FDA WARNING_LETTER - GOLDEN EAGLE DISTRIBUTORS - October 01, 2025

The FDA issued a Warning Letter to Golden Eagle Distributors LLC on October 2, 2025, following a review of its distribution records. The company was found to be selling and distributing electronic nicotine delivery system (ENDS) products, specifically "Hyppe Max Air 5000 13ML 5% Nic Strawberry Sky," without the legally required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are considered "new tobacco products" because they were not commercially marketed in the United States before February 15, 2007, and lack the mandatory FDA authorization. Consequently, the FDA deemed these products to be in violation of federal regulations, specifically adulterated and misbranded, due to the absence of the necessary marketing order. Golden Eagle Distributors LLC is required to immediately cease the unlawful sale and distribution of these products. The company must submit a written response within 15 working days, detailing the corrective actions taken, including the dates sales were discontinued, and outlining its plan for maintaining ongoing compliance with the FD&C Act. Failure to comply may lead to further enforcement actions, such as civil money penalties, product seizure, or legal injunctions.