On September 14, 2023, the FDA issued warning letters to 15 online retailers and 3 manufacturers and/or distributors, accusing them of selling or distributing unauthorized e-cigarette products, including Captivape, Smoke Smart, Kangertech, etc. .
The FDA stated that the companies that received the warning letters violated the Federal Food, Drug, and Cosmetic Act by selling or distributing e-cigarette products in the United States that were not authorized by the FDA. Recipients of these warning letters have 15 working days to respond and describe the steps they will take to correct the violation and prevent future violations.
The FDA said most warning letter recipients take corrective action. Failure to promptly correct violations may result in additional FDA action, such as injunctions, seizures, or civil penalties.
Last year, the FDA issued its first injunctions and civil fines against e-cigarette manufacturers, and issued its first warning letters to dealers distributing illegal e-cigarettes. Since January 2023, the agency has imposed civil penalties on 29 manufacturers for illegally selling e-cigarettes.