FDA postpones its decision on Juul e-cigarettes
The Food and Drug Administration (FDA) postponed its decision on whether to allow e-cigarette giant Juul Labs and other companies to sell their vaping products on the U.S. market, beyond the expected Thursday deadline.
The apparent pushback of the anticipated decision comes a year after e-cigarette manufacturers, including the most popular brand Juul, submitted applications to prove their devices overall served as a benefit for public health.
The federal agency is still working “expeditiously on the remaining applications” that are “in the final stages of review,” FDA Commissioner Janet Woodcock and Director of the Center for Tobacco Products Mitch Zeller said in a release.
The FDA has faced growing pressure to regulate vaping as e-cigarette use has skyrocketed among youth and teenagers, worrying parents and health experts about their ingestion of the nicotine-based product. More than 80 percent of users are between ages 12-17, and e-cigarette are the most used tobacco product among youth.
But as the review process continues past the deadline, Juul and other e-cigarette products are allowed to stay on the market in the meantime.
A spokesperson for Juul Labs said in a statement that they “respect the central role of the FDA and the required through science- and evidence-based review of our applications.”
“We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use,” the statement said.
The FDA had a year to determine whether millions of these products effectively helped people trying to quit smoking and whether the benefits outweigh the potential harms to youth. In that time, the agency said it denied applications for almost 950,000 e-cigarette or related products due to concerns they appealed to teenagers.
“We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard,” the officials said in a statement.
“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,” they added.
But the FDA did not gain the authority to monitor the e-cigarette industry until 2016. Products seeking to go to market after Aug. 8, 2016 required the agency’s approval. However, the agency did not remove any e-cigarette products from the market until recently.
Last month, the FDA denied applications for 55,000 flavored e-cigarette products from three companies to be sold, citing that flavored vapes have sparked a “youth e-cigarette epidemic.”
Juul took its fruit- and mint-flavored nicotine pods off the market in 2019, shortly before the FDA prohibited such flavors last year.