FDA WARNING_LETTER - China Cigarette Manufacture Co., Ltd

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Colon after reviewing his website, http://www.marlboronewport.com, which offers cigarette products for sale in the United States. The FDA determined that these tobacco products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are promoted as modified risk tobacco products (MRTPs) without an FDA order in effect. Specifically, the website uses descriptors such as "light" and "ultra light" in product labeling and advertising, including product names like "Marlboro Lights (Gold)" and "Marlboro Ultra Lights (Silver)." Under section 911(b)(2)(A)(ii) of the FD&C Act, such descriptors classify products as MRTPs. Section 911(a) prohibits the introduction of MRTPs into interstate commerce without an FDA order under section 911(g), and products in violation are deemed adulterated under section 902(8). The letter requires immediate correction of these violations and similar ones, ensuring all tobacco products and promotional materials comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuing violative promotion and a compliance plan, 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, or injunction, and imported products may be detained.