FDA WARNING_LETTER - jadepouch.com - April 01, 2026

On April 23, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to jadepouch.com, an online retailer based in China, following a review of its website. The FDA determined that the company is unlawfully selling and distributing nicotine pouch products, such as Ice Cream Nicotine Pouch and Red Fruit Nicotine Pouch, to consumers in the United States without the required marketing authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these items are classified as new tobacco products because they were not commercially available before February 15, 2007. Federal law requires that any new tobacco product receive a formal marketing authorization order from the FDA before being sold. Because these specific nicotine pouches lack such authorization, they are legally considered adulterated and misbranded. The FDA has directed jadepouch.com to take immediate action to address these violations. The company must provide a written response within 15 working days, outlining the specific steps taken to stop the illegal sale of these products and describing a plan to ensure future compliance with federal regulations. Failure to resolve these issues may result in enforcement actions, including civil financial penalties, product seizures, or the refusal of imported goods at the U.S. border.