FDA WARNING_LETTER - Tribal Discounts

The FDA's Center for Tobacco Products issued a Warning Letter to Tribal Discounts after reviewing their website, tribaldiscounts.com, and finding smokeless tobacco products offered for sale in the U.S. The FDA determined that these products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because the product webpages failed to include any required health warning label statements. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act, mandates specific health warnings for smokeless tobacco advertisements. The letter listed numerous products lacking these warnings. The company is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuation of violative activities, and a plan for maintaining compliance, must be submitted within 15 working days. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.