• June 22, 2024

US FDA Updates ‘Red List’ for Illegal Vaping Products

 US FDA Updates ‘Red List’ for Illegal Vaping Products

Credit: Eduardo Barraza

Credit: Eduardo Barraza

The U.S. Food and Drug Administration updated its import alert on May 23, which includes a “red list” of manufacturers, distributors, and brands of vapor products that may be detained “without physical examination,” the agency announced.

The alert authorizes U.S. Customs and Border Protection (CBP) to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products.

The full list of products now includes Chinese manufacturers and distributors as well as U.S. importers and distributors.

The FDA announced last week that it is taking stronger enforcement actions against unauthorized e-cigarettes. The agency is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling unauthorized Elf Bar brand vaping products. The FDA is seeking a penalty of more than $20,000 from each retailer.

“In order to remove a firm’s product from the Red List, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation,” the FDA states. “The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).”