FDA Tobacco Regulation Update


FDA Files Second Report with Court on Status of PMTAs
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 September 9, 2020. The court-imposed deadline to complete agency review was September 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, 2022 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 August 8, 2016, with a PMTA filed with the FDA by September 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, 2022, the FDA “met its prior estimate of taking action on 51 percent of Covered Applications by June 30, 2022” and expects the other estimates listed below to also be met in a timely manner:

  • 52 percent of Covered Applications by Sept. 30, 2022
  • 56 percent of Covered Applications by Dec. 31, 2022
  • 56 percent of Covered Applications by March 31, 2023; and
  • 100 percent of Covered Applications by June 30, 2023.

The FDA is scheduled to file another status report with the court on Oct. 26, 2022. A copy of the court-filed status report accompanies this bulletin.

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