FDA WARNING_LETTER - Malton International LTD

The FDA issued a Warning Letter after reviewing multiple affiliated websites (e.g., cigs4girls.com, tobaccopub.com) offering cigarettes to U.S. customers, determining these products fall under FDA jurisdiction as tobacco products. The letter identified two primary violations. First, the firm promotes several products as "modified risk tobacco products" by using descriptors like "light," "mild," or "ultra light," and making claims of reduced harm, exposure, or toxicity (e.g., "Safe Smoke Filter," "less toxic product"). These products are adulterated under section 902(8) of the FD&C Act because they lack an FDA order permitting such promotion, as required by section 911(a). Second, the firm offers flavored cigarettes (e.g., Kiss Fresh Apple, Sobranie Mints) containing characterizing flavors other than tobacco or menthol, which is prohibited by section 907(a)(1)(A). These flavored products are adulterated under section 902(5) or, if they lack characterizing flavors, misbranded under section 903(a)(1) due to false labeling. The FDA requires immediate correction of these violations and a written response within 15 working days detailing corrective actions, including the cessation of violative promotion and sales. Failure to comply could lead to severe enforcement actions, including civil money penalties, criminal prosecution, seizure, and import refusal.