FDA WARNING_LETTER - Sunshine Vape

The FDA Center for Tobacco Products issued a Warning Letter to Keith Cohen-Skali regarding e-liquid products sold on sunshinevape.com. An FDA review determined that Sunshine Vape Cowboy e-liquid, classified as a tobacco product under section 201(rr) of the FD&C Act, was sold to a person younger than 18 years of age. This sale constitutes a violation of 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. Consequently, the product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act. The letter emphasizes that this violation is not exhaustive and requires immediate correction of the identified issue and similar deficiencies to ensure full compliance with the FD&C Act and FDA regulations across all sales and advertising platforms. The firm must submit a written response within 15 working days detailing corrective actions, including dates of discontinuing violative sales and a plan for sustained compliance. Failure to comply could lead to severe FDA enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, or detention of imported products.