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McCraney Enterprises Corporation d/b/a Vapors Heaven manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, which fall under the definition of electronic nicotine delivery systems, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements that mandate "new tobacco products" obtain premarket approval before commercial distribution. The inspection identified that these products were being offered for sale in the United States without the necessary FDA authorization that has been required since August 8, 2016.