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7 DAZE LLC manufactured and distributed e-liquid tobacco products containing nicotine without the required premarket authorization orders mandated by the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA jurisdiction as tobacco products containing nicotine from any source, a classification expanded in March 2022 to include non-tobacco-derived nicotine. The FDA determined the products were not in compliance with applicable tobacco product regulations and required premarket approval before legal marketing in the United States.