FDA WARNING_LETTER - www.fontanasmokeshop.com

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Patel after reviewing his website, http://www.fontanasmokeshop.com, which offers smokeless tobacco products for sale in the United States. The FDA determined these products are subject to their jurisdiction. The primary violation identified was that the firm's smokeless tobacco products, including Skoal, Kodiak, and Copenhagen chewing tobacco, 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 required health warning label statements in advertisements, as mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. The letter also reminded the firm of other applicable federal laws, specifically noting the requirement under section 3(b)(3) of the Smokeless Tobacco Act for quarterly rotation of warning label statements. The FDA requires immediate corrective actions, including discontinuing violative promotions, and a written response within 15 working days detailing corrective actions and a plan for sustained compliance. Failure to comply may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.