• February 21, 2024

More Marketing Denial Orders From FDA

 More Marketing Denial Orders From FDA
Photo: Jhvephotos | Dreamstime.com

The U.S. Food and Drug Administration has issued additional marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products.

As of Sept. 23, the agency has issued 323 MDOs accounting for more than 1,167,000 flavored ENDS.

The list of MDOs is available here.

The FDA issued the first MDOs in August.

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.