Today, the U.S. Food and Drug Administration issued 22 warning letters to online and brick-and-mortar e-cigarette product retailers and manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system (ENDS) products advising them that selling these products, which lack marketing authorization, is illegal.
The warning letters were sent to some establishments with well-known names such as 7-Eleven and Shell and are the first of what will be a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
he warning letters notify the retailers and manufacturers that selling or distributing ENDS products without a marketing authorization order to customers in the U.S. is prohibited under the Food, Drug and Cosmetic (FD&C) Act. Retailers and distributors are encouraged to communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.
Additionally, as part of the agency’s efforts, the FDA recently issued import alerts (here and here) for certain unauthorized ENDS products offered for import into the U.S. based on the agency’s enforcement priorities. These import alerts describe products that, if imported, would violate the FD&C Act. These import alerts were issued in advance of any specific products being detained.
The agency also recently issued separate letters to nine manufacturers and importers seeking information about their ENDS products, including requesting evidence that the product is legally marketed and was not introduced or modified after Aug. 8, 2016, the effective date of the final rule that extended the FDA’s tobacco product authorities to all tobacco products. As of March 10, 2020, the FDA has sent letters to more than 100 companies seeking information about more than 140 ENDS products. A number of companies have now removed products from the market.
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