FDA WARNING_LETTER - Cool Vape LLC

The FDA Center for Tobacco Products issued a Warning Letter to Thuan Pham concerning the website http://www.coolvape.com, which sells e-liquid products in the U.S. The FDA determined these e-liquids are tobacco products under the FD&C Act. The primary violation identified was the sale of "The Milkman Churrios" e-liquid to a person younger than 18 years of age. This sale constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), as it violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. The letter mandates immediate correction of this violation and similar deficiencies, emphasizing the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales platforms. A written response detailing corrective actions, including dates of discontinued violative sales and a compliance plan, is required within 15 working days. Non-compliance may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction, with imported products also subject to detention.