FDA WARNING_LETTER - Tampa FuM Corp. - June 16, 2020

The FDA issued a Warning Letter to Ken Villei, Francis K. II Villei, and Lissette C. Villei after reviewing their website, https://fumvaping.com, and determining that their e-liquid tobacco products are subject to FDA jurisdiction. The primary violation identified is that the advertising for several e-liquid products, including FuM Jolly Melon and FuM Chocolate Bar, fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the e-liquid products 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 deficiencies across all advertising platforms. A written response is required within 15 working days, detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance. Failure to comply could result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.