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Custom Vapors LLC 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's e-liquid products, which are classified as electronic nicotine delivery systems under FDA jurisdiction since the August 2016 deeming rule, failed to comply with FD&C Act requirements for new tobacco products that must receive marketing authorization before commercial distribution. The Center for Tobacco Products determined the products were adulterated and misbranded due to their lack of premarket approval and non-compliance with applicable tobacco product regulations.