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Talk to a SpecialistTalk to a SpecialistDKD Vapor LLC d/b/a Phoenix Rising Vapor manufactured and distributed e-liquid tobacco products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction since the August 8, 2016 deeming rule, were found to be in violation of Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products," which require premarket authorization before commercial distribution. The FDA determined the products were adulterated and misbranded based on the company's failure to obtain required regulatory approvals prior to marketing and selling these products in the United States.