content of each statement (e.g., that smoking causes the health condition noted), if that health condition was new information to participants, and other feedback about the statement and how to make it more understandable or convey the intended message more clearly. Generally, participants reported the initial revised statements presented new information more than the TCA statements. FDA considered this information in identifying 15 revised statements5for further quantitative (see section VI.C) and qualitative (see section VI.D) testing. C. FDA's Consumer Research Study on Revised Textual Warning Statements FDA next conducted a large quantitative consumer research study to assess which, if any, of the revised warning statements would promote greater public understanding of the risks associated with cigarette smoking as compared to the TCA statements (OMB control number 0910''0848, ''Experimental Study on Warning Statements for Cigarette Graphic Health Warnings''). A secondary goal of this study was to inform the selection of health conditions and specific statements that, when paired with color graphics depicting the health conditions described in the warning statements, would form new cigarette health warnings for further testing. 1. Study Design FDA's study on revised textual warning statements had two phases, both of which were completed during a single online session. The study sample comprised 2,505 participants. This included adolescents (aged 13 to 17 years), half of whom were current smokers and the rest of whom had never smoked but were at risk for starting smoking; younger adult (aged 18 to 24 years) current smokers; and older adult (aged 25 years and older) current smokers. Study participants in all age groups were randomly assigned to a condition that determined which warning statements they viewed during the study. Participants in the control condition viewed the nine TCA statements. Participants in each of the treatment conditions viewed one of 15 revised warnings statements plus 8 TCA warning statements. Table 1 provides a list of the 9 TCA statements and 15 revised warning statements that FDA evaluated in this study. TABLE1'--TCA ANDREVISEDSTATEMENTSSTUDIED INFDA'SCONSUMERRESEARCHSTUDY TCA statements (short name) Revised statements (short name) WARNING: Cigarettes are addictive (addictive). WARNING: Tobacco smoke can harm your children (harm children). WARNING: Cigarettes cause fatal lung disease (fatal lung disease in smokers). WARNING: Cigarettes cause cancer (unspecified cancer). WARNING: Cigarettes cause strokes and heart disease (strokes and heart disease). WARNING: Smoking during pregnancy can harm your baby (harm your baby). WARNING: Smoking can kill you (kill you). WARNING: Tobacco smoke causes fatal lung disease in nonsmokers (fatal lung disease in nonsmokers). WARNING: Quitting smoking now greatly reduces serious risks to your health (quit now). WARNING: Smoking causes mouth and throat cancer (mouth and throat cancer). WARNING: Smoking causes head and neck cancer (head and neck cancer). WARNING: Smoking causes bladder cancer, which can lead to bloody urine (bladder cancer). WARNING: Smoking during pregnancy causes premature birth (pre- mature birth). WARNING: Smoking during pregnancy stunts fetal growth (stunts fetal growth). WARNING: Smoking during pregnancy causes premature birth and low birth weight (low birth weight). WARNING: Secondhand smoke causes respiratory illnesses in chil- dren, like pneumonia (pneumonia). WARNING: Smoking can cause heart disease and strokes by clogging arteries (clogged arteries). WARNING: Smoking causes COPD, a lung disease that can be fatal (COPD). WARNING: Smoking causes serious lung diseases like emphysema and chronic bronchitis (emphysema and chronic bronchitis). VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42768 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 6FDA will conduct a peer review of this consumer research study. FDA's peer review plans are available online at https://www.fda.gov/science- research/science-and-research-special-topics/peer- review-scientific-information-and-assessments. 7There was one exception: The TCA statement ''Fatal lung disease in nonsmokers'' was new information to 41.9 percent of participants. TABLE1'--TCA ANDREVISEDSTATEMENTSSTUDIED INFDA'SCONSUMERRESEARCHSTUDY'--Continued TCA statements (short name) Revised statements (short name) WARNING: Smoking reduces blood flow, which can cause erectile dys-function (erectile dysfunction). WARNING: Smoking reduces blood flow to the limbs, which can re-quire amputation (amputation). WARNING: Smoking causes type 2 diabetes, which raises blood sugar (diabetes). WARNING: Smoking causes age-related macular degeneration, which can lead to blindness (macular degeneration). WARNING: Smoking causes cataracts, which can lead to blindness (cataracts). In Phase 1 of the study, all participants viewed nine warning statements, one at a time, presented in random order. Participants in the control condition viewed the nine TCA statements. Participants in the treatment condition viewed 8 TCA statements plus 1 of 15 revised statements, for a total of 9 statements. Revised statements that did not have a TCA counterpart (e.g., the diabetes statement) are called ''new content'' statements for short. Each revised statement either was presented in place of a more general TCA statement on the same or similar health condition (e.g., a revised statement on head and neck cancer replaced the TCA unspecified cancer statement) or, for ''new content'' statements, was presented in place of a randomly selected TCA statement (e.g., a revised statement on diabetes was presented in place of the TCA statement on fatal lung disease in smokers). After viewing each individual warning statement, participants answered questions about that statement before viewing and answering questions about the next assigned statement. The study evaluated the following outcomes: ' Whether the warning statement was new information to participants (''new information'') (i.e., participants reported that they had not previously heard of that specific health effect from cigarette smoking); ' Whether participants learned something from the warning statement (''self-reported learning''); ' Whether the warning statement made participants think about the health risks of smoking (''thinking about risks''); ' Whether the warning statement was believable (''believable''); ' Whether the warning statement was informative (''informativeness'') (i.e., participants reported that the warning was informative to them); ' Whether the warning statement was perceived to be a fact or an opinion (''factuality''); and ' Whether participants reported beliefs linking smoking and the health consequences in the warning statement (''health beliefs''). In Phase 2 of the study, all participants viewed nine warning statements presented at the same time. Participants assigned to the control condition viewed the nine TCA warning statements again. Participants assigned to the treatment conditions viewed one of several different combinations of nine revised warning statements. After viewing the nine warning statements, all participants answered questions about their beliefs about the link between smoking and each of the health consequences presented in the warning statements they viewed (''Health beliefs''). More details about the study methodology can be found in the study report, which we have included in this docket (Ref. 129).6 2. Study Findings The outcomes ''new information'' and ''self-reported learning'' provide useful data for determining whether a revised warning statement would promote greater understanding than a TCA statement of the risks associated with cigarette smoking, as described below. In general, relatively few participants reported that the content of the TCA statements was new information; more participants reported that the revised statements were new information than did participants who viewed the TCA statements on the same health conditions; and most participants reported that the ''new content'' statements were new information. For example, fewer than 24 percent of participants reported that the TCA statements were new information to them,7whereas more than 66 percent of participants who viewed the ''new content'' statements (e.g., blindness, diabetes) reported that the ''new content'' statements were new information to them. When a specific health condition was covered by both a revised and TCA statement (e.g., cancer), the revised statement was new information to more participants than the TCA statement. At the level of the individual warning statement, 10 of the 15 revised statements tested demonstrated statistically significant higher levels of both ''new information'' and ''self- reported learning'' when compared to a TCA statement (see Ref. 129, Table 4'' 1, ''Summary of Significant Results''). Those 10 revised statements focused on the following negative health effects of cigarette smoking: Age-related macular degeneration, cataracts, type 2 diabetes, peripheral vascular disease (amputation), bladder cancer, erectile dysfunction, head and neck cancer, heart disease and stroke (clogged arteries), stunted fetal growth, and COPD. There were two revised statements that had statistically significant higher levels of ''new information'' but not ''self-reported learning,'' both of which focused on pregnancy-related health consequences (premature birth; low birth weight). For two revised statements (emphysema and chronic bronchitis; pneumonia), participants had statistically significant higher levels of ''self-reported learning'' but not ''new information.'' For one revised statement (mouth and throat cancer), participants did not have statistically significant higher levels of either of these two outcomes. Of the five revised warning statements that lacked statistically significant higher outcomes for both ''new information'' and ''self-reported learning'', four focused on a health condition for which another revised statement had statistically significant higher levels of both ''new information'' and ''self-reported learning'' (e.g., premature birth versus stunts fetal VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42769 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 8Five of the 15 revised statements were ''new content'' statements, without a comparator TCA statement on the same health condition. Those five revised statements were compared to a randomly selected TCA statement on a different health condition, which may have resulted in larger effects for these ''new content'' statements as compared to the effects for the remaining 10 revised statements. growth); only the revised warning statement on pneumonia did not. More details about the full study results can be found in the study report, which we have included in this docket (Ref. 129). 3. How Study Findings Were Used FDA determined that the scientific literature demonstrates that the outcomes ''new information'' and ''self- reported learning'' are predictive for the task of identifying which, if any, of the revised warning statements would promote greater public understanding of the risks associated with cigarette smoking as compared to a TCA statement. Communication science research shows that an important first step in promoting public understanding of health risks is to raise public awareness of those risks, particularly if the risks are not commonly known (Refs. 130 and 131) (see section V.B). Measuring whether information is new helps identify opportunities to improve understanding through increased awareness. Additionally, communication science research has found that people are more likely to pay attention to information that is new, and attention plays a vital role in message comprehension and learning (Ref. 128). Therefore, ''new information'' and ''self- reported learning'' are often linked and are both predictive of improved understanding. Other study outcomes, such as ''thinking about the risks'' and ''health beliefs,'' were unlikely to change with a single brief exposure to the text-only statements'--as was provided in this first quantitative consumer research study'--and therefore were not considered predictive of improved understanding in the way the ''new information'' and ''self-reported learning'' measures were. Because the purpose of this first quantitative consumer research study was to determine which, if any, revised warning statements promote greater public understanding of the risks associated with cigarette smoking (as per section 4(d) of the FCLAA) when compared to a TCA warning statement, the study was not designed to put the revised statements in a rank order or compare individual results of one revised statement to another. Rather, FDA interpreted the presence of a statistically significant finding in a positive direction as support for a revised warning statement over its comparator TCA statement.8 FDA evaluated the research results for each individual warning statement to determine which statements would move on for further testing. Based on this analysis, a total of 10 revised statements and 5 TCA statements were selected for such further testing. As discussed above, at the level of the individual warning statement, 10 of the 15 revised warning statements tested demonstrated statistically significant higher levels of both ''new information'' and ''self-reported learning'' when compared to a TCA warning statement. FDA selected those 10 revised statements for further testing in the final consumer research study discussed below. Of the five revised warning statements that did not have statistically significant higher outcomes for both ''new information'' and ''self-reported learning,'' four focused on a health condition for which another revised statement did have statistically significant higher levels for both ''new information'' and ''self-reported learning''; only the revised statement on harms of secondhand smoke exposure in children (pneumonia) did not. Because there was not another revised statement on harms of secondhand smoke exposure in children, FDA selected the TCA statement on the same health condition (harm children) for further testing in the final quantitative consumer research study. Additionally, as described above, FDA did not test a revised warning statement for four TCA statements (addictive, kill you, fatal lung disease in nonsmokers, quit now; see table 1 for full statements). Although these TCA statements were new information to relatively few participants and self- reported learning was low, FDA determined that it would provide a better basis for decision-making to pursue additional data on these four TCA statements, and thus included them for further testing. Based on the Agency's analysis of the research results and evaluation of other considerations as just described, FDA selected a total of 15 textual warning statements for further testing. FDA selected the following five TCA statements for the final quantitative consumer research study: ' WARNING: Cigarettes are addictive. ' WARNING: Tobacco smoke can harm your children. ' WARNING: Smoking can kill you. ' WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 'WARNING: Quitting smoking now greatly reduces serious risks to your health. Additionally, FDA selected the following 10 revised or ''new content'' statements for the final quantitative consumer research study (see section VI.E for a discussion of that study): ' WARNING: Smoking causes head and neck cancer. ' WARNING: Smoking causes bladder cancer, which can lead to bloody urine. ' WARNING: Smoking during pregnancy stunts fetal growth. ' WARNING: Smoking can cause heart disease and strokes by clogging arteries. ' WARNING: Smoking causes COPD, a lung disease that can be fatal. ' WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. ' WARNING: Smoking reduces blood flow to the limbs, which can require amputation. ' WARNING: Smoking causes type 2 diabetes, which raises blood sugar. ' WARNING: Smoking causes age- related macular degeneration, which can lead to blindness. ' WARNING: Smoking causes cataracts, which can lead to blindness. D. Developing and Testing Images Depicting the Negative Health Consequences of Smoking To Accompany the Textual Warning Statements Section 4(d) of the FCLAA, as amended by section 201(a) of the Tobacco Control Act, directs FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany textual warning statements on cigarette packages and in cigarette advertisements. In parallel with FDA's efforts to develop and test revised warning statements, the Agency also undertook an iterative, research-based approach to develop color graphics depicting the negative health consequences of cigarette smoking to accompany those statements. This process required considering how to help promote greater public understanding of the negative health consequences of cigarette smoking given that the general public comprises individuals with many varied backgrounds, knowledge, beliefs, and abilities to read and understand health information. According to National Assessment of Adult Literacy estimates, about 12 percent of U.S. adults have proficient health literacy (i.e., the ability to access, understand, and use health information and services (Refs. 125 and VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42770 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 132). Among the remaining adults, 53 percent have intermediate health literacy, 22 percent have basic health literacy, and 14 percent have below basic health literacy (Ref. 125). Individuals with basic or below basic health literacy are more likely to be cigarette smokers (Refs. 133''135) and are more likely to have limited knowledge about the negative health consequences of smoking (Refs. 136 and 137). National surveys also indicate that about half of the U.S. adult population has only very basic or below basic quantitative skills, and only 9 percent of U.S. adults scored in the highest numeracy levels (i.e., the ability to understand and use numbers, including the ability to read and interpret data presented in tables, graphs, and bar charts) (Refs. 138 and 139). To determine the best way to visually depict the negative health consequences of cigarette smoking to promote greater understanding among such a diverse population, FDA considered findings from health communication science research regarding best practices for helping the public better understand health risk information. As described in section V.B, it is well established in the scientific literature that vivid features (e.g., images) increase noticeability of and attention to textual health risk information (e.g., cigarette health warnings) and increase comprehension, understanding, and recall of health messages (Refs. 43, 50, 75, 78''81, 118, and 140''145). Research also indicates that visual depictions of textual health risk information are especially beneficial in aiding comprehension and understanding among subpopulations that have lower health literacy and numeracy skills (Refs. 118, 144, and 146''148), including greater disparities in knowledge about the negative health consequences of smoking (Ref. 69). However, multiple factors influence whether a specific type of visual depiction (such as an image compared to a bar chart or graph) ultimately aids or impedes message comprehension, including the level of concordance between the text and accompanying visual depiction (e.g., using an image of an eye to depict the word ''eye''); the level of cognitive effort required to understand the information (e.g., using a stacked bar chart to depict multiple data comparisons requires greater cognitive effort); and the type of communication channel used to deliver the message (e.g., information presented by a doctor as part of a conversation with a patient, versus information presented in a mass media campaign) (Refs. 118, 140''143, 146, 147, and 149'' 152). For example, some types of visual depiction, such as bar charts and graphs, are better suited to certain communication purposes such as depicting comparisons (bar charts) or conveying numerical information (graphs) (Refs. 142 and 152). When used to communicate health risk information to the public, bar charts and graphs are often misperceived, especially when not accompanied by further instruction on how to read and interpret the information (Refs. 140, 141, 149, and 151). Bar charts and graphs also require a higher degree of numerical proficiency and cognitive effort to promote consumer understanding than do other types of visual depiction, such as illustrations and photographs. In comparison, illustrations, photographs, and other pictorial visual depictions are more likely to aid comprehension when used for mass-communication purposes as these types of visual depictions are more easily made congruent (i.e., the type of visual is appropriate for the message) and concordant, and they require less numerical proficiency and cognitive effort to understand the information (Refs. 141, 142, 149, and 150). Therefore, based on this review of the literature, the proposed cigarette health warning message content, and the communication channel, FDA determined that textual warning statements paired with factually accurate, concordant photographs or photorealistic images of specific health conditions, presented in a realistic and objective format, would be most likely to advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking. FDA then undertook a rigorous multistep process to develop, test, and refine images that: (1) Are factually accurate; (2) depict common visual presentations of the health conditions (intended to aid understanding by building on existing consumer health knowledge and experiences) and/or show disease states and symptoms as they are typically experienced; (3) present the health conditions in a realistic and objective format that is devoid of non-essential elements; and (4) are concordant with the statements on the same health conditions. After developing initial image concepts, FDA used information gathered through a series of 53 indepth individual interviews with adolescents and adults (OMB control number 0910'' 0796, ''Qualitative Study of Perceptions and Knowledge of Visually Depicted Health Conditions'') to further refine the concepts. FDA evaluated the extent to which participants found the initial image concepts clear (in terms of recognizing what was being depicted in the image), attention-grabbing, worth remembering, credible, and relevant, and whether the concepts provided any new information. The interviews found that some image concepts were very clear, while others were less understood. When there were multiple image concepts on the same or similar health conditions, participants reacted similarly to those concepts. Overall, the majority of participants found the image concepts to be credible and rated most of the concepts as medium to high in terms of image clarity. FDA used the feedback from these qualitative interviews to further refine the initial image concepts, eliminate some image concepts from further consideration, and inform a future quantitative consumer research study (see section VI.E). FDA used a photorealistic illustration format for the images rather than photographs, because this format best allowed depicting specific features of the health conditions as described by the textual warning statements. The photorealistic illustration format also facilitated providing factually accurate images that depict common presentations of the health conditions in a realistic and objective format devoid of non-essential elements. Using photorealistic images allowed further editing and refinements for clarity and ease of understanding throughout the research and development process for new cigarette health warnings. A certified medical illustrator developed high quality, medically accurate, photorealistic images in close collaboration with FDA staff. After the photorealistic images were created, FDA paired each textual warning statement (the 9 TCA statements and the 15 revised statements tested in the first quantitative consumer research study) with a concordant image for further testing. To do this further testing, FDA evaluated the photorealistic images through a series of 20 qualitative focus groups with adolescent smokers, adolescents at risk for starting smoking, and adult smokers (OMB control number 0910''0796, ''Qualitative Study on Consumer Perceptions of Cigarettes Health Warning Images''). The focus groups examined what factual information the images conveyed to participants about the negative health consequences of cigarette smoking in the absence of a paired textual warning statement, as well as how concordant participants considered the images to be when paired with potential textual warning statements (both TCA VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42771 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules statements and the revised statements). Based on feedback received in these focus groups, FDA further refined some images for additional clarity and eliminated other images that were not well understood or where potential confusion could not be resolved through additional revisions. FDA then completed final pairings of textual warning statements and concordant photorealistic images for testing in the final quantitative consumer research study. As noted earlier (see section VI.C), FDA selected a total of 15 textual warning statements for further testing. However, two of the textual warning statements (fatal lung disease in nonsmokers, COPD) shared similar concordant images (diseased lungs). To preserve the option of potentially requiring both warning statements but without using two similar images, FDA paired an additional concordant image that tested well in the qualitative focus groups (man with oxygen tank) with the COPD warning statement for further testing. Therefore, FDA prepared a total of 16 statement-and-image pairings to test in the final quantitative consumer research study. E. FDA's Consumer Research Study on New Cigarette Health Warnings Once FDA examined opportunities to promote greater public understanding of the risks associated with cigarette smoking, developed potential revised statements to address gaps in public understanding, tested the revised statements in a consumer research study, and developed concordant photorealistic images that depict the negative health consequences of smoking, the Agency prepared a set of 16 cigarette health warnings (statements paired with their concordant photorealistic images) to be tested in a final consumer research study. The purpose of the final research study was to assess the extent to which any of the cigarette health warnings, developed through FDA's science-based, iterative research process, increase understanding of the negative health consequences of cigarette smoking. For warnings to be considered for this proposed rule, FDA decided that a warning tested in this final consumer research study must demonstrate statistically significant improvements, as compared to the control condition, on both the two outcomes of ''new information'' and ''self-reported learning'' (more discussion about the study design, including the control and outcomes follows). 1. Study Design FDA's final research study on new cigarette health warnings was a three- session internet-based consumer research study using an online research panel (OMB control number 0910''0866, ''Experimental Study of Cigarette Warnings''). The study included 9,760 participants, including: (1) Adolescents (aged 13''17 years) who were current smokers and those at risk for starting smoking; (2) younger adults (aged 18''24 years) who were current smokers and nonsmokers; and (3) older-adults (aged 25 years and older) who were current smokers and nonsmokers. Study participants in all age groups were assigned to a condition that determined which warnings they viewed during the study. Participants in the control condition viewed one of the four current Surgeon General's cigarette warnings. Participants in each of the treatment conditions viewed one of 16 of the new cigarette health warnings (i.e., text- image pairings) FDA developed through the process described in sections VI.B'' D. Table 2 provides a list of the 16 textual warning statements (paired with images) that FDA evaluated in this study. TABLE2'--TEXT OFCIGARETTEHEALTHWARNINGSTESTED INFDA'SCONSUMERRESEARCHSTUDY Statements WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your heal\th. WARNING: Smoking causes head and neck cancer. WARNING: Smoking causes bladder cancer, which can lead to bloody urine. \WARNING: Smoking during pregnancy stunts fetal growth. WARNING: Smoking can cause heart disease and strokes by clogging arterie\s. WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired \with an image of diseased lungs] WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired \with an image of man with oxygen tank] WARNING: Smoking reduces blood flow, which can cause erectile dysfunctio\n. WARNING: Smoking reduces blood flow to the limbs, which can require ampu\tation. WARNING: Smoking causes type 2 diabetes, which raises blood sugar. WARNING: Smoking causes age-related macular degeneration, which can lead\ to blindness. WARNING: Smoking causes cataracts, which can lead to blindness. All participants viewed their assigned warnings on both a mock three- dimensional cigarette package that could be rotated on screen and as part of a mock full-page magazine cigarette advertisement in either their current (e.g., on the side of the package for the Surgeon General's warnings) or proposed (e.g., on the top 50 percent of the front and rear panel of the package for the new cigarette health warnings) size and location. The study took place over three sessions over more than two weeks for each respondent. During the first session, participants answered baseline questions about their beliefs about the negative health consequences of cigarette smoking. Next, they viewed their assigned warning on both the mock cigarette package and in the mock cigarette advertisement and answered questions assessing the following outcomes: 'Whether the warning was new information to participants (''new information); ' Whether participants learned something from the warning (''self- reported learning''); ' Whether the warning made participants think about the health risks of smoking (''thinking about risks''); ' Whether the warning was perceived to be informative (''perceived informativeness''); VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42772 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 9As with the first consumer research study, FDA will conduct a peer review of this consumer research study. FDA's peer review plans are available online at https://www.fda.gov/science- research/science-and-research-special-topics/peer- review-scientific-information-and-assessments. 10As discussed in section VI.D, FDA paired two concordant images (i.e., diseased lungs, man with oxygen tank) with the COPD warning statement for final testing. Both text and image pairings demonstrated statistically significant improvements, as compared to the control condition (i.e., the Surgeon General's warnings), on both the outcomes of ''new information'' and ''self- reported learning'' (i.e., knowledge gain). 'Whether the warning was perceived to be understandable (''perceived understandability''); ' Whether the warning was perceived to be a fact or opinion (''perceived factualness''); ' Whether participants reported beliefs linking smoking and each of the health consequences presented in the warning (''health beliefs''); ' Whether the warning was perceived to help participants understand the negative health effects of smoking (''perceived helpfulness understanding health effects''); ' Whether the warning grabbed their attention (''attention''); and ' Whether the warning was recalled (''recall''). Approximately 1 day later, during the second session, participants viewed their assigned warning again and answered questions assessing their beliefs about the negative health consequences of cigarette smoking. Approximately 14 days after the second session, during the third session (i.e., a delayed post-test), participants answered questions about their beliefs about the negative health consequences of cigarette smoking as well as questions assessing recall of the warning they viewed. More details about the study methodology, including the sample size calculation and analysis plan, can be found in the study report, which we have included in this docket (Ref. 153).9 2. Study Findings The results of the final consumer research study allowed FDA to draw important conclusions that provide a basis for the cigarette health warnings included in this proposed rule. Overall, relative to the average of the Surgeon General's warnings, most of the new cigarette health warnings were reported to be new information; resulted in greater self-reported learning; led to thinking about risks; were higher on perceived informativeness, perceived understandability, and perceived helpfulness understanding health effects; increased agreement with accurate health beliefs over time; attracted attention; and were recalled. As discussed above (see section VI.C.3), FDA determined that the outcomes ''new information'' and ''self- reported learning'' are predictive for the task of identifying which of the cigarette health warnings increase understanding of the negative health consequences of cigarette smoking. Participants were significantly more likely, relative to the control condition (i.e., the Surgeon General's warnings), to report that, for 13 of the 16 cigarette health warnings tested (except for the warnings related to addiction, smoking can kill, and quitting smoking), the new cigarette health warnings provided new information and resulted in greater self- reported learning (see Ref. 153, Table 4'' 1, ''Summary of Results''). More details about the full study results can be found in the study report, which we have included in this docket (Ref. 153). 3. How Study Findings Were Used Because the purpose of this final quantitative consumer research study was to identify which of the cigarette health warnings increase understanding of the negative health consequences of cigarette smoking, the study was not designed to put the cigarette health warnings in a rank order or compare individual results of one cigarette health warning to another. FDA evaluated the research results for each individual cigarette health warning to determine which warnings to include in this proposed rule. FDA is including in this proposed rule only the warnings that demonstrate statistically significant improvements, as compared to the control condition (i.e., the Surgeon General's warnings), on both the outcomes of ''new information'' and ''self-reported learning'' (i.e., knowledge gain). Following review of the findings of the final quantitative consumer research study, FDA is proposing 13 cigarette health warnings that use the following 12 statements: ' WARNING: Tobacco smoke can harm your children. ' WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. ' WARNING: Smoking causes head and neck cancer. ' WARNING: Smoking causes bladder cancer, which can lead to bloody urine. ' WARNING: Smoking during pregnancy stunts fetal growth. ' WARNING: Smoking can cause heart disease and strokes by clogging arteries. ' WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired with two images]10 'WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. ' WARNING: Smoking reduces blood flow to the limbs, which can require amputation. ' WARNING: Smoking causes type 2 diabetes, which raises blood sugar. ' WARNING: Smoking causes age- related macular degeneration, which can lead to blindness. ' WARNING: Smoking causes cataracts, which can lead to blindness. The cigarette health warnings using the following three statements did not demonstrate statistically significant improvements, as compared to the control condition, on the outcomes of ''new information'' and ''self-reported learning'' and therefore are not included as part of this proposed rule: ' WARNING: Cigarettes are addictive. ' WARNING: Smoking can kill you. ' WARNING: Quitting smoking now greatly reduces serious risks to your health. VII. FDA's Proposed Required Warnings The initial section 4(d) of the FCLAA, as amended by section 201 of the Tobacco Control Act, directs FDA to issue ''regulations that require color graphics depicting the negative health consequences of smoking'' to accompany the textual warning statements specified in section 4(a)(1) of the FCLAA. A second section 4(d) of the FCLAA, as created by section 202(b) of the Tobacco Control Act, permits FDA, through notice and comment rulemaking, to adjust the format, type size, color graphics, and text of any of the label requirements if such a change would promote greater public understanding of the risks associated with the use of tobacco products. FDA interprets these provisions of the FCLAA to permit a rulemaking that establishes new cigarette health warnings and at the same time adjusts the text and color graphic requirements, including the number of required warnings, so long as the adjustments promote greater public understanding of the risks of the use of tobacco products. As described in section VI.B, FDA undertook a science-based, iterative research and development process to consider whether revisions to the textual warning statements specified in section 4(1) of the FCLAA would promote greater public understanding of the risks associated with cigarette smoking. The empirical results VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42773 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules demonstrate sufficient scientific support to adjust the textual warning statements. Also, as described in section VI.D, FDA carefully developed and tested concordant color graphics, in the form of photorealistic images, depicting the negative health consequences of smoking to accompany each of the textual warning statements included in this proposed rule. Based on the results of FDA's research, we intend to finalize some or all of the 13 new cigarette health warnings proposed in this rule. We invite comment on how many warnings should be selected for the final rule and whether fewer than, more than, or exactly nine warnings would advance the Government's interest in promoting greater public understanding of the negative health consequences of smoking. The 13 proposed warnings, each of which consists of a textual warning statement paired with a concordant photorealistic image depicting the negative health consequences of smoking, are available in an electronic PDF in this docket (Ref. 18). For the final rule, the required warnings will be contained in a document entitled ''Required Cigarette Health Warnings,'' as is further discussed in section II.C. These proposed required warnings, as shown through the robust scientific evidence described in detail in sections V and VI and in the remainder of this section, are factual and accurate, advance the Government's interest, and are not unduly burdensome (see section VIII for a more detailed discussion). In determining which proposed cigarette health warnings will be required in the final rule, FDA will consider public comments submitted to this docket, full research results from our final quantitative consumer research study (including peer reviewer comments), scientific literature, and other considerations as discussed in this proposal. A. FDA's Proposed Required Warnings As discussed above, we assessed whether the new cigarette health warnings, developed through FDA's science-based, iterative research process, will advance the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking. Based on available data and information available to us at this time, including results from FDA's final consumer research study (see section VI for a full description of the final consumer research study) (Ref. 153), we identified 13 cigarette health warnings for this proposed rule. Each of the proposed warnings described in this section demonstrated statistically significant higher levels of providing new information and self- reported learning when compared to the control condition (i.e., the Surgeon General's warnings) (Ref. 153). While the final consumer research study was designed to measure a range of outcomes related to consumer understanding, as an initial matter, FDA is including in this proposed rule only the warnings that demonstrate statistically significant improvements, as compared to the control condition (i.e., the Surgeon General's warnings), on both the outcomes of ''new information'' and ''self-reported learning'' (i.e., knowledge gain). As described above, the scientific literature demonstrates that these two outcomes are predictive for the task of assessing which of the new cigarette health warnings increase understanding of the risks associated with cigarette smoking. Other study outcomes provide additional, useful information and are reflected in the study report (Ref. 153). FDA solicits comment on the individual cigarette health warnings included in this proposal, and we ask that comments provide data and factual information that would help us to further consider which proposed warnings to include in the final rule or whether such warnings should be altered, consistent with the Government's interest, and how. For additional consideration, the following subsections provide relevant scientific support for each of the proposed required warnings. 1. WARNING: Tobacco smoke can harm your children. This proposed warning consists of the TCA statement ''WARNING: Tobacco smoke can harm your children'' paired with a concordant, factually accurate, photorealistic image depicting a negative health consequence of secondhand smoke exposure in children. The image shows the head and shoulders of a young boy (aged 8''10 years) wearing a hospital gown and receiving a nebulizer treatment for chronic asthma resulting from secondhand smoke exposure. Since 2004, several Surgeon General's Reports have confirmed the causal link between exposure to secondhand smoke and several negative health consequences in children, including middle ear disease, respiratory symptoms, impaired lung function, lower respiratory illness, and SIDS (Refs. 8, 154, and 155). The 2006 Surgeon General's Report stated that the evidence is sufficient to conclude'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--that secondhand smoke exposure from parental smoking causes the following negative health effects: Lower respiratory illness in infants and children; middle ear disease in children, including acute and recurrent otitis media and chronic middle ear effusion; cough, phlegm, wheeze, and breathlessness among children of school age, and ever having asthma among children of school age; the onset of wheeze illnesses in early childhood; persistent adverse effects on lung function across childhood; and a lower level of lung function during childhood (Ref. 155). More recently published studies on the topic support the Surgeon General's Reports' conclusion that parental secondhand smoke influences child health, particularly respiratory health (Refs. 156''158). 2. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. This proposed warning consists of the TCA statement ''WARNING: Tobacco smoke causes fatal lung disease in nonsmokers'' paired with a concordant, factually accurate, photorealistic image depicting fatal lung disease. The image shows gloved hands holding a pair of diseased lungs containing cancerous lesions from chronic secondhand smoke exposure. The 1986 and subsequent Surgeon General's Reports have confirmed the causal link between secondhand smoke exposure and lung cancer, a fatal lung disease, among nonsmokers (Refs.155 and 159). The conclusion in the 2006 Surgeon General's Report extends to all secondhand smoke exposure, regardless of location of exposure (e.g., at home, at work, in other settings); the combined evidence from multiple studies indicates a 20 to 30 percent increase in the risk of lung cancer from secondhand smoke exposure associated with living with a smoker (Ref. 155). For example, a meta-analysis of 43 studies, including studies conducted in both the United States and outside of the United States, found that the relative risk of lung cancer among nonsmoking women who live with partners who smoke (i.e., the risk of the lung cancer among nonsmokers living with smokers compared to nonsmokers not living with smokers) was 1.29 (Ref. 160). This means that nonsmoking women who live with partners who smoke have 1.29 times higher risk of lung cancer compared to nonsmoking women who live with partners who do not smoke. Recent studies support and extend these conclusions (Refs. 161''164). In addition to the many lung cancer deaths caused directly by smoking, researchers VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42774 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules estimate that another 5 percent of all lung cancer deaths, or 7,300 deaths annually (as measured in 2006), can be attributed to secondhand smoke exposure (Ref. 165). 3. WARNING: Smoking causes head and neck cancer. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes head and neck cancer'' paired with a concordant, factually accurate, photorealistic image depicting neck cancer. The image shows the head and neck of a woman (aged 50'' 60 years) who has neck cancer caused by cigarette smoking. The woman has a visible tumor protruding from the right side her neck just below her jawline. Common head and neck cancers include mouth, nose, pharynx, and larynx. Since 1979, Surgeon General's Report have recognized that smoking causes head and neck cancers, and the 2004 Surgeon General's Report stated that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between smoking and cancers of the oral cavity, pharynx, and larynx (Ref. 154), building on the strong conclusions of causality from previous reports. The magnitude of this relationship is substantial'--male and female smokers who currently smoke and have smoked only cigarettes experience 10- and 5-fold higher risk of head and neck cancers than lifetime nonsmokers, respectively. The 2004 Surgeon General's Report summarized clinical studies showing that premalignant lesions in the mouth and throat are most commonly found in areas that have direct contact with tobacco or smoke and that quitting smoking causes most premalignant lesions to regress and reduces oral and pharyngeal cancer incidence and mortality (Ref. 154). In 2015, there were 44,430 new cases of cancer of the oral cavity and pharynx and 12,292 new cases of cancer of the larynx (Ref. 166). There were approximately 14,000 deaths from head and neck cancer in 2016 (approximately 10,000 from cancer of the lip, oral cavity, and pharynx, and approximately 3,900 from cancer of the larynx) (Ref. 166). Most head and neck cancers are attributable to smoking, with almost 70 percent of lip, oral cavity, pharynx, and larynx cancer deaths from 2000 to 2004 attributable to smoking, representing 7,900 deaths a year (Ref. 30). 4. WARNING: Smoking causes bladder cancer, which can lead to bloody urine. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes bladder cancer, which can lead to bloody urine'' paired with a concordant, factually accurate, photorealistic image depicting bloody urine. The image shows a gloved hand holding a urine specimen cup containing bloody urine resulting from bladder cancer caused by cigarette smoking. The association between smoking and bladder cancer has been noted since the first Surgeon General's Report in 1964, and a causal conclusion was reported in the 1990 report (Refs. 183 and 219). The 2014 Surgeon General's Report again confirmed that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between cigarette smoking and bladder cancer (Ref. 8). Recent research illustrates that even smoking a few cigarettes per day is associated with an increased risk of bladder cancer (Ref. 167) and that low intensity/long duration smoking is particularly associated with increased bladder cancer risk (Ref. 168). In most cases, blood in the urine (called hematuria) is the first visible sign of bladder cancer (Ref. 169), although there are other causes of hematuria. The number of cases of bladder cancer related to smoking is considerable. There were 73,000 bladder cancer cases in the United States in 2015 and 16,650 deaths from bladder cancer in 2017 (Ref. 166). According to the American Cancer Society, 1 in 27 men and 1 in 89 women will develop bladder cancer during their lifetime (Ref. 170). The Centers for Disease Control and Prevention (CDC) has estimated that 40 percent of bladder cancer deaths in 2000 through 2004 were attributable to smoking, representing almost 5,000 deaths a year (Ref. 30). 5. WARNING: Smoking during pregnancy stunts fetal growth. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking during pregnancy stunts fetal growth'' paired with a concordant, factually accurate, photorealistic image depicting a negative health consequence of smoking during pregnancy: An infant with low birth weight resulting from stunted fetal growth. The image shows a newborn infant on a medical scale, and the digital display on the scale reads four pounds. The 2004 Surgeon General's Report concluded for the first time that the evidence was sufficient to infer a causal relationship'--the highest level of evidence of causal inferences based on the criteria applied in the Surgeon General's Reports'--between maternal smoking and fetal growth restriction and preterm delivery (Ref. 154). The 2004 Surgeon General's Report summarized many studies that found a consistent and strong relationship between smoking and reduced birth weight as well as a strong dose-response relationship between smoking intensity and birth weight, and the 2010 Surgeon General's Report cited additional studies further supporting that conclusion (Ref. 171). New studies published since 2014 further support the causal relation between smoking and restricted fetal growth (Refs. 172'' 175). In the United States, around eight percent of newborns have low birth weight each year (Ref. 176). The CDC reported that low birth weight was twice as common among smoking mothers compared to nonsmoking mothers in Ohio in a 6-month period in 1989, with 20 percent of cases of low birth weight among infants during the same period due to maternal smoking (Ref. 177). Low birth weight was almost 60 percent more common among mothers who smoked during pregnancy than mothers who did not in a study in Massachusetts in 1998 (Ref. 32). The California EPA estimated 24,500 cases of low birth weight due to maternal exposure to environmental tobacco smoke (i.e., secondhand smoking) in the United States per year (Ref. 34). 6. WARNING: Smoking can cause heart disease and strokes by clogging arteries. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking can cause heart disease and strokes by clogging arteries'' paired with a concordant, factually accurate, photorealistic image depicting a patient who recently underwent heart surgery to treat heart disease caused by smoking. The image shows the chest of a man (aged 60''70 years) wearing an open hospital gown. The man has a large, recently-sutured incision running down the middle of his chest and is undergoing post-operative monitoring. Surgeon General's Reports since the 1970s have concluded that smoking is causally related to heart disease and stroke (Refs. 154 and 178). The 2014 Surgeon General's Report summarized the evidence and focused on new insights into causal mechanisms gained since the earlier report (Ref. 8). Coronary heart disease'--often simply called heart disease'--is a disorder of the blood vessels of the heart that can lead to a heart attack. A heart attack happens when an artery becomes blocked, preventing oxygen and nutrients from getting to the heart. Stroke occurs when blood supply to part of the brain is interrupted or reduced, depriving brain VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42775 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules tissue of oxygen and nutrients (Ref. 179). Atherosclerosis, or clogged arteries, is a disease in which plaque builds up inside the arteries that carry oxygen-rich blood to the heart and other parts of the body and can lead to heart attack and stroke through thrombosis, or blockage of the arteries (Refs. 8 and 179). Most coronary heart disease involves atherosclerosis, or clogged arteries. The 2004 Surgeon General's Report concluded that evidence from several different populations, multiple age groups, and both genders is sufficient to conclude that there is a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between smoking and atherosclerosis and related health conditions such as heart disease and stroke (Ref. 154). Across many studies over time, a clear dose-response relationship has been established with smoking more cigarettes and smoking for a longer time linked to greater risk of heart disease and stroke. More recent evidence demonstrates that even a very low frequency of smoking (i.e., even as few as one cigarette per day) has a measurable increase in the risk for cardiovascular disease (Ref. 180). The 2004 Surgeon General's Report further concluded that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between smoking and subclinical (or very early signs of) atherosclerosis (Ref. 154). The public health burden of heart disease and stroke is considerable. It has been estimated that, in the United States, over 2 million people have had a heart attack during their lifetime and over 1 million have had a stroke during their lifetime due to smoking (Ref. 21). The mortality burden is also substantial. There are approximately 635,000 deaths from heart disease and 140,000 deaths from stroke in the United States each year (Ref. 181). Recent data showed that the mortality risk (i.e., the risk of dying) for current smokers compared to never smokers from heart disease was 2.50 times greater for men and 2.86 times greater for women. The risk of having a stroke was 1.92 times greater for men and 2.10 times greater for women who were current smokers compared to never smokers (Ref. 182). The proportion of all deaths from heart attack and stroke due to active smoking is notable'--24.1 percent for heart disease deaths and 11.3 percent for stroke deaths. This represents approximately 100,000 deaths from heart attack due to smoking, and 15,000 stroke deaths due to smoking (Ref. 8). 