FDA Rejects 950K Applications for Flavored e-Cigarettes, Delays Decision on Juul

The U.S. Food and Drug Administration said it rejected applications for nearly 950,000 flavored e-cigarettes and related products, but the decision on whether to permit the vaping brand Juul to stay on shelves has been delayed.

The FDA said the applications for other e-cigarettes were rejected mainly due to their potential appeal to children between the ages of 12 and 17. Some products the agency rejected are currently being sold, while many others were only being proposed by manufacturers.

It hasn't yet ruled on Juul, which is the most popular brand for many adults and teen smokers, and the agency noted that 80 percent of teens and children who vape use flavored products. On its website, Juul offers at least eight different flavors of vape pods.

"Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency's highest priorities," the FDA said in a statement.

For more reporting from the Associated Press, see below.

Juul Flavored Products
The Food and Drug Administration ruled on Sept. 9, 2021, on nearly 950,000 applications for flavored e-cigarette products, but has yet to make a decision on Juul. Electronic cigarettes and pods by Juul, the nation's largest maker of vaping products, are offered for sale at the Smoke Depot on Sept. 13, 2018 in Chicago, Ill. Scott Olson/Getty Images

Parents, politicians and anti-tobacco advocates have pressured the FDA for years to ban Juul's high-nicotine devices, which many blame for the recent spike in underage vaping. But the agency said it would need more time to rule on that company's products.

"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 all tobacco products, including e-cigarettes," the agency said in a statement.

Thursday's action is part of a sweeping review by the FDA to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. The agency has yet to authorize any vaping product as a less harmful option for smokers.

The FDA faced a court deadline Thursday to issue decisions on marketing applications from Juul and hundreds of other companies. The date was set by a federal judge after anti-tobacco groups successfully sued the FDA to speed up its review.

To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

FDA regulators previously said they would prioritize evaluating products from Juul and a handful of other key players before reviewing most larger vaping devices with refillable tanks and other products. Those products are mainly popular with adults and sell at specialty vape shops.

Vaping Pens
On Thursday, Sept. 9, 2021, U.S. health officials delayed a high-stakes decision on whether to permit best selling vaping brand Juul to stay on the market, while ordering thousands of other electronic cigarettes off store shelves. In this April 16, 2019 file photo, a researcher holds vape pens in a laboratory in Portland, Ore. Craig Mitchelldyer, File/AP Photo