New legislation enacted on March 15 makes clear that the Food and Drug Administration (FDA) regulates tobacco products containing nicotine from any source.

As of April 14, 2022, 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 (FD&C Act). Manufacturers of NTN products who wish to market their products are required to submit a premarket application and obtain FDA authorization to market their product, or they will be subject to FDA enforcement; the deadline for premarket application submissions for currently marketed NTN products was Saturday, May 14, 2022

Entry lines consisting of tobacco products that contain NTN must be transmitted to FDA for review, when filed electronically, to ensure compliance with the requirements. The filer should use the same product codes as traditional tobacco products when transmitting these products.

For assistance with product code identification, the public may also refer to the FDA Product Code Builder. Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov

For additional information or for any questions about the implementation of this new law, please contact CTP.