George Katsafados Ltd. – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Katsafados after reviewing websites http://www.katsafados.com and http://www.tropicalcigars.com, which offer cigarette tobacco and/or roll-your-own tobacco products for sale in the U.S. The FDA determined these products are subject to its jurisdiction. The letter identifies two primary categories of violations. First, several products, including various Red Bull tobacco brands, are described as "mild" in their labeling or advertising, classifying them as "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. These products are sold without the required FDA order under section 911(g), rendering them adulterated under section 902(8). Second, products like Nostos Vanilla Blend and Red Bull Vanilla Shag purport to contain artificial or natural characterizing flavors, which are prohibited in cigarette tobacco and roll-your-own tobacco by section 907(a)(1)(A). This makes them adulterated under section 902(5). Alternatively, if these products lack the claimed flavor, their false or misleading labeling/advertising makes them misbranded under section 903(a)(1) or 903(a)(7)(A). The company must immediately correct these violations and submit a written response within 15 working days, detailing corrective actions and a compliance plan. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, and criminal prosecution.