FDA WARNING_LETTER - smokin4free.com@iprivacyltd.com

The FDA Center for Tobacco Products issued a Warning Letter to Smokin4Free.com after reviewing their website and identifying cigarette products offered for sale in the U.S. The FDA determined that several products are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act. Specifically, the firm is selling or distributing modified risk tobacco products without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). These products are advertised with descriptors like "Lights," "mild," or claims of reduced harm, nicotine, or tar, classifying them as modified risk products under section 911(b)(2)(A) (21 U.S.C. § 387k(b)(2)(A)). Additionally, the firm offers flavored cigarette products, such as apple, rum & cherry, and mint varieties, which purport to contain characterizing flavors. These products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) for violating section 907(a)(1)(A) (21 U.S.C. § 387g(a)(1)(A)). If the flavors are not present, the products are misbranded under section 903(a)(1) or 903(a)(7)(A) (21 U.S.C. § 387c(a)(1) or § 387c(a)(7)(A)) due to false or misleading labeling. Smokin4Free.com must immediately correct these violations and discontinue all violative promotion, advertising, sale, and distribution. A written response detailing corrective actions and a compliance plan is required within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal.