FDA Vape Ban

FDA Vape Ban

The FDA annouced a proposal to ban vape (e-cigarette) flavored products including mint and menthol. The details are just emerging but here’s what’s been released so far.

  • “FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon.”
  • The compliance policy the FDA anticipates announcing in the coming weeks will outline enforcement policy addressing non-tobacco-flavored e-cigarette products that lack premarket authorization moving forward.

The FDA vape ban, at least at this early stage, appears to utilize strict enforcement of the Pre-Market Tobacco Application (PMTA) with any product sold requiring a PMTA. In other words, the days of grace periods is crashing down and the FDA intends to clear the market and allow a trickle of players back in who can obtain a PMTA. Behind the FDA ban on flavored e-cigarettes, is a deep skepticism about the safety of these products that will make the already onerous PMTA an even bigger challenge. The FDA will need convincing that vape products are safe.

US Health and Human Services Chief Alex Aza mentioned “waivers” that could be filed by May 2020. His comments were not included in the HHS press release leaving us all to guess.

A new post will be written when the official policy is annouced.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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