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FDA Will Seek to Remove Flavored E-Cigarettes from the Market

On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”, are currently allowed to be marketed until Premarket Tobacco Product Applications (PMTAs) are due – the deadline for which has shifted numerous times over the years, and is currently set for May 11, 2020. See American Academy of Pediatrics v. FDA.

Prior to the American Academy of Pediatrics decision, in March 2019 FDA had published a draft guidance that proposed to modify the compliance policy and accelerate the PMTA deadline for certain flavored products.  Specifically, that draft guidance proposed to move the PMTA deadline for most flavored e-cigarettes from August 2022 to August 2021, and to eliminate the compliance policy entirely (immediately enforcing PMTA requirements) for any flavored e-cigarette (but not tobacco, menthol or mint) that are marketed toward youth (e.g., youth-appealing packaging, branding, social media) or sold in non-adult only retail locations. See our blog post summarizing this here.

The shift to potentially eliminating the compliance policy entirely for all flavored e-cigarettes (including mint and menthol flavors) follows a tumultuous few weeks for the vapor industry.  The FDA and CDC are currently investigated 380 “vape related” lung illnesses, including several tragic deaths. FDA has indicated, however, that these appear to be the result of certain thickening agents (e.g., vitamin E acetate) used in illicit THC and marijuana oil vaporizers, not nicotine e-liquids.  See FDA’s website on Lung Illnesses Associated with Use of Vaping Products here.  Earlier this month, Michigan Governor Gretchen Whitmer announced that the Michigan Department of Health and Human Services would be promulgating emergency rules to ban the sale of all flavored e-cigarettes in the state. And FDA has now released preliminary results from the 2019 National Youth Tobacco Survey (NYTS) which appear to demonstrate both an increase in flavored e-cigarette experimentation (i.e., past 30-day ever use) among teenagers, but also a significant decrease in traditional cigarette smoking – which is at historic lows among youth in the U.S.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 256


About this Author

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...