FDA Puts Juul Ban on Hold

There are "scientific issues" unique to Juul's application to stay on the market, the FDA says, which temporarily halts last month's order.

Jessica Rendall Wellness Writer
Jessica is a writer on the Wellness team with a focus on health news. Before CNET, she worked in local journalism covering public health issues, business and music.
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Jessica Rendall
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The US Food and Drug Administration announced Tuesday that it temporarily stayed the marketing denial order it placed on Juul Labs for the company's products in the US. 

This means that Juul products will continue to stay on the market while the FDA considers "scientific issues unique to the JUUL application that warrant additional review." The agency noted that it isn't rescinding its order and that all vaping or nicotine-delivery products are still required to have FDA authorization to stay on the US market.

Last month, the FDA denied Juul authorization and the company was ordered to stop selling and distributing its e-cigarettes and pens as well as its tobacco and menthol-flavored pods in the US. But a federal appeals court issued a temporary stay on the ban shortly after it was issued, and the block hasn't been enforced. 

The FDA will continue to review Juul's application to stay on the market. When it originally denied Juul authorization, the FDA said the company's study findings "raised concerns due to insufficient and conflicting data -- including regarding genotoxicity and potentially harmful chemicals leaching from the company's proprietary e-liquid pods."

Juul maintains that its products meet the "statutory standard of being appropriate for the protection of the public health," Joe Murillo, Juul's chief regulatory officer, said in a statement.

"We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products," Murillo said.

Even when in effect, the FDA's orders won't affect consumers and won't punish people who use Juul products. The FDA "cannot and will not enforce against individual consumer possession or use of Juul products," the agency said in a news release.

The authorization denial followed a broad two-year review of Juul, which needed FDA authorization for its e-cigarettes to stay on the market. E-cigarettes were initially marketed toward former smokers to help them avoid the harmful effects of real cigarettes; they work by converting liquid nicotine into vapor. But experts have warned that the smooth delivery of a high nicotine content, packaged in a sleek design, may promote nicotine addiction in younger people. Juul specifically has been reprimanded by the FDA in the past for promoting the company's products as safer than other tobacco products.

The FDA has taken many steps to regulate the e-cigarette and vaping industry, including issuing a ban on flavored cartridge-based vaping products. And while Juul is one of the bigger names in the industry, the company isn't the only one selling e-cigarettes. The FDA has cleared several of Juul's rivals, including Reynolds American and Njoy Holdings, to keep tobacco-flavored e-cigarettes on the market, according to the Wall Street Journal, which originally reported the FDA's anticipated plans to ban Juul.

The announcement from the FDA came one day after the agency announced plans to set a maximum nicotine level for tobacco products. The agency has also proposed banning all traditional menthol cigarettes. There is no timeline for when these plans would go into effect, but they're expected to get major pushback from the tobacco industry. 

Each year, 480,000 people die from diseases attributed to smoking, according to the FDA. 

Read more: Juul Vape: What Is It, Why Are Teens Addicted and Is It Safe?

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.