Advocacy Submits Letter to FDA on PMTA Review Process

The Food and Drug Administration’s (FDA) final Deeming Rule requires manufacturers of deemed tobacco products to submit their products to the agency for approval before those products can be introduced into the market. On September 25, 2019, the FDA published a proposed rule titled Premarket Tobacco Product Applications and Recordkeeping Requirements.[1] The premarket tobacco product application (PMTA) rule has yet to be finalized. For most electronic nicotine delivery systems (ENDS) products, the only approval pathway available is the PMTA. There are timely submitted PMTAs for millions of ENDS products for the FDA to review, and the agency only has until September 9, 2021, to do so before the court-ordered one-year moratorium on FDA enforcement actions ends. The Office of Advocacy (Advocacy) writes to encourage the FDA to request an extension of the court-ordered one-year moratorium on FDA enforcement actions against manufacturers that timely submitted a PMTA to the agency by September 9, 2020, and to reverse its policy of reviewing submitted PMTAs by market share to keep small manufacturers’ products on the market.

Comment Letter

Fact Sheet

[1] 84 Fed. Reg. 50,566 (Sept. 25, 2019).