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Nuvo Silver Inc. was warned for importing and distributing electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to receive marketing authorization orders before commercial distribution in the United States. As ENDS products (including e-cigarettes and e-liquids) were deemed tobacco products subject to FDA jurisdiction effective August 8, 2016, Nuvo Silver's distribution of these products without proper premarket approval violated sections 910 and 901(b) of the Federal Food, Drug, and Cosmetic Act.