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Better Vapes LLC 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 under the expanded definition that includes products containing nicotine from any source, following legislation signed in March 2022. The FDA determined that these e-liquid products were being offered for sale or distribution in the United States without compliance with applicable tobacco product regulations, including the requirement for new tobacco products to obtain premarket authorization before legal marketing.