• Deanna Clark-Esposito

CBP has Finally Offered Guidance for Transmitting Non-Tobacco Nicotine Data to the FDA



H.R. 2471, signed by President Biden 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 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). These products collectively are labeled as containing non-tobacco nicotine (NTN). 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 has since passed on Saturday, May 14, 2022.

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


Are you confused by this new guidance?

Do you think you may have a problem with obtaining FDA authorization?

Are you confused about how to classify non-tobacco nicotine in your products?


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