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Talk to a SpecialistTalk to a SpecialistFuZion Vapor LLC manufactured and distributed e-liquid nicotine products without obtaining required premarket authorization from the FDA. The company's products, containing nicotine from any source, fell under FDA's expanded tobacco product jurisdiction following March 2022 legislation and were subject to compliance requirements under the Federal Food, Drug, and Cosmetic Act. The inspection and submission review determined the products were being offered for sale or distribution in the United States without the legally mandated premarket authorization for new tobacco products.