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Visible Vapors, LLC was cited for manufacturing and selling e-liquid tobacco products without required premarket authorization from the FDA. The company's e-liquids, offered through their website, were deemed tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, but lacked the legally mandated marketing authorization orders necessary for new tobacco products. The warning specifically noted that as e-liquids fall under the FDA's deeming rule effective August 8, 2016, they cannot be legally marketed in the United States without proper premarket review and approval.