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Custom Vapors Inc. was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's nicotine-containing e-liquids fall under FDA jurisdiction as tobacco products and must comply with Federal Food, Drug, and Cosmetic Act requirements, including obtaining marketing authorization for products not commercially available prior to February 15, 2007. The inspection found the company was offering these products for sale in the United States without the legally mandated premarket review and approval.