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ecmvape.com was cited for offering electronic nicotine delivery system (ENDS) products for sale in the United States without premarket authorization as required under the Federal Food, Drug, and Cosmetic Act. The company's products are subject to FDA jurisdiction as tobacco products under section 901(b) of the FD&C Act because they contain nicotine from any source and are intended for human consumption. The FDA determined that these "new tobacco products" require a marketing authorization order under section 910 of the FD&C Act to be legally marketed in the United States, which the company had failed to obtain.