December 16, 2018

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FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

  • On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 to 2018 in high school students who identify as current e-cigarette users and a 48 percent increase amongst middle schoolers (up to 3.05 and 0.57 million users respectively).  Dr. Scott Gottlieb, commissioner of FDA, and Department of Health and Human Services (HHS) Secretary Alex Azar state that “These new data show that America faces an epidemic of youth e-cigarette use.”

  • As previously reported on this blog, Dr. Gottlieb has taken steps to curb use by youth, including calling for voluntary action by five manufacturers of electronic nicotine delivery systems (ENDS) that make up 97 percent of the cartridge-based ENDS market.  Dr. Gottlieb has indicated that FDA would also take regulatory steps to help reduce use by youth.  In the past week, FDA has hinted through the media that new policies would be announced in the near future.

  • Concurrent with the release of the NYTS results, Commissioner Gottlieb on November 15 issued a statement detailing FDA’s updated policies to help protect youth by preventing their access to tobacco products, particularly flavored cartridge-based ENDS.  These policies include:

    • Restricting in-person sales of all flavored ENDS (except mint, menthol, and tobacco flavor) to adult (18+) only facilities such as vape shops;

    • Requiring, soon-to-be-announced, “heightened” age-verification for online sales of flavored ENDS;

    • Proposing a rule to eliminate all flavored cigars from the market;

    • Continued enforcement against youth appealing vape products, including those marketed to youth via children’s cartoon or animated characters or by imitating products favored by kids; and

    • Proposing a rule to ban menthol cigarettes from the market.
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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