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Viper Vapor LLC manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act and regulations governing new tobacco products, which mandate premarket review and approval before commercial distribution in the United States. This violation applied to all e-liquid products the company manufactured and offered for sale, including those made with nicotine from any source following the March 2022 expansion of FDA's tobacco product jurisdiction.