The Food and Drug Administration is going to need until the end of 2023 to review covered applications under the premarket tobacco product application (PMTA) process. Previously, the agency said it would be done by June, but challenges in court from e-cigarette suppliers Juul, Logic, Njoy and Fontem are delaying the process, the FDA said.
Each of the companies above sued the FDA in federal courts of appeals challenging the agency’s decision on their covered applications. Since September 2021, the FDA has seen more than 50 lawsuits challenging its e-cigarette marketing decisions, the agency said in a Jan. 24 update to the U.S. District Court for the District of Maryland.
“Defending those lawsuits and undertaking multiple related application re-reviews continues to require substantial agency resources,” the FDA said in its filing, a copy of which was provided by the National Association of Tobacco Outlets (NATO). “The FDA’s revised projections also reflect the fact that, for some pending covered applications, the agency has received amendments that it has accepted and is considering.”
Despite some challenges, the FDA has acted on more than 99% of the nearly 6.7 million deemed products for which applications were submitted by the Sept. 9, 2020, deadline.
The FDA’s court-ordered deadline to complete the review of PMTAs was Sept. 9, 2021, one year after the applications were due; however, it did not meet that deadline. Now the agency is under a court order to file regular status reports on its review of PMTAs.
The FDA laid out a new timeline on when it expects covered application review to be complete. Covered applications are limited to applications for new tobacco products on the market by Aug. 8, 2016. They also must have been filed by the Sept. 9, 2020, PMTA deadline. Finally, covered applications are products sold under the brand names Juul, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar, or that reach 2% of total retail dollar sales in Chicago-based NielsenIQ’s Total E-Cig Market and Players or Disposable E-Cig Market and Players reports.
The FDA expects to have acted on:
- 52% of covered applications by March 31;
- 53% of covered applications by June 30;
- 55% of covered applications by Sept. 30; and
- 100% of covered applications by Dec. 31.
The FDA is set to give its next status update to the court on April 24.
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