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Route 66 Vapor manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products qualified as tobacco products under FDA jurisdiction because they contained nicotine from any source, a definition expanded by legislation signed in March 2022. The products were deemed adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act for being marketed without the legally required premarket authorization for new tobacco products.