FDA PMTA (In)Action

E-Cigarettes, FDA, Flavors (including Menthol), Product Availability

September 9, 2021 was the date after which products without an affirmative marketing order resulting from the FDA’s premarket review would supposedly no longer be allowed to remain on the market. This was ideally the date the FDA would have finished their review by, but they had no actual deadline for review  – only for enforcement – as described in this update from the Public Health Law Center, and FDA Center for Tobacco Products Director Mitch Zeller previously acknowledged that the likelihood of the agency actually completing review of the thousands of applications they received by that date was very low. On September 9th, Zeller gave this update.

In short, while the FDA has now issued at least 323 marketing denial orders for 1.1 million flavored e-cigarette products, they have made no decision on Juul, Vuse, NJOY or other e-cigarette brands that command the vast share of the e-cigarette market, despite pulling those products into a separate queue in order to prioritize their review. They have also issued at least 170 warning letters to tobacco companies that did not submit premarket applications for their products.

What we still don’t know includes:

  • what products the FDA has issued marketing denial issues for, given that we currently only know the manufacturers;
  • how the FDA will treat menthol e-cigarettes;
  • what products the FDA will authorize for continued marketing as “appropriate for the protection public health;”
  • whether and how this public health standard, which includes consideration of the risks and benefits of a given product to the population as a whole, will prioritize considerations of health equity;
  • whether any e-cigarettes will be authorized, weighing any possibility for harm reduction against youth initiation;
  • whether any new oral nicotine products like oral nicotine pouches will receive marketing authorization;
  • what conditions they might place on the marketing of any products that are authorized;
  • what FDA enforcement will look like for product removal, though we know they have stated that their enforcement going forward will be on a case-by-case basis with prioritization for products for which companies never submitted a premarket application, products with marketing denial orders, and products that market to youth or have flavors that appeal to youth; and
  • when they will ultimately make these decisions.

You can look for any updates from the FDA on their Tobacco Product Applications: Metrics & Reporting page and find any affirmative marketing authorizations posted here. In the meantime, state and local action to protect youth and public health by regulating these products and prohibiting the sale of menthol and other flavored tobacco products remains critical.

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