September 21, 2018

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FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

  • In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar and online retailers that have sold JUUL and other cartridge-based e-cigarettes, all of which are marketed by large tobacco companies, to minors.  Nearly all of those retailers cited appear to be convenience and similar stores, rather that vape shops dedicated to vapor products.   However, twelve warning letters were also issued to retailers that continue to offer several e-liquid products that were the subject of FDA enforcement in May 2018, based on their resemblance of kid-friendly foods (e.g., candy, cookies, juice boxes, etc.).

  • FDA Commissioner Scott Gottlieb stated in the press release that the agency will “revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization” and that the agency remains concerned that “certain flavors are one of the principal drivers of the youth appeal of these products.”  FDA’s announcement comes just a few weeks after the comment period closed on its Advance Notice of Proposed Rulemaking on the Regulation of Flavors in Tobacco Products.

  • FDA is increasing its enforcement on illegal sales to minors “indefinitely” in an effort to reduce the current use of e-cigarettes in middle and high schoolers, which was 2.1 million users as of 2017.  Of note, U.S. cigarette smoking rates have continued to fall dramatically, alleviating fears of a potential “gateway” effect from vaping, and is now at its lowest point in history, amongst both adults and adolescents. FDA Commissioner Gottlieb did note that “the biggest youth use seems to be among cartridge-based e-cigarettes, and not open-tank vaping products.” For more on developments on e-liquids and related products, please visit our companion blog, the Continuum of Risk.

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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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