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Sema International Inc. was warned for manufacturing and selling e-liquid tobacco products through its website without obtaining required premarket authorization orders from FDA. The company's e-liquid products, deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act effective August 8, 2016, were found to violate Federal Food, Drug, and Cosmetic Act requirements by lacking the necessary marketing authorization for new tobacco products. The Center for Tobacco Products identified these violations following a review of the company's website (semavape.com) showing e-liquids offered for sale or distribution in the United States.