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Elk River Vapor Shop was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as deemed tobacco products subject to FDA jurisdiction since August 2016, failed to comply with Federal Food, Drug, and Cosmetic Act requirements for new tobacco products that were not commercially marketed prior to February 15, 2007. The FDA determined that the products were adulterated and/or misbranded under applicable tobacco product regulations.