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Captivape LLC manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA jurisdiction as tobacco products under the expanded definition that includes all nicotine-containing products regardless of source, a requirement that took effect in March 2022. The inspection determined that Captivape was commercially distributing these e-liquid products in the United States without the legally mandated premarket approval for new tobacco products.