On Apr. 13, 2022, the U.S. Food and Drug Administration (FDA) announced that the legislation clarifying the agency can regulate tobacco products containing nicotine from any source took effect Apr. 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