SWT Global Supply Inc. d/b/a Hooligan Vapes LLC – FDA Warning Letter, Sep 8, 2020

On September 8, 2020, the FDA issued a Warning Letter to Susan Thomas and William Thomas regarding their website, http://www.hooliganvapes.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 Hooligan Vapes Lemon Meringue, Hooligan Vapes Choco Nana, Hooligan Vapes Red Velvet Cake, and Hooligan Vapes Twisted Pear, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because their website advertising 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). These e-liquid products are classified as "covered tobacco products" subject to these regulations.

The FDA requires immediate corrective actions, including discontinuing the violative advertising, labeling, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.