FDA Warns Online Retailers Over Sales of Unauthorized Vapor Products
The retailers receiving the current round of letters sold or distributed e-cigarette products in the United States that lack authorization from the FDA, in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure and/or monetary penalties.
Overall, the FDA has issued more than 670 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, and filed civil money penalty complaints against more than 55 manufacturers and more than 100 retailers for the manufacture and/or sale of unauthorized tobacco products.
In coordination with the U.S. Department of Justice, the agency has also sought injunctions against seven manufacturers of unauthorized products and seized unauthorized e-cigarette products valued at more than $700,000.
The full list of 23 tobacco-flavored e-cigarette products and devices authorized by the FDA for legal sale can be found on the new Searchable Tobacco Products Database.