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E-Cig Innovation manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic 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 the requirement that "new tobacco products" obtain marketing authorization orders before commercial distribution. The Center for Tobacco Products determined the products were adulterated and misbranded due to these premarket approval violations.