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Day 2 Day LLC d/b/a Day 2 Day Tobacco was cited for offering electronic nicotine delivery system (ENDS) products for sale on their website without obtaining required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act by marketing these new tobacco products—which contain nicotine from any source and are subject to FDA jurisdiction—without the legally mandated premarket authorization orders in effect. The violations constituted adulteration and misbranding of tobacco products under FDA regulations.