Loading…
Great Vapes II LLC manufactured and distributed e-liquid tobacco products containing nicotine without the required premarket authorization mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing tobacco products, particularly following the March 2022 legislative expansion of FDA jurisdiction to include products containing nicotine from any source, not just tobacco-derived nicotine. The products were being manufactured and offered for sale in the United States without the necessary premarket approval required for "new tobacco products" under FDA law.