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Vaper Generation 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 Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, which apply to all products containing nicotine from any source following the March 2022 legislative expansion of FDA jurisdiction. As a manufacturer and distributor of unapproved "new tobacco products," the company was in violation of section 901(b) of the FD&C Act and its implementing regulations.