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Talk to a SpecialistTalk to a SpecialistGN Tobacco Sweden AB d/b/a White Fox USA was warned for manufacturing and distributing nicotine pouch products without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's nicotine pouches, offered for sale on their website, constitute tobacco products subject to FDA jurisdiction under the expanded definition that includes products containing nicotine from any source (effective March 15, 2022). The products were found to be adulterated and/or misbranded because they lacked the legally required premarket authorization order necessary for new tobacco products to be marketed in the United States.