FDA Issues Another Round of Marketing Denial Orders

134 MDOs cover more than 637,000 flavored ENDS products
Photograph: Shutterstock

SILVER SPRING, Md. — More than 637,000 flavored electronic nicotine delivery system (ENDS) products must be pulled off the market following the issuance of 134 marketing denial orders (MDOs) from the U.S. Food and Drug Administration.

This set of denials follows several others over the past few weeks, including a round that went to 31 companies for more than 300,000 flavored ENDS. In total, the FDA has issued 168 MDOs for more than 992,000 flavored ENDS products.

Companies receiving these orders may have submitted premarket applications for other products, such as menthol-flavored ENDs, and those products, if still pending, remain under FDA review. Several of the MDOs were issued to companies that are not currently marketing their products, and therefore, their information was not released by the FDA.

Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If it’s already on the market, it must be removed or the manufacturers risk enforcement, the FDA said.

The FDA continues to make progress on its review of premarket tobacco product applications (PMTAs) and will update its progress on its website, the group said. A full list of the companies that have received MDOs can also be found online.

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