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niqpouches.com was warned on January 30, 2026, for offering nicotine pouch products for sale to U.S. customers without required FDA premarket authorization. The company's products fell under FDA jurisdiction as tobacco products containing nicotine from any source following the 2022 expansion of the FD&C Act definition, yet the company failed to comply with the requirement that new tobacco products obtain a marketing authorization order before being legally marketed in the United States. The warning addressed violations of the Family Smoking Prevention and Tobacco Control Act and regulations governing adulterated and misbranded tobacco products.