FDA WARNING_LETTER - Beard Management Inc. d/b/a Beard Vape Co. d/b/a Lucky Bar Holdings, d/b/a Fifty Bar - September 13, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Brady Bates, Casey Bates, Colbey Pfund, and Josey Orr regarding electronic nicotine delivery system (ENDS) products sold on thefiftybar.com. The FDA determined that these products, specifically "Fifty Bar 6500 Puff Rechargeable Disposable" (Mint, Vanilla Custard, Pacific Cooler), are "new tobacco products" under the FD&C Act, including those containing nicotine from any source, and require premarket authorization. The firm is manufacturing and offering these ENDS products for sale or distribution in the United States without the necessary FDA marketing authorization orders, as required by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required notice or information under section 905(j). The FDA mandates prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in further regulatory actions, such as civil money penalties, product seizure, or injunction.