FDA WARNING_LETTER - www.cigarette-brands.com

The FDA's Center for Tobacco Products issued a Warning Letter after reviewing http://www.cigarette-brand.com, identifying cigarette products offered for sale in the U.S. as tobacco products under the FD&C Act. The letter cites two primary categories of violations. First, several cigarette products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (MRTPs), using descriptors like "lights" or "ultra lights" or claiming reduced substances (e.g., "Lower tar variants of Gauloises"), sold without a required FDA order under section 911(g). Second, various flavored cigarette products, such as "Aroma Rich Apple" and "Kiss Mohito(mini)," are adulterated under section 902(5) for containing prohibited characterizing flavors, violating section 907(a)(1)(A). Alternatively, if these products lack the advertised flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling. The FDA demands immediate correction of these violations and similar deficiencies, requiring the company to ensure all tobacco products and promotional materials comply with the FD&C Act. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days. Non-compliance could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product seizure.