FDA WARNING_LETTER - www.smokesky.net

The FDA's Center for Tobacco Products issued a Warning Letter to smokesky.net after reviewing its website, which offered cigarette products for sale or distribution in the United States. The FDA determined these products are tobacco products under the FD&C Act. The letter identifies two primary categories of violations. First, the firm sells or distributes "modified risk tobacco products" (MRTPs) without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act. These MRTPs include cigarettes described as "light," "mild," or "low," or those making claims of reduced risk, harm, or exposure (e.g., "less toxic," "less harmful"). Second, the firm offers flavored cigarette products (e.g., apple, cherry, mint) which are adulterated under section 902(5) of the FD&C Act, violating the ban on characterizing flavors in cigarettes per section 907(a)(1)(A). Alternatively, if these products lack the claimed flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling. The FDA demands immediate correction of all violations, discontinuation of violative activities, and a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal.