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Tiger Vapor, LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating 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 since August 8, 2016, were found to be in violation of Federal Food, Drug, and Cosmetic Act requirements because they were not commercially marketed in the United States as of February 15, 2007, and therefore qualified as "new tobacco products" requiring premarket approval under section 910 of the FD&C Act. The FDA determined that the products were adulterated and/or misbranded due to lack of proper authorization and marketing compliance.