Victory Vapor Inc. – FDA Warning Letter, Dec 9, 2021

The FDA issued a Warning Letter to Victory Vapor Company on December 9, 2021, following a review of submissions and inspection records. The FDA determined that Victory Vapor Company manufactures and distributes e-liquid products, specifically identifying "Flavor Bomb Plain Tobacco 3mg e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Flavor Bomb Plain Tobacco 3mg e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p). The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

Victory Vapor Company is required to submit a written response within 15 working days detailing actions