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mynicco.com, a Sweden-based company, was cited for offering nicotine pouch products for sale to U.S. consumers without required premarket authorization. The products violated the Federal Food, Drug, and Cosmetic Act because they are tobacco products subject to FDA jurisdiction under section 901(b) of the FD&C Act, including those containing nicotine from non-tobacco sources as defined by the 2022 Consolidated Appropriations Act. The company failed to obtain a marketing authorization order under section 910 of the FD&C Act, which is required for new tobacco products to be legally marketed in the United States.