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Talk to a SpecialistTalk to a SpecialistHotHead Vapor manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. As e-liquids are deemed tobacco products under FDA jurisdiction, the company was required to obtain marketing authorization for these "new tobacco products" that were not commercially marketed in the United States as of February 15, 2007. The company's failure to comply with premarket authorization requirements rendered their e-liquid products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.