FDA WARNING_LETTER - Smart Vending Services, LLC - April 01, 2026

On April 7, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Smart Vending Services, LLC, based in Henderson, Nevada. Following a recent review of inspection records, the FDA determined that the company is selling and distributing unauthorized nicotine pouch products, specifically HYPPE Wintergreen 8 mg, to customers in the United States. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act), nicotine pouches are classified as tobacco products. Any "new tobacco product" not on the market before February 15, 2007, requires a premarket authorization order to be legally sold. Because Smart Vending Services, LLC lacks this authorization, the FDA has classified the products as adulterated and misbranded. The company is required to take immediate action to correct these violations and ensure all products comply with federal law. Smart Vending Services, LLC must provide a written response within 15 working days detailing the steps taken to discontinue the sale of unauthorized products and outlining a plan for future compliance. Failure to address these issues may lead to regulatory enforcement, such as civil penalties, product seizures, or legal injunctions.