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05/21/2021

FDA Posts List of PMTA Product Submissions

The agency's Center for Tobacco Products will host a virtual meeting about the scientific review of the applications on June 11.
tobacco products in FDA's deeming rule

SILVER SPRING, Md. — Eight months after the deadline for premarket tobacco applications (PMTA), the Federal Drug Administration (FDA) released a list of product applicants.

The Sept. 9 deadline covered newly deemed tobacco products in the agency's 2016 deeming rule, including electronic cigarettes, certain cigars and hookah. Any newly deemed products that were not on the market before the Feb. 15, 2007 grandfather date needs to receive premarket authorization from the FDA to be legally marketed.

Tobacco companies and manufacturers were required to file a PMTA by the deadline to remain on the market until the agency can complete its review. The FDA has 12 months — until Sept. 9, 2021 — to review the applications.

In late summer 2020, NACS joined FMI, the Food Industry Association, the National Association of Truckstop Operators, the Petroleum Marketers Association of America, and SIGMA to urge the FDA to publish a list of electronic nicotine delivery systems (ENDS) that have PMTAs on file, as Convenience Store News previously reported.

The groups argued that retailers needed the list to know which products it could legally sell as of Sept. 10.

The FDA's Center for Tobacco Products (CTP) will host a virtual meeting about the about the scientific review of applications received by the Sept. 9 deadline from 1 p.m. to 3 p.m. on June 11. The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question and answer session with Holman and additional Office of Science staff. The meeting is free of charge, but prior registration is required.