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D&C Beckley, Inc d/b/a Kickin' Ash Vapors manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company failed to comply with the 2016 Deeming Rule, which established that electronic nicotine delivery systems and e-liquids are regulated tobacco products subject to FDA jurisdiction and require marketing authorization orders for "new tobacco products" introduced after February 15, 2007. The Center for Tobacco Products determined the company's e-liquids were being offered for commercial sale and distribution in the United States without the legally mandated premarket approval.