FDA WARNING_LETTER - www.tobaccocityfargo.com

The FDA's Center for Tobacco Products reviewed Tobacco City's website, tobaccocityfargo.com, and determined that their smokeless tobacco products, including Camel Snus, Copenhagen Wintergreen, and Marlboro Snus, are offered for sale in the U.S. and are misbranded.

The misbranding violation, under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)), stems from the failure to include required health warning label statements in advertisements for these smokeless tobacco products. This violates section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act. The required warnings include statements such as "This product can cause mouth cancer" and "Smokeless tobacco is addictive." Additionally, the letter notes the requirement for quarterly rotation of warning statements on advertising, in accordance with an FDA-approved plan.

Tobacco City must immediately correct these violations and ensure all tobacco products and promotional materials 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, including discontinuation of violative promotions and a compliance plan, is required