FDA WARNING_LETTER - Monkey Vapors - July 23, 2019

The FDA issued a Warning Letter to Kirby Fuller and Jamie Fuller of Monkey Vapors after reviewing their website, monkeyvapors.net, which offers e-liquid products for sale. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The primary violation identified was the sale of Monkey Vapors Baja Blast e-liquid to a person younger than 18 years of age, with a complimentary Monkey Vapors Strawberry Watermelon e-liquid also sent. This sale to a minor violates 21 C.F.R. § 1140.14(b) and renders the Monkey Vapors Baja Blast e-liquid misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The FDA requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and its implementing regulations. A written response detailing corrective actions, dates of discontinuance, 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, or injunction.