FDA WARNING_LETTER - Tobacco Exotica

The FDA issued a Warning Letter to Mr. Burkett of Tobacco Exotica after reviewing their website, http://www.tobaccoexotica.com, which offers smokeless tobacco products for sale in the United States. The FDA determined that several products, including Gawith Apricot Snuff and various Ozona Snuffs, are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)). This misbranding stems from the website's failure to include any of the health warning label statements required by Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402). The letter also reminded the firm of its obligation to comply with all federal laws, including the quarterly rotation of warning labels on advertising as per Section 3(b)(3) of the Smokeless Tobacco Act. Tobacco Exotica must immediately correct these violations and submit a written response within 15 working days, detailing corrective actions, including dates of discontinuing violative sales/advertising, and a plan for sustained compliance. Failure to comply could lead to severe FDA enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of import.