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Wyoming Vapor Company was warned that its e-liquid products constitute tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, and that these products were being manufactured and distributed without required premarket authorization as "new tobacco products." The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, specifically the requirement that new tobacco products obtain premarket approval before commercial distribution. The inspection and submission review by the Center for Tobacco Products determined the company was manufacturing and selling e-liquid products for human consumption without the necessary regulatory compliance and authorization.