FDA WARNING_LETTER - VaporBombCOM - April 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Harry Patterson and Jerry Litton concerning e-liquid products, specifically "Cafe Mocha" and "Cinnamon Danish Swirl," offered for sale on https://vaporbomb.com. The FDA determined these e-liquids are "new tobacco products" under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. prior to February 15, 2007. As such, these products require a premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, which the firm failed to obtain. This lack of authorization renders the products 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 mandates a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for sustained compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction.