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Moti Global, a China-based manufacturer, was warned for manufacturing and distributing electronic nicotine delivery system (ENDS) products through their website motiplanet.com to U.S. customers without required premarket authorization. The company's products fell under FDA jurisdiction as tobacco products following the August 8, 2016 deeming rule but lacked the legally required marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act for new tobacco products. The violation involved offering these newly deemed tobacco products for sale in the United States without obtaining premarket approval from the FDA's Center for Tobacco Products.