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Craving Vapor Industries, LLC manufactured and distributed e-liquid products that are regulated as tobacco products under the Family Smoking Prevention and Tobacco Control Act, but the company failed to obtain required premarket authorization for these "new tobacco products" as mandated by the Federal Food, Drug, and Cosmetic Act. The FDA determined that the e-liquid products, which are electronic nicotine delivery systems deemed subject to FDA regulation effective August 8, 2016, were being offered for sale or distribution without the legally required premarket approval.