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Steep Slope Vape Supply manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization orders under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing "new tobacco products," which require premarket approval before products can be legally marketed in the United States. The violation encompasses e-liquids containing nicotine from any source, as FDA's jurisdiction was expanded in March 2022 to include all nicotine-containing products regardless of their origin.