FDA WARNING_LETTER - Wild Bill's Tobacco of Alpena LLC - September 11, 2025

The FDA issued a Warning Letter to Wild Bill"s Tobacco of Alpena LLC, located at 1037 North Bagley Street, Alpena, MI, following an inspection by the Center for Tobacco Products. The inspection revealed that the company sells electronic nicotine delivery system (ENDS) products, specifically the Geek Bar Pulse X Blackberry Blueberry 50MG/ML Nicotine, without the required premarket authorization. This product is classified as a "new tobacco product" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it was not commercially available in the U.S. before February 15, 2007.

The FD&C Act mandates that all new tobacco products must have a marketing authorization order to be legally sold in the U.S. The absence of such authorization renders the product adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively. The regulatory framework requires compliance with the FD&C Act and its implementing regulations, which now include products containing nicotine from any source, as amended by the Consolidated Appropriations Act, 2022.

Wild Bill"s Tobacco is required to cease the sale and distribution of the non-compliant products and submit a written response within 15 working days detailing corrective actions taken to comply with the FD&C Act. Failure to address these violations may result in enforcement actions, including civil penalties or product seizure. The company must ensure all products and related advertising comply with the FD&C Act to avoid further regulatory action.