April 13, 2022
New legislation enacted on March 15 makes clear that FDA can regulate tobacco products containing nicotine from any source. This law takes effect April 14, 2022.
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) 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 the 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 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 is Saturday, May 14, 2022 (Note: this is the deadline for those using the recommended electronic submission process. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13, 2022).
Recently, FDA leaders authored an opinion piece on the legislation that describes how this new law closes a loophole and allows FDA to use its authorities to protect the public health from the harms of tobacco products, regardless of the source of nicotine.
We are committed to providing additional information moving forward about the implementation of this new law. We encourage you to contact CTP if you have questions.