Cendano Corporation Ltd. – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Pak after reviewing his websites (galastore.com, shopcig.com, mcity4.com, cigarettesmania.com) which offer cigarette products to U.S. customers. The FDA determined these products are tobacco products under the FD&C Act. The letter identifies two primary categories of violations. First, several products, including "Marlboro Gold (Lights)" and "Winston Super Slims Silver (Super Lights)," are promoted with descriptors like "light" or "super light," classifying them as modified risk tobacco products (MRTPs) under section 911(b)(2)(A)(ii). These products are offered for sale without an FDA order, rendering them adulterated under section 902(8) of the FD&C Act. Second, products such as "Kiss Fresh Apple Superslims" and "Marlboro Crisp Mint" are purported to contain characterizing flavors (other than tobacco or menthol), violating section 907(a)(1)(A) and making them adulterated under section 902(5). Alternatively, if these flavored cigarettes lack characterizing flavors, their false and misleading labeling constitutes misbranding under section 903(a)(1). Mr. Pak must immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, and product detention.