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Six Months After Court-Ordered Deadline, FDA Still Hasn’t Ruled on Major E-cigarette Manufacturers’ Product Applications

March 8, 2022

Washington, D.C.— Wednesday marks six months since the U.S. Food and Drug Administration (FDA) failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications. While the FDA has ruled on some applications with marginal market share, the products that make up the majority of the market share, including JUUL, remain on store shelves unregulated.

The September 9, 2021, deadline was set as the result of a 2018 lawsuit filed by the American Cancer Society Cancer Action Network (ACS CAN) and numerous other public health groups. As a result of FDA’s failure to act by the court ordered deadline, ACS CAN and its partners requested that the court require status reports from FDA on their progress in assessing remaining applications. A ruling on this request is pending.

A statement from Lisa Lacasse, president of ACS CAN follows:

“The FDA’s continued failure to act on applications that make up the majority of the e-cigarette market share, like JUUL, is extremely disappointing and will allow the industry to further endanger public health by addicting more kids to their products. The FDA has had ample time to review the applications and this extended unregulated time for these products to remain on the market is unconscionable. There is overwhelming data to demonstrate the negative impact these flavored products have had in the youth e-cigarette epidemic. It’s well past time to act.

“If we are to reduce suffering and death from cancer, we must prevent youth tobacco initiation and FDA’s premarket review process must play a critical role. While FDA fails to do its job, federal, state and local officials must continue their essential work regulating the sale of these highly addictive, harmful products.”

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Media Contacts

Emily Burr
Director, Media Advocacy
Washington, D.C.