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Cloud House Vape manufactured and distributed e-liquid products containing nicotine without the required premarket authorization mandated by the FDA for new tobacco products. The company failed to comply with the Federal Food, Drug, and Cosmetic Act and its implementing regulations governing tobacco products, which now include any products containing nicotine from any source following legislation signed in March 2022. The FDA determined that Cloud House Vape's e-liquid products, intended for human consumption and commercially distributed in the United States, were subject to FDA jurisdiction and required premarket approval before legal marketing.