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McVapour LLC manufactured and distributed e-liquid tobacco products without the required premarket authorization orders mandated by the FDA for new tobacco products. The company failed to comply with FDA regulations governing tobacco products containing nicotine from any source, which became subject to FDA jurisdiction following the Consolidated Appropriations Act of 2022. The Center for Tobacco Products determined that the company's e-liquid products required marketing authorization under section 910 of the Federal Food, Drug, and Cosmetic Act but were being sold without such approval.