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Tiger Vapes manufactured and distributed e-liquid tobacco products without obtaining required FDA premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company's products, which contain nicotine from tobacco or other sources, were being sold commercially in the United States without compliance with FDA regulations governing new tobacco products, which require premarket authorization to be legally marketed. This violation fell under FDA's Center for Tobacco Products jurisdiction, particularly following the March 2022 legislation that extended FDA authority to all nicotine-containing products regardless of nicotine source.