FDA WARNING_LETTER - www.ciggiesworld.com

The FDA Center for Tobacco Products issued a Warning Letter to Ciggiesworld.com after reviewing its website and finding cigarette products offered for sale to U.S. customers in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations. The letter identified multiple violations. Firstly, several products were promoted as "mild," "low tar," or "low nicotine," classifying them as modified risk tobacco products (MRTPs). These products are adulterated under section 902(8) of the FD&C Act because they lack the required FDA order for MRTP promotion under section 911(g). Secondly, numerous "Clove Cigarettes (Kretek)" and other flavored cigarettes were offered, which are adulterated under section 902(5) for containing prohibited characterizing flavors, violating section 907(a)(1)(A). Alternatively, if these products do not contain the claimed flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) due to false and misleading labeling. Lastly, the firm sold cigarette packages containing fewer than 20 cigarettes, violating 21 C.F.R. §1140.16(b) and rendering them misbranded under section 903(a)(7)(B). The FDA requires immediate corrective actions, including discontinuing violative activities, and a written response within 15 working days detailing compliance plans. Failure to comply could lead to severe enforcement actions, including penalties, no-tobacco-sale orders, seizure, and refusal of admission for imported products.