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Caribbean Cloud Dot Com d/b/a Gorilla Vapes manufactured and distributed e-liquid products containing nicotine, which fall under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with federal requirements governing tobacco products, including the requirement that new tobacco products obtain premarket authorization before being legally marketed in the United States. The FDA's jurisdiction over these products was expanded in March 2022 to include all nicotine-containing products regardless of nicotine source, establishing that the company's e-liquid offerings required regulatory compliance.