Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSmooth Vapes Hawaii 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, classified as electronic nicotine delivery systems under FDA jurisdiction since August 8, 2016, were deemed new tobacco products requiring marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act, which the company had failed to secure. The FDA determined the products were adulterated and misbranded due to their lack of premarket approval and noncompliance with applicable tobacco product regulations.