7. WARNING: Smoking causes COPD, a lung disease that can be fatal. [image of diseased lungs] This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes COPD, a lung disease that can be fatal'' paired with a concordant, factually accurate, photorealistic image depicting COPD. The image shows gloved hands holding a pair of diseased, darkened lungs removed from a smoker with COPD. Because a similar image of diseased lungs was paired with the TCA statement regarding fatal lung disease in nonsmokers, FDA paired this revised statement with two different images for final testing (see next subsection). Chronic obstructive pulmonary disease (COPD) includes the diseases emphysema and chronic bronchitis. The 1964 Surgeon General's Report concluded that smoking is a primary cause of chronic bronchitis, and subsequent reports summarized additional evidence to conclude, in the 2004 Surgeon General's Report, at the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports, that the evidence is sufficient to infer a causal relationship between active smoking and COPD morbidity and mortality (Refs. 154, 183, and 184). The 2014 Surgeon General's Report reinforced and extended this evidence to discuss the relationship between smoking and COPD mortality (Ref. 8). The 2014 Surgeon General's Report concluded that the evidence is sufficient to infer'-- once again, the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--that smoking is in fact the dominant cause of COPD in the United States (Ref. 8). The report also concluded that smoking causes all elements of COPD, including emphysema and damage to the airways of the lung (Ref. 8). The public health burden of COPD is substantial. The National Heart, Lung, Blood Institute estimates that there are 12 million U.S. adults currently living who have been diagnosed with COPD and another 12 million who have COPD but have not yet been diagnosed (Ref. 185). It has also been estimated that approximately 7.5 million people currently living with COPD (whether diagnosed or undiagnosed) have the disease because of smoking (Ref. 21). The mortality risk from COPD for current smokers compared to never smokers was 25.61 times higher for men and 22.35 times higher for women, according to 50-year trends published in the New England Journal of Medicine (Ref. 182). There are about 128,000 COPD deaths in the United States each year, of which 101,000 (79 percent) are attributable to smoking (Ref. 8). 8. WARNING: Smoking causes COPD, a lung disease that can be fatal. [image of man with oxygen tank] This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes COPD, a lung disease that can be fatal'' paired with a concordant, factually accurate, photorealistic image depicting a man receiving oxygen support because he has COPD caused by cigarette smoking. The image shows the head and neck of a man (aged 50''60 years) who has a nasal canula under his nose supplying oxygen; the oxygen tank can be seen behind his left shoulder. Because, based on the findings from previous qualitative testing (see section VI.D), both this warning statement and the TCA statement regarding fatal lung disease in nonsmokers were paired with similar images of diseased lungs (see previous subsection), FDA decided to pair this revised statement with an additional concordant image for testing in the final quantitative consumer research study. As explained in the previous subsection (''7. WARNING: Smoking causes COPD, a lung disease that can be fatal. [image of diseased lungs]''), COPD includes the diseases emphysema and chronic bronchitis. The 1964 Surgeon General's Report concluded that smoking is a primary cause of chronic bronchitis, and subsequent reports summarized additional evidence to conclude, in the 2004 Surgeon General's Report, at the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports, that the evidence is sufficient to infer a causal relationship between active smoking and COPD morbidity and mortality (Refs. 154, 183, and 184). The 2014 Surgeon General's Report reinforced and extended this evidence to discuss the relationship between smoking and COPD mortality (Ref. 8). The 2014 Surgeon General's Report concluded that the evidence is sufficient to infer'--once again, the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--that smoking is in fact the dominant cause of COPD in the United States (Ref. 8). The report also concluded that smoking causes all elements of COPD, including emphysema and damage to the airways of the lung (Ref. 8). The public health burden of COPD is substantial. The National Heart, Lung, Blood Institute estimates that there are VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42776 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 12 million U.S. adults currently living who have been diagnosed with COPD and another 12 million who have COPD but have not yet been diagnosed (Ref. 185). It has also been estimated that approximately 7.5 million people currently living with COPD (whether diagnosed or undiagnosed) have the disease because of smoking (Ref. 21). The mortality risk from COPD for current smokers compared to never smokers was 25.61 times higher for men and 22.35 times higher for women, according to 50-year trends published in the New England Journal of Medicine (Ref. 182). There are about 128,000 COPD deaths in the United States each year, of which 101,000 (79 percent) are attributable to smoking (Ref. 8). 9. WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking reduces blood flow, which can cause erectile dysfunction'' paired with a concordant, factually accurate, photorealistic image depicting a man who is experiencing erectile dysfunction caused by smoking. The image shows a man (aged 50''60 years) sitting on the edge of a bed and leaning forward, with one elbow resting on each knee. The man's head is tilted down, with his forehead pressed into the knuckles of his right hand. Behind him on the bed, his female partner looks off in another direction. The 2014 Surgeon General's Report concluded, for the first time, that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between smoking and erectile dysfunction (Ref. 8). This conclusion is supported by the consistency of the strength of the association across numerous studies that evaluated rates of erectile dysfunction among smokers. For example, a recent meta-analysis of studies that included 50,360 participants found that smoking more cigarettes and smoking for a longer time were associated with increased erectile dysfunction risk (Ref. 186). Erectile dysfunction is likely under- reported in epidemiological studies; therefore, the effect estimates observed in studies are likely an underestimate. However, given that limitation of being under-reported in studies, at least 20 percent of all men have some degree of erectile dysfunction (Ref. 187). Among men between the ages of 40 and 70 years, approximately 50 percent have some degree of erectile dysfunction (Ref. 187). Smokers have been found to have a 40 percent increased risk of erectile dysfunction in studies such as the Health Professionals Follow-up Study and the Olmsted County Study of Urinary Symptoms and Health Status (Refs. 27 and 28). 10. WARNING: Smoking reduces blood flow to the limbs, which can require amputation. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking reduces blood flow to the limbs, which can require amputation'' paired with a concordant, factually accurate, photorealistic image depicting the feet of a person who had several toes amputated due to tissue damage resulting from peripheral vascular disease caused by cigarette smoking. Peripheral arterial disease (PAD), also known as peripheral vascular disease (PVD), is a condition in which narrowed arteries reduce blood flow to the limbs, especially the legs. Plaque is made up of fat, cholesterol, calcium, fibrous tissue, and other substances in the blood. Over time, plaque can harden and narrow the arteries. This limits the flow of oxygen-rich blood to organs and other parts of the body. PAD/PVD usually affects the arteries in the legs (Ref. 188). Complications of PAD/PVD occur because of decreased or absent blood flow and may include amputation or loss of limb due to tissue not getting enough oxygen from blood and dying. The 1983 Surgeon General's Report entitled ''The Health Consequences of Smoking: Cardiovascular Disease'' summarized evidence regarding smoking and PAD/PVD and concluded that cigarette smoking is the most powerful risk factor predisposing to this condition and that smoking cessation plays an important role in its medical and surgical management (Ref. 189). Since that time, other Surgeon General's Reports have extended this evidence base, through the 2014 report (Ref. 8). The population health burden of PAD/PVD is substantial. Overall prevalence of PAD/PVD was found to be 13.5 percent in 2012 in the Atherosclerosis Risk in Communities study, a multi-site, biracial, prospective cohort study investigating the causes and clinical effects of atherosclerosis in four U.S. communities (Ref. 190). A meta-analysis of studies of PAD/PVD and smoking found that the risk of the condition was 2.71 times greater for current smokers and 1.67 times greater for former smokers compared to never smokers (Ref. 26). In its summary of a recent prospective analysis using the Women's Health Study, which evaluated the relationships of smoking and smoking cessation with PAD/PVD, the 2014 Surgeon General's Report showed that risk estimates have increased over time (Ref. 8). Results from that study found higher risks than those in the meta-analysis; compared to never smokers, the risk of PAD/PVD in the Women's Health Study was 3.16 times greater for former smokers, 11.94 times greater for current smokers reporting less than 15 cigarettes per day, and 21.08 times greater for current smokers reporting 15 or more cigarettes per day (Ref. 191). One estimate from a review of the scientific literature suggests that there are between 160,000 and 180,000 amputations due to PAD/PVD annually in the United States, and, among people with critical limb ischemia (i.e., a severe blockage of the arteries that greatly reduces blood flow due to PAD/PVD), 25 percent have amputations each year (Ref. 192). Another article estimates that ''over 90% of all limb amputations in the Western world occur as a direct or indirect consequence'' of PAD/PVD (Ref. 193). 11. WARNING: Smoking causes type 2 diabetes, which raises blood sugar. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes type 2 diabetes, which raises blood sugar'' paired with a concordant, factually accurate, photorealistic image depicting a personal glucometer device being used to measure the blood glucose level of a person with type 2 diabetes caused by cigarette smoking. The digital display reading of 175 mg/dL and a notation on the glucometer indicate a high blood sugar level. The 2014 Surgeon General's Report concluded, for the first time, that: (1) The evidence is sufficient to infer'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--that cigarette smoking is a cause of type 2 diabetes; (2) the risk of developing diabetes is 30 to 40 percent higher for active smokers than nonsmokers; and (3) there is a relationship between increased number of cigarettes smoked and increased risk of developing diabetes (Ref. 8). Across the 25 studies included in the 2014 Surgeon General's Report updated summary, the associations were strong and consistent and were found in many subgroups, and these results have been replicated in many different study populations and study locations. The public health burden of smoking and diabetes is substantial. The prevalence of diabetes among U.S. adults was estimated to be 12.1 percent in 2005 through 2010 National Health and Nutrition Examination Survey data (Ref. 194). A meta-analysis of studies VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42777 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules found the risk of type 2 diabetes to be 44 percent greater among current smokers and 23 percent greater among former smokers compared to never smokers (Ref. 25). Smoking has been estimated to cause 9,000 of the 70,810 deaths (12.7 percent) due to diabetes in the United States each year (Ref. 8). 12. WARNING: Smoking causes age- related macular degeneration, which can lead to blindness. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes age- related macular degeneration, which can lead to blindness'' paired with a concordant, factually accurate, photorealistic image depicting a closeup of an older man (aged 65 years or older) who has age-related macular degeneration caused by cigarette smoking. The man is receiving an injection in his right eye to prevent additional vessel growth. Macular degeneration is an incurable eye disease that causes blindness. The 2014 Surgeon General's Report on cigarette smoking concluded, for the first time, that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between cigarette smoking and the two major types of advanced age-related macular degeneration (Ref. 8). The association is found across a range of populations and through various study designs. The prevalence of any macular degeneration among U.S. adults aged 40 years and older was estimated to be 6.5 percent (Ref. 216). A meta-analysis found that current smokers were approximately twice as likely (relative risks for cohort studies of 2.06 and for case-control studies of 2.38), as never smokers to have macular degeneration (Ref. 23). 13. WARNING: Smoking causes cataracts, which can lead to blindness. This proposed warning consists of the revised textual warning statement ''WARNING: Smoking causes cataracts, which can lead to blindness'' paired with a concordant, factually accurate, photorealistic image depicting a closeup of the face of a man (aged 65 years or older) who has a cataract caused by cigarette smoking. The man's right pupil is covered by a large cataract. A cataract is a clouding of the lens in the eye that affects vision. Without treatment, the area of clouding of the lens can increase and eventually leads to blindness. The 2004 Surgeon General's Report on cigarette smoking concluded that the evidence is sufficient to infer a causal relationship'--the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports'--between smoking and nuclear cataracts (Ref. 154). A nuclear cataract is one of the three types of cataracts and refers to the location of the clouding in the lens of the eye. The epidemiologic studies examined in the 2004 Surgeon General's Report found generally consistent associations between smoking and nuclear cataracts, with most studies reporting that smoking doubled or tripled the relative risk of nuclear cataracts; in addition, a dose-response relationship was observed as risk increased with the number of cigarettes smoked (Ref. 154). Data for other types of cataracts were less strong, and these subtypes are also less common in the population (Ref. 154). Authors have continued to identify smoking as a major causal risk factor in the development and progression of cataracts (Refs. 195''197). Studies of smoking cessation and risk of cataracts has affirmed that risk decreases, but is not equivalent to never smokers, upon elimination of the exposures of tobacco smoke (Ref. 198). Prevalence of cataracts among U.S. adults aged 40 years and older in 2010 was estimated to be 17.1 percent by the National Eye Institute (Ref. 199). By age 75, more than half of non-Hispanic whites have cataracts (Ref. 199). A meta- analysis found that the risk of cataracts was about 50 percent higher for current smokers and 20 percent to 60 percent higher for former smokers compared to never smokers (Ref. 24). VIII. First Amendment Considerations The Government may, consistent with the First Amendment, require the disclosure of factual information in commercial marketing where the disclosure is justified by a Government interest and does not unduly burden protected speech. Zauderer v. Office of Disciplinary Counsel; Nat'l Inst. of Family and Life Advocates v. Becerra, 138 S. Ct. 2361, 2372 (2018). The proposed new cigarette health warnings, including their images, fully satisfy those requirements. The proposed warnings are factual and accurate. As described in greater detail in section VI.A above, ''Review of the Negative Health Consequences of Cigarette Smoking,'' in developing the new warnings, FDA relied on the 2014 Surgeon General's Report, entitled ''The Health Consequences of Smoking: 50 Years of Progress'' (Ref. 8), in addition to previous reports of the Surgeon General and other scientific literature, which together present a robust body of evidence documenting the health consequences from both active smoking and exposure to secondhand smoke across a range of diseases and organ systems. In particular, Surgeon General's Reports provide definitive syntheses of the available evidence on smoking and health (Ref. 8, p. 3). Surgeon General's Reports classify the strength of causal inferences in a four- level hierarchy based upon work of the IOM (now the National Academy of Medicine) and the IARC (Refs. 200 and 212). Because of the rigor and consistent application of these causal standards, the Surgeon General's Reports are the preeminent authority for determinations of conditions caused by cigarette smoking and by exposure to secondhand smoke. Every smoking- related condition in every warning statement that FDA tested is supported at the very highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports. Based upon this research and upon the substantial scientific literature on the significant gaps and misperceptions in public understanding of the negative health consequences of smoking (see section V.A.3 above, ''There Remain Significant Gaps in Public Understanding About the Negative Health Consequences of Cigarette Smoking''), FDA developed initial versions of revised statements for further review, testing, and refinement. These initial revised statements were further reviewed by FDA internal epidemiological experts to confirm that the health conditions under consideration were causally linked to cigarette smoking or exposure to secondhand smoke. In parallel with FDA's work to develop and test revised warning statements, the Agency also undertook an iterative, research-based approach to develop and test color graphics depicting the negative health consequences of cigarette smoking to accompany the statements. As discussed in section VI.D above (''Developing and Testing Images Depicting the Negative Health Consequences of Smoking to Accompany the Textual Warning Statements''), FDA used a photorealistic illustration format for the images because this format best allowed FDA to ensure that the final images would be fully concordant with the ultimate textual statements addressing the same health conditions. The photorealistic illustration format also facilitated providing factually accurate images that depict common presentations of the health conditions in a realistic and objective format devoid of non-essential elements. FDA also carefully considered the D.C. Circuit Court findings regarding the VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42778 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules Agency's 2010''2011 cigarette warning rule, including the court's statements criticizing the images as having been designed ''to evoke an emotional response'' with ''inflammatory images and the provocatively-named hotline.'' R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d at 1216 (D.C. Cir. 2012). The court further found that some of the images ''could be misinterpreted by consumers'' and some did ''not convey any warning information at all.'' Id. (emphasis omitted) (''For example, the images of a woman crying, a small child, and the man wearing a T-shirt emblazoned with the words 'I QUIT' do not offer any information about the health effects of smoking.''). As discussed below, FDA's science-based, iterative research process to develop and select the current proposed cigarette health warnings thoroughly addresses any such criticisms. To ensure that all proposed warnings are unambiguous, are unlikely to be misinterpreted or misunderstood by consumers, and do convey warning information, FDA repeatedly tested potential text statements, potential images, and potential pairings of statements with images. To assess the 9 statements set out in the TCA and the 17 potential revised statements that were under consideration at the start of its consumer research, FDA conducted 16 qualitative focus groups with adolescent smokers, adolescents at risk for starting smoking, and adult smokers. As discussed in section VI.B above (''Developing Revised Textual Warning Statements''), these focus groups provided qualitative feedback on consumers' comprehension of each potential statement; the believability of each statement's content (e.g., that smoking causes the health condition noted); whether the relationship between smoking and the relevant health conditions was new information for them; and other feedback to make the statement more understandable or convey the intended message more clearly. This qualitative consumer focus group feedback informed FDA's selection and refinement of the warning statements for the next phase of research, a large (2,505 participant) quantitative consumer research study that tested potential statements on their own, without images. See details in section VI.C above (''FDA's Consumer Research Study on Revised Textual Warning Statements'') and in the study results included in this docket (Ref. 129). Obviating any potential concern that the proposed new warnings would ''not convey any warning information at all,'' Reynolds, 696 F.3d at 1216, FDA used the results of this quantitative research, especially ''self-reported learning'' and ''new information'' outcomes, to identify the warning statements, to be paired with accompanying concordant photorealistic images, for testing in the final quantitative consumer research study. FDA's rigorous process for developing the proposed images likewise obviates any potential concerns of the kind raised in Reynolds that they might ''not offer any information about the health effects of smoking'' or be discordant from the text statements with which they are paired. Id. FDA used different development and research processes to select and study the images in this rule than it did for the 2010''2011 rulemaking. As discussed above, two of FDA's criteria for images require them to be factually accurate and to be concordant with the textual warning statements on the same health condition. FDA sought repeated consumer feedback to ensure that its proposed images meet these criteria, including 53 indepth individual interviews with adolescents and adults, and later on, 20 qualitative focus groups with adolescent smokers, adolescents at risk for starting smoking, and adult smokers. Based on feedback received in these focus groups, FDA further refined some images for additional clarity and identified and eliminated images that were not well understood or where potential confusion could not be resolved through additional revisions. See details in section VI.D above (''Developing and Testing Images Depicting the Negative Health Consequences of Smoking to Accompany the Textual Warning Statements''). The Agency took careful and deliberate steps to develop and test images that are unambiguous and unlikely to be misinterpreted or misunderstood by consumers. Presenting the health condition in an objective format devoid of non-essential elements ensures that the focus of the image remains on the smoking-related health condition. The process FDA engaged in to develop and study the warnings was far more extensive than could be completed in the short timeframe for the prior rule. The proposed warnings are clearly justified by the Government's interest in promoting greater public understanding of the negative health consequences of cigarette smoking. As the Supreme Court has recognized, ''tobacco products are dangerous to health when used in the manner prescribed.'' FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 135 (2000). Indeed, as discussed above, cigarette smoking remains the leading cause of preventable disease and death in the United States. Given the magnitude of this public health problem from cigarette smoking, in the Tobacco Control Act Congress required nine new health warning statements appear on cigarette packages and in cigarette advertisements; directed FDA to develop color graphics ''depicting the negative health consequences of smoking'' to accompany the warning statements; and provided that FDA may adjust the warnings to ''promote greater public understanding of the risks associated with the use of tobacco products'' (sections 201 and 202 of the Tobacco Control Act). In reviewing and upholding the Tobacco Control Act's new warning requirements, the Sixth Circuit concluded that ''[t]here can be no doubt that the government has a significant interest in . . . warning the general public about the harms associated with the use of tobacco products.'' Disc. Tobacco City & Lottery, Inc. v. U.S., 674 F.3d 509, 519 (6th Cir. 2012). FDA's research and review of the scientific literature has confirmed that many smokers and nonsmokers hold misperceptions about the health risks associated with cigarette smoking, even among the health conditions most commonly focused on in health warnings and public health education campaigns. And studies have shown that consumers are largely unaware of many of the negative health consequences of cigarette smoking not mentioned in the current 1984 warnings (see section V.A.3 above, ''There Remain Significant Gaps in Public Understanding About the Negative Health Consequences of Cigarette Smoking''). Accordingly, the proposed rule is justified by the Government's substantial interest in informing consumers regarding the negative health consequences of smoking. Furthermore, the proposed warnings do not unduly burden protected speech. As the Sixth Circuit held, the Tobacco Control Act's warning requirement for cigarettes is not unduly burdensome because a manufacturer has the ability to convey other information of its choosing in the remaining space available. Disc. Tobacco City & Lottery, Inc. v. U.S., at 530''31. By statute, the required warnings for cigarette packages must comprise the top 50 percent of the front and rear panels, and for advertisements at least 20 percent of the area at the top of the advertisement. The Sixth Circuit found that ''ample evidence support[s] the size requirements for the new warnings'' and ''that the remaining portions of their packaging'' are sufficient for the VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42779 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 11We note that manufacturers who are also retailers would be subject to the proposed requirements as manufacturers. companies ''to place their brand names, logos or other information.'' Id. at 531, 567. See also Spirit Airlines, Inc. v. United States Dep't of Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for airlines to make total price the most prominent cost figure does not significantly burden airlines' ability to advertise). The scientific literature strongly supports that larger warnings, such as those of the size proposed in this rule, are necessary to ensure that consumers notice, attend to, and read the messages conveyed by the warnings, which leads to improved understanding of the specific health consequences that are the subject of those warnings (Refs. 3 and 4). See discussions above in, e.g., section V.A (''The Current 1984 Surgeon General's Warnings Are Inadequate''); section V.B.2.a (''Pictorial cigarette warnings increase knowledge and accurate health beliefs by addressing gaps in public understanding about the negative health consequences of smoking''). Accordingly, the proposed warnings are constitutional under Zauderer. Although Zauderer provides the appropriate framework for review, the rule also satisfies the elements of the test for commercial speech articulated in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n. Under that test, agencies can regulate speech where the regulation advances a substantial Government interest and the regulation is no more extensive than necessary. This standard does not require the Government to employ ''the least restrictive means'' of regulation or to achieve a perfect fit between means and ends. Board of Trustees v. Fox, 492 U.S. 469, 480 (1989). Instead, it is sufficient that the Government achieve a ''reasonable'' fit by adopting regulations ''in proportion to the interest served.'' Id. As discussed above, the Government's interest in informing the public and correcting misperceptions about the risks of cigarette smoking is undeniably substantial. See Disc. Tobacco City & Lottery, Inc., 674 F.3d at 519. The proposed warnings directly and materially advance the Government's interest by helping consumers understand the negative health consequences associated with cigarette smoking. As discussed above, the current 1984 warnings on cigarettes are virtually invisible and ineffective (see section V.A above, ''The Current 1984 Surgeon General's Warnings Are Inadequate''). FDA has developed new warnings with new information, in the form of text paired with concordant images, to promote greater public understanding of the negative health consequences of smoking. FDA's extensive qualitative and quantitative consumer research'--on potential statements, potential images, and potential pairings of statements and images'--amply demonstrate that the proposed cigarette health warnings do in fact promote better understanding by the public of the negative health effects of smoking. All 13 of the proposed cigarette health warnings statistically significantly outperformed the control condition (i.e., the current 1984 Surgeon General's warnings) on the dimensions of ''new information'' and ''self-reported learning.'' See discussion above in sections VI.B (''Developing Revised Textual Warning Statements'') through VI.E (''FDA's Consumer Research Study on New Cigarette Health Warnings''), and the consumer research study reports, which we have included in the docket (Refs. 129 and 153). The warnings selected for this proposal will advance the Government's interest. Finally, the regulation is appropriately tailored to achieve that result. The warnings relate to the dangers of smoking cigarettes and will be required on all cigarette packages and advertisements, so there is nothing over- or underinclusive in the rule's scope. As the Sixth Circuit held, the size of the warnings is justified by the ample data demonstrating that larger warnings ''materially affect consumers' awareness of the health consequences of smoking,'' Disc. Tobacco City & Lottery, Inc., 674 F.3d at 530, and there is sufficient remaining room for the manufacturers' speech. Accordingly, the proposed rule is constitutionally permissible under the First Amendment. IX. Description of the Proposed Rule Section 4 of the FCLAA, as amended by sections 201 and 202 of the Tobacco Control Act, directs FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany textual warning label statements, and permits FDA to adjust the format, type size, color graphics, and text of any of the label requirements, or establish the format, type size, and text of any other disclosures required under the FD&C Act, if such a change would promote greater public understanding of the risks associated with the use of tobacco products. This proposed rule would replace part 1141 in Title 21 of the Code of Federal Regulations to implement these FCLAA requirements. As described in detail in sections VI''VII, the proposed required warnings are intended to promote greater public understanding of the negative health consequences of cigarette smoking. We are seeking comments on these proposed provisions; if you have comments on specific provisions, we request that you identify the specific provisions in your comments. A. General Provisions (Proposed Subpart A) 1. Scope (Proposed § 1141.1) As directed by section 4 of the FCLAA, proposed § 1141.1(a) would explain that proposed part 1141 sets forth the requirements for the display of required warnings on packages and in advertisements cigarettes (proposed § 1141.3 includes a definition of cigarette). These requirements would be applicable to manufacturers, distributors, and retailers except as described in this proposed section. Retailers who are also manufacturers would be subject to both the requirements for retailers and manufacturers, as applicable. Proposed § 1141.1(b) provides that the requirements of this proposed part would not apply to manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or distribution within the United States. This proposed subsection is consistent with section 4(a)(3) of the FCLAA. Manufacturers and distributors are defined in proposed § 1141.3. In addition, retailers would not be in violation of the requirements of section 4 of the FCLAA and this proposed part for cigarette packaging that: (1) Contains a warning; (2) is supplied to the retailer by a license- or permit-holding tobacco product manufacturer or distributor; and (3) is not altered by the retailer in a way that is material to 15 U.S.C. 1333 or proposed part 1141 (see proposed § 1141.1(c)). We believe most, if not all, retailers would fall under this scenario.11This proposed subsection is consistent with section 4(a)(4) of the FCLAA. However, this proposed subsection would require that a retailer ensure that all cigarette packages they display or sell contain a warning that is unobscured by stickers, sleeves, or other materials on the packages, for example. Under proposed § 1141.1(d), the advertisement requirements in proposed § 1141.10 would apply to a retailer only if the retailer is responsible for or directs the warnings for advertising. Importantly, this provision would not relieve a retailer of liability if the retailer displays in a location open to the public an advertisement that does VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42780 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules not contain a warning or that contains a warning that has been altered by the retailer in a way that is material to section 4 of the FCLAA or the requirements of this proposed part. Retailers would be in violation of the FCLAA and this proposed part if they alter cigarette packaging or advertising in a way that is material to the requirements of section 4 of the FCLAA or proposed part 1141, for example, by obscuring or covering up the warning (e.g., blocking with a sticker or marker), shrinking the warning, or using a sleeve to cover the warning. Retailers also would be liable if they display, in a location open to the public, an advertisement that does not contain a warning (proposed § 1141.1(d)). 2. Definitions (Proposed § 1141.3) Proposed § 1141.3 provides the definitions for the terms used in the proposed rule. Proposed § 1141.3 sets forth the meaning of terms as they apply to proposed subparts A and B of part 1141. Proposed § 1141.3 includes the following definitions from the FCLAA (15 U.S.C. 1332): ' Cigarette. As defined in section 3(1) of the FCLAA, the term ''cigarette'' means: (1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco and (2) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (1) of this definition. ' Commerce. As defined in section 3(2) of the FCLAA, ''commerce'' means'-- † Commerce between any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof; † Commerce between points in any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any place outside thereof; or † Commerce wholly within the District of Columbia, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman Reef, or Johnston Island. ' Package or packaging. As defined in section 3(4) of the FCLAA, ''package'' means a pack, box, carton, or container of any kind in which cigarettes are offered for sale, sold, or otherwise distributed to consumers. The proposed rule would use ''packaging'' interchangeably with package. ' Person. As defined in section 3(5) of the FCLAA, ''person'' means an individual, partnership, corporation, or any other business or legal entity. ' United States. As defined in section 3(3) of the FCLAA, ''United States,'' when used in a geographical sense, includes the several States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, and Johnston Island. The term ''State'' includes any political division of any State. In addition, FDA proposes the following definitions: ' Distributor. FDA proposes to define ''distributor'' as any person who furthers the distribution of cigarettes, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this proposed part. This proposed definition of distributor would be consistent with the definition of distributor in section 900(7) (21 U.S.C. 387(7)) of the FD&C Act. FDA believes using this definition would help ensure consistent understanding of the scope of distributor across tobacco product regulations issued by FDA. For example, § 1140.3 (21 CFR 1140.3) uses a definition of distributor that is the same as this proposed definition except that § 1140.3 uses ''tobacco product'' instead of ''cigarette.'' ' Front panel and rear panel. FDA proposes to define ''front panel'' and ''rear panel'' to mean the two largest sides or surfaces of the package. FDA is proposing to include a definition of front and rear panels because section 4 of the FCLAA, in setting out the placement requirements for the label statements, provides that each label statement shall comprise the top 50 percent of the front and rear panels of the package. This proposed definition would help ensure that all persons responsible for complying with the FCLAA and this proposed part identify the sides or surfaces of the cigarette package on which the required warnings must appear. On almost all cigarette packages, these two panels are oriented directly opposite from one another and are the same size. ' Manufacturer. FDA proposes to define ''manufacturer'' as any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette product; or imports any cigarette that is intended for sale or distribution to consumers in the United States. ' Retailer. FDA proposes to define ''retailer'' as any person who sells cigarettes to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of cigarettes are permitted. This definition would include any person who sells cigarettes online (e.g., through a website or mobile phone application). The proposed definitions of manufacturer and retailer are similar to those used in part 1140 (which establishes sale and distribution restrictions for cigarettes, as well as other tobacco products), but with some edits to reflect that the scope of this proposed part is cigarette packaging and advertisements. 3. Incorporation by Reference (Proposed § 1141.5) Proposed § 1141.5 would identify the material that FDA proposes to incorporate by reference in this proposed part, entitled ''Required Cigarette Health Warnings.'' This section states that FDA is proposing to incorporate by reference each required warning, consisting of a textual warning label statement and its accompanying color graphic. Any final rule would provide information on how to obtain the electronic, layered design files for each required warning, as well as technical specifications to help manufacturers appropriately select, crop, and scale the warnings to ensure the required warnings are accurately reproduced during implementation across various sizes of cigarette packaging and cigarette advertisements. This material would be available for download either through FDA's website or a file transfer protocol website. For ease of review for this proposed rule, we have included an electronic PDF file, containing the proposed required warnings, as a reference in the docket for this proposed rule (Ref. 18). As described in section II.C, FDA intends to provide the required warnings selected for the final rule as electronic, layered design files and incorporate those by reference. The material incorporated by reference must meet the OFR's requirements for incorporating material by reference, and thus the way this material is displayed may be changed for the final rule to meet such requirements. Proposed § 1141.5(a) would identify the material that FDA proposes to incorporate by reference, ''Required Cigarette Health Warnings,'' and how to obtain the material from FDA. This material would include the electronic, layered design files for each required VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42781 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules warning in a range of sizes and aspect ratios, including the textual statements in English and Spanish, font files, color spaces, the accompanying color graphics, and the white and black warning backgrounds and borders. These layered design files would be accompanied by technical specifications describing how to use the layered design files to help manufacturers appropriately select, crop, and scale the warnings to ensure the required warnings are accurately reproduced during implementation of the required warnings on cigarette packages and in cigarette advertisements. Manufacturers, distributors, and, when applicable, retailers would obtain the required warnings by downloading the files directly from FDA's website or via a file transfer protocol website and accurately reproduce them on cigarette packages and in advertisements as required by section 4 of the FCLAA and proposed part 1141. This proposed section would also explain that the material is incorporated by reference with the approval of the Director of the Federal Register and where interested parties may obtain a copy of the material (1 CFR part 51). Specifically, if the proposed incorporation by reference is approved by the OFR and incorporated in the final rule, interested parties would be able to examine the incorporated material at that National Archives and Records Administration and at FDA's Dockets Management Staff. Proposed § 1141.5(b) would list the source where interested parties may obtain a copy of the incorporated material, i.e., by contacting FDA's Center for Tobacco Products at the address listed. B. Required Warnings for Cigarette Packages and Advertisements (Proposed § 1141.10) To promote greater public understanding of the negative health consequences of cigarette smoking, proposed § 1141.10 would establish required warnings for cigarette packages and advertising. The proposed requirements comply with section 4 of the FCLAA and include a textual warning label statement (proposed § 1141.10(a)(1)) with an accompanying color graphic (proposed § 1141.10(a)(2)). Proposed § 1141.10(a) would establish that a required warning must contain both one of the textual warning label statements and a color graphic to accompany the textual warning label statement. The textual warning label statements that would be required will be set out in any final rule. As FDA has described in section VI.D, we have identified concordant color graphics proposed to accompany each textual warning label statement. FDA invites comment on the proposed textual warning statements and accompanying color graphics. Given the degree of public and stakeholder interest in this area, and the legal complexities involved, FDA also seeks proposals for alternative text and images you believe would advance the Government's interest in promoting greater public understanding of the negative health consequences of smoking. If proposing alternative text and images to those in this proposed rule, please provide scientific information that supports that the alternative text and images would, in fact, promote greater public understanding of the negative health consequences of smoking. Proposals for alternative images should accompany either one of FDA's proposed textual warning statements or an alternative textual warning statement you are proposing. These comments and information will help inform the required warnings to be included in a final rule. Section 4(d) of the FCLAA directs that the required warnings be clear, conspicuous, and legible. Accordingly, proposed § 1141.10(b) and (c) are intended to address those FCLAA requirements. Proposed § 1141.10(b) would require that manufacturers and distributors (and retailers in the specific circumstances described in proposed § 1141.1(c)) obtain and accurately reproduce the required warning (which would comprise the combination of the textual warning label statement and its accompanying color graphic), from the electronic files contained in the material to be incorporated by reference at proposed § 1141.5. These entities would be responsible for ensuring that the required warnings are not distorted, obscured, or otherwise inaccurately reproduced from the incorporated material when reproduced for use in differing types of media (e.g., print, digital). For example, the required warnings would need to be accurately reproduced, including maintaining text specifications such as font face and size; using capital letters for the word ''WARNING'' in each statement; and maintaining the relationship of text to image for each warning. As per the requirements laid out in section 4 of the FCLAA, the text of the cigarette health warnings on packages must be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with all other printed material on the package. Proposed § 1141.10(c) would establish generally that it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarette unless the package of which bears a required warning (as described in proposed § 1141.10(a)) in accordance with section 4 of the FCLAA and this proposed part. This provision would apply to any package, including a pack, box, carton, or container, all of which are included in the definition of package in section 3(4) of the FCLAA. Thus, in the instance of a carton that contains packs of cigarettes, the carton and each pack would be required to bear a required warning. This proposed requirement helps to promote public understanding of the negative health consequences of cigarette smoking by ensuring that all cigarette packages bear the required warning. In addition, proposed § 1141.10(c)(1) would require that the warning appear directly on the package and be clearly visible underneath any cellophane or other clear wrapping. This proposed requirement is intended to ensure that the warning is not obscured in any way, e.g., any outer wrapping and tear tape would be required to be clear and otherwise not interfere with the required warning's visibility. For packages that are soft-sided (i.e., ''soft pack'' style packaging), the overwrap closure must not obscure the warning, and, for hinged lid packages, this would mean that no word of the textual warning statement may be severed when the package is opened. Proposed § 1141.10(c)(2) would implement the requirements in section 4 of the FCLAA that the required warning comprise at least the top 50 percent of the front and rear panels of the package. For cartons (which are included in the definition of package), proposed § 1141.10(c)(2) would specify that the required warning be located on the left side of the front and rear panels of the carton and comprise at least the left 50 percent of these panels. This proposed requirement is intended to ensure that when cigarettes are sold in cartons and not as individual packs, the required warnings are clearly visible, conspicuous, and legible to consumers as required by the FCLAA. As described earlier in this section, the required warning would need to be on the carton and on each pack to ensure compliance with the FCLAA and this proposed part. Proposed § 1141.10(c)(3) would specify that the required warning be positioned such that the text of the required warning and other information on that panel of the package have the same orientation. For example, if the front panel of a cigarette package contains information, such as the brand VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42782 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 12FCLAA prohibits any advertising of cigarettes on radio, television, or other media regulated by the Federal Communications Commission. name of the cigarette, in a left to right orientation, the required warning could not be placed such that it appears at a right angle to this text. Rather, the required warning, including the textual warning label statement, must also appear in a left to right orientation. This would help ensure that the required warnings on cigarette packages would be conspicuous and legible to consumers, as required by section 4 of the FCLAA and this proposed part. Cigarette advertisements are addressed in proposed § 1141.10(d). This section would establish requirements related to cigarette advertising, including that it is unlawful for any manufacturer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless each advertisement bears a required warning in accordance with section 4 of the FCLAA and this proposed part. As per the requirements laid out in section 4 of the FCLAA, the text of the cigarette health warnings in advertisements must be black if the background is white and white if the background is black. More specifically, for print advertisements and other advertisements with a visual component, the required warning must appear directly on the advertisement (proposed § 1141.10(d)(1)). Advertisements that would be subject to this proposed rule may appear in or on, for example, promotional materials (point-of-sale or non-point-of-sale), billboards, posters, placards, published journals, newspapers, magazines, other periodicals, catalogues, leaflets, brochures, direct mail, shelf-talkers, display racks, internet web pages, electronic mail correspondence, and also may include those communicated via mobile telephone, smartphone, microblog, social media website, or other communication tool;12websites, applications, or other programs that allow for the sharing of audio, video, or photography files; video and audio promotions; and items not subject to the sale or distribution ban in § 1140.34. Proposed § 1141.10(d)(1) includes some of these examples for reference but neither the examples in § 1141.10 (d) nor this discussion are intended to be exhaustive. Proposed § 1141.10(d)(2) would require that the warning comprise at least 20 percent of the area of the advertisement in a conspicuous and prominent format and location at the top of each advertisement, and that no part of the required warning would fall in the ''trim area'' (i.e., the area of an advertisement that is cut off as part of the print publishing process). To meet the proposed requirement, the required warning would need to be in the advertisement's ''safe area'' (i.e., not in the trim area) and not be placed in any area of an advertisement that may be cropped or folded during final publishing. For advertisements in digital media, proposed § 1141.10(d)(2) would mean that a required warning must be appropriately scaled in its coding for both standard desktop and mobile sizes to ensure that the full required warning is visible on the screen in its entirety (i.e., a user does not need to scroll in any direction to see any areas of the warning), is located at the top of the screen, and is displayed at each point of access to such advertisements. These proposed requirements are consistent with the language of section 4(b) of the FCLAA, which mandates that the required warning comprise at least 20 percent of the area of the advertisement and specifies that the advertisement appear in a conspicuous and prominent format and location at the top of the advertisement. We recognize that there is a wide variation in advertisement size and media, and we are requesting comments and information on how advertisements in different types of media might comply with these proposed requirements, including comments on issues related to small- size advertisements, advertisements in digital media, and non-visual advertisements. Proposed § 1141.10(d)(3) would require that the text of the required warning be in English, with the two exceptions established in section 3(b) of the FCLAA. First, the text of the required warning should not be in English when the advertisement appears in a non-English medium. In that case, the text of the required warning would be required to appear in the predominant language of the medium regardless of whether the advertisement is in English (the predominant language is the primary language used in the non- sponsored content in the publication). For example, if the predominant language of the medium is French, but the advertisement is in English, the text of the required warning would be required to be in French. Second, the text of the required warning would not need to appear in English when the advertisement appears in an English language medium but the advertisement is not in English; in this case, the text of the required warning would need to appear in the same language as that principally used in the