Synthetic Nicotine Products: What Happens Now?


    As a result of this new law, the regulatory status of synthetic nicotine products is now clear, as are the next steps for the product manufacturers and the FDA. The focus now turns to U.S. tobacco and nicotine retailers and distributors, who will have a responsibility for ensuring that illicit synthetic nicotine products are not offered for sale to U.S. consumers.

    This means that retailers and wholesalers need to contact their manufacturers very soon to determine whether they will submit a PMTA to the FDA by the May 14, 2022, deadline. Retailers and wholesalers place themselves at risk of FDA enforcement actions and penalties if they continue to sell a synthetic nicotine product that does not have a PMTA filed by May 14, 2022, or sell a synthetic nicotine product if the FDA does not issue a PMTA authorization order by July 13, 2022.

    Generally, the FDA does not grant a “sell-through” period if a manufacturer does not file a PMTA by a filing deadline or if the agency issues a PMTA marketing denial order disapproving the PMTA application. This means that retailers and wholesalers would not have additional time to sell tobacco products with synthetic nicotine from their inventories: (1) after May 14, 2022, if a PMTA is not submitted to the FDA, or (2) after July 13, 2022, if the FDA does not issue a PMTA marketing authorization order for the product that contains synthetic nicotine.

    This story first appeared in the May/June 2022 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas Briant, Executive Director, National Association of Tobacco Outlets (NATO)