FDA WARNING_LETTER - Morris and Green Limited

The FDA Center for Tobacco Products issued a Warning Letter to Cigma Vape following a review of their website, cigmavape.com, which revealed e-liquid products offered for sale in the U.S. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act. The primary violation identified was the sale of Cigma Caramel Apple e-liquid to a person younger than 18 years of age. This action misbrands the product under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. Cigma Vape is required to immediately correct this violation and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to achieve full compliance could result in significant enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products. A written response detailing corrective actions, including dates of discontinuance of violative sales and a plan for ongoing compliance, must be submitted within 15 working days.