FDA WARNING_LETTER - Cherokee Brands, LLC

The FDA issued a Warning Letter to Cherokee Brands, LLC following a review of their websites (www.cherokeebrands.com, www.cherokeetobacco.com, and www.firebirdmanufacturing.com). The review identified several violations of the Federal Food, Drug, and Cosmetic Act and associated regulations. Specifically, the FDA determined that Cherokee Blue, Cherokee Sky, and Cherokee Menthol Gold products are adulterated under section 902(8) of the Act (21 U.S.C. § 387b(8)). All Cherokee brand cigarettes are also misbranded under section 903(a)(7)(B) of the Act (21 U.S.C. § 387c(a)(7)(B)) due to non-compliance with FDA's Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (21 C.F.R. Part 1140). A key deficiency is the introduction of modified risk tobacco products, such as those labeled "light" or "ultra light," into interstate commerce without an FDA order in effect under section 911(g) of the Act (21 U.S.C. § 387k(g)), rendering them adulterated. Furthermore, the company violated 21 C.F.R. § 1140.34(c) by sponsoring the 2010 Halifax County Fair using the "Cherokee Brands, LLC" name, which includes a cigarette brand name. Cherokee Brands, LLC is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates violative activities ceased. Failure to comply may result in FDA enforcement actions, including civil money penalties, no-tobacco-sale orders, seizure, and/or injunction.