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Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Forest 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 Family Smoking Prevention and Tobacco Control Act, including products containing nicotine from any source following the March 2022 legislative expansion of FDA's tobacco product definition. The products were determined to be adulterated and/or misbranded as they were not in compliance with FD&C Act requirements for legally marketed new tobacco products.