Mod Fuel, LLC – FDA Warning Letter, May 30, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Mod Fuel, LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Mod Fuel, LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source and being intended for human consumption.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products CHUBBY VAPES ICE RAZZ 3MG 60ML, CHUBBY SALT ICE ICED OUT 50MG 30ML, and JOOST AMORE 3MG 30ML were identified as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and failure to provide necessary reports under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(