FDA Regulation of Synthetic Nicotine Begins Today

Manufacturers have until May 14 to submit a premarket application to continue marketing their products.

April 14, 2022

Woman with Nicotine Gum Pack

CHICAGO—Beginning today, the U.S. Food and Drug Administration (FDA) has the authority to regulate synthetic nicotine products through recently passed legislation, according to a news release.

As of April 14, 2022, manufacturers, distributors, importers and retailers of tobacco products containing non-tobacco nicotine (which 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.

Requirements include 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.

Also, anyone who manufactures, compounds or processes synthetic nicotine products must register with the FDA and list all these tobacco products that they manufacture, prepare, compound or process for commercial distribution.

The FDA now requires that any manufacturers of synthetic nicotine that want to market their products must submit a premarket tobacco application (PMTA) and obtain FDA authorization to market their product.

The deadline for premarket application submissions for currently marketed synthetic nicotine products is Saturday, May 14, 2022, for online applications, and mailed applications must be received by the FDA no later than Friday, May 13, 2022.

Any retailer selling synthetic nicotine products should contact the manufacturers to verify whether a PMTA has been submitted or not. If a PMTA hasn’t been submitted by the May 14th deadline, retailers must remove the product from shelves immediately or else they could be subject to FDA enforcement.