sioux smokeless, llc – FDA Warning Letter, May 26, 2020

On May 1, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to Blaine Styles regarding the website https://www.vxcvapor.com. The FDA determined that 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 several e-liquid products, including Almond Amaretto, Banana Foster, Gummy Candy, Fruit Circles, and Bavarian Cream, are misbranded. This misbranding occurs because their advertising on the website fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 CFR 1143.3(b), which mandates this warning for covered tobacco products. Consequently, the products are misbranded under section 903(a)(7)(B) of the FD&C Act. Additionally, the failure to include this material fact renders the advertising misleading, leading to misbranding under section 903(a)(7)(A) of the FD&C Act.

The letter requires immediate corrective actions, including discontinuing violative advertising, labeling, sale, and distribution. A written response detailing these actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders,