FDA WARNING_LETTER - Blowing Vapors

The FDA Center for Tobacco Products issued a Warning Letter to Gerri Simon and Brenda Neaville-Simon of Swamp Vapor after reviewing their website, http://www.swampvapor.mybigcommerce.com. The FDA determined 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 Swamp Vapor Vanilla Hazelnut e-liquid to a person younger than 18 years of age. This action renders the product misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and constitutes a direct violation of 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. The letter emphasizes that this violation is not exhaustive and requires immediate corrective actions to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Swamp Vapor must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales, and a plan for sustained compliance. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product seizure.