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FDA Orders Juul to Stop Selling in the US

Because it was denied authorization, Juul must stop selling and distributing pods and e-cigarettes.

Juul products on a store shelf
Bloomberg/Getty Images

The US Food and Drug Administration on Thursday issued marketing denial orders to Juul Labs for all of the company's products currently marketed in the US. 

This means Juul must stop selling and distributing its e-cigarettes and pens as well as its tobacco and menthol-flavored pods. All products must be removed from the US market or the company risks "enforcement action," the FDA said. 

The FDA's orders don'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. Retailers who sell Juul should contact the company if they have questions, the FDA said.

"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," FDA Commissioner Robert M. Califf said in the release. 

The ban follows 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.

When it 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."

In a statement, Joe Murillo, chief regulatory officer at Juul, said that the company "respectfully disagrees" with the FDA's decision and that it's exploring options under the new regulation, including appealing the decision. 

"We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide," Murillo said.

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 one selling e-cigarettes. The FDA has cleared several of Juul's rivals, including Reynolds American Inc. and Njoy Holdings, to keep tobacco-flavored e-cigarettes on the market, according to the Wall Street Journal, which reported the FDA's anticipated plans on Wednesday.

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, per 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.