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Talk to a SpecialistTalk to a SpecialistGuangdong Sigelei Electronic Technology Co., Ltd. d/b/a Sigelei Vape, Inc. was cited for manufacturing and distributing electronic nicotine delivery systems (ENDS) products without required premarket authorization. The company's ENDS products, listed on their website sigelei.com, were deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act and subject to FDA jurisdiction, yet lacked the legally mandated premarket authorization order required for new tobacco products to be marketed in the United States.