The Food and Drug Administration is under a Maryland Federal District Court order to file regular status reports on the agency’s review of pending premarket tobacco product applications (PMTAs).
The underlying court case was filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020. The court-imposed deadline to complete agency review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.
The FDA’s fifth status report was filed with the Maryland Federal District Court on April 21. In this latest status report, the FDA reports that it has met its estimate of the timeframe to finalize the agency’s review of pending PMTA “covered applications.” A covered application is for new tobacco products that were on the market as of Aug. 8, 2016, with a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and reach 2% or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
According to the latest status report, the FDA has taken, and expects to have taken, action as follows:
- 52% of covered applications were reviewed and action was taken by March 31.
- 53% of covered applications will have action taken by June 30.
- 55% of covered applications will have action taken by Sept. 30.
- 100% of covered applications will have action taken by Dec. 31.
In this latest status report, the FDA states that it will file another status report with the court by July 24.
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at info@natocentral.org.