FDA WARNING_LETTER - Texas Central Distribution LLC - November 03, 2025

The FDA issued a Warning Letter to Texas Central Distribution LLC on November 24, 2025, following a review of inspection records, citing violations related to the marketing of unauthorized tobacco products. The company is distributing electronic nicotine delivery system (ENDS) products, specifically the "North 5000 Puffs Blueberry Mint 5% nicotine 10 ML," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), this product is classified as a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks an FDA marketing order.

This unauthorized marketing renders the product adulterated under FD&C Act section 902(6)(A) and misbranded under section 903(a)(6) for not providing required information. The regulatory framework underscores that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act and its implementing regulations.

Texas Central Distribution LLC must promptly address these violations by discontinuing the sale and distribution of the unauthorized ENDS product. A written response is required within 15 working days, detailing the actions taken to correct the violations, including dates of discontinuation, and outlining a plan for maintaining future compliance with the FD&C Act. Failure to comply may result in further regulatory actions.