FDA WARNING_LETTER - www.1cigarettesonline.net

The FDA's Center for Tobacco Products reviewed the website http://www.1cigarettesonline.com, identifying cigarette products offered for sale to U.S. customers that are subject to FDA jurisdiction. The agency determined that several products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (MRTPs) sold without an FDA order in effect, as required by section 911(a). These products are described as "light," "ultra light," "super light," or imply reduced levels of substances (e.g., nicotine/tar), qualifying them as MRTPs under section 911(b)(2)(A). Additionally, the firm offers flavored cigarette products, such as Aroma Rich Apple and Kiss Mohito, which purport to contain characterizing flavors. These products violate section 907(a)(1)(A) and are adulterated under section 902(5). If these products do not contain characterizing flavors, their labeling is considered false or misleading, rendering them misbranded under section 903(a)(1) or 903(a)(7)(A). The FDA requires immediate correction of all identified violations and similar issues, including discontinuing the violative promotion, advertising, sale, and distribution of these tobacco 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, or injunction, and import refusal.