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JDVapour LLC d/b/a McVapour E-Cig's & Novelties manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products qualified as "new tobacco products" subject to FDA jurisdiction under the deeming rule effective August 8, 2016, yet the company failed to obtain premarket approval before marketing these products in the United States. The FDA determined the products were adulterated and misbranded due to the absence of required premarket authorization.