Tobacco

FDA Files 2nd Report With Court on PMTA Status

Agency is on track for June 2023 completion
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LAKEVILLE, Minn. —The U.S. 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 Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

The FDA’s first status report dated and filed with the Maryland court on May 13 stated that there were 240 pending PMTAs for “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 Nielsen’s various retail e-cigarette sales reports. 

According to the second status report filed with the court on July 28, the FDA “met its prior estimate of taking action on 51% of covered applications by June 30, 2022,” and expects the other estimates listed below to also be met in a timely manner:

  • 52% of covered applications by Sept. 30, 2022
  • 56% of covered applications by Dec. 31, 2022
  • 56% of covered applications by March 31, 2023; and
  • 100% of covered applications by June 30, 2023.

The FDA is scheduled to file another status report with the court on Oct. 26, 2022. 

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.

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