advertisement. The purpose of the proposed requirement and the two proposed exceptions in § 1141.10(d)(3) is to help promote public understanding of the negative health consequences of cigarette smoking by ensuring that the textual warning label statement component of the required warning is in the language that is most likely to be understood by the majority of the public who would view the advertisement. Proposed § 1141.10(d)(4) would state that for English-language or Spanish- language warnings, each required warning must be obtained from the electronic files contained in ''Required Cigarette Health Warnings,'' which would be incorporated by reference (see proposed § 1141.5). The required warnings would need to be accurately reproduced as specified in ''Required Cigarette Health Warnings,'' to help ensure that the required warnings are not distorted or obscured, and are prominent and legible, consistent with the requirements of the FCLAA and this proposed part. Proposed § 1141.10(d)(5) would require that non-English-language warnings, other than Spanish-language warnings, be adapted using the English- language required warnings obtained from the electronic files contained in ''Required Cigarette Health Warnings,'' which would be incorporated by reference at proposed § 1141.5. As with the proposed requirement in § 1141.10(d)(4), the required warnings would be required to be accurately reproduced as specified in ''Required Cigarette Health Warnings,'' but for these warnings this would also include the substitution and insertion of a true and accurate translation of the textual warning label statement in place of the English-language version. The proposed rule would require that the inserted textual warning label statement comply with all requirements of section 4 of the FCLAA and this proposed part. The manufacturer, distributor, or retailer would be required to accurately and appropriately translate the textual warning label statement into the appropriate non-English language or the advertisement would be in violation of the FCLAA and this proposed part. The translated required warning would also need to meet the area, format, and other requirements of the FCLAA and this proposed part. Proposed § 1141.10(e) would require that the required warnings be indelibly printed on or permanently affixed to the package or advertisement. These required warnings, for example, must not be printed or placed on a label VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42783 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules affixed to a clear outer wrapper that is likely to be removed to access the product within the package. This provision is intended to ensure that the required warnings cannot be easily ripped off, obscured, or otherwise tampered with, which would undermine the proposed requirement. For an advertisement in digital media to meet this proposed requirement, the required warning must remain on the advertisement at all times and be clear, conspicuous, and legible as required in section 4 of the FCLAA and this proposed part. Thus, for example, it would not be enough to display the required warning only for a period of time in an advertisement in digital media. We invite comments and information on how advertisements in digital media might appropriately satisfy this proposed requirement. Proposed § 1141.10(f) would provide that no person may manufacture, package, sell, offer for sale, distribute, or import for sale or distribution within the United States cigarettes whose packages or advertisements are not in compliance with section 4 of the FCLAA and this proposed part, except as provided by proposed §§ 1141.1(c) and 1141.1(d). Proposed § 1141.10(g) would establish marketing requirements applicable to cigarettes. The marketing requirements would include the random and equal display and distribution of the required warnings for cigarette packages and quarterly rotation of the required warnings in advertisements. The marketing requirements would also require submission of a plan that provides for the random and equal display and distribution of the required warnings on cigarette packaging and the quarterly rotation of the required warnings in cigarette advertising, as described under section 4 of FCLAA and part 1141 (referred to as ''plan''). These proposed requirements would ensure that all of the required warnings would be displayed by the tobacco product manufacturer, distributor, or retailer at the same time. As described in more detail in the following paragraphs, under proposed § 1141.10(g)(1), each required warning would be required to be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and the packages randomly and equally distributed in all areas of the United States in which the cigarette is marketed. A manufacturer, distributor, or retailer would be required to submit a plan for random and equal display and distribution of the required warnings for packaging to FDA for approval. In addition, proposed § 1141.10(g)(2) would establish quarterly rotation requirements for the required warnings in advertisements. Under this proposed requirement, the required warnings for advertisements must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan approved by FDA. The manufacturer, distributor, or retailer would be required to submit the plan for quarterly rotation of the required warnings in advertisements to FDA for approval. For efficiency of review, each plan submitted under proposed § 1141.10(g)(1) and (2) should cover both packaging and advertising, rather than submitting each plan separately, to the extent applicable. The tobacco product manufacturer, distributor, or retailer should describe how their plan would achieve the random and equal display and distribution of the required warnings on packages and the quarterly rotation of the required warnings in advertisements. Under proposed § 1141.10(g)(1), for each brand of cigarettes, the plan for packaging would explain how each of the required warnings would be randomly displayed during each 12- month period on each brand; how each of the warnings would be displayed in as equal a number of times as possible on each brand of the product; and how product packages would be randomly and equally distributed in all areas of the United States in which the product is marketed. FDA expects that a plan for the random and equal display and distribution of required warnings on packages would ordinarily be based on the date of manufacture or shipment of the product. For each cigarette brand, the plan for advertising would be required to explain how the required warnings would be rotated quarterly in advertisements and how the quarterly rotations would occur in alternating sequence (proposed § 1141.10(g)(2)). Among other things, the plan should specify the initial rotation timeframe on which quarterly rotation is based and, if the rotation timeframe varies for different types/forms of advertising, specify the different quarterly timeframes associated with the different types/forms of advertising, and describe the quarterly schedule for rotating each of the required warnings for each cigarette brand. FDA would not consider a plan that merely restated the regulatory requirements to be sufficiently detailed to enable FDA to approve the plan. After FDA approval of an initial plan, a supplement to the approved plan should be submitted to FDA and approved before making changes to the random and equal display or distribution of required warning statements on packages or the quarterly rotation of required warning statements in advertisements. For a new brand, a new plan or a supplement to an approved plan would be required to be submitted and approved before displaying or distributing packages and advertisements for that new brand. However, in lieu of a supplement to an approved plan for a new brand, manufacturers may reference in their initial plan all brands in their product listing(s) under section 905(i) of the FD&C Act and incorporate any new brands into their approved plan, so long as no other changes are made to the plan. For retailer-generated advertising, retailers may list ''all brands'' in their plan, which would cover future brands, so long as the plan provides for the same schedule for quarterly rotation of the required warning statements for all brands. Proposed § 1141.10(g)(3) would explain that FDA would review each plan submitted. FDA's review of a plan would only be for the purpose of determining compliance with the regulatory criteria for approval of a plan, as set forth in proposed § 1141.10(g)(1) and (2). FDA requests that each plan include representative samples of packages and advertisements with each of the required warnings. Such samples would place the plan in context and, therefore, facilitate FDA's review of the plan, not a review of the content of the package labels and advertisements. During the course of a review of a plan, FDA may request an amendment to a plan under review if FDA needs clarification of information in the plan or other additional information to determine whether FDA could approve the plan. As described in proposed § 1141.10(g)(3), FDA intends to approve the plan if it would: (1) Provide for the random and equal distribution and display of the required warnings on packaging and the quarterly rotation of the required warnings in advertising, as set out in proposed § 1141.10(g)(1) and (2) and (2) assure that all required warnings would be displayed by the manufacturer, distributor, or retailer at the same time. Approval of a plan would not represent a determination by FDA that any specific package or advertisement complies with any of the other requirements of the FCLAA and proposed part 1141, including those regarding the placement, font type, size, and color of the warnings, or any other requirements under the FD&C Act and VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42784 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules its implementing regulations. FDA intends to communicate the approval of a plan by issuing a letter to the submitter. After FDA approval of a plan, if a manufacturer, distributor, or retailer intends to make changes to the approved plan, they should first submit a supplement to FDA for review and approval. To provide FDA sufficient time to review a supplement to an approved plan, FDA strongly recommends allowing up to 6 months for FDA to review and approve a supplement. The amount of time it would take FDA to review a supplement, however, would depend upon the volume and quality of the submissions. Plans, and any amendments or supplements, should be submitted to FDA's Center for Tobacco Products, Office of Compliance and Enforcement. FDA intends to allow electronic submissions, via FDA's Electronic Submissions Gateway (https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm ), and written submissions, directed to: Food and Drug Administration, Center for Tobacco Products, Office of Compliance and Enforcement, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993''0002. FDA strongly encourages electronic submission to facilitate efficiency and timeliness of submission and processing. Proposed § 1141.10(g)(4) would establish that each manufacturer required to randomly and equally display and distribute warnings on packaging or quarterly rotate the required warnings in advertisements in accordance with an FDA-approved plan under section 4 of the FCLAA and this proposed part must maintain a copy of the FDA-approved plan and make it available for inspection and copying by officers or employees of FDA. The FDA- approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect. FDA has selected 4 years as a means to help ensure that the FDA- approved plan would be available for at least one biennial FDA inspection under sections 704 and 905(g) of the FD&C Act. Retaining the FDA-approved plan for 4 years from the date it was last in effect would allow FDA to evaluate, for example, whether the warnings are randomly and equally displayed on product packaging during the time period in which such products are offered for sale to consumers. In addition, based on FDA's experience with smokeless plans, FDA has observed at times in conducting inspections that firms, including contract manufacturers, have not been aware of the FDA-approved plan that they should be following. Requiring that the FDA-approved plan is retained for 4 years from the date it was last in effect would help ensure that FDA has the opportunity to confirm during the course of an inspection that firms are aware of and following an approved plan. As discussed in section X, FDA intends to establish an effective date for the submission of plans to FDA, by each person subject to proposed § 1141.10(g). This would require submission of plans no later than 5 months from the date of publication of any final rule. Although FDA believes this timeframe would provide sufficient time for the plan to be submitted to FDA and reviewed by FDA in advance of the effective date for the required warnings on packages and advertisements (which, consistent with section 4 of the FCLAA, would be 15 months from the publication date of any final rule), we encourage the submission of these plans as soon as possible once the final rule is published. We invite comment on these proposed requirements, including whether and how the number of final required warnings selected would affect the random and equal display and distribution of the required warnings on packages and the quarterly rotation of the required warnings in advertisements. C. Misbranding of Cigarettes (Proposed § 1141.12) Proposed § 1141.12(a) sets out that a cigarette package would be deemed misbranded under section 903(a)(1) of the FD&C Act if its package and labeling do not bear one of the required warnings in accordance with section 4 of the FCLAA and this proposed part. In addition, proposed § 1141.12(a) would provide that a cigarette would be deemed misbranded under section 903(a)(7)(A) of the FD&C Act if its advertising does not bear one of the required warnings in accordance with section 4 of the FCLAA and this proposed part. Proposed § 1141.12(b) would explain that a cigarette advertisement and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributer, would be deemed to include a brief statement of relevant warnings for the purposes of section 903(a)(8) of the FD&C Act, if it bears one of the required warnings in accordance with section 4 of the FCLAA and this proposed part. However, FDA is proposing that a cigarette distributed or offered for sale in any State would be deemed misbranded under section 903(a)(8) of the FD&C Act unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to the cigarette one of the required warnings in accordance with section 4 of the FCLAA and this proposed part. Section 201(a)(1) of the FD&C Act (21 U.S.C. 321(a)(1)) defines ''State'' as ''any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.'' The warnings required by section 4 of the FCLAA for cigarette advertising and packages are ''relevant warnings'' with respect to cigarettes as that phrase is used in section 903 of the FD&C Act. For the purpose of this proposed provision, ''other descriptive printed matter'' would include the packages of cigarettes and would be required to bear one of the required warnings. X. Proposed Effective Dates FDA is proposing that the required warnings for packages and advertisements (proposed § 1141.10) would become effective 15 months after the date the final rule publishes in the Federal Register. This proposed effective date is consistent with the language of section 201(b) of the Tobacco Control Act, which contemplates that the amendments to the FCLAA established by the Tobacco Control Act would take effect 15 months after the issuance of the regulations set out in 201(a) of the Tobacco Control Act. FDA is also proposing an effective date for submission of plans under the FCLAA and this proposed part (§ 1141.10(g)) of no later than 5 months after the final rule publishes in the Federal Register. This would help ensure that FDA has time to review the plan in advance of the effective date requiring that packaging and advertising of cigarettes bear the required warnings. Thus, cigarette packages that do not comply with the requirements of any final rule must not be manufactured for sale or distribution in the United States as of the effective date (i.e., 15 months after the date the final rule publishes in the Federal Register). Section 201(b) of the Tobacco Control Act provides that, beginning 30 days after the effective date, a manufacturer must not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 4 of the FCLAA, as amended by the Tobacco Control Act. As provided by section 201(b), after the 30-day period, manufacturers would not be permitted VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42785 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules to introduce into domestic commerce any cigarette packages that do not contain the required warnings, irrespective of the date of manufacture. While this statutory limitation applies to only manufacturers, FDA believes that keeping products without the required warnings under any final rule on the market for an extended period would not be in the interest of public health. We request comments regarding ways to differentiate cigarette packages sold from existing inventory from those that were manufactured after the effective date. In addition, as of 15 months from the publication of any final rule mandating that cigarette packages and advertisements bear the required warnings, no tobacco product manufacturer, distributor, or retailer of cigarettes may advertise or cause to be advertised within the United States any cigarette product unless the advertising complies with the final rule. XI. Severability and Other Considerations In accordance with section 5 of the Tobacco Control Act, the various requirements established by this proposed rule, when finalized, would be considered severable and the individual provisions of this rule would be considered workable on their own. Section 5 of the Tobacco Control Act states that, if any provision of a regulation issued under the Act is held to be invalid, the remainder of the regulation ''shall not be affected and shall continue to be enforced to the fullest extent possible.'' (Section 5 of the Tobacco Control Act is codified at 21 U.S.C. 387 note.) Consistent with that directive, it is FDA's intent that the invalidity of any provision of the final rule shall not affect the validity of any other part of the rule. In the event any court or other lawful authority were to temporarily or permanently invalidate, restrain, enjoin, or suspend any provision of the final rule, FDA intends for the remaining parts to continue to be valid. Each provision of the proposed rule is independently supported by data and analysis as described or referenced in this preamble and, if issued separately, would remain a proper exercise of FDA authority under sections 201 and 202 of the Tobacco Control Act and sections 701, 704, 903, 905(g), and 909 of the FD&C Act, as amended by the Tobacco Control Act. If a court were to invalidate some but not all of the images within the cigarette health warnings, the corresponding textual warning statements would go into effect without the invalidated images, along with the remaining cigarette health warnings that pair a textual warning statement with an image. The remaining pairings and the textual warning statements without images would still be required to be randomly and equally displayed and distributed on packages and quarterly rotated in advertisements. This approach would advance the Government's interest in promoting greater public understanding of the negative health consequences of smoking. In the event that a court were to invalidate all of the images within the cigarette health warnings, FDA intends for all the warnings to go into effect with only their textual warning statements, without the invalidated images. These too would be randomly and equally displayed and distributed on packages and quarterly rotated in advertisements as required. FDA believes this approach could serve as an interim measure to address Congress's intent to replace the stale Surgeon General's warnings and to promote greater public understanding of the negative health consequences of smoking while FDA worked to develop new pictorial warnings. If a court were to invalidate some of FDA's revised textual warnings with their paired images but some remained valid, FDA intends that the remaining revised textual warning statements and their paired images would go into effect. Alternatively, FDA might also choose to require that the textual warning statements specified in section 4(1) of the FCLAA go into effect without an accompanying image. In determining the appropriate approach, relevant circumstances could include whether there were a sufficient number of warnings to be randomly and equally displayed and distributed on packages and quarterly rotated in advertisements as required by statute. As described above, FDA proposes implementing text-only cigarette health warnings as an interim measure as a means to address Congress's intent to replace the stale Surgeon General's warnings and to promote greater understanding of the negative health consequences of smoking while FDA worked to develop new pictorial warnings. FDA invites public comment on the application of the severability provision in section 5 of the Tobacco Control Act to this rulemaking and how any severed portions of a final rule would operate, advance the Government's interest, and address Congress's intent to replace the stale 1984 Surgeon General's warnings. FDA also seeks comment on whether additional codified language should be added for any of the scenarios described in this section. FDA further requests public comment, in the event a court were to invalidate all of the images within the cigarette health warnings or were to vacate this rule once finalized, as to whether and how FDA should implement textual warning statements without images as an interim measure. Additionally, FDA requests comment on whether, in the event that a court were also to invalidate the size or location of revised cigarette warnings as directed by Congress (i.e., for packages, at least the top 50 percent of the front and rear panels of the packages), it should require that such interim textual warning statements comprise, for example, at least the top 30 percent of the front and rear panels of the packages, consistent with warnings for other categories of tobacco products that are comprised of textual statements only, while FDA sought to develop new pictorial warnings. XII. Preliminary Economic Analysis of Impacts We have examined the impacts of the proposed rule under Executive Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601''612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104''4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). E.O. 13771 requires that the costs associated with significant new regulations ''shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.'' We believe that this proposed rule is an economically significant regulatory action as defined by E.O. 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We estimate that for a small manufacturer or importer who would be affected by this proposed rule, one-time costs could represent between 2.5 and 35.6 percent of their annual receipts and recurring costs could represent from 0.4 to 4.4 percent of their annual receipts. Hence, we find that the proposed rule will have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42786 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules includes an assessment of anticipated costs and benefits, before proposing ''any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $154 million, using the most current (2018) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would result in an expenditure in any year that meets or exceeds this amount. This proposed rule would require that one of up to 13 new cigarette health warnings, each comprising a textual warning statement paired with an accompanying color graphic image, appear on cigarette packages and in cigarette advertisements. The proposed rule would further require that, for cigarette packages, the required cigarette health warnings be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed throughout the United States in accordance with a plan approved by FDA. The proposed rule would also require that, for cigarette advertisements, the required cigarette health warnings must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan approved by FDA. Pictorial cigarette health warnings promote greater public understanding about the negative health consequences of smoking as they increase the noticeability of the warning's message, increase knowledge and learning of the negative health consequences of smoking, and benefit diverse populations that have disparities in knowledge about the negative health consequences of smoking. The direct economic benefits of providing information on cigarette health warnings are difficult to quantify, and we do not predict the size of these benefits at this time. We discuss the informational effects qualitatively. The cost of this proposed rule consists of initial and recurring labeling costs associated with changing cigarette labels to accommodate the new cigarette health warnings, design and operation costs associated with the random and equal display and distribution of required cigarette health warnings for cigarette packages and quarterly rotations of the required warnings for cigarette advertisements, advertising- related costs, and costs associated with government administration and enforcement of the rule. Using a 20-year time horizon, we estimate that the present value of the costs of this proposed rule ranges from $1.3 billion to $1.9 billion, with a mean estimate of $1.6 billion, using a three percent discount rate, and ranges from $1.0 billion to $1.5 billion, with a mean estimate of $1.2 billion, using a seven percent discount rate (2018$). Annualized costs, which are presented below in table 3, range from $88.6 million per year to $129.7 million per year, with a mean estimate of $107.5 million per year, using a three percent discount rate, and range from $94.6 million per year to $139.8 million per year, with a mean estimate of $115.3 million per year, using a seven percent discount rate (2018$). Because it is not possible to compare benefits and costs directly when the benefits are not quantified, we employ a break-even approach. If the information provided by the cigarette health warning on each cigarette package was valued at about $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the proposed rule would equal or exceed the estimated annual costs. TABLE3'--SUMMARY OF THEINFORMATIONALEFFECTS ANDCOSTS OF THEPROPOSEDRULE [in millions of 2018$] Category Primary estimate Low esti-mate High esti-mate Units Notes Year dollars Discount rate Period covered Informational Effects. ......................... Pictorial cigarette health warnings promote greater public understanding\ about the negative health con-sequences of smoking as they increase the noticeability of the warning'\s message, increase knowledge and learning of the negative health consequences of smoking and help red\uce disparities in knowledge about the negative health consequences of smoking across diverse populat\ions. If the information pro-vided by the cigarette health warning on each cigarette package was valu\ed at about $0.01 (for every pack sold annually nationwide), then the benefits that would be generat\ed by the proposed rule would equal or exceed the estimated annual costs. Costs ............... Annualized Monetized $millions/year. $115.3 $94.6 $139.8 2018 7% 20 Years .... Effective date of 15 months from date of publica-tion of final rule. 107.5 88.6 129.7 2018 3% 20 Years.In line with E.O. 13771, in table 4 we estimate present and annualized values of costs and cost savings over an infinite time horizon. Based on these costs, when finalized this proposed rule would be considered a regulatory action under E.O. 13771. VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42787 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules TABLE4'--E.O. 13771 SUMMARY TABLE [in millions of 2016$, over an infinite time horizon] Item Primary estimate (7%) Present Value of Costs ................ $985.8 Present Value of Cost Savings .... 0 Present Value of Net Costs .......... 985.8 Annualized Costs .......................... 69.0 Annualized Cost Savings ............. 0 Annualized Net Costs ................... 69.0 Notes: All amounts have been discounted relative to year 2016 from year 2021, the latter of which is the estimated year in which the proposed rule would become effective once fi-nalized. Because of this additional discounting step, the present value estimates presented here are in all instances lower than the com-parable present value estimates associated with a 20-year time horizon. Effective date is 15 months from date of publication of the final rule. We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 220) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. XIII. Analysis of Environmental Impact The labeling regulation is a class of actions that are ordinarily categorically excluded under 21 CFR 25.30(k). Additionally, the proposed action is not anticipated to pose serious harm to the environment and to adversely affect a species or the critical habitat of a species as stipulated under 21 CFR 25.21(b). The proposed action is of a type that does not individually or cumulatively have a significant effect on the human environment. No extraordinary circumstances exist that would require a preparation of an environmental assessment or an environmental impact statement. XIV. Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501''3520). A description of these provisions is given in the Description section immediately below, with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Required Warnings for Cigarette Packages and Advertisements Description: The requirement for submission of plans for cigarette packages and advertisements, and the specific marketing requirements relating to the random and equal display and distribution of required warning statements on cigarette packaging and quarterly rotation of required warning statements in alternating sequence in cigarette product advertising, appear in proposed § 1141.10(d)(5). A record of the FDA-approved plan must also be established and maintained. Description of Respondents: The respondents to this collection of information are manufacturers, distributors, and certain retailers of cigarettes who will be required to submit plans for cigarette packages and advertisements to FDA. FDA intends to ask that each plan cover both packaging and advertising to the extent applicable. The tobacco product manufacturer, distributor, or retailer should demonstrate how they plan to achieve the random and equal display and distribution of the required warning statements on packages and the quarterly rotation in advertisements. Required warnings for cigarettes must be randomly and equally displayed and distributed on packages, and rotated quarterly in advertisements, in accordance with an FDA-approved plan. Plans should be submitted to FDA no later than 5 months after the date of publication of the final rule and before advertising or commercially marketing a product that is subject to the rule. Packages and advertisements of cigarettes would be required to bear the required warnings beginning 15 months after the date of publication of the final rule. FDA intends to request an amendment to a plan under review if FDA needs clarification of information in the plan or other additional information to determine whether it could approve the plan. Any such amendments would likely increase the overall review time. After FDA approval of an initial plan, a supplement to the approved plan should be submitted to FDA and approved before making changes to the random and equal display or distribution of required warning statements on packages or the quarterly rotation of required warning statements in advertisements. For a new brand, a new plan or a supplement to an FDA- approved plan would be required to be submitted and approved before displaying or distributing packages and advertisements for that new brand. However, in lieu of a supplement to an FDA-approved plan for a new brand, manufacturers may reference in their initial plan all brands in their product listing(s) under section 905(i) of the FD&C Act and incorporate any new brands into their approved plan, so long as no other changes are made to the plan. For retailer-generated advertising, retailers may list ''all brands'' in their plan, which would cover future brands, so long as the plan provides for the same schedule for quarterly rotation of the required warning statements for all brands. FDA intends to allow electronic submissions, via FDA's Electronic Submissions Gateway, and written submissions. FDA strongly encourages electronic submission to facilitate efficiency and timeliness of submission and processing. For each brand of cigarettes, the plan for packaging should explain how: Each of the warnings will be randomly displayed during each 12-month period on each brand; each of the warnings will be displayed in as equal a number of times as possible on each brand of the product; and product packages will be randomly and equally distributed in all areas of the United States in which the product is marketed. FDA expects that a plan for random and equal display and distribution of warnings on packages will ordinarily be based on the date of manufacture or shipment of the product. For each cigarette brand, the plan for advertising should explain how the required warning statements will be rotated quarterly in advertisements and how the quarterly rotations will occur in alternating sequence. Among other things, the plan should specify the initial rotation timeframe on which quarterly rotation is based and, if the rotation timeframe varies for different types/forms of advertising, specify the different quarterly timeframes associated with the different types/ forms of advertising, and describe the quarterly schedule for rotating each of the required warnings for each cigarette VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42788 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules brand. FDA would not consider a plan that merely restated the regulatory requirements to be sufficiently detailed to enable FDA to approve the plan. FDA's review of a plan would only be for determining compliance with the regulatory criteria for approval of a plan, as set forth in proposed § 1140.10(g)(1) and (2). FDA requests that plans submitted for review include representative samples of packages and advertisements with each of the required warning statements. Such samples would place the plan in context and, therefore, facilitate FDA's review of the plan, not a review of the content of the package labels and advertisements. Approval of a plan does not represent a determination by FDA that any package or advertisement complies with any of the other requirements regarding the placement, font type, size, and color of the warnings found in section 4 of the FCLAA and proposed part 1141, or any other requirements under the FD&C Act and its implementing regulations. FDA intends to communicate the approval of a plan with a letter to the submitter. After FDA approval of an initial plan, a supplement to the approved plan would need to be submitted to FDA for review and approved before making changes to the display or distribution of required warnings on packages or the rotation of required warning statements in advertisements. For a new brand, a new plan or a supplement to an approved plan would need to be submitted and approved before displaying or distributing packages and advertisements for that new brand. However, in lieu of a supplement to an approved plan for a new brand, manufacturers may reference in their initial plan all brands in their product listing(s) under section 905(i) of the FD&C Act and incorporate any new brands into their approved plan, so long as no other changes are made to the plan. For retailer-generated advertising, retailers may list ''all brands'' in their plan, which would cover future brands, so long as the plan provides for the same schedule for quarterly rotation of the required warning statements for all brands. TABLE5'--ESTIMATEDONE-TIMEREPORTINGBURDEN1 Type of plan Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Initial Plans ........................................................................\...59 1 59 150 8,850 Supplements ........................................................................\ 30 1 30 75 2,250 Total ........................................................................\...... ........................ ........................ ........................ ........................ 11,100 1There are no capital costs or operating and maintenance costs associated\ with this collection of information. The burden estimates are based on FDA's experience with information collections for other tobacco product plans (i.e., smokeless OMB control number 0910''0671 and cigars OMB control number 0910''0768) and 2017 Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) data. As discussed in the preliminary regulatory impact analysis (see section XII; Ref. 220), based on 2017 TTB data FDA estimates 59 entities will be affected by the rule. We estimate these 59 entities will submit a one-time initial plan, and it will take an average of 150 hours per respondent to prepare and submit a plan for packaging and advertising for a total of 8,850 hours. We estimate that about half of respondents will submit a supplement. If a supplement to an approved plan is submitted, FDA estimates it will take half the time per response. We estimate receiving 30 supplements at 75 hours per response for a total of 2,250 hours. FDA estimates that the total hours for submitting initial plans and supplements will be 11,100. Proposed § 1141.10(g)(4) would establish that each tobacco product manufacturer required to randomly and equally display and distribute warnings on packaging or quarterly rotate warnings on advertisements in accordance with an FDA-approved plan under section 4 of the FCLAA and this proposed part must maintain a copy of the FDA-approved plan (approved under proposed § 1141.10(g)(3)). This copy (or record) of such FDA-approved plan must be available for inspection and copying by officers or employees of FDA. This proposed subsection would require that the record(s) be retained for a period of not less than 4 years from the date of FDA's approval of the plan. TABLE6'--ESTIMATEDANNUALRECORDKEEPINGBURDEN1 Plan records Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Records ........................................................................\........59 1.5 89 3 267 Total ........................................................................\...... ........................ ........................ ........................ ........................ 267 1There are no capital costs or operating and maintenance costs associated\ with this collection of information. FDA estimates that 59 recordkeepers will keep a total of about 89 records at 2 hours per record for a total of 267 hours. As stated previously, these estimates are based on FDA's experience with information collections for other tobacco product plans (i.e., smokeless OMB control number 0910''0671 and cigars OMB control number 0910''0768). Based on our estimates for the submission of initial plans and supplements (that all respondents will submit initial plans and about half of respondents will submit supplements), we estimate that each recordkeeper will keep an average of 1.5 records. FDA estimates that the total burden for this information collection is 11,367 hours (11,100 reporting + 267 recordkeeping). FDA believes that the proposed required warnings for cigarette packages and cigarette advertisements in proposed § 1141.10 are not subject to VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42789 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules review by OMB under the PRA because they do not constitute a ''collection of information'' under that statute (44 U.S.C. 3501''3520). Rather, these labeling statements are a ''public disclosure'' of information originally supplied by the Federal Government to the recipient for the purpose of ''disclosure to the public'' (5 CFR 1320.3(c)(2)). To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB or emailed to oira_ submission@omb.eop.gov (see ADDRESSES). All comments should be identified with the title of the information collection. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register. XV. Federalism We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132 and seek input from State and local officials on potential federalism impacts of the proposed regulation. Section 4(a) of the Executive Order requires agencies to ''construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.'' This rule is being proposed under section 4 of the FCLAA, as amended by the Tobacco Control Act, and sections 701, 704, 903, 905(g), and 909 of the FD&C Act, as amended by the Tobacco Control Act. Federal law includes an express preemption provision that preempts any requirement, except pursuant to the Tobacco Control Act, for a ''statement relating to smoking and health, other than the statement required by section 4 of [FCLAA], . . . on any cigarette package.'' Section 5(a) of the FCLAA. It also includes an express preemption provision that preempts any ''requirement or prohibition based on smoking and health . . . imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of [FCLAA],'' which includes section 4 of the FCLAA. Section 5(b) of the FCLAA. However, section 5(b) of the FCLAA does not preempt any State or local statutes and regulations based on smoking and health, that take effect after June 22, 2009, imposing specific bans or restrictions on the time, place, and manner, but not content, of the advertising or promotion of any cigarettes. Section 5(c) of the FCLAA. In addition, section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) expressly preempts any state or local requirement which is different from, or in addition to, any requirement under Chapter IX of the FD&C Act relating to, among other things, misbranding and labeling. This express preemption provision, however, does not apply to requirements relating to among other things the sale, distribution, access to, or the advertising and promotion of tobacco products. XVI. Consultation and Coordination With Indian Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action. XVII. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. *1. U.S. Congress. House. Committee on Energy and Commerce, Subcommittee on Health. H.R. 1108, Family Smoking Prevention and Tobacco Control Act: Hearing Before the House Subcommittee on Health of the Committee on Energy and Commerce. Testimony of Richard Bonnie. 110th Cong., 1st sess., October 3, 2007. *2. IOM of the National Academies. Ending the Tobacco Problem: A Blueprint for the Nation. R.J. Bonnie, K. Stratton, R.B. Wallace, Eds. Washington, DC: The National Academies Press, 2007. Available at http://www.nationalacademies.org/hmd/ Reports/2007/Ending-the-Tobacco- Problem-A-Blueprint-for-the- Nation.aspx. 3. Hammond, D., G.T. Fong, A. McNeill, et al. ''Effectiveness of Cigarette Warning Labels in Informing Smokers About the Risks of Smoking: Findings from the International Tobacco Control (ITC) Four Country Survey.'' Tobacco Control, 15(Suppl. 3):iii19''iii25, 2006. Available at https://doi.org/10.1136/ tc.2005.012294. 4. Hammond, D., G.T. Fong, R. Borland, et al. 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Preliminary Regulatory Impact Analysis; Initial Regulatory Flexibility Analysis; Unfunded Mandates Reform Act Analysis, Required Warnings for Cigarette Packages and Advertisements; Proposed Rule. List of Subjects in 21 CFR Part 1141 Advertising, Incorporation by reference, Labeling, Packaging and containers, Tobacco, Smoking. Therefore, under the Federal Cigarette Labeling and Advertising Act, the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the Food and Drug Administration proposes to revise 21 CFR part 1141 to read as follows: PART 1141'--REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS Subpart A'--General Provisions Sec. 1141.1 Scope. 1141.3 Definitions. 1141.5 Incorporation by reference. Subpart B'--Required Warnings for Cigarette Packages and Advertisements 1141.10 Required warnings. 1141.12 Misbranding of cigarettes. Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 387i; Secs. 201 and 202, Pub. L. 111''31, 123 Stat. 1776. Subpart A'--General Provisions § 1141.1 Scope. (a) This part sets forth the requirements for the display of required warnings on cigarette packages and in advertisements for cigarettes. (b) The requirements of this part do not apply to manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or distribution within the United States. (c) A cigarette retailer will not be in violation of § 1141.10 for packaging that: (1) Contains a warning; (2) Is supplied to the retailer by a license- or permit-holding tobacco product manufacturer, or distributor; and (3) Is not altered by the retailer in a way that is material to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) or this part. (d) Section 1141.10(d) applies to a cigarette retailer only if that retailer is responsible for or directs the warnings required under § 1141.10 for advertising. However, this paragraph (d) does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a warning or has been altered by the retailer in a way that is material to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act or this part. § 1141.3 Definitions. For purposes of this part: Cigarette means'-- (1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco; and (2) Any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (1) of this definition. Commerce means: (1) Commerce between any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof; (2) Commerce between points in any State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any place outside thereof; or (3) Commerce wholly within the District of Columbia, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman Reef, or Johnston Island. Distributor means any person who furthers the distribution of cigarettes, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this part. Front panel and rear panel mean the two largest sides or surfaces of the package. Manufacturer means any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette product; or imports any cigarette that is intended for sale or distribution to consumers in the United States. Package or packaging means a pack, box, carton, or container of any kind in which cigarettes are offered for sale, sold, or otherwise distributed to consumers. Person means an individual, partnership, corporation, or any other business or legal entity. Retailer means any person who sells cigarettes to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of cigarettes are permitted. United States, when used in a geographical sense, includes the several States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, and Johnston Island. The term ''State'' includes any political division of any State. § 1141.5 Incorporation by reference. (a) Certain material titled ''Required Cigarette Health Warnings,'' appearing in § 1141.10, is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42797 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules CFR part 51. All approved material is available for inspection at U.S. Food and Drug Administration, Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the source listed in paragraph (b) of this section. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to https://www.archives.gov/federal- register/cfr/ibr-locations.html. (b) Center for Tobacco Products, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993; 1''888''463''6332. (1) ''Required Cigarette Health Warnings'' (2) [Reserved] Subpart B'--Required Warnings for Cigarette Packages and Advertisements § 1141.10 Required warnings. (a) A required warning must include the following: (1) One of the following textual warning label statements: (i) WARNING: Tobacco smoke can harm your children. (ii) WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. (iii) WARNING: Smoking causes age- related macular degeneration, which can lead to blindness. (iv) WARNING: Smoking causes type 2 diabetes, which raises blood sugar. (v) WARNING: Smoking reduces blood flow to the limbs, which can require amputation. (vi) WARNING: Smoking causes cataracts, which can lead to blindness. (vii) WARNING: Smoking causes bladder cancer, which can lead to bloody urine. (viii) WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. (ix) WARNING: Smoking causes head and neck cancer. (x) WARNING: Smoking can cause heart disease and strokes by clogging arteries. (xi) WARNING: Smoking during pregnancy stunts fetal growth. (xii) WARNING: Smoking causes COPD, a lung disease that can be fatal. (2) A color graphic to accompany the textual warning label statement. (b) Each required warning, comprising a combination of a textual warning label statement and its accompanying color graphic, must be obtained and accurately reproduced as specified from the electronic files contained in ''Required Cigarette Health Warnings,'' which is incorporated by reference at § 1141.5. (c) It is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes unless the package of which bears a required warning in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. (1) The required warning must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping. (2) The required warning must comprise at least the top 50 percent of the front and rear panels; provided, however, that on cigarette cartons, the required warning must be located on the left side of the front and rear panels of the carton and must comprise at least the left 50 percent of these panels. (3) The required warning must be positioned such that the text of the required warning and the other information on that panel of the package have the same orientation. (d) It is unlawful for any manufacturer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless each advertisement bears a required warning in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. (1) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, retail displays, internet web pages, digital platforms, mobile applications, and email correspondence), the required warning must appear directly on the advertisement. (2) The required warning must comprise at least 20 percent of the area of the advertisement in a conspicuous and prominent format and location at the top of each advertisement within the trim area, if any. (3) The text in each required warning must be in the English language, except as follows: (i) In the case of an advertisement that appears in a non-English medium, the text in the required warning must appear in the predominant language of the medium whether or not the advertisement is in English; and (ii) In the case of an advertisement that appears in an English language medium but that is not in English, the text in the required warning must appear in the same language as that principally used in the advertisement. (4) For English-language and Spanish- language warnings, each required warning must be obtained from the electronic files contained in ''Required Cigarette Health Warnings,'' which is incorporated by reference at § 1141.5, and must be accurately reproduced as specified in ''Required Cigarette Health Warnings.'' (5) For non-English-language warnings, other than Spanish-language warnings, each required warning must be obtained from the electronic files contained in ''Required Cigarette Health Warnings,'' which is incorporated by reference at § 1141.5, and must be accurately reproduced as specified in ''Required Cigarette Health Warnings,'' including the substitution and insertion of a true and accurate translation of the textual warning label statement in place of the English language version. The inserted textual warning label statement must comply with the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act, including area and other formatting requirements, and this part. (e) The required warnings must be indelibly printed on or permanently affixed to the package or advertisement. These warnings, for example, must not be printed or placed on a label affixed to a clear outer wrapper that is likely to be removed to access the product within the package. (f) No person may manufacture, package, sell, offer for sale, distribute, or import for sale or distribution within the United States cigarettes whose packages or advertisements are not in compliance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part, except as provided by § 1141.1(c) and (d). (g)(1) Random display. The required warnings for packages specified in paragraph (a) of this section must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, distributor, or retailer to, and approved by, the Food and Drug Administration. (2) Rotation. The required warnings for advertisements specified in paragraph (a) of this section must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan submitted by the tobacco product manufacturer, distributer, retailer to, and approved by, the Food and Drug Administration. (3) Review. The Food and Drug Administration will review each plan VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

