FDA WARNING_LETTER - Oxboro Tobacco & Cigars

The FDA Center for Tobacco Products issued a Warning Letter to Shahir regarding the website http://www.oxborotobacco.com, which offers smokeless tobacco products for sale in the U.S. The FDA determined that the product "General Snus" is a tobacco product under section 201(rr) of the FD&C Act.

The primary violation identified is that the website fails to include any required health warning label statements for smokeless tobacco products, rendering the product misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act), as amended by the Tobacco Control Act, mandates specific warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive." The letter also notes the requirement for quarterly rotation of warning label statements on advertising, per section 3(b)(3) of the Smokeless Tobacco Act.

Shahir is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising on this and any other websites comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of