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Trippy Drips LLC 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—either as products derived from tobacco or containing nicotine from any source following the March 2022 legislative expansion—and were required to comply with FD&C Act regulations before commercial distribution. The inspection determined the company was manufacturing and selling these products in the United States without the legally mandated premarket approval for new tobacco products.