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Island Ecig & Vape Co manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which fall under FDA jurisdiction as electronic nicotine delivery systems, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements applicable to newly deemed tobacco products as of August 8, 2016. The FDA determined that the company's products qualified as "new tobacco products" requiring premarket approval before commercial distribution in the United States.