On December 19, 2024, FDA announced the issuance of warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes. Some of the unauthorized products cited in the warning letters are marketed under brand names popular among youth, including Geek Bar and Lost Mary. Other unauthorized products cited feature the names and/or images of celebrities.
The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act. In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law. Failure to promptly correct the violations can result in additional actions such as an injunction, seizure, and/or civil money penalty.
FDA is committed to enforcing the law, and the agency will continue to work with its federal enforcement partners, as needed, to address unauthorized tobacco products in the United States. This latest round of warning letters demonstrates FDA’s continued efforts to remove unauthorized e-cigarette products from the market, particularly those that appeal to youth. To date, FDA has issued more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 800 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against more than 83 manufacturers and more than 175 retailers for distribution and/or sale of unauthorized tobacco products.
As of December 19, 2024, 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 consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.
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