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Yogi's Vape 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 failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems that have been subject to FDA jurisdiction since August 8, 2016. As e-liquids containing nicotine derived from tobacco, these products qualified as "new tobacco products" requiring premarket marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act prior to commercial distribution in the United States.