Huff Vape LLC d/b/a Huff Vape – FDA Warning Letter, Dec 13, 2023

On December 12, 2023, the FDA issued a Warning Letter to Antonios Hanna regarding the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products on the website https://www.huffvape.com. The FDA's Center for Tobacco Products determined that products offered for sale, including Elf Bar BC5000 Miami Mint, Elf Bar EBDesign TE6000 Hawaii Punch, and Funky Republic TI7000 Passion Fruit Kiwi Lime, are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because no notice or information was provided as required by section 905(j). The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The recipient is required to submit a