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Vapor Vapes Inc. 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, classified as electronic nicotine delivery systems under FDA jurisdiction since August 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products" that must receive marketing authorization orders before commercial distribution. The FDA identified that these products were being offered for sale in the United States without the necessary premarket approvals mandated by section 910 of the FD&C Act.