Compliance With Federal Synthetic Nicotine Requirements In Effect
On March 15, 2022, President Biden signed H.R. 2471 – the Consolidated Appropriations Act 2022.
As a result, the Federal Food, Drug, and Cosmetic Act (FD&C Act) now includes specific language that makes clear the U.S. Food and Drug Administration (FDA) can, as of March 15, regulate tobacco products containing nicotine from any source. This law took effect yesterday, April 14, 2022.
Now manufacturers, distributors, importers and retailers of tobacco products containing 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.
Manufacturers of synthetic nicotine who wish to market their products are required to submit a premarket application and obtain FDA authorization by May 14, 2022, or they will be subject to FDA enforcement.
If a manufacturer does not submit a PMTA by the May 14th deadline, retailers then must remove the product from shelves or else they could also be subject to FDA enforcement.
Convenience store owners selling synthetic nicotine products should contact the manufacturers to verify whether a PMTA has been submitted or not.