FDA Received Over 15,000 PMTAs in FY2020

Update: The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, according to a press release. 

More than 15,000 premarket tobacco product applications (PMTA) were submitted to the U.S. Food and Drug Administration (FDA) during fiscal year 2020, according to data provided on the regulatory agency’s website.

In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567. Prior to August, the FDA had only received 686 applications. The FDA does not distinguish how many of those products are electronic nicotine-delivery system (ENDS) devices.

Of the 15,437 applications turned in during fiscal year 2020 (October 2019 to September 2020), 767 PMTAs were closed, according to FDA data. An application is considered closed after the FDA issues an order letter, a refuse-to-accept letter or the PMTA is withdrawn by the applicant.

Companies that submitted a PMTA by the Sept. 9, 2020 deadline and were previously on the market before Aug. 8, 2016, can remain on the market for up to one year while the FDA reviews the PMTA. The FDA said it will release a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, however, no date has set for the list’s release.