Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

The Hill

6 days ago

WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.
FDA regulators said Thursday that studies from Juul show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping.
The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with nicotine-filled cartridges sold in two different strengths. Juul previously discontinued several fruit and candy flavors that helped drive its popularity but were favored by teens.
Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor.
'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press.
Parents, politicians and antitobacco groups are certain to oppose FDA's decision. They have argued for years that Juul should be permanently banned from selling its products due to its role in triggering a yearslong spike in underage vaping
Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping.
The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course and agreed to reopen its scientific review of Juul's application after the company pushed back in court.
Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission.
Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes.
The FDA decision applies to Juul's original product, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors.
In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on traditional cigarettes, while rejecting more than a million other vaping products that failed to meet agency standards. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market.
To meet FDA requirements, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market.
Juul quickly outpaced earlier brands with its high-nicotine, fruity-flavored vape cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices.
But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. high schools and middle schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored cartridges for its device.
By then the company was already the target of multiple investigations and lawsuits by Congress, state and local officials and class action attorneys.
In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company has separately agreed to pay $1.1 billion to settle lawsuits with most U.S. states.
Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by Reynolds American.
Teens have also shifted away from the brand amid a wider drop in vaping, according to the latest federal survey. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar.
Unlike Juul, disposable e-cigarettes like Elf Bar still come in fruit and candy flavors, despite efforts by regulators to block their use.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.