FDA WARNING_LETTER - http://www.cigs7.com

The FDA Center for Tobacco Products issued a Warning Letter to the operator of cigs7.com for distributing tobacco products to U.S. customers in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A review of the website identified two main categories of violations. First, the firm sells or distributes modified risk tobacco products, including cigarettes, cigarette tobacco, and roll-your-own tobacco, without an FDA order. This encompasses products labeled with descriptors like "Light," "Mild," "Low," or similar terms, and those making claims of being "safer," "healthier," or "relatively harmless." These products are adulterated under section 902(8) of the FD&C Act. Second, the firm offers flavored cigarette products (e.g., Rum & Cherry, Mojito, Strawberry, Apple, Mint) purported to contain artificial or natural characterizing flavors, rendering them adulterated under section 902(5) of the FD&C Act. Alternatively, if these products lack the claimed flavors, their labeling is false or misleading, making them misbranded under sections 903(a)(1) or 903(a)(7)(A). The FDA demands immediate correction of all violations, cessation of violative sales and advertising, and a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, and criminal prosecution.