FDA WARNING_LETTER - Classica Trading Center

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Horst after reviewing www.shopping-heaven.com, which offers cigarette products to U.S. customers. The FDA determined that products like "Kiss Super Slims Fresh Apple," "Richmond Cherry," and "Doina Lux Premium" (chocolate flavor) are subject to FDA jurisdiction. These cigarettes are deemed adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) because they are purported to contain artificial or natural characterizing flavors, which is prohibited for cigarettes under section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) since September 22, 2009. Alternatively, if these products lack the advertised flavors, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) due to false and misleading labeling. The firm must immediately correct these violations and ensure all tobacco products comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuing violative activities, is required within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and refusal of admission for imported products.