FDA Temporarily Suspends Recent Order Banning Juul E-Cigarettes from U.S. Market

Electronic cigarettes and pods by Juul, the nation's largest maker of vaping products, are offered for sale at the Smoke Depot on September 13, 2018 in Chicago, Illinois
Electronic cigarettes and pods by Juul, the nation's largest maker of vaping products, are offered for sale at the Smoke Depot on September 13, 2018 in Chicago, Illinois

Scott Olson/Getty

The Food and Drug Administration is temporarily suspending its recent marketing denial order against Juul Labs Inc., the largest e-cigarette manufacturer, allowing the company to keep its products on the market.

The agency cited in a Twitter post Tuesday that there are "scientific issues" that warrant further review, but assured that the temporary suspension "does not rescind" the initial order.

The decision comes after the FDA first ordered Juul, whose products make up 40% of the e-cigarette market, to take their products off the U.S. market on June 23.

At the time, the FDA said Juul's application to stay on the market had "insufficient and conflicting" data regarding "potentially harmful chemicals" leaching from its e-liquid pods. The agency also noted the application lacked evidence to support that the company's products would be "appropriate for the protection of the public health."

"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," Dr. Robert Califf, FDA Commissioner, said in a release. "The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping."

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Last month's order follows nearly two years since the FDA began its review of data from Juul as it sought authorization for its products to remain on the market, according to The Wall Street Journal.

Juul has been highly criticized in recent years for the increasing use of its nicotine products by teenagers. In September, the company claimed they were "committed to transitioning adult smokers away from combustible cigarettes while combating underage use."

Months prior, Juul was ordered to pay $40 million to the state of North Carolina for marketing its product to teens. Attorney General Josh Stein said in a July statement that "JUUL targeted young people, including teens, with its highly addictive e-cigarette," adding, "It lit the spark and fanned the flames of a vaping epidemic among our children – one that you can see in any high school in North Carolina."

A woman using an electronic cigarette exhales in Mayfield Heights, Ohio. Only two years ago e-cigarettes were viewed as holding great potential for public health: offering a way to wean smokers off traditional cigarettes. But now Juul and other vaping companies face an escalating backlash that threatens to sweep their products off the market Vaping Backlash Smokers, Mayfield Heights, USA - 04 Oct 2019

Tony Dejak/AP/Shutterstock

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The country's vaping epidemic has caused teens to suffer serious lung and kidney issues, with some coming close to death after experiencing illnesses caused by vaping. According to the FDA,  flavored e-cigarettes are "extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them."

Juul, who previously sold e-cigarette products in flavors like cool cucumber and crème brûlée, pulled its flavored vape pods from the U.S. market in 2019.

At the time, the company's CEO Kevin Burns stepped down amid growing backlash against vaping. He was replaced by K.C. Crosthwaite, an executive at the tobacco company Altria, which owns a 35 percent stake in Juul.

The company also said that it would stop all print, broadcast and digital advertisements in the U.S., including its "Make the Switch" campaign promoting Juul as a healthier alternative to traditional cigarettes, a claim that the Food and Drug Administration said was illegal.