FDA WARNING_LETTER - Foggy Gorilla Vaping Company

The FDA Center for Tobacco Products issued a Warning Letter to fgvaping.com after reviewing their website and determining that their e-liquid products, specifically "Funky Gorilla e-liquid," are offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of "Funky Gorilla e-liquid" to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18.

The FDA requires immediate correction of this violation and similar issues, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance.