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Kealani Distribution LLC/Violet Vapor LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and FDA regulations governing newly deemed tobacco products. The company's e-liquids, which are subject to FDA jurisdiction as tobacco products containing or derived from tobacco, were offered for sale on their website without compliance with FD&C Act requirements for new tobacco products that lack premarket approval as of February 15, 2007. The FDA's inspection of the company's website identified these unapproved products being marketed directly to U.S. consumers.