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Modfathers Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and FDA regulations governing newly deemed tobacco products. The company failed to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which mandates that "new tobacco products"—defined as any tobacco product not commercially marketed in the United States before February 15, 2007—must receive FDA marketing authorization before distribution. The Center for Tobacco Products identified these compliance failures through review of the company's submissions and inspection records.