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    U.S. - F.D.A. Targets Vaping, Alarmed by Teenage Use 
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    F.D.A. Targets Vaping, Alarmed by Teenage Use
    Sheila Kaplan and Jan Hoffman
    The New York Times
    September 12th, 2018

    WASHINGTON -- The Food and Drug Administration on Wednesday declared that teenage use of electronic cigarettes has reached "an epidemic proportion," and it put makers of the most popular devices on notice that they have just 60 days to prove they can keep their devices away from minors.

    The order was part of a sweeping government action that targeted both makers and sellers of e-cigarettes. If Juul Labs and four other major manufacturers fail to halt sales to minors, the agency said, it could remove their flavored products from the market. It also raised the possibility of civil or criminal charges if companies are allowing bulk sales through their websites.

    The agency said it was sending warning letters to 1,100 retailers -- including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations -- and issued another 131 fines, ranging from $279 to $11,182, for selling e-cigarettes to minors.

    Federal law prohibits selling e-cigarettes to anyone under 18. In a briefing with reporters, the F.D.A. commissioner, Dr. Scott Gottlieb, said that more than two million middle and high school students were regular users of e-cigarettes last year.

    The government's tactics underscore a dilemma in the public health community: In addressing one public health problem -- cigarette smoking, which kills 480,000 people in the United States each year -- e-cigarettes are creating another -- hooking teenagers who have never smoked on nicotine.
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    FDA Threatens to Ban E-Cigarettes If Teenagers Keep Using Them
    Jacob Sullum
    Reason
    September 12th, 2018

    Declaring that "youth use of e-cigarettes is reaching epidemic proportions," the Food and Drug Administration today threatened to remove vaping products from the market unless their manufacturers come up with satisfactory plans to prevent underage consumption. FDA Commissioner Scott Gottlieb acknowledged that the demand conflicts with efforts to promote vaping as a harm-reducing alternative to smoking. "Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on-ramp for kids," he told reporters. "It's an unfortunate tradeoff."

    That tradeoff is not just unfortunate; it is morally unacceptable and scientifically suspect. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death. Short of that, he suggests the FDA might force companies to stop offering e-liquid flavors that appeal to minors, which are an important factor in quit attempts by adult smokers. The premise of such threats is that the interests of adults who might want to switch from smoking to a far less hazardous form of nicotine consumption should be sacrificed for the sake of curtailing e-cigarette use by minors, which is already illegal.

    The FDA says it has issued "more than 1,300 warning letters and fines to retailers" as a result of "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors." But it also sent letters to five leading manufacturers of "electronic nicotine delivery systems" (ENDS), insisting that they do more to keep their products away from teenagers. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping.

    The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months." But the agency also thinks ENDS makers should consider "revising your current marketing practices to help prevent use by minors" and "removing flavored products from the market until those products can be reviewed by FDA" as part of the pre-market approval process. While "Juul Labs will work proactively with FDA in response to its request," a company spokesperson says, "appropriate flavors play an important role in helping adult smokers switch." More generally, the FDA wants Juul and the other companies to contemplate "the particular youth appeal of their products," which involves features, such as style and convenience, that adults also happen to like.

    ...

    On the other side of the public health ledger, there is little reason to think that restricting information about ENDS, making them less cool, or banning e-liquid flavors would reduce morbidity and mortality among today's adolescents, either now or in the future. The FDA is alarmed that, according to the National Youth Tobacco Survey (NYTS), "more than 2 million middle and high school students were current users of e-cigarettes in 2017." But that number includes respondents who reported vaping at all during the previous month, even just once. The number of regular users is much smaller, and almost all of them are current or former smokers. The "epidemic" perceived by the FDA is mainly an epidemic of e-cigarette experimentation, and even that trend seems to have reversed, judging from the latest NYTS results.
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