FDA Denies 55,000 E-Cigarette Product Applications

The U.S. Food and Drug Administration (FDA) this week announced it had issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for approximately 55,000 flavored electronic cigarette products lacked sufficient evidence that they have a benefit to adult smokers to overcome the public health threat posed by using such products. The FDA’s actions represent a step toward making progress on the unprecedented number of premarket applications for new tobacco products.

To date, the FDA has received applications from over 500 tobacco companies comprising more than 6.5 million tobacco products. This week’s steps were the first set of MDOs issued for applications that have reached the substantive scientific review of the FDA’s premarket review process. As the FDA indicates, products subject to an MDO for a premarket application are prohibited from being introduced or delivered for introduction into interstate commerce. Products already on the market must be removed or risk enforcement actions.

The full FDA announcement is available here.