Retailers: Check Your Synthetic Nicotine Products

Products with PMTAs can stay on shelves for another month, and then only those with marketing granted orders can be sold after that time.

June 13, 2022

Lady with Synthetic Nicotine Gum Pack

ALEXANDRIA, Va.—Retailers will be required to remove any synthetic nicotine product that has not received a marketing granted order from the Food and Drug Administration (FDA) in one month from today. Any retailer selling synthetic nicotine products should contact the manufacturers of the products to see if they submitted premarket tobacco product applications (PMTA) by FDA’s deadline, which was May 14, 2022. If they didn’t, retailers must stop selling the products or else retailers may be subject to FDA enforcement.

If a manufacturer submitted 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.

In March, President Biden signed off on a $1.5 trillion spending package giving the FDA authority to regulate synthetic nicotine products. The administration’s regulatory authority began on April 15, 2022. Manufacturers of synthetic nicotine had until May 14, 2022, to either submit a PMTA or pull their products from the market.

In 2020, the FDA announced that the agency was ordering the removal of most flavored e-cigarettes from the market pending approval of their PMTAs. During the past two years, products looking to avoid the FDA’s regulations have started using synthetic nicotine.

The bipartisan effort to include this language in the omnibus bill was championed by Sens. Richard Burr (R-NC), Dick Durbin (D-IL) and Patty Murray (D-WA), along with Rep. Frank Pallone (D-NJ), according to Bloomberg.