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Savant Industries, LLC, operating as Paradigm Distribution, manufactured and distributed e-liquid products containing nicotine that are subject to FDA tobacco product jurisdiction but lacked required premarket authorization orders for new tobacco products. The company failed to comply with the Federal Food, Drug, and Cosmetic Act's requirements applicable to tobacco products, including those containing nicotine from any source following the 2022 legislative expansion of FDA's tobacco product definition. The violation was identified during FDA's review of inspection records related to the company's e-liquid product manufacturing and distribution operations.