FDA WARNING_LETTER - Allen Winner

The FDA reviewed http://www.cigarette-shop.biz and determined that cigarette products offered for sale to U.S. customers are tobacco products subject to FDA jurisdiction. The website promotes "Marlboro Gold (Light)," "Marlboro Silver (Ultra Light)," and "Davidoff Gold (Lights/Gold)" as modified risk tobacco products by using descriptors like "light" or "ultra light." These products are adulterated under section 902(8) of the FD&C Act because they are offered without an FDA order permitting such promotion, violating section 911(a).

Additionally, "Kiss Fresh Apple," "Marlboro Crisp Mint," "Marlboro Fresh Mint," and "Sobranie Mints" cigarettes are offered, which appear to contain characterizing flavors other than tobacco or menthol. If these products contain characterizing flavors, they are adulterated under section 902(5) of the FD&C Act, violating section 907(a)(1)(A). If they do not contain characterizing flavors, their labeling is false and misleading, making them misbranded under section 903(a)(1).

The company must immediately correct these violations and ensure all tobacco products comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products are subject to detention