Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCustom Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of section 910 of the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as newly deemed tobacco products under the August 2016 Final Rule, were being sold or offered for distribution in the United States without the mandated marketing authorization order for new tobacco products. The FDA determined that these products did not qualify for any applicable exemptions from premarket review requirements.