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HotHead Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as newly deemed tobacco products under FDA jurisdiction as of August 8, 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements, specifically lacking the marketing authorization order required for new tobacco products under section 910 of the act.