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September 13, 2018

FDA eyeing complete ban on flavored e-cigs amid 'epidemic' of teen use

Daily Briefing

    FDA Commissioner Scott Gottlieb on Wednesday announced the agency is considering a ban on flavored electronic cigarette (e-cigarettes) sales in the United States to address an "epidemic" of e-cigarette use among youth.

    Teen e-cigarette use has reached 'epidemic' levels, Gottlieb says

    Gottlieb in a speech said, "The number of teenagers we believe are now using these [e-cigarettes] … has reached an epidemic proportion." FDA data show more than two million middle and high school students used e-cigarettes in 2017.

    Gottlieb said, "While [FDA] remain[s] committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can't come at the expense of kids." Gottlieb noted the appeal of flavored e-cigarettes among youth, and said, "I think we're going to have to step into this market. I am willing to narrow the off-ramp for adults to close the on-ramp for kids."

    Gottlieb announces new FDA actions targeting youth e-cigarette use

    Gottlieb said FDA is asking e-cigarette makers blu e-cigs, JUUL Labs, Logic, MarkTen, and Vuse to submit plans within 60 days on how they intend to address widespread e-cigarette use among youth.

    Gottlieb said FDA also plans to investigate the five manufacturers' marketing and sales practices and determine whether some e-cigarette makers are subject to enforcement under federal premarket authorization requirements.

    In addition, Gottlieb said FDA has taken enforcement actions against retailers found to be selling e-cigarettes to youth. FDA said it "issued more than 1,300 warning letters and civil money penalty … fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar, and online stores this summer," which represented "the largest coordinated enforcement effort in the FDA's history." The agency also issued warning letters to 12 online retailers for advertising and selling e-cigarettes in a misleading manner that resembled products typically sold to children, such as cookies or candies.

    Further, the agency announced plans to launch a national public health campaign warning youth about the risks associated with nicotine and e-cigarettes. Gottlieb also said FDA will reevaluate its delay of a final rule that extends the agency's regulatory authority over tobacco products to include e-cigarettes, cigars, pipe tobacco, and water pipe tobacco.


    According to Reuters, FDA's actions could result in some e-cigarettes—such as those produced by JUUL—being removed from the market if the e-cigarette producers do not meet FDA requirements.

    Bonnie Herzog, a Wells Fargo analyst, in a research note wrote that e-cigarette maker JUUL seems to be "most at risk" from FDA's latest actions because JUUL products have "strong appeal to youth." In contrast, Herzog said Altria appears to be better positioned to address FDA's concerns because the company in the past has handled issues related to youth access, and the company currently sells a limited number of flavored e-cigarettes when compared with JUUL.

    JUUL, which comprises about 72% of the U.S. e-cigarette market, said the company is committed to keeping underage users from accessing its e-cigarettes and working with FDA to address the issue. However, Victoria Davis, a JUUL spokesperson, said "appropriate flavors play an important role in helping adult smokers switch."

    Altria spokesperson George Parman said, "We welcome FDA's action today and look forward to sharing our thoughts about how to prevent and reduce youth use, an issue we have focused on for decades."

    British American's R.J. Reynolds Vapor Company said the company plans to comply with FDA's request. The company said, "[Y]outh tobacco prevention is a priority for our companies."

    Logic Technology Development said it plans to show FDA "that Logic markets its products only to adults."

    The Campaign for Tobacco-Free Kids said FDA's "announcement will represent a fundamental turning point, if but only if, FDA formally requires all manufactures to comply with these requirements and FDA reverses its policy and requires that all of these products undergo premarket review now, not four years from now" (Abutaleb, Reuters, 9/12; Maloney, Wall Street Journal, 9/12; Wang [1], Inside Health Policy, 9/12 [subscription required]; Wang [2], Inside Health Policy, 9/12 [subscription required]; Wang [3], Inside Health Policy, 9/12 [subscription required])

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