FDA WARNING_LETTER - www.duty-free-goods.com

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of http://www.duty-free-goods.com after reviewing the website and determining that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA identified two primary categories of violations. First, the firm is selling or distributing modified risk tobacco products, specifically cigarettes labeled with descriptors like "Lights" or "Ultra Lights," without an FDA order in effect under section 911(g) of the FD&C Act. This renders these products adulterated under section 902(8) of the FD&C Act. Second, the firm offers flavored cigarette products, such as "Aroma Rich Apple" and "Richmond Cherry," which are prohibited from containing artificial or natural characterizing flavors under section 907(a)(1)(A) of the FD&C Act, making them adulterated under section 902(5). If these products do not contain such flavors, their labeling is considered false or misleading, leading to misbranding under sections 903(a)(1) or 903(a)(7)(A). The FDA requires immediate corrective actions, including discontinuing the violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction.