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

While the FDA has taken action on applications from other e-cigarette retailers, it hasn’t made a decision on Juul – by far the largest vape maker in the United States.

The U.S. Food and Drug Administration (FDA). said it will take more time to decide if some of the most popular e-cigarette devices and accessories can stay in the market.

According to CNN, the FDA said it has taken action on approximately 93% of the applications submitted – a milestone the agency describes as “significant progress.”

However, the department has not yet announced any action against or against Juul Labs, the largest – and most controversial – manufacturer and retailer of e-cigarettes in the United States.

CNN notes that while e-cigarettes have been sold domestically for years, they have never been approved for retail sale by the FDA

That changed when the FDA announced that e-cigarette manufacturers would need to file applications to stay in the market. Applications, adds CNN, were due on September 9, 2020.

The FDA then gave itself a year to review the applications.

But now the federal government is saying it needs more time.

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

“More needs to be done to complete our remaining reviews and ensure that we continue to take reasonable steps to protect our country’s youth from the dangers of tobacco products, including e-cigarettes, which remain the most common use by youth tobacco products consumed in the United States are states, “said Acting FDA Commissioner Dr. Janet Woodcock and the director of the FDA Center for Tobacco, Mitch Zeller, in a joint statement Thursday.

The FDA’s unexpected delay has been criticized by doctors and health advocates.

For example, the American Cancer Society’s Cancer Action Network joined a lawsuit to enforce the September 9 deadline.

“The failure of the FDA to respond today to filings from JUUL, the company with the largest e-cigarette market share, is extremely disappointing and will allow the industry to continue to pose a threat to public health and keep more children involved in their highly addictive products “Said ACS-CAN President Lisa Lacasse.

“The FDA has had ample time to review the applications and it is unacceptable to allow additional delays,” added Lacasse. “There is overwhelming data to show the negative public health impact of these types of flavored products and their role in the e-cigarette epidemic among adolescents.”

“The time to act,” said Lacasse, “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 permit.

“Although products like JUUL are technically marketed illegally, the FDA has signaled that it will not take immediate action to remove them,” Beers said. “This is a reckless decision that will allow us to keep selling products that have been shown to be addictive and put young people at risk.”

Juul has announced that it will continue operations as usual. A company spokesman told Fox News that while Juul respects the federal government’s review, he still believes his products play an important role in weaning adult smokers off traditional tobacco products.

“We respect the pivotal role of the FDA and the need for thorough scientific and evidence-based review of our applications, which is key to harm reduction and licensing,” said Juul. “We continue to work to turn adult smokers away from flammable cigarettes while at the same time combating consumption by minors.”

sources

FDA postpones decision to ban Juul products, citing more time

FDA needs more time to make decisions about e-cigarettes

The FDA’s delayed decision on Juul e-cigarettes is “inconsiderate,” says the pediatric group