FDA WARNING_LETTER - MadTown Vapor LLC - April 21, 2020

The FDA issued a Warning Letter to MadTown Vapor LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Berry Splash, which are deemed tobacco products. The letter identifies multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. Firstly, MadTown Vapor LLC failed to provide an ingredient listing for its Berry Splash e-liquid to the FDA as required by section 904(a)(1) of the FD&C Act. This failure renders the product misbranded under section 903(a)(10)(A) and constitutes a prohibited act under sections 301(k) and 301(q)(1)(B). Secondly, packages for the Berry Splash e-liquid product do not include the required nicotine warning statement as mandated by 21 C.F.R. § 1143.3(a). This omission causes the product to be misbranded under sections 903(a)(7)(B) and 903(a)(1) of the FD&C Act, and also constitutes a prohibited act under section 301(k). The FDA requires prompt corrective action, including discontinuing violative sales and distribution, and submitting a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, and refusal of admission for imported products.