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Moonlight Vapers manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of 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 being sold commercially in the United States without compliance with Federal Food, Drug, and Cosmetic Act requirements, specifically the requirement that "new tobacco products" obtain marketing authorization orders before distribution.