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WillyAnjel Enterprises LLC dba Emote Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which contain nicotine from tobacco or other sources, are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act and must comply with FDA regulations, including the premarket authorization requirements for new tobacco products. The FDA determined the products were being manufactured and offered for sale in the United States in violation of applicable tobacco product regulations.