Upcoming Premarket Review Deadline for the FDA

E-Cigarettes, FDA, Flavors (including Menthol)

September 9, 2021 is the date by which the FDA is supposed to be done reviewing tobacco product applications for premarket review, and it is the date after which products without an affirmative marketing order resulting from FDA review would no longer be allowed to remain on the market. However, FDA Center for Tobacco Products Director Mitch Zeller acknowledged in this perspective piece published in February that the likelihood of the FDA actually completing review of the thousands of applications they have received by this date is very low. This update from the Public Health Law Center summarizes what we know so far about the process. Given that the FDA is prioritizing review of products with the greatest market share, we can expect one of their earliest decisions to be regarding the e-cigarette product Juul, which many public health groups have advocated for the FDA to deny a marketing order to. Earlier this month, a group of 31 state Attorneys General sent a letter to the FDA, asking the agency to help protect youth from nicotine addiction by not approving any flavored e-cigarette products or flavored oral nicotine products, limiting nicotine concentrations in these products, and restricting marketing to youth.

What we still don’t know includes:

  • 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 products they will deny marketing authorization for and order to be removed from the market;
  • what conditions they might place on the marketing of any products that are authorized;
  • what FDA enforcement will look like for product removal; 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.

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