FDA orders Juul products off the shelves, and firm asks court to block it; rule to limit level of nicotine in cigarettes is coming

Photo from Juul Labs

UPDATE, June 27: A federal judge blocked the order pending proceedings in Juul's lawsuit.

By Melissa Patrick
Kentucky Health News

The federal government has ordered Juul Labs to stop selling and distributing its products in the United States after denying the company's application to keep selling them, saying the company did not provide adequate data to determine "relevant health risks." 

Meanwhile, the Food and Drug Administration is planning to establish a maximum nicotine level in cigarettes and other combustible tobacco products to reduce the addictiveness of the products, which claim the lives of 480,000 Americans each year, with more than 8,000 in Kentucky.

"While we welcome the ban on Juul -- we think that's a good thing -- it is not nearly enough, and until they actually come to grips with the nicotine problem, they're not going to solve this," said Ben Chandler, president of the Foundation for a Healthy Kentucky. "The central problem here is that we are addicting an entire new generation of young people to nicotine."

The FDA issued marketing denial orders against Juul that require the company to remove its electronic-cigarette products from the U.S. market, or risk enforcement action. 

“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. He also noted the role of e-cigarettes in the rise of youth vaping.

The 2020 National Youth Tobacco Survey found Juul was the most popular e-cigarette brand used by adolescents with 25.4% of high school e-cigarette users and 35.1% of middle school users saying Juul was their most used brand.

According to the latest 2019 Youth Risk Behavior Surveillance System report, 26% of Kentucky's high school students had used an electronic vapor product on at least one day in the 30 days prior to the survey, while just 8.9% had smoked cigarettes. A national survey found youth vaping rates have declined during the pandemic, but a separate survey taken in late 2020 found that 34% of the 400 Kentucky youth surveyed believed there had been an increase in tobacco use due to the pandemic.

The FDA said the company's marketing applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” 

A key public-health issue the FDA looks for in reviewing electronic cigarettes is whether the potential benefit to adult smokers who may be using them to quit smoking is greater than the risks to youth. 

The agency said it didn't see clinical information suggesting there is an immediate risk to using Juul products, but "Some of 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 – that have not been adequately addressed."

Joe Murillo, chief regulatory officer at Juul Labs, issued a statement saying the company had "provided sufficient information and data based on high-quality research to address all issues raised by the agency" and that the data meets the standard of being "appropriate for the protection of the public health." He added, "We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator."

UPDATE, June 24: Juul asked a federal court in Washington to block the order.

Juul, which has long been blamed for the surge in teen vaping, had already stopped selling its sweet-flavored e-cigarette pods, but had continued selling tobacco- and menthol-flavored cartridges while it waited on the FDA to review its marketing application. The company had also worked on efforts to stop teens from buying its products, like halting television, print and digital advertising. ”

Anti-smoking advocates praised the FDA's ruling. 

Ellen Hahn, a University of Kentucky nursing professor and the director of the Bridging Research Efforts and Advocacy Toward Healthy Environments (BREATHE) initiative, said in an email that the decision "is long overdue. This move is particularly important [for] our ability to breathe in Kentucky. Kentucky youth smoke e-cigarettes, or vapes, over twice the rate of high school students in the U.S. (26.1% vs. 11.3%). E-cigarette aerosol contains highly addictive nicotine that damages the lungs and the developing brain. Vaping is a cause of serious lung injury and makes it harder for the user to fight infection. Lung damage from vaping is comparable to conventional cigarette use." 

That said, Hahn cautioned that since the FDA's decision to limit flavorings in Juul products, other "disposable" vapes have become more popular because they continue to offer a variety of flavors. "So while today’s decision shows the power of FDA’s premarket review, there are plenty of other e-cigarette products still on the market," she said. 

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the decision "represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic." 

Harold Wimmer, president and CEO of The American Lung Association, commended the FDA for "following the science and denying Juul the ability to sell its products that are clearly marketed to addict a new generation of youth to tobacco."

Limiting nicotine: The FDA's goal in limiting nicotine in cigarettes and other combusted tobacco products is to reduce youth use, addiction and death, says the FDA news release announcing the effort. 

The FDA notes that while nicotine is not what makes cigarettes so toxic, it is the ingredient that makes it hard to quit. And says if the proposed reduction is successful, it "would make those products minimally- or non-addictive." 

"The U.S. Surgeon General has reported that 87% of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit," Califf said in the release. 

Inside Health Policy reports that the FDA is expected to publish its proposed rule in December. It was originally scheduled for July.