PMTA Review Target Date Pushed Back
The U.S. Food and Drug Administration has submitted a new timeline for its review of premarket tobacco product applications (PMTAs).
In prior status reports, the FDA indicated that it expected to have taken action 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 acted 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
In response to litigation by public health groups, a Maryland Federal District Court in April 2022 ordered the FDA to file regular status reports on its progress in reviewing PMTAs for the most popular vapor products on the U.S. market, including Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar.
The original target completion date for the review process 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 due in part to ongoing litigation and to the agency’s acceptance of amendments to some already filed PMTAs, according to the report.
The FDA is expected to give its next status update to the court on April 24.