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Everything Vapor Aztec manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA jurisdiction as tobacco products because they contained nicotine from any source, triggering compliance obligations following the March 2022 legislative expansion of FDA authority over nicotine-containing products. The company failed to demonstrate that these "new tobacco products" had premarket authorization in effect, as mandated for legal U.S. marketing.