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13 Vapor Co LLC 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, 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 orders required for new tobacco products. The inspection revealed the company was commercially distributing these products in the United States without the necessary premarket approval documentation.