FDA WARNING_LETTER - Freshvaping.com

The FDA Center for Tobacco Products issued a Warning Letter to Fresh Vaping after reviewing their website, freshvaping.com, and determining that their e-liquid products are tobacco products subject to FDA jurisdiction under sections 201(rr) and 901(b) of the FD&C Act. The primary violation identified was the sale of an e-liquid product, specifically SmokeTip Coffee e-liquid (received after ordering Fresh Vaping Java Jolt e-liquid), to a person younger than 18 years of age. This action constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act, as it contravenes the regulation 21 C.F.R. § 1140.14(b) which prohibits the sale of covered tobacco products to minors. The letter mandates immediate correction of this violation and similar deficiencies, requiring Fresh Vaping to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales platforms. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinuance for violative sales and a plan for sustained compliance. Failure to comply could lead to severe enforcement actions such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.