The U.S. Food and Drug Administration in August issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products and is continuing processing applications and making decisions. As of Sept. 23, a total of 323 MDOs accounting for more than 1,167,000 flavored ENDS products have been issued.
Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.
The aggregate information on these actions will be provided within our regular updates on the Tobacco Product Applications: Metrics and Reporting page.