Status Report Confirms FDA Time Changes to PMTAs

Credit: Fizkes

The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.

In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs 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

The FDA is expected to give its next status update to the court on April 24.

The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.

The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.

The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

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