42798 Federal Register/ Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules submitted under this section and approve it if the plan: (i) Will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and (ii) Assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, distributor, or retailer at the same time. (4) Record retention. Each tobacco product manufacturer required to randomly and equally display and distribute warnings on packaging or rotate warnings in advertisements in accordance with an FDA-approved plan under section 4 of the Federal Cigarette Labeling and Advertising Act and this part must maintain a copy of such FDA- approved plan and make it available for inspection and copying by officers or employees duly designated by the Secretary of Health and Human Services. The FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect. § 1141.12 Misbranding of Cigarettes. (a) A cigarette will be deemed to be misbranded under section 903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. A cigarette will be deemed to be misbranded under section 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act if its advertising does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. (b) A cigarette advertisement and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor will be deemed to include a brief statement of relevant warnings for the purposes of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act if it bears one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. A cigarette distributed or offered for sale in any State shall be deemed to be misbranded under section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to the cigarette one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. Dated: July 24, 2019. Norman E. Sharpless, Acting Commissioner of Food and Drugs. Dated: August 9, 2019. Eric D. Hargan, Deputy Secretary, Department of Health and Human Services. [FR Doc. 2019''17481 Filed 8''15''19; 8:45 am] BILLING CODE 4164''01''P VerDate Sep2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00046 Fmt 4701 Sfmt 9990 E:\FR\FM\16AUP3.SGM 16AUP3khammond on DSKBBV9HB2PROD with PROPOSALS3

