FDA WARNING_LETTER - www.cigarettes4.me

The FDA Center for Tobacco Products issued a Warning Letter to Ms. Tillman regarding the website http://www.cigarettes4.me, which offers cigarette products for sale in the United States. The FDA determined that several products, including Benson & Hedges Smooth Lights Gold, Gitanes Blondes Light, and L&M Box Light/Blue, are modified risk tobacco products (MRTPs) because they use "Light" or similar descriptors. Under sections 911(a) and 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(a), § 387k(b)(2)(A)(ii)), it is prohibited to introduce or deliver MRTPs into interstate commerce without an FDA order in effect under section 911(g). Consequently, these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). The letter mandates immediate correction of these violations and similar issues across all tobacco products, labeling, and advertising. A written response detailing corrective actions, dates of discontinuation of violative activities, and a compliance plan must be submitted within 15 working days. Failure to comply may lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.