FDA WARNING_LETTER - Blaze USA, LLC, d/b/a Blaze Wholesale - October 09, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Blaze USA, LLC, d/b/a Blaze Wholesale, after reviewing inspection records. The firm was found to be selling and distributing electronic nicotine delivery system (ENDS) products, which are regulated as tobacco products under the FD&C Act, including those containing nicotine from any source as per the March 2022 amendment. The primary violation identified is the marketing of a "new tobacco product," specifically GEEK BAR PULSE META MOON 50MG/ML 16ML, without the required premarket authorization order. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice under section 905(j) was not provided. The FDA emphasizes that all new tobacco products require premarket authorization. Blaze USA, LLC must respond within 15 working days, detailing actions taken to cease violative sales and ensure future compliance. Failure to address these violations could result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be refused admission.