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Business Trading Company LLC, d/b/a Vapor Tonics manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA's Center for Tobacco Products. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, which include all products containing nicotine from any source intended for human consumption. The FDA determined the e-liquid products lacked the legally mandated premarket approval needed to remain lawfully marketed in the United States.