Congress passed legislation this spring that places synthetic nicotine under the authority of the Food & Drug Administration (FDA). This brings with it requirements for manufacturers, distributors and retailers of the products. 

The FDA has had regulatory and enforcement authority over tobacco products since 2009 when Congress passed the Tobacco Control Act. This new measure will give the FDA the same authority over products that contain nicotine not derived from tobacco but made in a lab, known as synthetic nicotine. 

Starting on April 14, 2022, manufacturers, distributors, importers and retailers of synthetic nicotine products must comply with 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 authorization; and 

• Not distributing free samples of these products.

Since the products are now regulated by the FDA, the manufacturers must go through the premarket tobacco application (PMTA) process. Manufacturers of synthetic nicotine products had to submit PMTAs by May 14 or pull their products from the market. 

Any retailer selling synthetic nicotine products should contact the manufacturers of the products and ask them to verify that they submitted PMTAs by the deadline. If they didn’t, retailers must stop selling the products or else they could be subject to FDA enforcement. 

If a manufacturer submits a PMTA by the deadline, it can continue marketing its products until July 13, 2022. After that date, the products must be removed from retail shelves unless the FDA has issued a marketing granted order.