FDA WARNING_LETTER - Samar Tobacco Company, Inc.

The FDA's Center for Tobacco Products reviewed the website http://www.mysmokeshop.net and found that smokeless tobacco products, specifically "Dark Fire Cured Tobacco Leaf Dark Fonto/Grabba," were offered for sale in the U.S. These products are subject to FDA jurisdiction.

The FDA determined that the "Dark Fire Cured Tobacco Leaf Dark Fonto/Grabba" product is misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because its webpage lacks required health warning label statements. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco products, such as "WARNING: This product can cause mouth cancer." The absence of these warnings makes the product's labeling and/or advertising false or misleading.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan.

The company must immediately correct these violations and ensure all tobacco products, labeling, and advertising 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 dates of violative activities and a compliance plan, is required within 15 working