Companies now have less than 30 days to submit to FDA premarket applications for their products that contain synthetic nicotine in order to be able to stay in the US market.
New legislation enacted on March 15 allowing the US Food and Drug Administration (FDA) to regulate tobacco products containing nicotine from any source, including synthetic nicotine, is now in effect.
As of April 14, manufacturers, distributors, importers, and retailers of tobacco products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act resulting from this law, such as not selling these products to persons under 21 years of age (both in-person and online), not marketing these products as modified risk tobacco products without FDA’s authorization, and not distributing free samples of these products.
Additionally, the owners and operators of establishments engaged in the manufacture, preparation, compounding, or processing of NTN products must register with FDA and list all these tobacco products that they manufacture, prepare, compound, or process for commercial distribution.
Further, manufacturers of NTN products who wish to market their products must submit a premarket application and obtain FDA authorization to market their product, or they will be subject to FDA enforcement. The deadline for electronic premarket application submissions for currently marketed NTN products is Saturday, May 14, 2022. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13, 2022.
FDA’s must issue marketing orders (PMTA approval) for products to stay on the market within 90 days of the effective date.