FDA WARNING_LETTER - Austin Vape and Smoke - April 21, 2020

On March 27, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to Kemal Whyte, operating Austin Vape and Smoke, following a review of their website, https://www.austinvapeandsmoke.com. The FDA determined that several e-liquid products advertised and sold on the website are tobacco products under section 201(rr) of the FD&C Act. The primary violation identified is that the advertising for these e-liquid products fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 CFR 1143.3(b). This omission renders the products misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d), and also misbranded under section 903(a)(7)(A) because the advertising is considered misleading due to the failure to reveal material facts about the product's consequences (section 201(n)). The letter requires immediate corrective actions, including discontinuing violative advertising, sale, and distribution. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction.