FDA WARNING_LETTER - Smiley National Inc. d/b/a Vapor-Blends - June 16, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Dustin Otto Neilson concerning e-liquid tobacco products advertised and sold on vapor-blends.com. The FDA determined that several e-liquid products are misbranded because their website advertising fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products. Specifically, the products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) for violating regulations under section 906(d), and under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the advertising is considered false or misleading due to the omission of material facts. The letter requires immediate correction of these and similar violations to ensure compliance with the FD&C Act. A written response detailing corrective actions, including dates of discontinuing violative activities 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, injunction, and refusal of admission for imported products.