FDA WARNING_LETTER - www.cigsclub.net

The FDA's Center for Tobacco Products issued a Warning Letter to cigsclub.net after reviewing its website and identifying cigarette products offered for sale in the U.S., which are subject to FDA jurisdiction. The letter identifies two primary categories of violations. First, the firm is selling "modified risk tobacco products" (MRTPs), including those described as "Light" or "Ultra Light" (e.g., Pall Mall Lights, Marlboro Gold, Winston Blue), without an FDA order in effect under section 911(g) of the FD&C Act. This renders these products adulterated under section 902(8). Second, the firm offers flavored cigarette products (e.g., Aroma Rich Apple, Kiss Mohito, Richmond Cherry) which purport to contain characterizing flavors, violating section 907(a)(1)(A) and making them adulterated under section 902(5). Alternatively, if these products lack the advertised flavors, their labeling is false or misleading, leading to misbranding under sections 903(a)(1) or 903(a)(7)(A). The FDA requires immediate correction of these violations, discontinuation of all non-compliant sales and advertising, and a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, and criminal prosecution.