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EBCREATE Store was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization. The company's tobacco products, which contain nicotine from any source, were found to be in violation of the Federal Food, Drug, and Cosmetic Act, as they lacked the mandatory marketing authorization order required for new tobacco products under section 910 of the FD&C Act. The FDA determined that as of the warning letter date, these ENDS products had not obtained the necessary premarket review and approval required for legal distribution in the United States.