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D & J Vapors, LLC-Horse Cave manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FD&C Act requirements applicable to newly deemed tobacco products (e-cigarettes and e-liquids), which have been subject to FDA jurisdiction since August 8, 2016. The inspection and submission review determined the e-liquid products were being manufactured and offered for sale in the United States without the mandatory premarket approval required for new tobacco products under section 910 of the FD&C Act.