FDA WARNING_LETTER - www.cigoutlet.biz

The FDA's Center for Tobacco Products issued a warning letter to cigoutlet.biz after reviewing its website and identifying violations related to cigarette products sold in the U.S. The firm is selling modified risk tobacco products (MRTPs) without the required FDA order. Products labeled with descriptors like "light," "super light," or "ultra light" (e.g., Marlboro Lights) are considered MRTPs under section 911(b)(2)(A)(ii) of the FD&C Act, and their sale without an FDA order under section 911(g) makes them adulterated under section 902(8). Additionally, the firm offers flavored cigarette products (e.g., Aroma Rich Apple, Kiss Super Slim Fresh Apple) that purport to contain a natural or artificial characterizing flavor. This violates section 907(a)(1)(A) of the FD&C Act, rendering them adulterated under section 902(5). If these products lack the purported flavor, their false labeling constitutes misbranding under section 903(a)(1) or 903(a)(7)(A). The FDA demands immediate correction of all violations and similar issues, requiring a written response within 15 working days detailing corrective actions, discontinuation dates, and a compliance plan. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, or refusal of import.