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Talk to a SpecialistTalk to a SpecialistSouth Coast Vapor Company manufactured and distributed e-liquid products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products qualified as "new tobacco products" subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act, requiring premarket review and approval before commercial distribution. The company failed to comply with applicable tobacco product regulations governing electronic nicotine delivery systems that were deemed tobacco products effective August 8, 2016.