FDA Issues Additional Marketing Denial Orders on ENDS Products

Agency is not noting names of specific denied products
Disposable e-cigarettes
Photograph: Shutterstock

LAKEVILLE, Minn. — According to an announcement issued on Sept. 17 by the U.S. Food and Drug Administration’s Center for Tobacco Products, the agency has issued a total of 295 Marketing Denial Orders (MDOs) to an aggregate of 240 manufacturers that submitted premarket tobacco product applications (PMTAs) covering more than 1.1 million different flavored electronic nicotine delivery systems (ENDS)/nicotine vapor products.

When the MDOs are added to other actions taken by the FDA to refuse to accept or refuse to file PMTAs from other manufacturers for flavored electronic delivery systems/nicotine vapor products, the total number of such products under applications that have been refused or denied is upwards of 6 million ENDS/nicotine vapor products.

In the Sept. 17 announcement, the FDA also stated that 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. Also, other PMTAs remain under review and the agency is working to finalize action on these other pending applications.

In its announcement, the FDA did not disclose either the actual number of flavored electronic nicotine vapor products subject to each MDO for each manufacturer nor the specific product names. 

The issuance of these MDOs means the electronic nicotine products that are the subject of the PMTAs may not be introduced into the market or, if the products are already on the market, the products must be removed from the market or risk enforcement action by the FDA. This includes a requirement that retailers remove the electronic nicotine products from store shelves which are the subject of the MDOs issued by the FDA. However, as was the case with the FDA’s other recent announcements about MDOs being issued, the FDA website continues to contain the same notice that the names of the specific products are not being released at this time. That FDA notice reads as follows:

“Note:  FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions. However, before releasing this information, FDA needs to ensure the agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.”

Tobacco retailers need to keep themselves informed as the FDA process continues, and to work with manufacturers and distributors to ensure that they are not selling products for which MDOs have been issued or PMTAs have been rejected for filing.

Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.

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