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Talk to a SpecialistTalk to a SpecialistShindler Distribution Inc. d/b/a VapoRush was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA's requirement that "new tobacco products" obtain premarket authorization orders before being legally marketed in the United States, regardless of whether the nicotine source was derived from tobacco or from any other source. As a distributor of these unapproved tobacco products, the company was operating in violation of FDA jurisdiction established under section 901(b) of the FD&C Act and applicable implementing regulations.