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Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, which are classified as "new tobacco products" under FDA regulations, were not commercially marketed in the United States as of February 15, 2007, and therefore required FDA premarket approval before being offered for sale or distribution. The FDA determined that these products were adulterated and/or misbranded due to the lack of required compliance with applicable tobacco product regulations.