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Pure Vapor USA LP manufactured and distributed e-liquid products without obtaining required premarket authorization, as e-liquids are deemed tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with the requirement that "new tobacco products" obtain marketing authorization orders before commercial distribution in the United States. The Center for Tobacco Products determined the e-liquid products were being manufactured and offered for sale in violation of section 910 of the Federal Food, Drug, and Cosmetic Act.