Link to Article

Archived Version

Sat, 29 Feb 2020 09:34

1.This Act may be cited as the Reversing the Youth Tobacco Epidemic Act of 2019 .

2.The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Title I'--Food and Drug Administration

Sec. 101. Cigarette graphic health warnings.

Sec. 102. Advertising and sales parity for all deemed tobacco products.

Sec. 103. Reducing child and adolescent nicotine addiction.

Sec. 104. Prohibition against remote retail sales.

Sec. 105. Fees applicable to all tobacco products.

Sec. 106. Regulation of products containing synthetic nicotine.

Sec. 107. Update to youth tobacco prevention public awareness campaigns.

Sec. 108. Exemption from premarket approval of certain tobacco products.

Sec. 109. Public education.

Sec. 110. Regulations for recordkeeping concerning tracking and tracing.

Title II'--Federal Trade Commission

Sec. 201. Advertising of tobacco products.

Title III'--Public Health Programs

Sec. 301. Outreach to medically underserved communities.

Sec. 302. Demonstration grant program to develop strategies for smoking cessation in medically underserved communities.

Title IV'--Nicotine or Vaping Access Protection and Enforcement

Sec. 401. Short title.

Sec. 402. Increasing civil penalties applicable to certain violations of restrictions on sale and distribution of tobacco products.

Sec. 403. Study and report on e-cigarettes.

I 101. (a)Not later than March 15, 2020, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a final rule pursuant to section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(d) ). If the Secretary fails to promulgate such final rule by March 15, 2020, then the proposed rule titled Tobacco Products; Required Warnings for Cigarette Packages and Advertisements published by the Food and Drug Administration on August 16, 2019 (84 Fed. Reg. 42754) shall be treated as a final rule beginning on March 16, 2020.

(b)The first section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(d) ) (relating to graphic labeling statements) is amended by striking Not later than 24 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary and inserting The Secretary.

