Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010170910.
Violations1
Issue DateOct 2, 2025
Product TypeTobacco
StatusOpen
Letter Details
Firm
Ultimate Product Distributors, LLC
Location
Ultimate Product Distributors, LLC
504 Hudson Street
Hackensack , NJ 07601
United States
FEI Number
3010170910
Country
United States
Issue Date
October 02, 2025
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Open
Summary
Ultimate Product Distributors, LLC was cited for selling and distributing nicotine pouch products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing tobacco products, including those containing nicotine from any source following the 2022 legislative expansion of FDA jurisdiction. As a distributor of "new tobacco products" not commercially marketed before February 15, 2007, the company was required to obtain premarket authorization orders but had not done so.
Ultimate Product Distributors, LLC FDA Warning Letter, October 2, 2025