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Talk to a SpecialistTalk to a SpecialistKure Corporation was cited for manufacturing and distributing e-liquid products containing nicotine without obtaining required premarket authorization orders as mandated under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing "new tobacco products," which require premarket approval before legal marketing in the United States. The FDA determined that the e-liquid products fall under its jurisdiction as tobacco products because they contain nicotine from any source and are intended for human consumption, particularly following the 2022 legislative expansion of FDA authority to regulate all nicotine-containing products regardless of their origin.