FDA Issues 115 Warning Letters to Retailers Selling Unauthorized E-Cigarettes

On November 26, 2024, the U.S. Food and Drug Administration (FDA) issued 115 warning letters to brick-and-mortar retailers for selling unauthorized disposable electronic cigarette (e-cigarette) products. This action was taken as part of the Agency's efforts, in coordination with state partners, to identify and eliminate the sale of such products to the U.S. market.

Before marketing and distributing a new tobacco product, a company must submit a marketing application to FDA and receive authorization. Absent this authorization, such products are considered unlawfully marketed and subject to enforcement action at FDA’s discretion. Currently, only 34 e-cigarette products have received FDA authorization, meaning they are the only e-cigarettes that may be lawfully marketed and sold in the U.S. at this time.

Enforcement against unauthorized tobacco products, including electronic nicotine delivery systems (ENDS) like e-cigarettes, has been increasing in recent years. In fact, FDA has emphasized that enforcement against unauthorized tobacco products, particularly unauthorized products popular with youth, are among its highest enforcement priorities. FDA also has Tobacco Retail Inspection Contracts with various states, territories, or third-party entities to assist with compliance check inspections of retail establishments to further their goals related to such products. To date, FDA has issued more than 800 warning letters to retailers for selling unauthorized tobacco products and more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized tobacco products, with more than 100 being sent to firms for unauthorized non-tobacco nicotine products.

Recipients of the recently issued 115 warning letters have 15 working days to respond with the steps they will take to correct the stated violations and to prevent future violations. Failure to promptly correct the violations may result in further FDA actions, such as injunctions, seizures, or civil penalties.

Overall, in its issuance of these 115 warning letters, FDA has made clear that enforcement against unauthorized tobacco products will remain a priority in the near future. The experienced FDA team at Buchanan Ingersoll & Rooney is available to discuss this recent development and to assist companies with questions regarding regulatory requirements for tobacco products.