FDA WARNING_LETTER - www.cheap-smokes2.biz

The FDA's Center for Tobacco Products reviewed the website http://www.cheap-smokes2.biz and found cigarette products offered for sale in the United States. These products, including Davidoff Gold, Gauloises Blondes Yellow, and Winston Blue Super Slims 100?s, are classified as tobacco products under section 201(rr) of the FD&C Act. The FDA determined that these products are adulterated under section 902(8) of the FD&C Act because they are promoted as modified risk tobacco products (MRTPs) without an FDA order in effect. Specifically, the website uses descriptors such as "Lights" or "Ultra Lights" in product labeling or advertising, which designates them as MRTPs under section 911(b)(2)(A)(ii). Introducing or delivering MRTPs into interstate commerce without an FDA order, as required by section 911(a), renders them adulterated. The firm is required to immediately correct these violations, discontinue all violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions, discontinuation dates, and a compliance plan must be submitted within 15 working days. Failure to comply may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction, with products also subject to detention and refusal of admission.