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Kure CBD & Vape dba Madvapes manufactured and distributed e-liquid products containing nicotine that fall under FDA jurisdiction as tobacco products but lacked required premarket authorization orders. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to new tobacco products, which mandate premarket approval before legal marketing in the United States. This violation was identified during an FDA inspection by the Center for Tobacco Products, which determined the e-liquids were subject to FDA tobacco product regulations under the expanded definition of tobacco products that includes any product containing nicotine from any source, effective April 14, 2022.