FDA WARNING_LETTER - tobaccovip.com - January 16, 2016

The FDA Center for Tobacco Products issued a Warning Letter to tobaccovip.com after reviewing its website and identifying violations related to the sale and distribution of cigarette products in the United States. The letter states that several cigarette products are adulterated because they are modified risk tobacco products (MRTPs) sold without an FDA order, as required by section 911(a) of the FD&C Act, making them adulterated under section 902(8). These MRTPs include products described as "lights," "ultra light," or those claiming reduced harm or lower levels of substances (e.g., "low nicotine"). Additionally, the company offers flavored cigarette products (e.g., honey, vanilla, apple, cherry, rum) which are prohibited under section 907(a)(1)(A) of the FD&C Act, rendering them adulterated under section 902(5). If these products do not actually contain the advertised flavors, their labeling and advertising are considered false or misleading, making them misbranded under sections 903(a)(1) or 903(a)(7)(A). The FDA requires immediate correction of all identified violations and similar issues. A written response detailing corrective actions, including dates of discontinuing violative sales and advertising, and a plan for maintaining compliance, must be submitted within 15 working days. Failure to comply could result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal.