FDA WARNING_LETTER - niqpouches.com - January 20, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to niqpouches.com on January 30, 2026, after reviewing their website and identifying that nicotine pouch products were offered for sale to customers in the United States. The primary violation centers on the unlawful marketing of several "On! PLUS" brand nicotine pouch products, including Berry, Watermelon Mint, Citrus, and Raspberry Lemon flavors, without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products introduced after February 15, 2007, or modified versions, are considered "new tobacco products" and must receive FDA approval before commercial marketing. These unauthorized products are deemed adulterated and misbranded because they lack the necessary marketing orders. This regulatory action reflects the expanded definition of "tobacco product" under the FD&C Act to include nicotine from any source, effective March 2022. niqpouches.com is mandated to submit a written response within 15 working days. This response must detail the corrective actions taken, including the discontinuation of sales for the violative products, and outline a plan to ensure full compliance with the FD&C Act and its regulations. Failure to comply may lead to further enforcement actions, such as civil penalties or product seizure.