FDA WARNING_LETTER - Bisket Vapes, LLC - October 08, 2019

The FDA's Center for Tobacco Products reviewed the website https://bisketvapes.com and determined that e-liquid products advertised and sold, such as Bisket Vapes – Cotton Candy Grape, Queen Bisket’s Elixirs – Fool, and Bisket Vapes – Killer Custard, are tobacco products under section 201(rr) of the FD&C Act. These products are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act because their website advertising fails to include the required nicotine warning statement as mandated by 21 C.F.R. § 1143.3(b). This regulation requires the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." The absence of this warning also renders the products misbranded due to false or misleading labeling/advertising by failing to reveal material facts. The FDA requires immediate correction of these violations and similar issues across all advertising platforms and retail establishments. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions and a compliance plan is required within 15 working days.