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Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to new tobacco products, which mandate premarket review before commercial distribution in the United States. This violation applied to all nicotine-containing e-liquid products, including those made with non-tobacco-derived nicotine, following the March 2022 legislative expansion of FDA's tobacco product jurisdiction.