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Vertigo Vapor Inc. d/b/a Baton Vapor was cited for manufacturing and distributing e-liquid tobacco products without the required premarket authorization order mandated by the Family Smoking Prevention and Tobacco Control Act. The company's e-liquids, sold through their website batonvapor.com, were deemed tobacco products subject to FDA jurisdiction under section 901(b) of the Federal Food, Drug, and Cosmetic Act but lacked compliance with the statutory requirement for "new tobacco products" to obtain marketing authorization before being legally sold in the United States.