102. (a)Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate a final rule amending part 1140 of subchapter K of title 21, Code of Federal Regulations'--

(1)to apply the provisions of such part 1140 to all tobacco products, as applicable, to which chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a et seq.) applies pursuant to section 901(b) of such Act (21 U.S.C. 387a(b) ), as amended by section 103(a) of this Act; and

(2)to make such changes as may be necessary for consistency with the amendments made by section 103 of this Act, including by updating all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations.

(b)The final rule required by subsection (a) shall take effect on the date that is 2 years after the date of enactment of this Act.

103. (a) (1)Subsection (b) of section 901 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a ) is amended to read as follows:

(b)This chapter shall apply to all tobacco products.

.

(2)Paragraph (1) and the amendment made thereby shall not be construed to limit the applicability of chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a et seq.) to'--

(A)products that were listed in section 901(b) of such Act as in effect on the day before the date of enactment of this Act; and

(B)products that were deemed by regulation to be subject to such chapter pursuant to section 901(b) of such Act as in effect on the day before the date of enactment of this Act.

(b) (1)Section 906(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d) ) is amended by striking paragraph (3) and inserting the following:

(3) (A)It shall be unlawful for any retailer, manufacturer, distributor, third-party marketplace, or any other commercial entity to sell a tobacco product to any person younger than 21 years of age.

(B)To ensure compliance with subparagraph (A), a retailer shall, at a minimum, verify by means of a government-issued photographic identification the age of the individual purchasing the product as prescribed in'--

(i)subpart B of part 1140 of subchapter K of title 21, Code of Federal Regulations; and

(ii)successor regulations, including the regulation required by section 102 of the Reversing the Youth Tobacco Epidemic Act of 2019 and any applicable regulation imposing restrictions pursuant to paragraph (1).

(C)Not later than 180 days after the date of enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 , the Secretary shall promulgate a final regulation to implement and enforce subparagraphs (A) and (B).

(D)Subparagraphs (A) and (B) shall take effect on the date that is 180 days after the date of enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 , regardless of whether the Secretary has promulgated the final regulations required by subparagraph (C).

.

(2)Nothing in the amendment made by paragraph (1) shall be construed to affect the preservation of State and local authority pursuant to section 916 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387p ).

(c) (1) (A)Subparagraph (A) of section 907(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)(1) ) is amended to read as follows:

(A) (i)Beginning on the date that is 1 year after the date of enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 , a tobacco product (including its components, parts, and accessories, including the tobacco, filter, or paper) that is not an electronic nicotine delivery system shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco) that is a characterizing flavor of the tobacco product or tobacco smoke or an herb or spice, including menthol, mint, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee.

(ii)Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act applicable to any artificial or natural flavor, herb, or spice.

(iii)Notwithstanding any provision of this Act, no individual who purchases or possess for consumption a tobacco product that is in violation of the prohibition under this subparagraph shall be subject to any criminal penalty under this Act for such purchase or possession, nor shall it be used as a justification to stop, search, or conduct any other investigative measure against any individual.

.

(B)Section 907(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)(1) ), as in effect on the date of enactment of this Act, shall remain in effect until the amendments made to such section 907(a)(1) by this paragraph take effect.

(2)Section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j ) is amended by inserting at the end the following:

(h) (1)Beginning on the date that is 30 days after the date of enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 , any flavored electronic nicotine delivery system that is a new tobacco product, including any liquid, solution, or other component or part or its aerosol, shall not contain an artificial or natural flavor (other than tobacco) that is a characterizing flavor, including menthol, mint, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, unless the Secretary has issued a marketing order as described in paragraph (2). Nothing in this paragraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act applicable to any artificial or natural flavor, herb, or spice.

(2)The Secretary shall not issue a marketing order under subsection (c)(1)(A)(i) or a substantial equivalence order under subsection (a)(2)(A)(i) for any electronic nicotine delivery system, including any liquid, solution, or other component or part or its aerosol, that contains an artificial or natural flavor (other than tobacco) that is a characterizing flavor, unless the Secretary issues an order finding that the manufacturer has demonstrated that'--

(A)use of the characterizing flavor'--

(i)will significantly increase the likelihood of smoking cessation among current users of tobacco products; and

(ii)will not increase the likelihood that individuals who do not use tobacco products, including youth, will start using any tobacco product, including an electronic nicotine delivery system; and

(B)such electronic nicotine delivery system is not more harmful to users than an electronic nicotine delivery system that does not contain any characterizing flavors.

.

(3)Section 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 ) is amended'--

(A)by redesignating paragraphs (8) through (22) as paragraphs (9) through (23), respectively; and

(B)by inserting after paragraph (7) the following new paragraph:

(8)The term electronic nicotine delivery system'--

(A)means any electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and

(B)does not include a product that'--

(i)is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and

(ii)is marketed and sold solely for a purpose described in clause (i).

.

104. (a)Paragraph (4) of section 906(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d) ) is amended to read as follows:

(4) (A)Not later than 18 months after the date of enactment of the the Reversing the Youth Tobacco Epidemic Act of 2019 , the Secretary shall promulgate a final regulation prohibiting the retail sale of all tobacco products other than retail sales through a direct, face-to-face exchange between a retailer and a consumer.

(B) (i)The regulation required by subparagraph (A) shall not apply to tobacco products described in section 910(a)(2)(A)(iii).

(ii)Not later than 18 months after the date of enactment of the the Reversing the Youth Tobacco Epidemic Act of 2019 , the Secretary shall promulgate regulations regarding the sale and distribution of tobacco products described in section 910(a)(2)(A)(iii) that occur through means other than a direct, face-to-face exchange between a retailer and a consumer in order to prevent the sale and distribution of tobacco products described in section 910(a)(2)(A)(iii) to individuals who have not attained the minimum age established by applicable law for the purchase of such products, including requirements for age verification.

(C)Nothing in this paragraph'--

(i)limits the authority of the Secretary to take additional actions under the other paragraphs of this subsection; or

(ii)preempts the authority of a State or local government to establish restrictions on the retail sale of tobacco products that are at least as restrictive as the prohibition under subparagraph (A).

.

(b)Section 906(d)(4) of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of enactment of this Act, shall continue to apply until the effective date of the regulations required by section 906(d)(4) of such Act, as amended by subsection (a).

105. (a)Section 919(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(1) ) is amended by striking subparagraph (K) and inserting the following subparagraphs:

(K)For fiscal year 2019, $712,000,000.

(L)For fiscal year 2020, $812,000,000.

(M)For each subsequent fiscal year, the amount that was applicable for the previous fiscal year, increased by the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year.

.

(b) (1)Subparagraph (A) of section 919(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2) ) is amended to read as follows:

(A) (i)For fiscal years 2020 and 2021, user fees shall be assessed and collected under subsection (a) only with respect to the classes of tobacco products listed in subparagraph (B)(i), and the total such user fees with respect to each such class shall be an amount that is equal to the applicable percentage of each such class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.

(ii)For fiscal year 2022 and each subsequent fiscal year, user fees shall be assessed and collected under subsection (a) with respect to each class of tobacco products to which this chapter applies (including tobacco products that the Secretary by regulation deems to be subject to this chapter), and the total user fees with respect to each such class shall be'--

(I)with respect to each class of tobacco products listed in subparagraph (B)(i), an amount that is calculated in the same way as the amounts calculated for fiscal years 2020 and 2021 under clause (i), except that for purposes of fiscal years 2022 and subsequent fiscal years, instead of multiplying the applicable percentage of each such class by the amount specified in paragraph (1) for the fiscal year, the applicable percentage shall be multiplied by'--

(aa)the amount specified in paragraph (1) for the fiscal year, reduced by

(bb)the total user fees assessed and collected pursuant to subclause (II) for the fiscal year; and

(II)with respect to each class of tobacco products to which this chapter applies but which is not listed in subparagraph (B)(i), an amount determined pursuant to a formula under subparagraph (C).

.

(2)Section 919(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2) ), as amended by paragraph (1), is further amended by adding at the end the following new subparagraphs:

(C) (i)Beginning with fiscal year 2022, the total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products not listed in subparagraph (B)(i) shall be an amount that is determined pursuant to a formula developed by the Secretary by regulation using information required to be submitted under subparagraph (D).

(ii)For each class of tobacco products not listed in subparagraph (B)(i), the percentage of fees under the formula under clause (i) for the respective fiscal year shall be equal to the percentage of the gross domestic sales in the previous calendar year that is attributable to such class of tobacco products in such calendar year, as determined by the Secretary.

(iii)The percentage of the total user fee to be paid by each manufacturer or importer of tobacco products in a class not listed in subparagraph (B)(i) shall be determined by the Secretary, based on the percentage of the gross domestics sales of all such classes of tobacco products by all manufacturers and importers in the previous calendar year that is attributable to such manufacturer or importer.

(iv)If the Secretary for any reason fails to finalize by fiscal year 2022 the formula required by this subparagraph for the assessment and collection of user fees for classes of tobacco products not listed in subparagraph (B)(i)'--

(I)the Secretary shall continue to assess and collect fees under subsection (a) with respect to each class of tobacco products listed in subparagraph (B)(i); and

(II)until the first fiscal year commencing after the finalization of such formula, the exception described in subparagraph (A)(ii)(I) shall not apply.

(v)Any revisions to the formula promulgated pursuant to this subparagraph shall be by regulation.

(vi)In this subparagraph, the term gross domestic sales means the total value in dollars of the sale or distribution by manufacturers and importers of tobacco products in the United States in classes not listed in subparagraph (B)(i), as determined based on the aggregation of sales data from every manufacturer and importer of tobacco products that submits sales data to the Secretary.

(D)Each manufacturer or importer of any tobacco product shall submit to the Secretary the information required under this subparagraph by March 1, 2021, for calendar year 2020, by April 1, 2021, for the period of January 1, 2021, through March 30, 2021, and monthly thereafter. Such information shall include'--

(i)the identification of the manufacturer or importer;

(ii)the class or classes of tobacco products sold by the manufacturer or importer;

(iii)the full listing of the finished tobacco products in a class not listed in subparagraph (B)(i) sold or distributed by the manufacturer or importer in the United States; and

(iv)the gross domestic sales data for each class of finished tobacco products sold or distributed by the manufacturer or importer in the United States.

.

(3)Section 301(q)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(1)(B) ) is amended by inserting 919(b)(2)(D), before or 920.

(c)Section 919(b)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(4) ) is amended by striking shall be the percentage determined for purposes of allocations under subsections (e) through (h) of section 625 of Public Law 108''357 and inserting shall be the percentage determined by the Secretary.

(d)Section 919(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b) ) is amended'--

(1)by striking paragraph (5);

(2)by redesignating paragraphs (6) and (7) as paragraphs (5) and (6), respectively; and

(3)by amending paragraph (6), as redesignated, to read as follows:

(6)The Secretary shall request the appropriate Federal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of all necessary information regarding all tobacco product manufacturers and importers required to pay user fees. The Secretary shall maintain all disclosure restrictions established by the head of such agency regarding the information provided under the memorandum of understanding.

.

(e)The amendments made by subsections (b), (c), and (d) apply beginning with fiscal year 2022. Subject to the amendment made by subsection (a), section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s ), as in effect on the day before the date of enactment of this Act, shall apply with respect to fiscal years preceding fiscal year 2022.

(f)For fiscal year 2020 and each subsequent fiscal year for which fees are collected under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s ), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall, by the end of the respective fiscal year, submit to the Congress financial and performance reports with respect to such fees.

106. (a)The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall'--

(1)not later than 1 year after the date of enactment of this Act, issue an interim final rule providing for the regulation of products containing synthetic nicotine under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and

(2)not later than 2 years after such date of enactment, issue a final rule providing for such regulation.

(b)In this section, the term synthetic nicotine means nicotine that is not made or derived from tobacco.

107. (a)The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall'--

(1)review all public health awareness campaigns of the Department of Health and Human Services designed to educate at-risk individuals about the harmful effects of tobacco use, including the use of e-cigarettes and other electronic nicotine delivery systems; and

(2)as applicable, modify such campaigns to include awareness and education materials designated for individuals who are 18 to 21 years of age.

(b)In carrying out subsection (a), the Secretary of Health and Human Services may consult with medical and public health associations and nonprofit organizations.

108. (a)Section 910(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2) ) is amended'--

(1)in subparagraph (A)'--

(A)in clause (i)(II), by striking or;

(B)in clause (ii), by striking the period at the end and inserting ; or; and

(C)by adding at the end the following:

(iii)subject to subparagraph (C), for the period beginning on the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 and ending on September 30, 2028, the tobacco product is a cigar and'--

(I)is wrapped in whole tobacco leaf;

(II)contains a 100-percent leaf tobacco binder;

(III)contains primarily long filler tobacco;

(IV)does not have a characterizing flavor other than tobacco;

(V)weighs more than 6 pounds per 1000 units;

(VI)has no filter, tip, or non-tobacco mouthpiece;

(VII) (aa)is made by combining manually the wrapper, filler, and binder and is capped by hand; or

(bb)has a homogenized tobacco leaf binder and is made in the United States using human hands to lay the 100-percent leaf tobacco binder onto only one machine that bunches, wraps, and caps each individual cigar; and

(VIII)has a retail price (after discounts or coupons) per cigar of no less than'--

(aa)for calendar years 2019 and 2020, $12; and

(bb)for each subsequent calendar year, $12 multiplied by any percent increase in the Consumer Price Index for all urban consumers (all items; U.S. city average) since calendar year 2020.

; and

(2)by adding at the end the following:

(C) (i)The Secretary shall, notwithstanding subparagraph (A)(iii) or any determination of substantial equivalence, if any of the conditions specified in clause (ii) are met'--

(I)withdraw any exemption applicable to a tobacco product or products described in such subparagraph;

(II)require that applications for review under this section be submitted with respect to such product or products; and

(III)require that manufacturers may only market such tobacco product after the issuance of an order under subsection (c)(1)(A)(i) with respect to such product or products.

(ii)The conditions specified in this clause are that'--

(I)the Secretary determines that the use of a tobacco product or products described in subparagraph (A)(iii) has resulted in an emerging public health threat;

(II)data from a National Youth Tobacco Survey (or successor survey) conducted after the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 identifies a rise in youth usage of tobacco products described in section 910(a)(2)(A)(iii); or

(III)the Secretary determines that a tobacco product or products no longer meets the criteria specified in such subparagraph.

.

(b) (1)The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine under which the National Academies shall conduct a study on'--

(A)the public health impact of having tobacco products described in subsection (a)(2)(A)(iii) of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2) ), as amended by subsection (a), exempt from premarket review under such section;

(B)the youth usage of such tobacco products; and

(C)the market share of such products.

(2)The agreement under paragraph (1) shall include a requirement that the National Academies of Sciences, Engineering, and Medicine submit to Congress, not later than December 31, 2026, a report on the findings of the study conducted under such paragraph.

109.Section 906 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f ) is amended by adding at the end the following:

(g) (1)Not later than 6 months after the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall provide educational materials for health care providers, members of the public, and law enforcement officials, regarding'--

(A)the authority of the Food and Drug Administration with respect to the regulation of tobacco products (including enforcement of such regulation);

(B)the processes of the Food and Drug Administration for enforcing restrictions on the manufacture and sale of tobacco products;

(C)the prohibition on characterizing flavors in tobacco products and the under section 907(a)(1) and the exception from such prohibition under subparagraph (C) of such section;

(D)the public health impact of tobacco products with characterizing flavors; and

(E)other information as the Secretary determines appropriate.

(2)Educational materials provided under paragraph (1) may include'--

(A)explanations of key statutory and regulatory terms, including the terms tobacco product,component parts, accessories, constituent, additive, tobacco product manufacturer, and characterizing flavor;

(B)an explanation of the Food and Drug Administration's jurisdiction to regulate tobacco products, including tobacco products with characterizing flavors under section 907(a)(1);

(C)information related to enforcement tools and processes used by the Food and Drug Administration for violations of the prohibition specified in section 907(a)(1);

(D)an explanation of the health effects of using tobacco products, including those with characterizing flavors; and

(E)information on resources available related to smoking cessation.

(3)Educational materials provided under paragraph (1) may be'--

(A)published in any format, including an Internet website, video, fact sheet, infographic, webinar, or other format, as the Secretary determines is appropriate and applicable; and

(B)tailored for the unique needs of health care providers, members of the public, law enforcement officers, and other audiences, as the Secretary determines appropriate.

.

110.The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate the regulations required by section 920(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387t ) in accordance with the following schedule:

(1)Not later than 1 year after the date of enactment of this Act, the Secretary shall issue proposed regulations.

(2)Not later than 2 years after the date of enactment of this Act, the Secretary shall promulgate final regulations.

II 201. (a) (1)It shall be unlawful'--

(A)to market, advertise, or promote any electronic nicotine delivery system in a manner that appeals to an individual under 21 years of age; or

(B)to market, advertise, promote, or endorse, or to compensate any person for the marketing, advertising, promotion, or endorsement of, any electronic nicotine delivery system without clearly disclosing that the communication is an advertisement, unless the communication is unambiguously identifiable as an advertisement.

(2) (A)A violation of paragraph (1) shall be treated as a violation of a regulation under section 18(a)(1)(B) of the Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B) ) regarding unfair or deceptive acts or practices.

(B)The Commission shall enforce paragraph (1) in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this Act. Any person who violates such paragraph shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act.

(3) (A)If the attorney general of a State has reason to believe a violation of paragraph (1) has occurred or is occurring, the attorney general, in addition to any authority the attorney general may have to bring an action in State court under the law of the State, may bring a civil action in any court of competent jurisdiction to'--

(i)enjoin further such violation by the defendant;

(ii)enforce compliance with such paragraph;

(iii)obtain civil penalties in the same amount as may be obtained by the Commission in a civil action under section 5(m) of the Federal Trade Commission Act (15 U.S.C. 45(m) ); or

(iv)obtain damages, restitution, or other compensation on behalf of residents of the State.

(B)Before filing an action under subparagraph (A), the attorney general of a State shall provide to the Commission a written notice of such action and a copy of the complaint for such action. If the attorney general determines that it is not feasible to provide the notice described in this subparagraph before the filing of the action, the attorney general shall provide written notice of the action and a copy of the complaint to the Commission immediately upon the filing of the action.

(C) (i)On receiving notice under subparagraph (B) of an action under subparagraph (A), the Commission shall have the right'--

(I)to intervene in the action;

(II)upon so intervening, to be heard on all matters arising therein; and

(III)to file petitions for appeal.

(ii)If the Commission has instituted a civil action for violation of paragraph (1) (referred to in this clause as the Federal action), no attorney general of a State may bring an action under subparagraph (A) during the pendency of the Federal action against any defendant named in the complaint in the Federal action for any violation of such paragraph alleged in such complaint.

(D) (i)Nothing in this section shall prevent the attorney general of a State from bringing an action under State law for acts or practices that also violate paragraph (1).

(ii)If the attorney general of a State has authority to bring an action under State law for acts or practices that also violate paragraph (1), the attorney general may assert the State-law claim and the claim for violation of such paragraph in the same civil action.

(E)In addition to civil actions brought by attorneys general under subparagraph (A), any other consumer protection officer of a State who is authorized by the State to do so may bring a civil action under such subparagraph, subject to the same requirements and limitations that apply under this paragraph to civil actions brought by attorneys general.

(4)The Commission may promulgate regulations under section 553 of title 5, United States Code, to implement paragraph (1).

(b) (1)Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Commission shall submit to Congress a report relating to each category of products described in paragraph (2) (or a single report a portion of which relates to each such category) that contains the following:

(A)Information on domestic sales and advertising and promotional activity by the manufacturers that have the largest market shares of the product category.

(B)Such recommendations for legislation as the Commission may consider appropriate.

(2)The categories of products described in this paragraph are the following:

(A)Cigarettes.

(B)Cigars.

(C)Smokeless tobacco.

(D)Electronic nicotine delivery systems.

(c)Nothing in this section may be construed in any way to limit the Commission's authority under any other provision of law.

(d)In this section:

(1)The term cigar means a tobacco product that'--

(A)is not a cigarette; and

(B)is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco.

(2)The term cigarette has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 ).

(3)The term Commission means the Federal Trade Commission.

(4)The term electronic nicotine delivery system'--

(A)means any electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and

(B)does not include a product that'--

(i)is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and

(ii)is marketed and sold solely for a purpose described in clause (i).

(5)The term endorse means to communicate an advertising message (including a verbal statement, demonstration, or depiction of the name, signature, likeness, or other identifying personal characteristics of an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertiser, even if the views expressed by such party are identical to those of the sponsoring advertiser.

(6)The term nicotine has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 ).

(7)The term smokeless tobacco has the meaning given such term in section 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 ).

(8)The term tobacco product has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 ).

III 301.The Secretary shall ensure that programs at the Centers for Disease Control and Prevention related to outreach to medically underserved communities, including racial and ethnic minority populations, include efforts to educate and provide guidance regarding effective evidence-based strategies'--

(1)to prevent tobacco, e-cigarette, and nicotine addiction; and

(2)for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems.

302. (a)The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to or contract with State, local, Tribal, or territorial public health departments to support'--

(1)the development of improved evidence-based strategies for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems for populations in medically underserved communities, particularly racial and ethnic minority populations;

(2)the development of improved communication and outreach tools to reach populations in medically underserved communities, particularly racial and ethnic minority populations, addicted to tobacco and e-cigarette products; and

(3)improved coordination, access, and referrals to services for smoking cessation and the cessation of the use of e-cigarettes and electronic nicotine delivery systems, including smoking cessation products and mental health and counseling services.

(b)To be eligible to receive a grant under subsection (a), a State, local, Tribal, or territorial public health department shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

(c)There are authorized to be appropriated to carry out this section, $3,000,000 for each of fiscal years 2020 through 2024.

IV 401.This title may be cited as the Nicotine or Vaping Access Protection and Enforcement Act of 2019 or the NO VAPE Act of 2019 .

402. (a)Subparagraph (A) of section 103(q)(2) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 333 note) is amended to read as follows:

(A)The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d), as described in paragraph (1), shall be as follows:

(i)With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed'--

(I)in the case of the first violation, $0, together with the issuance of a warning letter to the retailer;

(II)in the case of a second violation within a 12-month period, $500;

(III)in the case of a third violation within a 24-month period, $1,000;

(IV)in the case of a fourth violation within a 24-month period, $4,000;

(V)in the case of a fifth violation within a 36-month period, $10,000; and

(VI)in the case of a sixth or subsequent violation within a 48-month period, $20,000 as determined by the Secretary on a case-by-case basis.

(ii)With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed'--

(I)in the case of the first violation, $500;

(II)in the case of a second violation within a 12-month period, $1,000;

(III)in the case of a third violation within a 24-month period, $2,000;

(IV)in the case of a fourth violation within a 24-month period, $4,000;

(V)in the case of a fifth violation within a 36-month period, $10,000; and

(VI)in the case of a sixth or subsequent violation within a 48-month period, $20,000 as determined by the Secretary on a case-by-case basis.

.

(b)The amendment made by subsection (a) applies with respect to a violation of a restriction promulgated under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)(1) ), as described in section 103(q)(1) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 333 note), occurring on or after the date that is 6 months after the enactment of this Act. The penalties specified in such section 103(q)(1), as in effect on the day before such date, shall continue to apply to violations occurring before such date.

403.Not later than 5 years after the date of enactment of this Act, the Comptroller General of the United States shall'--

(1)complete a study on'--

(A)the relationship of e-cigarettes to tobacco cessation;

(B)the perception of the harmful effects of e-cigarettes; and

(C)the effects of secondhand exposure to smoke from e-cigarettes; and

(2)submit to the Congress a report on the results of such study, including recommendations based on such results.

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Archived Version

Sat, 29 Feb 2020 09:31

Tracker:This bill has the status Passed House

Here are the steps for Status of Legislation:

IntroducedArray( [actionDate] => 2020-02-21 [displayText] => Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-402. [externalActionCode] => 5000 [description] => Introduced)

Passed HouseArray( [actionDate] => 2020-02-28 [displayText] => Passed/agreed to in House: On passage Passed by the Yeas and Nays: 213 - 195 (Roll no. 78). [externalActionCode] => 8000 [description] => Passed House)

Passed SenateTo PresidentBecame Law Summary (2) Text (2) Actions (24) Titles (5) Amendments (1) Cosponsors (126) Committees (1) Related Bills (5) Go to: Summary: H.R.2339 '-- 116th Congress (2019-2020)All Information (Except Text)Shown Here: Reported to House (02/21/2020) Reversing the Youth Tobacco Epidemic Act of 2019

This bill revises requirements related to the safety, sale, and advertisement of tobacco products, including electronic nicotine delivery systems (e.g., e-cigarettes, e-hookah, e-cigars, and vape pens).

