Where the FDA Is at With PMTAs

About 362,000 electronic-cigarette and nicotine vapor products still have pending applications
Photograph: Shutterstock

LAKEVILLE, Minn. — Federal law and U.S. Food and Drug Administration regulations require that tobacco products introduced into the market after Feb. 15, 2007, must have a premarket tobacco product application (PMTA) submitted for review by the FDA. To receive marketing authorization from the agency to allow a product to continue to be sold, the law requires that the FDA must determine that a tobacco product is “appropriate for the protection of the public health.”

The products that require PMTAs include cigars, pipe tobacco, electronic cigarettes, hookah tobacco and modern oral products. There were two deadlines for filing PMTAs with the agency.  For products made or derived from tobacco itself, the FDA deadline was Sept. 9, 2020. Under a law passed earlier this year, products with nicotine made or derived from a source other than tobacco itself the PMTAs were due by May 14.

The FDA received PMTA applications by Sept. 9, 2020, for more than 8 million products which have nicotine derived from the tobacco leaf itself, the vast majority of which were electronic nicotine or vapor products. Specifically, the agency received PMTAs for 8,092,129 e-cigarette and vapor products, 2,296 cigar products, 1,264 hookah tobacco products, 579 pipe tobacco products, 76 roll-your-own products and 61 smokeless tobacco products.

However, through its PMTA review process, the FDA has refused to allow or denied marketing authorization to more than 7.7 million e-cigarette and nicotine vapor products, which means the products need to be removed from the market. This leaves approximately 362,000 e-cigarette and nicotine vapor products under pending PMTAs applications. The agency has stated in a report that it expects to finalize the review of these remaining PMTA applications, including applications for JUUL, Vuse, NJOY, Logic, Blu, Smok and Puff Bar by June 30, 2023.

Besides these PMTA refusals and denials, the FDA has issued orders authorizing the sale of only 23 electronic cigarette devices and nicotine e-liquids sold by R.J. Reynolds Vapor Co., NJOY and Logic. However, of the 23 products authorized, the only flavor allowed is tobacco flavored nicotine e-liquids. To date, the FDA has not authorized any flavor other than tobacco flavor for electronic cigarette and nicotine liquid products.

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.

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