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Wagco Distribution, Inc. manufactured and distributed e-liquid products containing nicotine without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act's new tobacco product requirements. The company failed to comply with FDA jurisdiction over tobacco products, including those containing nicotine from any source following the 2022 legislative expansion of FDA authority. The products were deemed adulterated and misbranded as they lacked the legally mandated premarket approval necessary for commercial distribution in the United States.