FDA on Track to Complete PMTA Review by June 2023

Agency reviewed 51% of covered applications as of June 30
FDA sign
Photograph: Shutterstock

SILVER SPRING, Md. — Waiting for more news on the status of premarket tobacco product applications (PMTAs)? In the U.S. Food and Drug Administration’s most recent check-in with the U.S. District Court of Maryland, the agency said it was on track to meet the goals for application review it set in May.

The FDA finished evaluating 51% of “covered applications,” or those that fit a set of guidelines set by the agency, as of June 30, according to a July 28 court filing, provided by the National Association of Tobacco Outlets (NATO).

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 Maryland Federal District Court order to file regular status reports on its review of PMTAs.

The FDA has resolved more than 99% of the more than 6.5 million timely applications it received, it said in a May 13 status report filed with the district court. The majority of those are for electronic nicotine delivery systems (ENDs).

The agency then gave a breakdown of when it expected to be done with decisions on covered applications. 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.

Using those definitions, the FDA identified 240 covered applications and provided the following forecast for review completion:

  • 52% by Sept. 30
  • 56% by Dec. 31
  • 56% by March 31, 2023
  • 100% by June 30, 2023

The latest PMTA the FDA ruled on was for San Francisco-based Juul Labs. After initially issuing the e-cigarette company a marketing denial order (MDO), the agency later stayed the decision, allowing Juul products back on the market pending further review.  

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