FDA Updates Status of Pending PMTA Applications

The US Food and Drug Administration (FDA) recently updated the status of its pending market pre-tobacco product applications (PMTAs) following an order from the federal court in Maryland.

The influx of a large number of PMTAs has made it impossible for the FDA to complete the review of applications submitted prior to September 9, 2020, by the September 9, 2021 deadline. As a result, the court has set a final review deadline.

The fifth status report submitted by the FDA on April 21st states that the FDA has met its estimated review time for "covered applications" in the processing of PMTAs.

The American Association of Tobacco Retailers has clarified that "premarket tobacco application (PMTA) covered products" refers to new tobacco products that were already on the market as of August 8, 2016, and have had their PMTA submitted to the FDA before September 9, 2020. Brands in this category include JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, and Puff Bar.

The FDA stated in a report that as of March 31, 2023, 52% of all "covered applications" have been reviewed and action has been taken.

As of June 30th, this figure will reach 53%; by September 30th, it will be 55%; and by December 31st, 2023, it will reach 100%.

Another status report will be submitted by July 24th or earlier.

Further reading:

The United States Food and Drug Administration (FDA) has launched a new resource to assist applicants in submitting premarket tobacco product application (PMTA) requests.

The FDA held a public hearing where attendees claimed that TPMP would stifle innovation in new tobacco products.

Reference: [1] FDA Provides Updated Information on Pending PMTA Timeline.