FDA Sends Warning Letters to Synthetic Nicotine Product Manufacturers

Two companies and 107 retailers received warnings for marketing and selling non-tobacco nicotine e-liquid products without a PMTA.

July 15, 2022

Devices Containing Synthetic Nicotine

WASHINGTON—The U.S. Food and Drug Administration (FDA) issued its first two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization. The two companies that received the warning letters were AZ Swagg Sauce LLC and Electric Smoke Vapor House.

In March, legislation was passed that gave the FDA authority to regulate synthetic nicotine products. 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.

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

The FDA now requires 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 was May 14, 2022.

Collectively, AZ Swagg Sauce and Electric Smoke Vapor House have listed a combined total of approximately 10,000 products with the FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the May 14 deadline as required by the new law, according to the FDA.

“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “In the coming weeks, we will continue to investigate companies that may be marketing, selling or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”

FDA also announced that it has issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.

The FDA said that after July 13, 2022, any non-tobacco nicotine product that has not received premarket authorization from the FDA cannot be legally marketed. The Food and Drug Administration is currently processing applications for approximately one million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline. The FDA will issue refuse-to-accept letters soon for those applications that do not meet the criteria for acceptance.