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Vaporwave LLC 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, which fall under the FDA's jurisdiction as newly deemed tobacco products effective August 8, 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products" that necessitate marketing authorization orders prior to commercial distribution.