FDA Issues Status Report on PMTA Review Process

Agency still expects to finish covered application review by end of year
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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) for new tobacco products that were on the market as of Aug. 8, 2016. For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.

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 sixth status report was filed with the Maryland Federal District Court on July 24. In this latest status report, the FDA said 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 electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had 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 FDA’s July 24 status report, there are now 189 Covered Applications. And the FDA has taken, and expects to have taken, action as follows:

  • FDA completed its review of 65% of the 189 pending Covered Applications as of June 30.
  • FDA expects to complete its review of 68% of the 189 Covered Applications by Sept. 30.
  • FDA expects to complete its review of 100% of the 189 Covered Applications by Dec. 31.

In this latest status report, the FDA states that it will file another status report with the court by Oct. 23.

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at

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