Victorious Vapors LLC – FDA Warning Letter, Oct 28, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Victorious Vapors, LLC, based on a review of submissions and inspection records. The FDA determined that Victorious Vapors manufactures and distributes e-liquid products, specifically the "Victorious Vapors Pep O Mint 6 mg e-liquid product," which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that this e-liquid product is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA 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. Victorious Vapors, a registered manufacturer with over 70