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K&D Vapors manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, classified as newly deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act (effective August 8, 2016), were subject to FDA jurisdiction but lacked the necessary marketing authorization orders required for new tobacco products under section 910 of the FD&C Act. The Center for Tobacco Products determined that K&D Vapors failed to comply with premarket review requirements before commercially distributing these products in the United States.