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The Food and Drug Administration (FDA) banned e-cigarette maker Juul from selling its products in the U.S. Thursday, after years of concerns that the product is unsafe and a danger to teenagers.
“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," FDA Commissioner Robert Califf said in a statement.
The decision comes two years after reviewing company data, as Juul pursued an authorization to stay on the market. Some analysts said the decision could be appealed, during which time Juul could still sell its products.
The FDA originally sought to make a decision in September of last year, weighing whether or not Juul is safe and whether its marketing tactics, and flavorful cartridges, contributed to an increase in usage among youth.
E-cigarettes have been pitched as a safer alternative to traditional cigarettes purely due to the type of smoke emitted.
The FDA said as much in its decisions to authorize some companies' products, noting that "authorized products’ aerosols are significantly less toxic than combusted cigarettes."
But both traditional and vaping products use nicotine, an addictive substance, adding to concerns about youth addiction — which spiked after Juul came on the market.
That is why Juul came under scrutiny in 2019, after its marketing campaign touted vaping as safer, and a way to help transition off of traditional tobacco products. It was also cited for selling to underaged users — as young as in middle school — and its products have been linked to dizziness and seizures, as well as longer term negative impact on the lungs.
But the FDA said it was due to insufficient data of the health risks that it pulled the products.
"To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device," according to the statement.
Former FDA Commissioner Scott Gottlieb, who was in charge of the regulatory agency when the problem first came to light, said in 2018 that vaping was leading to a rise in use with teens.
"E-cigs have become an almost ubiquitous ‒ and dangerous ‒ trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end," he said then.
Gottlieb applauded the FDA's moves Thursday.
JUUL was fulcrum of the youth vaping crisis; it was driven by their product and marketing practices. FDA is right to be circumspect. Electronic devices offer opportunity for adult smokers to transition off combustible products but must be conceived, marketed by responsible actors
— Scott Gottlieb, MD (@ScottGottliebMD) June 22, 2022
Juul first got into hot water in 2019, when its products were identified as a favorite for teen users. In 2018, the FDA found that nicotine use among middle schoolers jumped 48% year over year.
"The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes," the FDA said then.
The company has since spent millions trying to quell the pushback through settlements in courts, as well as on educational campaigns and commitments to prevent use in youth.
CEO K.C. Crosthwaite said at the time the company would not lobby the administration, and would listen to concerns.
"Unfortunately, today that future is at risk due to unacceptable levels of youth usage and eroding public confidence in our industry. Against that backdrop, we must strive to work with regulators, policymakers and other stakeholders, and earn the trust of the societies in which we operate. That includes inviting an open dialogue, listening to others and being responsive to their concerns," Crosthwaite said.
The FDA first clamped down on marketing of flavored products in January 2020, after youth surveys found they were used most by underaged youth. The agency subsequently denied marketing applications for 55,000 products in August 2021 that did not meet the standard for being able to help wean adults off of traditional cigarettes.
The moves have been part of a focus by the Biden administration to reduce nicotine addiction, with the hopes of reducing use in younger populations. On Tuesday, the FDA announced a proposal to cap nicotine levels in traditional steps, in order to meet that goal.
The pandemic further made a case against vaping, as studies showed e-cigarette users were more likely to face worse symptoms of COVID-19 than non-users.
Juul, which began in 2007 as PAX Labs, grew into an e-cigarette market leader, boasting 75% market share and a $38 valuation after Altria took a 35% stake in 2018. The company is now valued at about $1.6 billion as of March.
Follow Anjalee on Twitter @AnjKhem