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Black Hills Vapors LLC 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, failed to comply with Federal Food, Drug, and Cosmetic Act requirements mandating premarket approval before commercial distribution. The Center for Tobacco Products determined these violations based on review of the company's submissions and inspection records.