FDA Issues Deadline for Synthetic Nicotine Tobacco Products to Submit Applications

This week, the FDA Center for Tobacco Products announced that e-cigarettes and other tobacco related products that use synthetic nicotine must submit Pre-Market Tobacco Applications, known as PMTAs, to FDA by May 14, 2022. This aggressive deadline may force many synthetic nicotine product manufacturers to scramble to complete the extensive data and documentation requirements that are part of the FDA PMTA application process.

FDA’s announcement is a result of legislation enacted last month that gave FDA the authority to regulate as tobacco products any e-cigarettes that use synthetic nicotine. Several e-cigarette companies, including the brand most popular among children – Puffbar – tried to escape FDA regulation by using synthetic nicotine instead of tobacco-derived nicotine.

The ATS applauds FDA’s prompt action on synthetic nicotine products and urges FDA to take further action to require products that have not completed the PMTA process to be removed from the marketplace.