FDA WARNING_LETTER - Ultimate Product Distributors, LLC - October 01, 2025

The FDA issued a Warning Letter to Ultimate Product Distributors, LLC on October 2, 2025, following a review of inspection records. The company was found to be illegally selling and distributing nicotine pouch products, specifically "Lucy Brisk 4mg," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all products containing nicotine from any source are regulated as tobacco products. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007, and lacked the necessary FDA marketing authorization order. Consequently, the FDA determined that the "Lucy Brisk 4mg" product is both adulterated and misbranded under the FD&C Act for being marketed without proper authorization. Ultimate Product Distributors, LLC is mandated to submit a written response within 15 working days. This response must detail the actions taken to address these violations, including the dates when the sale and distribution of the non-compliant products ceased, and outline a plan for ensuring future compliance with the FD&C Act and its regulations. Non-compliance could result in further regulatory actions.