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Health & Medicine

F.D.A Delays Big Decision on E-Cigarettes

— September 10, 2021

While the F.D.A. has taken action on other e-cigarette retailers’ applications, it has not made a decision on Juul–by far the largest vape manufacturer in the United States.

The federal Food and Drug Administration (F.D.A). has said it will need more time to decide whether some of the most popular e-cigarette devices and accessories can remain on the market.

According to CNN, the F.D.A. said that it has taken action on about 93% of submitted applications—a milestone the agency has called “significant progress.”

However, the department has yet to announce any action on or against Juul Labs, the largest—and most controversial—e-cigarette manufacturer and retailer in the United States.

CNN notes that, while e-cigarettes have been sold domestically for years, they have never been approved for retail by the F.D.A.

That changed when the F.D.A announced that e-cigarette manufacturers would have to submit applications to remain on the market. The applications, adds CNN, were due on September 9th, 2020.

The F.D.A. then gave itself one year to review the applications.

But now, the federal government says it needs more time.

A Juul-made e-cigarette. E-cigarettes are purportedly popular with teens, another point of contention between the industry and FDA. Image via Wikimedia Commons/user:Mylesclark96. (CCA-BY-4.0).

“There’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States,” acting F.D.A Commissioner Dr. Janet Woodcock and F.D.A Center for Tobacco director Mitch Zeller said in a joint statement, issued Thursday.

The F.D.A’s unexpected delay has been criticized by physicians and health advocates.

The American Cancer Society’s Cancer Action Network, for instance, has joined a lawsuit intended to enforce the September 9th deadline.

“The FDA’s failure today to act on applications by JUUL, the manufacturer with the single biggest e-cigarette market share, is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products,” said ACS-CAN President Lisa Lacasse.

“The FDA has had ample time to review the applications and allowing additional delays is unconscionable,” Lacasse added. “There is overwhelming data to demonstrate the negative impact these kinds of flavored products have had on public health and their role in the youth e-cigarette epidemic.”

“The time to act,” Lacasse said, “is now.”

Similarly, Dr. Lee Savio Beers of the American Academy of Pediatrics, told CNN that the federal government’s delay has effectively given e-cigarette companies a pass.

“Even though products like JUUL are technically being marketed illegally, FDA signaled that it will not take imminent action to remove them,” Beers said. “This is a reckless decision that will allow products proven to addict and endanger young people to continue being sold.”

Juul has indicated that it will continue operations as usual. A company spokesperson told Fox News that, while Juul respects the federal government’s review, it still believes its products play an important function in weaning adult smokers away from traditional tobacco products.

“We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate,” Juul said. “We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”


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