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Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing "new tobacco products" under section 901(b) of the Federal Food, Drug, and Cosmetic Act, which require premarket approval for any tobacco product not commercially marketed in the United States as of February 15, 2007.