FDA WARNING_LETTER - Pamco Inc. d/b/a Tar Heel Tobacco

The FDA's Center for Tobacco Products (CTP) issued a Warning Letter to Mr. Patrick Shehan after reviewing advertisements in the Winston-Salem Journal from December 2011 promoting smokeless tobacco products (Kayak, Grizzly, Stokers, Bowie Box). The FDA determined these products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because the advertisements failed to include the mandatory health warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended. These warnings include statements about mouth cancer, gum disease/tooth loss, the product not being a safe alternative to cigarettes, and addictiveness. The letter also noted the requirement for quarterly rotation of warning labels on advertising per an FDA-approved plan. Mr. Shehan is required to immediately correct these violations and ensure full compliance with all applicable federal laws and regulations. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure, or injunction. A written response detailing corrective actions is required within 15 working days.