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Blackbeard Vapor LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, 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, failed to comply with Federal Food, Drug, and Cosmetic Act requirements mandating premarket approval for all new tobacco products not commercially marketed before February 15, 2007. The FDA's inspection records and review of the company's submissions confirmed these compliance failures in the manufacture and distribution of unapproved tobacco products for commercial sale in the United States.