FDA WARNING_LETTER - http://www.usa-cigarettes.com

The FDA's Center for Tobacco Products issued a Warning Letter after reviewing the website http://www.usa-cigarettes.com, which offers smokeless tobacco products for sale in the United States. The FDA determined that Copenhagen Fine Cut Regular and Copenhagen Pouches are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because the webpage fails to include required health warning label statements. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 mandates specific health warnings on labeling and advertisements for smokeless tobacco products. The absence of these warnings renders the products misbranded, as the failure to reveal material facts makes the advertising misleading under section 201(n) of the FD&C Act. The FDA also reminded the firm of other applicable federal laws, such as the quarterly rotation of warning statements. The company must immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all media. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction. A written response detailing corrective actions, discontinuation dates, and a compliance plan is required within 15 working days.