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Kure CBD & Vape manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization orders from the FDA. The company's products, which contain nicotine from any source, fall under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act and require compliance with the Federal Food, Drug, and Cosmetic Act. The FDA determined the products were being sold illegally in the United States without the necessary marketing authorization that is generally required for new tobacco products.