FDA WARNING_LETTER - gotpouches.com - January 30, 2026

On January 30, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to gotpouches.com after reviewing their website. The FDA determined that gotpouches.com is unlawfully offering for sale and distributing nicotine pouch products, specifically On! 6 mg Plus Raspberry Lemon and On! 11.5 mg Plus Raspberry Lemon, to customers in the United States. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are categorized as "tobacco products," subject to FDA jurisdiction. The main violation stems from the marketing of these items as "new tobacco products" without the legally required premarket authorization orders from the FDA, rendering them adulterated and misbranded under the FD&C Act. gotpouches.com is required to promptly address these violations and ensure all their tobacco products comply with the FD&C Act and its implementing regulations. A written response must be submitted within 15 working days, detailing actions taken to discontinue violative sales and outlining a comprehensive plan for future compliance. Failure to comply may lead to further regulatory actions, including civil money penalties or product seizure.