Among other requirements, the bill

requires the Food and Drug Administration (FDA) to implement regulations to require color graphics on the labeling of cigarette packages, depicting the negative health consequences of smoking; requires the FDA to apply regulations on tobacco products to all tobacco products, including e-cigarettes; generally prohibits the retail online sale of tobacco products, including electronic nicotine delivery systems; prohibits the use of flavored products in an electronic nicotine delivery system, except in specified circumstances; increases the user fees that the FDA collects from manufacturers and importers; directs the FDA to regulate products containing synthetic nicotine (not made or derived from tobacco); exempts certain cigars from premarket review requirements; establishes a demonstration grant program to develop strategies for smoking cessation in medically underserved communities; increases civil penalties for certain violations of restrictions on the sale of tobacco products; and requires the Government Accountability Office to study e-cigarettes.

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Archived Version

Sat, 29 Feb 2020 10:42

This article is copublished with Pete Buttigieg is leading at 63 percent. Andrew Yang came in second at 46 percent. And Elizabeth Warren looks like she's in trouble with 0 percent.

These aren't poll numbers for the U.S. 2020 Democratic presidential contest. Instead, they reflect which candidates were able to consistently land in Gmail's primary inbox in a simple test.

The Markup set up a new Gmail account to find out how the company filters political email from candidates, think tanks, advocacy groups, and nonprofits.

We found that few of the emails we'd signed up to receive '--11 percent'--made it to the primary inbox, the first one a user sees when opening Gmail and the one the company says is ''for the mail you really, really want.''

Google the Giant

How We Examined Gmail's Treatment of Political Emails We conducted an experiment with a new email address to try to figure out how Gmail's sorting algorithm worked without user input

February 26, 2020 06:00 ET Half of all emails landed in a tab called ''promotions,'' which Gmail says is for ''deals, offers, and other marketing emails.'' Gmail sent another 40 percent to spam.

For political causes and candidates, who get a significant amount of their donations through email, having their messages diverted into less-visible tabs or spam can have profound effects.

''The fact that Gmail has so much control over our democracy and what happens and who raises money is frightening,'' said Kenneth Pennington, a consultant who worked on Beto O'Rourke's digital campaign.

''It's scary that if Gmail changes their algorithms,'' he added, ''they'd have the power to impact our election.''

It's well known that Facebook and Twitter curate which posts people see through the news feed, highlighting some while others are scarcely shown. What's received less attention is how email has also become an algorithmically curated and monetized platform'--essentially another feed'--and the effect that can have. Some nonprofits and political causes said inbox curation is reducing donations and petition signatures.

Google communications manager Katie Wattie said in an email that the categories ''help users organize their email.''

''Mail classifications automatically adjust to match users' preferences and actions,'' she said. ''Users really like the tab organization.''

Gmail enables the tabs by default, but they can be disabled. Wattie declined to say whether most users keep the tabs, but an email deliverability firm said about 34 percent of respondents to a 2016 survey said they use them.

The tabs also serve another purpose: ad inventory. While Gmail does not sell ads in the primary inbox, advertisers can pay for top placement in the social and promotions tabs in free accounts.

Some fear that, as a result, Gmail has the same conflict of interest that exists on social networks: If the platforms make it too easy to reach people for free, no one will buy ads.

''The worry is that they want to basically turn Gmail into a Facebook-style news feed where you have to pay for placement in the inbox,'' said Ryan Alexander, a Democratic digital consultant.

Wattie, the Google spokesperson, replied: ''What you describe is not on our roadmap for Gmail.''

Gmail isn't the only email provider offering sophisticated inbox curation. The premium $30-a-month email provider Superhuman sorts messages into ''important'' and ''other,'' while Microsoft's Outlook sorts messages for its ''focused inbox.'' Outlook and Yahoo also sell ads in their inboxes in free accounts.

But with 1.5 billion active email addresses and an estimated 27.8 percent market share, Gmail's increasingly algorithmic inbox sorting has an outsized impact.

Nida Hasan, the director of Change.org in India, said she discovered in the spring of 2018 that the percentage of Gmail users opening her company's emails had suddenly plummeted around the world, stalling petitions. In India, 90 percent of Change.org's users are on Gmail, she said.

''There were a lot of really good campaigns which could not be mobilized or were stuck at a couple thousand signatures,'' Hasan said.

Employees tested their own Gmail accounts and found that Gmail was sending Change.org emails to the promotions tab'--even ''forgot password'' messages were winding up there.

A coalition of eight progressive advocacy groups in the U.S. noticed a similar change at about the same time and said it suppressed donations and petition signatures. We reviewed email data provided by Democracy for America, CREDO Action and SumOfUs and found their Gmail open rates did drop that spring, by about 50 percent compared with email sent to subscribers using other email providers.

''We believe that our ability to inform and engage the public in political action, which we believe is fundamental to a healthy democracy, is being impeded,'' the coalition wrote in a letter to Google in November 2018.

We believe that our ability to inform and engage the public in political action, which we believe is fundamental to a healthy democracy, is being impeded.''

Coalition of eight political action groupsDuring a phone conversation the following month, a Gmail official offered them a suggestion to get more eyeballs on their emails: ''You're not precluded from buying an ad in the promotions tab, or offering a deal,'' said Lee Carosi Dunn, who at the time led election sales, political outreach and policy for Google, according to notes taken by one person on the call. ''Your type of users may be looking for deals too, some deal that involves fund-raising or engagement.''

''We were appalled to hear that,'' said Robert Cruickshank, campaign director at Demand Progress, who was on the call. ''We don't want to sound like marketing, because we're not marketers. We're asking people to call Congress.''

Wattie, the Google spokesperson, did not respond directly to questions about the call but rather wrote in an email that Gmail has not allowed ''political content'' in ads since 2016 and that those would include issue advocacy and fund-raising.

To test how Gmail treats political email, we opened a new Gmail account using a new phone number and Tor, an anonymizing browser, to avoid sending signals about political leanings based on previous web activity. Google says Gmail categorization is personalized, meaning user activity can affect where an individual's emails are delivered.

We signed up for the email lists of 16 presidential candidates, both Democrats and Republicans. President Donald Trump's campaign never sent us any emails.

We also signed up for congressional candidates in competitive races, and advocacy groups, think tanks, and nonprofits from across the political spectrum.

In four months, we received more than 5,000 emails from 171 groups. Much of the email sought donations. Some senders were unrelenting'--at times sending more than one email a day. Nearly half of all groups and campaigns never got a single email into the primary inbox.

Presidential candidates' emails were less likely to end up in the primary inbox than the rest of the email we signed up for: Only 6 percent of presidential candidates' emails appeared there compared with 9 percent of other political and advocacy mail, on average.

When O'Rourke announced the end of his campaign, Gmail sent the message to spam.

Most often, presidential candidates' emails wound up in the promotions tab in our test'--90 percent of the time for some of them. Pennington, the consultant who worked on O'Rourke's digital campaign, said the campaign's internal data showed a lower spam rate than we found in our test.

''We are aware that emails go to Gmail's promotions tab and we are not concerned about our ability to communicate with supporters,'' said an email from Mike Casca, Bernie Sanders's communications director.

Former campaign workers for O'Rourke, Yang, Kamala Harris and Joe Walsh also said they aren't concerned about emails going to the promotions tab. Other candidates didn't respond to requests for comment or couldn't be reached.

Gmail

A screenshot of the tabbed inbox featuring the default categories: Primary, Social, and Promotions.Even emails sent by members of Congress through official House.gov addresses, which by law cannot be used for campaigning, were diverted to the promotions tab 25 percent of the time.

In marketing materials, Gmail gives straightforward examples of what kinds of emails belong in the promotions tab: ''50% off Kayaking Adventure,'' ''$20 Off Membership,'' ''7 Must-Try Romantic Restaurants.''

But in our tests, the distinctions between emails that wound up in the folder and those that went to the primary inbox were less consistent.

An email with the subject line ''NEW! Hoodies, sweatshirts, beanies'' from BernieStore2020 went to promotions, but another announcing ''So many new T-shirts! Grab yours today'' from Yang2020 Merch went to the primary inbox.

A heartfelt obituary for senior fellow Michael Martin Uhlmann from the conservative think tank Claremont Institute, which did not include any calls to action, went to promotions. So did signup confirmation emails for the Texas Young Republicans and New York Young Republican Club.

Some political organizers and advocates say they are frustrated by Gmail's categorization and questioned what political emails have to do with sales, as the ''promotions'' name implies.

Gavin Wax, president of the New York Young Republican Club, put it this way: ''It's just a step up above spam.''

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Archived Version

Source: Lobsters

Fri, 28 Feb 2020 10:36

A serious vulnerability deep inside Wi-Fi encryption

What is Kr00k?Kr00k '' formally known as CVE-2019-15126 '' is a vulnerability in Broadcom and Cypress Wi-Fi chips that allows unauthorized decryption of some WPA2-encrypted traffic.

Who is affected?The vulnerability affects all unpatched devices with Broadcom and Cypress FullMac Wi-Fi chips. These are the most common Wi-Fi chips used in today's client devices, made by well-known manufacturers including Amazon (Echo, Kindle), Apple (iPhone, iPad, MacBook), Google (Nexus), Samsung (Galaxy) as well as devices under many other brands.

Wi-Fi Access points and routers are also affected by Kr00k, making even environments with patched client devices vulnerable. All-in-all, before patching there were more than a billion affected devices.

ESET tested a number of popular devices with Broadcom and Cypress Wi-Fi chips and confirmed a manifestation of the Kr00k vulnerability. We have also tested some devices with Wi-Fi chips from other manufacturers, including Qualcomm, Realtek, Ralink and Mediatek, and did not see the vulnerability manifest itself. Obviously, we have not tested every possible Wi-Fi chip by every manufacturer, so while we are not aware of other affected chips, we also cannot rule this out.

How do I know if I'm still vulnerable to Kr00k? Make sure you have updated all your Wi-Fi capable devices, including phones, tablets, laptops, and Wi-Fi access points and routers to the latest operating system, software and/or firmware versions. According to our information, patches for devices by major manufacturers have been released by now.

Inquiries whether your devices with affected chips have been patched - or if your device uses the affected chips in the first place - need to be directed at your device manufacturer.

Please inquire about patches for the Kr00k vulnerability directly with your chip manufacturer.

ESET is also working with the Wi-Fi Alliance, which is developing additional tools that might help organizations identify vulnerable devices in their infrastructure.

What is the state of patching of Kr00k?

As this vulnerability affects Wi-Fi chips used in devices manufactured by various vendors, the patching process involves both the chip manufacturers (Broadcom and Cypress), as well as the device manufacturers. ESET responsibly disclosed the identified vulnerability to Broadcom and Cypress, who subsequently released patches to the individual device manufacturers.

Furthermore, to expand the scope of our responsible disclosure, ESET has worked with ICASI to ensure that all possibly affected device manufacturers are aware of Kr00k.

Where can I find more information?For more details, please read ESET's Kr00k white paper published at WeLiveSecurity.com. ESET researchers presented the results of this research at RSA 2020.

Additional information

Yes, that is the case if your device is not patched yet. Fortunately, there are a few aspects that limit the impact of the bug:

Firstly, it's a vulnerability concerning encryption on the wireless LAN (Wi-Fi) layer. It has nothing to do with TLS - the encryption that secures your online banking, email, and any website prefixed with HTTPS. In other words, a successful attack exploiting Kr00k degrades your security a step towards what you'd have on an open Wi-Fi network.Secondly, as it's tied to Wi-Fi, the attacker would have to be in close proximity to your Wi-Fi signal. (But - wouldn't need to know your Wi-Fi password!)Eavesdropping on the communication of an unpatched device is simple enough for most black-hat actors.

Kr00k is in no way tied to your Wi-Fi password, therefore the vulnerability does not affect its security and changing it does not hamper the ability of attackers trying to exploit the vulnerability.

Our research has focused on the most ubiquitous protocol WPA2 with CCMP. The outdated and insecure WEP, WPA-TKIP, and the new WPA3 protocols, were not the focus of our research.

Unfortunately, Kr00k also affects access points, meaning even communication between patched client devices and such vulnerable access points can be intercepted.

ESET Experimental Research and Detection Team, most prominently ESET security researcher MiloŠČermk.

Discover comprehensive ESET protection

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Archived Version

Sat, 29 Feb 2020 10:31

The controversial social news forum joins Snapchat on Chinese tech giant's growing list of U.S. investments. When Chinese tech giant Tencent (OTC:TCEHY) became Snap's (NYSE:SNAP) biggest shareholder in late 2017, it was considered an unusual move for Tencent, since it focused most of its overseas investments in video game makers and other tech companies. It was also ironic, since Snapchat isn't censored like Tencent's WeChat, the top mobile messaging app in China with 1.08 billion monthly active users (MAUs).

Over the past 12 months Snap has shed 40% of its value, making it not only unusual but also a potentially poor long-term investment for Tencent.

Despite that investment lesson, Tencent now plans to lead a new Series D funding round for Reddit, the social news forum plagued by controversy over the past decade. Reddit is hoping to raise up to $300 million and achieve a post-money valuation of $3 billion, up from a valuation of $2 billion in July 2017.

Image source: Getty Images.

How fast is Reddit growing?Reddit has over 330 million MAUs visiting its 150,000 Subreddits. It claimed that it reached 1.4 billion video views per month last December, representing a 40% increase from just two months earlier.

Reddit also started to sell cost-per-click ads, cost-per-impression ads, promoted posts, and video ads. Its revenue surpassed $100 million in 2018, according to CNBC, fueled by a 22% jump in engagement and 30% increase in total views. However, Reddit's heavy dependence on venture capital suggests that it isn't profitable, and its workforce of roughly 350 is based in pricey San Francisco.

Image source: Getty Images.

Tencent will reportedly invest $150 million in Reddit, which would make it one of the social platform's top stakeholders. Publisher Cond(C) Nast acquired a majority stake in 2006, and that stake now belongs to its parent company, Advance Publications. Reddit still operates independently from both companies.

Reddit has repeatedly struggled to moderate its freewheeling forums, which have often been breeding grounds for racist, misogynistic, and homophobic content. Both former CEO Ellen Pao and current CEO Steve Huffman have been criticized for their attempts to clean up the platform -- Pao tried to quarantine offensive Subreddits, while Huffman secretly edited user comments.

Despite those challenges, Reddit has been mulling an IPO since late 2017. Financial support from Tencent, which has backed a long list of IPOs in recent years, could help Reddit achieve that goal.

Check out the latest Tencent earnings call transcript.

Why does Tencent care about Reddit?$150 million is a drop in the pond for Tencent, which generated $11.8 billion in revenue and $3.4 billion in net income last quarter.

However, investing in a wide range of smaller companies like Snap and Reddit accomplishes two things. First, it diversifies its business away from online games (32% of its revenue last quarter ), which have been hit by a temporary freeze in gaming approvals, tougher censorship rules, and tighter playtime restrictions within China.

Second, investments boost Tencent's net profits. Tencent's investment in Snap wasn't a money maker, but its other investments (including its stake in the on-demand delivery platform Meituan-Dianping ) have paid off. That's why there was a big "gap" between its GAAP earnings (which include its investment gains) and non-GAAP earnings (which exclude those gains) last quarter.

Quarterly net profit

RMB

Year-over-year growth

GAAP

23.33 billion

30%

Non-GAAP

19.71 billion

15%

Source: Tencent Q3 report.

Tencent is often criticized for losing its focus by investing in too many "hot" companies. But in an interview with Business Week China last year, Tencent Investment Partnership Manager Li Zhaohui dismissed that notion, stating that the investments provided Tencent with "many opportunities and possibilities for expansion into new areas."

Li stated that Tencent only invested in sectors that it understood, and only "in areas related" to its core businesses. Li also noted that Tencent is a "long-term investor" and doesn't place short-term restrictions on its scattered bets.

A vote of confidence for RedditTencent's planned investment is a vote of confidence for Reddit, and could propel the controversial social platform closer to an IPO. Reddit will also join Tencent's growing list of U.S. investments, which already includes stakes in Tesla Motors, Activision Blizzard, and Glu Mobile.

This is just a small investment for Tencent. But if Reddit continues to grow, it could boost Tencent's bottom line growth and allow the tech giant to aggressively use lower-margin and loss-leading strategies to expand its core gaming, social, advertising, and/or cloud businesses.

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Sat, 29 Feb 2020 10:30

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Sat, 29 Feb 2020 10:29

Several moderators of The Donald, Reddit's largest pro-Trump community, have been purged by the site's administrators, who aim to replace them with moderators approved by the San Francisco company. The Donald's creators say this is the latest in Reddit's ''thousand cuts'' campaign to kill off its massively successful pro-Trump community.

The Donald is one of largest and influential hubs of pro-Trump activity on the web, with over 790,000 subscribed Reddit users. In 2016, the community's users were responsible for the creation and proliferation of numerous pro-Trump tropes and memes across the Internet, in what has colloquially become known as the ''great meme war.''

The Reddit administrators announced their purge in a post on The Donald, offering to ''help'' recruit new moderators, and implying a list of conditions on applicants.

In a statement to Breitbart News, moderators of The Donald accused Reddit of trying to kill its pro-Trump community with ''a thousand cuts,'' and urged subscribers to migrate to thedonald.win, an independent Reddit-like site created by the pro-Trump community.

The Donald's statement follows:

Reddit has been trying to slowly kill The_Donald since it played a role in getting Trump elected in 2016. It started with user harassment, moved on to restricting our posts from being seen by most of the rest of Reddit (The third highest-traffic website in the world), then entirely quarantining us from the rest of the website as well as search engine results.

In the last couple of days, China-backed Reddit has begun warning and banning our users not only for posting content that they disagree with, but even ''liking'' wrongthink. Finally, on Tuesday, Reddit admins removed more than half of the moderators that have spent the last four years of their lives building the number one Trump supporting online community and announced that they would be choosing users to replace us. Their post requesting new moderators was met with thousands of responses telling them, in no-so-nice words, to shove it.

As they've done with other Reddit communities, such as Kotaku In Action, they'll be installing their own puppet moderators to continue to silence and dilute our message. Reddit knows that to entirely ban what is effectively the only conservative voice on their website would garner them too much negative press, and possibly legal attention, so they've been trying to kill off The_Donald with a thousand cuts.

In preparation for this inevitable course of events, the mod team established a backup website, free from the political censorship of Reddit, and have encouraged our users to migrate to it (of which at least 100,000 have in the last day). The_Donald can now be found on an independent website, created and run by the people that have ran The_Donald for years, at http:// thedonald.win .

This is just the latest attempt by Reddit to interfere with its pro-Trump community. Reddit ''quarantined'' The Donald earlier this year, hiding its posts from Reddit's front page and forcing visitors to Reddit to sign up to the site before they can view The Donald's content.

Rep. Jim Banks (R-IN) has condemned Reddit for censoring the pro-Trump page, accusing the site of trying to tilt the scales against Republicans in 2020.

''I can't think of a more obvious and effective way to 'sway elections' than to hide the largest conservative forum on your site a year ahead of the 2020 elections,'' wrote Rep. Banks, in a letter to Reddit CEO Steve Huffman in October.

Are you an insider at Google, Facebook, Twitter, or any other tech company who wants to confidentially reveal wrongdoing or political bias at your company? Reach out to Allum Bokhari at his secure email address allumbokhari@protonmail.com. Allum Bokhari is the senior technology correspondent at Breitbart News.

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Fri, 28 Feb 2020 09:59

Authored by Jonathan Turley,

The Boston City Council is considering a new system for parking tickets that would set the amount paid by violators based on their income. The proposal newly elected city councilor at-large Julia Mejia would implement the system of income-adjusted fines '-- a system that could trigger some novel legal and political questions.

Mejia has declared that she is ''introducing legislation on income-adjusting parking tickets so low-income families don't have to decide between paying a parking ticket or putting food on their table.''

[ZH: Or maybe not breaking the law?]

Drivers could soon pay different prices for parking tickets in #Boston depending on how much $ they make. A hearing order on this is expected to be held at a City Council meeting today. Should parking tickets should be income driven or remain the same for everybody? @wbz

'-- Breana Pitts (@BrePWBZ) February 26, 2020However, it also means that the wealthier citizens will be charged more for the same offenses. The implications of such a system is fascinating for those of us who have complained (as recently as this week) of cities using parking and traffic tickets as a form of revenue. This proposal would seem to reinforce the concept of tickets as a revenue-generating source. The alternative model is the tradition one. Historically, the amount of tickets was not defended as a revenue source but a reflection of the costs of such violations for the cities. Under that approach, citizens are paid the amount that the city deems as reflective of the misconduct and its costs.

If we treat these tickets as a revenue source (adjusted like taxes for wealth levels), the question is what other areas should also be adjusted. How about environmental fines or housing fines or misdemeanor fines? Tickets are imposed for conduct that could have been avoided in compliance with the law. There are a host of similar fines for such violations.

The legal dimension is rather fluid and uncertain.

Charging wealthier citizens for the same acts can raise equal protection and other concerns. However, wealth is not a suspect classification. Thus, the courts would likely review such a proposal under a rational basis test, which is easily satisfied. Yet, this is a highly novel proposal that could lead to equally novel case law. There is an alternative approach to an income-adjusted fine system, which raises troubling issues. Instead, if Boston wants to protect low-income families, it could leave the fines as uniform and have a special program for deferred payments or even public support for low-income citizens. That would leave the tickets as ''priced'' at the cost of the offense or violation while allowing for public support of families. That system would also more clearly and directly show the costs of such a system.

One other concern with this approach is that it will only accelerate the trend toward using tickets for revenue. Once uncoupled from the expectation of uniformity or the inherent costs of violations, Boston would be free to redefine tickets as a taxing mechanism. Such predatory measures are already out of hand in our cities like Washington, D.C. and Chicago. The Mejia proposal would reduce the political costs of such alternative tax techniques.

For those reasons, I have serious reservations about the Mejia proposal from both legal and economic perspectives.

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Sat, 29 Feb 2020 09:04

MSNBC host Chris Matthews, whose long history of sexist comments and behavior have somehow not yet gotten him fired, tested the boundaries of his own misogyny again on Wednesday night. After the tenth Democratic presidential debate, the Hardball anchor grilled Elizabeth Warren about one of her lines of attack against Mike Bloomberg during the debate: that a pregnant female employee accused Bloomberg of telling her to ''kill it.''

''You believe he's lying?'' Matthews asked Warren of Bloomberg's denial.

''I believe the woman, which means he's not telling the truth,'' said Warren, who recently had to defend her own credible story of pregnancy discrimination.

''And why would he lie?'' Matthews said. ''Just to protect himself?''

''Yeah, and why would she lie?'' Warren responded pointedly.

''I just wanna make sure you're clear about this,'' Matthews said. Right there on America's purportedly liberal network, the anchor spoke to a 70-year-old United States senator who is running for president'--and a renowned Harvard Law professor, no less'--like she couldn't possibly understand her own words, as if she were a child choosing between a snack now or dessert later.

The allegation that Matthews, a veteran journalist, was trying so hard to undermine was actually corroborated by a third party to The Washington Post earlier this month. There was no reason for him to harp on its veracity, except, perhaps, that he himself has made so many sexist comments over the years that he has a vested interest in Bloomberg being let off the hook.

Some of Matthews's behavior has already been well-documented. Like Bloomberg, who frequently remarked ''nice tits'' and ''I'd do her'' at the office, Matthews has a pattern of making comments about women's appearances in demeaning ways. The number of on-air incidents is long, exhausting, and creepy, including commenting to Erin Burnett, for example, ''You're a knockout...it's all right getting bad news from you,'' while telling her to move closer to the camera. Behind the scenes, one of Matthews's former producers told The Daily Caller in 2017 that he allegedly rated his female guests on a numerical scale and would name a ''hottest of the week,'' like a ''teenage boy.'' In 1999, an assistant producer accused Matthews of sexual harassment, which CNBC, the show's network at the time, investigated. They concluded that the comments were "inappropriate," and Matthews received a ''stern reprimand,'' according to an MSNBC spokesperson.

