FDA WARNING_LETTER - Tobacco Barn Tucson

The FDA Center for Tobacco Products reviewed the website http://www.tobaccobarntucson.com and determined that smokeless tobacco products offered for sale, including Copenhagen, Skoal, Kodiak, Timberwolf, Longhorn, and Grizzly, are misbranded. This misbranding, under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act, stems from the website's failure to include any of the required health warning statements for smokeless tobacco products.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act, mandates specific health warnings for smokeless tobacco advertisements, such as "WARNING: This product can cause mouth cancer." The absence of these warnings renders the products misbranded because the advertising is false or misleading by failing to reveal material facts.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising, in accordance with an FDA-approved plan. The recipient must immediately correct these violations on their website and all other advertising platforms to comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions and a compliance plan is required within 15 working days.