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Stella Blues Vapors Inc manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act and regulations governing tobacco products, including those containing nicotine from non-tobacco sources following the 2022 legislative expansion of FDA jurisdiction. The Center for Tobacco Products determined the products were being offered for sale or distribution in the United States without the legally mandated premarket approval.