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Talk to a SpecialistTalk to a SpecialistBroken Coil manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of section 910 of the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as newly deemed tobacco products under the 2016 deeming rule, were subject to FDA jurisdiction but were being offered for sale or distribution in the United States without the mandatory marketing authorization order needed for new tobacco products. This violation of the Family Smoking Prevention and Tobacco Control Act requirements constituted adulteration and misbranding of tobacco products under FDA regulations.