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Dragon 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 fall under the FDA's jurisdiction as deemed tobacco products subject to regulation since August 8, 2016, failed to comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act, specifically lacking the necessary "new tobacco product" marketing authorization orders required before commercial distribution in the United States.