FDA Will Finish Reviewing E-Cigarette PMTAs by End of Year

Agency sticks to timeline presented at start of 2023
U.S. Food and Drug Administration website
Photograph: Shutterstock

The Food and Drug Administration said it is on track to review premarket tobacco product applications (PMTAs) for some of the most prevalent e-cigarettes by the end of the year.

As of March 31, the agency had reviewed 52% of covered applications. A covered application is for new tobacco products that were on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and reach2% or more of the total retail sales volumes per NielsenIQ reports.

The agency previously said it would be done reviewing applications by June, but in early 2023 it pushed the deadline to Dec. 31, 2023, due to challenges in court from e-cigarette suppliers Juul, Logic, Njoy and Fontem.

According to the latest status report, provided by the National Association of Tobacco Outlets (NATO), the FDA expects to have acted on:

  • 53% of covered applications by June 30.
  • 55% of covered applications by Sept. 30.
  • 100% of covered applications by Dec. 31.

The FDA’s court-ordered deadline to complete the review of PMTAs was Sept. 9, 2021, one year after the applications were due; however, it did not meet that deadline. Now the agency is under a court order to file regular status reports on its review of PMTAs. Its next status report is due by July 24.

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