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Talk to a SpecialistTalk to a SpecialistElite Brothers, LLC manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization orders, violating the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction, failed to comply with applicable regulations for new tobacco products that were not commercially marketed in the United States prior to February 15, 2007. The FDA determined that these products required premarket authorization before legal distribution in the U.S. market.