FDA WARNING_LETTER - Vape 180 LLC - December 10, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Ryan and Christina Baxter of Vape 180, following a review of their website, vape180.com, which advertises and sells e-liquid products. The FDA determined that these e-liquids are tobacco products subject to FDA jurisdiction. The letter identifies two primary violations: first, the Nappy Green Apple e-liquid was misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because it was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). Second, several e-liquid products, including Glass Bassix Butterscotch and Bad Drip Cereal Trip, were misbranded under the same section because their website advertising failed to include the required nicotine warning statement, as mandated by 21 C.F.R. § 1143.3(b). Vape 180 is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuation of violative activities and a compliance plan. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.