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Xtreme Vapour was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to obtain a marketing authorization order for its e-liquid products, which are classified as "new tobacco products" subject to FDA jurisdiction since the August 8, 2016 deeming rule that extended regulatory authority to electronic nicotine delivery systems. The violation involved offering tobacco products for commercial distribution in the United States without the legally mandated premarket review and approval from the Center for Tobacco Products.