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Cloudberry Vapors, LLC was cited for manufacturing and selling e-liquid tobacco products without the required premarket authorization order mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquids, offered through their website, constitute "new tobacco products" subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act and therefore require marketing authorization before legal sale in the United States. The company's failure to obtain premarket approval before distributing these products violated the deeming rule effective August 8, 2016, which brought electronic nicotine delivery systems and related products under FDA regulatory authority.