Synthetic Nicotine

Last Updated: April 13, 2022

The Issue

Congress passed legislation directing the Food & Drug Administration (FDA) to regulate non-tobacco derived nicotine, known as synthetic nicotine. President Biden signed the legislation into law on March 15, 2021. Manufacturers of synthetic nicotine products have until May 14, 2022 to submit a premarket tobacco application (PMTA) to FDA or else the products must be removed from shelves. Manufacturers that submit a PMTA by the deadline have until July 13, 2022 to market their products, unless FDA approves the products for the market.

Retail Impact

As of April 14, 2022, manufacturers, distributors, importers and retailers of synthetic nicotine products must ensure compliance with applicable requirements 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.

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.