FDA Seeks Fines Against 18 Retailers that Continue to Sell Unauthorized E-Cigarettes

November 26, 2024

On Nov. 26, FDA announced the agency is seeking fines against two brick and mortar retailers and 16 online retailers who have continued to break the law. FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products; however, follow-up inspections revealed that the retailers had failed to correct the violations. Many recipients of warning letters correct the violative conduct. However, failure to promptly correct the violations can result in additional enforcement actions such as civil money penalties, as is the case for these companies.

FDA remains committed to addressing unauthorized tobacco products throughout the entire supply chain. To date, FDA has filed civil money penalty complaints against 79 manufacturers and 175 retailers for distribution and/or sale of unauthorized tobacco products. Additionally, FDA works closely with federal enforcement partners, including through a newly announced federal interagency task force. For example, FDA and U.S. Customs and Border Protection recently announced the seizure of $76 million in illegal e-cigarettes.

To date, FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing e-cigarettes that lack the required premarket authorization risk enforcement actions.