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Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell manufactured and distributed e-liquid tobacco products containing nicotine without required premarket authorization as mandated by the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the expanded definition that includes all products containing nicotine from any source, following the March 2022 legislative amendment. The FDA determined that the company failed to comply with applicable tobacco product regulations and requirements necessary for legal marketing in the United States.