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.
Notice
1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.
2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.
3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.
Copyright
This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.
This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.
