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Talk to a SpecialistTalk to a SpecialistreBreathe Vapor Products manufactured and sold e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquids, identified on their website, qualified as newly deemed tobacco products subject to FDA jurisdiction as of August 8, 2016, and were required to have a marketing authorization order in effect to be legally marketed in the United States. The FDA determined the products were adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to the absence of this premarket approval.