FDA WARNING_LETTER - duty-free-cigs.com - August 25, 2011

The FDA issued a Warning Letter to duty-free-cigs.com after reviewing its website and determining that flavored cigarette products were offered for sale to U.S. customers. These products, including Kiss Superslims Fresh Apple, Kiss Superslims Strawberry, and Richmond Cherry, are classified as tobacco products under section 201(rr) of the FD&C Act and fall under FDA jurisdiction per section 901(b). The FDA found these products to be either adulterated or misbranded. Specifically, the flavored cigarettes are adulterated under section 902(5) of the FD&C Act because they contain artificial or natural characterizing flavors (apple, strawberry, cherry), which is prohibited for cigarettes by section 907(a)(1)(A) as of September 22, 2009. Alternatively, if these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) due to false and misleading labeling that represents them as having such flavors. The firm is required to immediately correct these violations and ensure all tobacco products comply with the FD&C Act. A written response detailing corrective actions, including the discontinuation of violative activities, must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.