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Mad Buck Vapes Inc d/b/a Detroit Rock Candy manufactured and sold e-liquid tobacco products through their website without obtaining required premarket authorization from the FDA. The company's e-liquid products, which contain nicotine and fall under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, were not in compliance with applicable regulatory requirements. The FDA determined that as "new tobacco products" not commercially marketed prior to February 15, 2007, these e-liquids required premarket authorization orders before legal distribution in the United States.