FDA Issues Warning Letters Related to Synthetic Nicotine Products

Synthetic Nicotine | Nicotine Pouches

The U.S. Food and Drug Administration (FDA) has issued its first two warning letters to manufacturers accused of unlawfully marketing non-tobacco nicotine e-liquid products without receiving proper authorization. This recent issuing of warning letters is a demonstration of the agency’s newly granted authority to regulate tobacco products containing any and all nicotine, even synthetic nicotine that’s made rather than derived from tobacco plants [read more here].

The two companies that received warning letters from the FDA were AZ Swagg Sauce, LLC and Electric Smoke Vapor House. These two companies have a total of 10,000 products listed with the FDA but neither company submitted Premarket Tobacco Product Applications (PMTAs) for its non-tobacco products by the May 14, 2022 deadline that was required by law. Additionally, the FDA has issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including some e-cigarette or e-liquid products, to underage purchases.

“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,” comments 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.”

Currently, the FDA is processing approximately one million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022 deadline. The FDA is preparing to issue refuse-to-accept (RTA) letters to those applications that fail to meet the criteria for acceptance.