This tendency to objectify women in his orbit has bled into his treatment of female politicians and candidates. He has repeatedly lusted over women in politics on air, including remarking in 2011 that there's ''something electric'' and ''very attractive'' about the way former vice presidential candidate Sarah Palin walks and moves, and noting in 2017 that acting attorney general Sally Yates is ''attractive, obviously.'' But he has reserved a particular contempt for the woman who made it closest to ascending the heights of American political power, Hillary Clinton, calling her ''witchy,'' ''anti-male,'' and ''She-Devil.'' The Cut obtained footage of him joking in early 2016, just before a live interview with then candidate Clinton, ''where's that Bill Cosby pill,'' referring to the date-rape drug. In 2005, he openly wondered whether the troops would ''take the orders'' from a female president; after another interview, he pinched Clinton's cheek; and in another, he suggested that she had only had so much political success because her husband had ''messed around.'' This evening anchor, in addition to everything else, has repeatedly challenged whether women are legitimate politicians or could be president at all. "I was thinking how hard it is for a woman to take on a job that's always been held by men," he said of Clinton in 2006.

Then there is the open secret of Matthews's everyday behavior off camera with guests, which often creeps up to the line of sexual harassment without actually crossing it, so that women can never feel that it's worth jeopardizing their own careers to complain. Many women in politics or media who have interacted with the bombastic host have some kind of story about him making them feel uncomfortable on the job. I have my own.

In 2017, I wrote a personal essay about a much older, married cable-news host who inappropriately flirted with me in the makeup room a few times before we went live on his show, making me noticeably uncomfortable on air. I was afraid to name him at the time for fear of retaliation from the network; I'm not anymore. It was Chris Matthews. In 2016, right before I had to go on his show and talk about sexual-assault allegations against Donald Trump, Matthews looked over at me in the makeup chair next to him and said, ''Why haven't I fallen in love with you yet?''

When I laughed nervously and said nothing, he followed up to the makeup artist. ''Keep putting makeup on her, I'll fall in love with her.''

Another time, he stood between me and the mirror and complimented the red dress I was wearing for the segment. ''You going out tonight?'' he asked.

I said I didn't know, and he said'--again to the makeup artist'--''Make sure you wipe this off her face after the show. We don't make her up so some guy at a bar can look at her like this.''

Again'--Matthews was never my boss. I'm pretty sure that behavior doesn't rise to the level of illegal sexual harassment. But it undermined my ability to do my job well. And after I published a story about it, even though I didn't name him, dozens of people reached out to say they knew exactly who it was. Many had similar stories.

A fellow cable-news pundit, who doesn't want to be named for professional reasons, said Matthews invited her on to talk about misogyny in the Republican Party, telling her that he planned to draw a comparison to the '60s ad-men show Mad Men. Right before going on air, he turned to her and asked ''whether Joan's proportions are real,'' referring to the body of a curvy character on the show, before seamlessly transitioning into a supposedly feminist segment. She was shaken, like I was. (At the time of publication, MSNBC had not yet responded to GQ with comment on either incident.)

In fact, Matthews's whole modus operandi seems to be inviting smart women onto his show, flirting with them or otherwise making them uncomfortable before or while the camera rolls, asking them a question on air and then immediately interrupting them to tell them why they're wrong. He repeated this playbook with Warren this week. The fact that this kind of behavior has not lost him his primetime cable-news show in the year 2020'--even aside from his egregious ''Bill Cosby pill'' joke and the sexual-harassment allegation against him'--speaks to how far the #MeToo movement still has to go to change the standards for what kind of attitudes toward women in the workplace are acceptable and even rewarded.

There is a worthy journalistic line of inquiry Matthews could take about nondisclosure agreements and the role they play in muzzling women and upholding abusive power structures. Instead of exploring that, Matthews attacked Warren's clarity on whether she believes another woman's corroborated testimony. He seems constitutionally incapable of probing these hyper-relevant topics with anything approaching intellectual curiosity or open-mindedness. In that way, he's also unfit for his job.

Beyond the question of Matthews's employment, there is the decision of keeping a man with this flagrant bias as the anchor of a major cable-news evening show. His position affords him the ability to affect public opinion, both sweeping away documented behavior of male presidential candidates and casting doubt on corroborated women's accusations against those men. Having a news anchor who calls women ''she-devil'' and treats their assessments with infantilizing suspicion while conducting post-debate interviews builds in a major disadvantage for female candidates. And that's downright irresponsible.

Laura Bassett is a freelance journalist writing about politics, gender, and culture.

Chaos at the Top of the World

It was one of the most arresting viral photos of the year: a horde of climbers clogged atop Mount Everest. But it only begins to capture the deadly realities of what transpired that day at 29,000 feet. These are the untold accounts of the people who were there.

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Source: Vox Popoli

Sat, 29 Feb 2020 12:03

Now that Weinstein has been convicted, it appears the #MeToo movement has another major Hollywood figure in its sights. CDAN offers a possible explanation for why Spielberg suddenly and unexpectedly bailed on the latest Indiana Jones movie:This permanent A+ list mostly movie director is bailing on a project because of news he is trying to keep under wraps. Apparently there are recordings of him interviewing young child actors and asking them wholly inappropriate questions. The recordings are from about two decades ago and are from either one or two movies filmed at around the same time. He was only the director on one of them but helped cast both. Yet God hath placed by the side of each a man’s own Guardian Spirit, who is charged to watch over him—a Guardian who sleeps not nor is deceived…. So when you have shut the doors and made a darkness within, remember never to say that you are alone; for you are not alone, but God is within, and your Guardian Spirit, and what light do they need to behold what you do?—EpictetusLabels: film, freakshow, law

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Sat, 29 Feb 2020 12:04

While promoting his new 20th Century Studios movie, Call of the Wild, Harrison Ford confirmed that production on the fifth Indiana Jones movie is set to begin year.

On the Ellen DeGeneres's chat show, the 77-year-old actor was asked if there was going to be another instalment happening, Ford said:

''Indeed, it is. It's going to be fun. They are great fun to make.''

And in a separate interview with the CBS' Sunday Morning show, he confirmed filming will begin in April. He also said:

''Well, I'm not going to share the story with you because that doesn't seem like a good idea. But we'll see new developments in his life, his relationship. We'll see part of his history resolved.''

You can check out the interview below:

He also said during an interview with IGN:

''I'm always delighted to come back to these characters. When we have the opportunity to make another it's because people have enjoyed them. I feel obliged to make sure that our efforts are as ambitious as they were when we started. You have a sense of responsibility to your customers.''

This will be the first Indiana Jones movie created since Disney purchased Lucasfilm. The four previous Indiana Jones movies, Raiders Of The Lost Ark, Temple Of Doom, The Last Crusade and Kingdom Of The Crystal Skull, are distributed by Paramount, which is why they aren't available on Disney+.

Are you looking forward to a new Indiana Jones movie?

Roger Palmer Roger has been a Disney fan since he was a kid and this interest has grown over the years. He has visited Disney Parks around the globe and has a vast collection of Disney movies and collectibles. He is the owner of What's On Disney Plus & DisKingdom. Email: Roger@WhatsOnDisneyPlus.com Twitter: Twitter.com/RogPalmerUKFacebook: Facebook.com/rogpalmeruk

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Sun, 01 Mar 2020 07:37

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Sun, 01 Mar 2020 06:54

Log in Sign up The Hill @ thehill .

@MikeBloomberg: "I'm the only candidate to come to Wilmington but all of them should visit. Sen. Warren could go to Elizabeth's Pizza on Market St., Klobuchar could do a Flaming Amy's restaurant, Sen. Sanders could go to the KGB bar."

pic.twitter.com/X5U8yX0RH0 4:01 AM - 1 Mar 2020 Twitter by: The Hill @thehill Donald Trump 2020 @ QPlus17

51m Replying to

@thehill @MikeBloomberg First time Mikey landed one of those, credit where it's due. That was funny.

View conversation · Amy4Bernie @ AmyCleveland79

47m Replying to

@QPlus17 @thehill @MikeBloomberg He hired a comedian to make him sound humorous

View conversation · Adele Abrams @ safetylawyer1

49m Replying to

@thehill @MikeBloomberg ... and Mike Bloomberg can go to the Hell Bar and stay there.

View conversation · Katie Porter 4VP @ bdphillip

50m Replying to

@thehill @MikeBloomberg Hope all those people are being compensated well

View conversation · Amber Thomasson @ AmberThomasson1

29m Replying to

@thehill @MikeBloomberg Oh wow, his staffers Googled my hometowns restaurants! He totally gets us!

View conversation · Hum Spot @ humspot1

45m Replying to

@thehill @MikeBloomberg pic.twitter.com/yQh5eMisbN View conversation · celeste krauss @ mededit2016

22m Replying to

@thehill @MikeBloomberg He should drop out and put his resources behind the nominee

View conversation · Zach Thomas 🌐 @ Zach___Thomas

15m Replying to

@thehill @MikeBloomberg A billionaire hired a team of writers to make him sound like a human. When he talks though it's as if he doesn't hear what comes out of his mouth. He just reads what's written and couldn't do or say anything without everyone around him. He's a robot.

View conversation · Zach Thomas 🌐 @ Zach___Thomas

12m Replying to

@thehill @MikeBloomberg He can't even remember what it is he is supposed to say. I can almost see him counting like it's all choreographed. Look this way 1 2 3 4 look that way 1 2 3 4 speak, smile, wait 2 3 4.

View conversation · Nick Galasso @ vngalasso

9m Replying to

@thehill @MikeBloomberg Oh not Wilmington, Delaware 🤷ðŸ>>''‚¸

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Sun, 01 Mar 2020 06:27

Scientists around the world are working on ways to stop banana crops being wiped out by a new strain of Panama disease.

The disease, which has so far affected farms on four continents, reaches the banana plants through infected soil.

Cleaning the soil is almost impossible.

One idea under development in the Netherlands is to take away the soil altogether and replace it with something produced in a factory - such as loft insulation.

Hear the full story in the People Fixing the World podcast

Video filmed and edited by Daniel Gordon

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Sun, 01 Mar 2020 06:25

US09:40 GMT 01.03.2020(updated 09:51 GMT 01.03.2020) Get short URL

Donald Trump has repeatedly quipped at Michael Bloomberg's stature, claiming that the Democratic presidential hopeful stands on a box behind the podium when speaking, allegations that are rejected by Bloomberg's team.

US President Donald Trump has again mocked billionaire Democratic presidential candidate Michael Bloomberg's height which reportedly stands at about 5 feet and 8 inches, or approximately 172 centimetres, prompting POTUS to nickname the former New York City Mayor ''Mini Mike''.

Addressing his supporters at the Conservative Political Action Conference (CPAC) in Maryland on Saturday, Trump crouched behind a podium as he mimicked Bloomberg's performance at a debate in Las Vegas last week.

''She was really mean to Mini Mike. The way she treated him, he didn't know what hit him'', Trump said referring to another Democratic presidential hopeful, Elizabeth Warren, issuing stern remarks against Bloomberg at the time.

Like him or not, this man is a comedian

'-- YANG🧠- NOW WHAT? (@US_Politics2020) February 29, 2020''He's going, 'Oh get me off this stage, get me off'. It's true. It's true'', Trump went on as he shrank behind the podium, prompting laughter and applause from the audience and then adding, ''We hit a nerve there, huh?''During the Las Vegas debate, Warren in turn said that she would like to talk about ''who we're running against, a billionaire who calls women 'fat broads' and 'horse-faced lesbians'''.

Oh my God I hate that I find him hilarious but I do ðŸ‚ðŸ‚ðŸ‚ðŸ‚ðŸ‚

'-- AnaBP (@BPoloAna) February 29, 2020''And, no, I'm not talking about Donald Trump. I'm talking about Mayor Bloomberg'', she noted.Trump has long made fun of Bloomberg's height, going as far as claiming last month that the 78-year-old's stature is ostensibly 5 feet and 4 inches, or 164 centimetres.

Bloomberg deserves to be mocked and I'm sorry this was hysterical!!! 🤣ðŸ‚🤣ðŸ‚🤣ðŸ‚🎉

'-- American Patriot (@dfshadow6890) March 1, 2020''Mini Mike is a 5'4'' mass of dead energy who does not want to be on the debate stage with these professional politicians. No boxes please'', Trump tweeted in mid-February.

Bloomberg launched a bid for the 2020 Democratic presidential nomination in November 2019, pointing out that he is ''running for president to defeat Donald Trump and rebuild America''.

''We cannot afford four more years of President Trump's reckless and unethical actions. He represents an existential threat to our country and our values. If he wins another term in office, we may never recover from the damage'', he added.

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Sun, 01 Mar 2020 00:11

As the country's top health officials work to contain the spread of the coronavirus, some journalists and politicians have used the opportunity to politicize the outbreak, from falsely accusing President Donald Trump of describing the illness as "a hoax" to saying the Center for Disease Control and Prevention is ill-equipped to handle the epidemic due to funding cuts.

At a White House press conference this afternoon concerning the coronavirus, also known as COVID-19, a reporter suggested that the Trump administration may be keeping renowned immunologist Dr. Anthony Fauci of the National Health Institute from communicating with reporters.

'Very dishonest'A video of the exchange shows a reporter asking President Trump whether the White House was attempting to silence health professionals:

I just want to ask you about this regarding the flow of information. From the very beginning you received a lot of criticism regarding that, in particular about Dr. Anthony Fauci. He is world-renowned in contagious diseases and there were reports out there that he was being muzzled. Can you tell us that this widely respected expert, Dr. Fauci, will have every opportunity to tell us the truth..."That's a very dishonest question," Trump replied. "He has had that ability to virtually do whatever he has wanted to do..."

"So he was not being muzzled?" the journalist shot back.

"He was never muzzled," the president responded while turning to Dr. Fauci. "Anthony, why don't you speak to that?"

'I'm not being muzzled by this administration'Fauci, who's a past Presidential Medal of Freedom recipient, then stood behind the lectern and did not mince words in blasting the suggestion that his words are being controlled.

In fact, he explained the White House has approved all of his requests to speak to the media:

Let me clarify it. I have never been muzzled '-- never '-- and I've been doing this since the administration of Ronald Reagan. I'm not being muzzled by this administration. What happened, which was misinterpreted, is that we were set-up to go on some shows, and when the vice president took over we said "Let's regroup and figure out how we're going to be communicating." So I had to just stand down on a couple of shows and we submit for clearance, and when I re-submitted for clearance, I got cleared. So I have not been muzzled at all. That was a real misrepresentation of what happened.

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Sat, 29 Feb 2020 23:48

E Martina @ EvelynMartina3

3h His wife, Jill, has to know that he has signs of Dimentia. Why wouldn't she try to talk him our of continuing on. I know the signs, as my mother had it. It's very sad to watch someone talk about so much of their past as if it is their life today; the anger episodes & more.ðŸ¥

View conversation · nottabot @ frizzledbeef

2h This man has dementia or Alzheimer's. It only gets worse, we're all watching it happen, and he is running for President in an attempt to avoid prosecution over Ukraine and China dealings. This is so pitiful, and his family has NO shame.

View conversation ·

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Sat, 29 Feb 2020 23:45

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Sat, 29 Feb 2020 23:38

Breadcrumb Home Mobile Clinic Providing mobile medical services is our specialty. We have been providing mobile medical surveillance evaluations for employers throughout California for nearly four decades. Our mobile clinics allow us to offer the flexibility and convenience of on-site group screenings while providing excellent care.

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Sat, 29 Feb 2020 11:26

Apple CEO Tim Cook discusses the coronavirus impacts on his specific business and his view on the short-term impacts from disruptions in China. While retail stores and some manufacturing are closed in the short-term, overall Cook sees very little change in the outlook for Apple business once the short-term impacts are removed.

Tim Cook also discusses his relationship with President Trump working together on jobs and education programs. Cook notes President Trump was able to influence Prime Minister Modi of India to allow Apple to enter the Indian market.

.

PS. if you are following the tiered and strategic deployment of COVID-19 hype, you'll note the next round of heavy artillery (the WHO/CDC have been saving) is the announcement of an official global ''pandemic status'' being reached. That will be worth a week of panic media and perhaps another thousand point drop for U.S. stock market.

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Sat, 29 Feb 2020 10:36

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Fri, 28 Feb 2020 20:06

Replying to

@lawyer4laws @DiMoraGifts They are NOT talking about many more deaths in other areas of life because they do NOT pull the stock Market down, & because those massive numbers of death cannot be blamed on Trump or used to scare people. Plus it's not as fun as scaring people unnecessarily.

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Fri, 28 Feb 2020 14:55

Replying to

@DailyCaller @IWashington Really, Carol Moseley Braun is the first African-American woman to be elected - or appointed - to the Senate after the ratification in 1920 of the Nineteenth Amendment to the United States Constitution. Mmmm.

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Fri, 28 Feb 2020 13:14

In Syria, Russia-backed forces killed 33 Turkish soldiers in Idlib, a "safe zone'' for refugees, according to

@avrilbenoit. People in the region have been ''subjected to aerial bombardment, to shelling, to ground forces. It has been catastrophic from a humanitarian perspective."

pic.twitter.com/4vsNzcClTU

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Fri, 28 Feb 2020 13:12

Published February 27, 2020

Last Update 15 hrs ago

As fears about the spread of the novel coronavirus continue to grow, Sen. Josh Hawley, R-Mo., introduced legislation on Thursday aimed at securing America's medical supply chain.

Discussing the bill entitled "The Medical Supply Chain Security Act," on "Tucker Carlson Tonight," Hawley said the proposal would amend the 1938 Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to monitor medical device shortages with greater accuracy and efficiency.

SEN. HAWLEY INTRODUCES CORONAVIRUS BILL AIMED AT SECURING MEDICAL SUPPLY CHAIN

"We're looking at potential shortages of up to 150 commonly prescribed antibiotics and anti-viral medications," Hawley explained. "That's bad. The problem is in whole or in part, these drugs are made in China. What we need to do is give the FDA new authority to figure out what components are made in China ... [and ask] 'Is there going to be a shortfall?' If there is, give them authority to fast-track new devices, new pharmaceuticals to take their place."

The bill would swap the words "shortage of a drug" for "shortage of a drug or device," and allow the FDA to expedite the review of essential medical devices that require pre-market approval. Drug and medical device manufacturers would be obligated to provide the FDA with an annual report about their manufacturing capacity as well.

If the bill became law, manufacturers would have to disclose details about "all locations of production, the sourcing of all component parts, the sourcing of any active pharmaceutical ingredients, and the use of any scarce raw materials." They would also be subject to FDA requests for any supply chain information that the agency deems necessary.

Hawley said the coronavirus outbreak brought the issue to light, and he hopes his legislation will be the first step in bringing medical supply chains back to the United States.

SEN. HAWLEY BLAMES BIG TECH LOBBYIST FOR LACK OF PROGRESS ON PRIVACY LAWS: 'THEY'VE GAMED THE SYSTEM'

"This is one of those things that over the last couple of decades, as with so much else, we watched so many jobs go to China, so many industries go to China. We've had all of our elites telling us there's no problem with this, it's secure and fine," Hawley said.

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE

"It's not secure. The coronavirus is exposing that. Just as with our manufacturing base, so too with our medical supply chains. They're exposed when they're in China. That's why long-term, we need to bring them home and I hope legislation like this will be a first step."

"We've been told for years, 'No problem. It's not an issue,'" Hawley concluded. "It's a big issue and it's time to take affirmative steps to secure the supply chains and bring them back here."

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Fri, 28 Feb 2020 10:20

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Fri, 28 Feb 2020 10:18

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Fri, 28 Feb 2020 10:01

On Sunday's What's Eating America?, hosted by celebrity chef Andrew Zimmern, the second episode of the new food-focused MSNBC series engaged in scaremongering with predictions about the food industry being hurt by climate change, and indicted "deniers" for not believing climate change is caused by human activity.

The show used several sources who are liberal activists critical of conservatives who are skeptical of climate alarmist views, with one even calling it "criminal" for skeptics to dispute the claims of alarmists.

The new MSNBC host teased the show holding a plate of food he had prepared containing Alaskan salmon, summer sweet corn, and green beans, before warning: "They're all threatened by climate change."

Zimmern focused the first segment of the show on highlighting the hundred-year tradition in Milwaukee of holding fish fries with local fish, noting that Perch now has to be imported because there is less of it locally than in the past.

About halfway through the show, he repeated the debunked claims that 97 percent of climate scientists believe climate change is caused by human activity as he was seen speaking with former EPA official Mike Kops. The word "criminal" came up as the two went back and forth:

ZIMMERN: The federal government isn't even willing to admit that there's a problem. It makes no sense to me.

KOPS: It makes no sense, and what bothers me about it is that there are a lot of valid scientific questions that we need to put research in and work on climate, no doubt. But when we can't even get past that initial stage, I would call it criminal.

A bit later, Zimmern was seen fretting over the conservative media encouraging Americans to be skeptical of climate alarmism as he spoke with David Armiak of the Center for Media and Democracy:

ZIMMERN: Meet David Armiak -- a research director with the Center for Media and Democracy. He's reported on the influence that conservative organizations have on America.

DAVID ARMIAK, CENTER FOR MEDIA AND DEMOCRACY: There's a lot of money that's going from, say, the Koch donor network, the Bradley Foundation, and to think tanks. And they provide the sort of, like, academic legitimacy for the climate denialism, right?

The pejorative "deniers" was repeatedly used to refer to conservative skeptics of climate alarmism.

A bit later, clips of Zimmern were shown in which he spoke with random people in Milwaukee in which they had a negative reaction to him informing him that the Bradley Foundation, centered in their town, spends money encouraging climate skepticism which, in his view, was against the economic interests of the city.

Toward the end of the one-hour show, the MSNBC host summed up by parroting the current claims of there being a "climate crisis" facing the world:

ZIMMERN: I firmly believe we're in a climate crisis, and the first victim is not the apple crop or sweet corn or the beef burgers we love -- it's our local farmers, the people who feed us and help keep food available.

ANDREW BARSNESS, MINNESOTA FARMER: The data is clear, and the consensus of the scientific community is clear that it's not a natural cycle.

('...)

ZIMMERN: Everywhere you turn, the world is enduring a climate crisis that is changing the nature of our food supply and changing the lives of the people who feed us.

Below is a transcript of relevant portions of the Sunday, February 23, What's Eating America? on MSNBC:

What's Eating America

2/23/2020

ANDREW ZIMMERN, MSNBC HOST, IN INTRODUCTION: This plate of food is a delicious meal, made from some of my favorite ingredients -- wild Alaskan salmon, summer sweet corn, green beans. What do they all have in common? Well, they're all being threatened by climate change.

I've spent the last 15 years traveling the world. I've eaten the most amazing things and gotten to know the people who provide them. They all tell the same story -- from fields to fisheries, our climate is in crisis.

('...)

ZIMMERN: Meet David Armiak -- a research director with the Center for Media and Democracy. He's reported on the influence that conservative organizations have on America.

DAVID ARMIAK, CENTER FOR MEDIA AND DEMOCRACY: There's a lot of money that's going from, say, the Koch donor network, the Bradley Foundation, and to think tanks. And they provide the sort of, like, academic legitimacy for the climate denialism, right?

('...)

ARMIAK: They also donate to other organizations, some of which are climate deniers -- most prominently, William Happer and his group, the CO2 Coalition.

ZIMMERN: Remember William Happer? He was the Trump administration's chief climate denier.

('...)

ZIMMERN: The millions of dollars being pumped into climate change denial seem to be working. Back in Apalachicola, Florida, citizens and state officials alike have been extremely skeptical.

DR. ROBERT LIVINGSTON, FLORIDA STATE UNIVERSITY PROFESSOR EMERITUS: The Republican party in Florida which governs Florida decided there is no such thing as climate change.

ZIMMERN: Florida officials were reportedly instructed to stop using the term "climate change" in official communications during the administration of Governor Rick Scott from 2011 to 2019. Scott, who is now a United States Senator, has said he is not convinced climate change is caused by human activity.

('...)

ZIMMERN: I firmly believe we're in a climate crisis, and the first victim is not the apple crop or sweet corn or the beef burgers we love -- it's our local farmers, the people who feed us and help keep food available.

ANDREW BARSNESS, MINNESOTA FARMER: The data is clear, and the consensus of the scientific community is clear that it's not a natural cycle.

('...)

ZIMMERN: Everywhere you turn, the world is enduring a climate crisis that is changing the nature of our food supply and changing the lives of the people who feed us.