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Disposable Vapez was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act, which mandates that "new tobacco products"—including vaping products containing nicotine from any source—obtain a marketing authorization order before being legally sold in the United States. The products listed on the company's website were determined to be unapproved tobacco products subject to FDA jurisdiction under section 901(b) of the FD&C Act and applicable regulations.