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Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, as they contained nicotine from any source and were intended for human consumption. The products were found to be adulterated and/or misbranded for lacking the legally mandated premarket review and approval required for new tobacco products marketed in the United States.