FDA WARNING_LETTER - www.tobaccocountry.com

The FDA's Center for Tobacco Products reviewed Tobacco Country's website, tobaccocountry.com, and determined that its promoted smokeless tobacco products are subject to FDA jurisdiction under the FD&C Act. The primary violation identified is that several smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). This misbranding stems from the failure to include any required health warning label statements in product advertisements, as mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act. The letter explicitly lists numerous products, such as Copenhagen and Skoal varieties, advertised without these critical warnings. The FDA also reminded the firm of other applicable federal laws, including the requirement for quarterly rotation of warning label statements on advertisements for each brand of smokeless tobacco under section 3(b)(3) of the Smokeless Tobacco Act. Tobacco Country is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, including discontinuation dates and a compliance plan, must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product detention.