City Vapes Premium eJuice Inc. – FDA Warning Letter, Mar 17, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Cityvapes.com after reviewing their website and determining that e-liquid products advertised and sold to U.S. customers are tobacco products under section 201(rr) of the FD&C Act. The primary violation identified is that several e-liquid products are misbranded under section 903(a)(7)(8) of the FD&C Act because their website advertising fails to include the required nicotine warning statement, as mandated by 21 C.F.R. § 1143.3(b). This regulation requires the warning "WARNING: This product contains nicotine. Nicotine is an addictive chemical." to be present in advertising for covered tobacco products. The company is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all platforms. A written response detailing corrective actions, including dates of discontinuation of violative activities and a compliance plan, must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.