FDA Issues Status Report on PMTA Review Process

The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of pending Pre-Market Tobacco 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 fourth status report was filed with the Maryland Federal District Court on Jan. 24, 2023.  In this latest status report, the FDA has revised 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 percent or more of the total retail sales volume in Nielsen’s various retail e-cigarette sales reports.

According to the status report, the FDA expects to have taken action as follows:

• 52 percent of Covered Applications by March 31, 2023
• 53 percent of Covered Applications by June 30, 2023
• 55 percent of Covered Applications by Sept. 30, 2023
• 100 percent of Covered Applications by Dec. 31, 2023

In prior status reports, the FDA indicated that it expected to finalize actions on all Covered Applications by June 30, 2023. This latest status report extends the expected finalization date from June 30, 2023 to Dec. 31, 2023.  According to the FDA, this extension of time to finalize actions on Covered Applications is due, in part, to a number of lawsuits filed against the agency by manufacturers challenging the agency’s decisions on their PMTAs and court decisions requiring that the FDA re-review multiple PMTAs. Also, the delay is also being cause by the agency accepting some amendments to already filed PMTAs that the agency now needs to review.