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Simply Vapour LLC was warned for manufacturing and distributing e-liquid tobacco products without the required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquids, as products made from tobacco and intended for human consumption, met the definition of newly deemed tobacco products subject to FDA regulation as of August 8, 2016, but were being marketed without compliance with premarket approval requirements. The company's website offered these products for sale in the United States without the necessary authorization to legally market them.