TopVapors.com – FDA Warning Letter, Oct 29, 2019

The FDA Center for Tobacco Products issued a Warning Letter to TopVapors.com after reviewing its website and determining that its e-liquid products are advertised and sold to U.S. customers, classifying them as tobacco products under sections 201(rr) and 901(b) of the FD&C Act. The letter identified two primary violations. First, the firm sold Tongue Slap Sweet Tart Salts e-liquid to a person younger than 18, which misbrands the product under section 903(a)(7)(B) of the FD&C Act and violates 21 C.F.R. § 1140.14(b). Second, several e-liquid products advertised on the website lacked the required nicotine warning statement, misbranding them under section 903(a)(7)(B) of the FD&C Act and violating 21 C.F.R. § 1143.3(b). TopVapors.com is required to immediately correct these and similar violations to ensure full compliance with the FD&C Act and FDA regulations. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinuation of violative sales and advertising, and a plan for maintaining compliance. Failure to comply could result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.