FDA WARNING_LETTER - TOMBAK LLC - February 22, 2026

The FDA issued a Warning Letter to Tombak LLC on January 22, 2026, following a review of its inspection records and website. The letter identified significant violations concerning the company"s "Tombak Loose Leaf Chewing Tobacco, unflavored" product. Firstly, the product was deemed a "new tobacco product" marketed without the required premarket authorization from the FDA, rendering it adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Secondly, Tombak LLC made unauthorized modified risk claims on its website, marketing pamphlet, and product label, stating that switching from cigarettes "reduces risk of lung cancer," without the necessary FDA order. This also resulted in the product being adulterated. Lastly, the company failed to include mandatory health warning statements for smokeless tobacco products on its website and marketing materials, leading to misbranding under the Comprehensive Smokeless Tobacco Health Education Act. The FDA requires Tombak LLC to immediately correct all identified violations, ensure full compliance with federal tobacco product regulations, and submit a written response within 15 working days detailing corrective actions and a plan for ongoing compliance. Failure to comply could result in enforcement actions, including civil penalties, product seizure, or injunction.