FDA WARNING_LETTER - www.cigaretteson.com

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of http://www.cigaretteson.com after reviewing their website and determining that their cigarette products are offered for sale to U.S. customers and fall under FDA jurisdiction. The letter identifies two primary categories of violations. First, the firm is selling or distributing "modified risk tobacco products," specifically cigarettes described as "light" or "mild" (e.g., "Donskoy Tabak Lights," "Rothmans Special Mild"), without an FDA order in effect as required by 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 for sale flavored cigarette products (e.g., "Aroma Rich Apple," "Esse Aura Pink Strawberry," "Kiss Mohito," "Richmond Cherry Gold") that purport to contain artificial or natural characterizing flavors. These products are adulterated under section 902(5) of the FD&C Act, as such flavors (other than tobacco or menthol) are prohibited in cigarettes. Alternatively, if these products do not contain the advertised characterizing flavors, their labeling/advertising is false or misleading, making them misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act. 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 further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.