FDA WARNING_LETTER - www.cigarettesbox.com - March 10, 2016

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of cigarettesbox.com after reviewing their website and determining that cigarette products offered for sale to U.S. customers violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violations include selling or distributing modified risk tobacco products (MRTPs) without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act. These MRTPs are described using terms like "light," "super light," "mild," or claim reduced levels of substances (e.g., "lower tar"). Additionally, the firm offers flavored cigarette products (e.g., "Rum & Cherry," "Apple," "Strawberry," "Mojito," "Cherry") which are adulterated under section 902(5) of the FD&C Act due to prohibited characterizing flavors. Alternatively, if these flavored products do not contain the claimed characterizing flavor, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) of the FD&C Act for false or misleading labeling. The FDA requires immediate corrective actions, including discontinuing the violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, or refusal of admission for imported products.