Cigabuy – FDA Warning Letter, Sep 8, 2020

On May 28, 2020, the FDA Center for Tobacco Products issued a Warning Letter to Cigabuy.com after reviewing their website, which advertised and offered e-liquid products for sale to customers in the United States. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation identified was that several e-liquid products were misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This misbranding stemmed from the website advertising's failure to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). The letter stressed that it is unlawful for any entity involved in the tobacco product supply chain to advertise such products without this warning. Cigabuy.com was directed to immediately correct this violation and similar issues, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including dates of discontinuance of violative activities and a compliance plan, was required within 15 working days. Non-compliance could lead to further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.