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snusme.com was warned for offering nicotine pouch products for sale in the United States without required FDA premarket authorization. The products violated the Federal Food, Drug, and Cosmetic Act because they are classified as "new tobacco products" under FDA jurisdiction—including products containing nicotine from any source following the 2022 legislative expansion of tobacco product definitions. The company failed to obtain a marketing authorization order under section 910(c) of the FD&C Act, which is required for any tobacco product not commercially marketed in the U.S. as of February 15, 2007.