FDA may toss Juul e-cigs from store shelves

Where it stands: The FDA is ready to deny Juul a marketing order for its menthol and tobacco-flavored products after a two-year review that weighed the products' benefits for adult smokers against risks to teens, the WSJ reported, citing people familiar with the matter.

• Juul has been in regulatory limbo for several years, even while its market share swelled, driven in part by flavored products popular among teens.
• Now, all e-cigarette products must go through pre-marketing reviews at the FDA, which missed a court-ordered deadline last fall to decide which products could be sold.
• The agency reviewed many smaller manufacturers' products, denying close to 1 million, but hasn't yet ruled on Juul.

What they're saying: The FDA wouldn't confirm or deny the WSJ report or provide a status on its Juul deliberations.

• Juul did not respond to emailed request for comment.
• Groups that oppose youth smoking say taking the company off the market would mark a dramatic step to discourage youth smoking.
• "This is a most-welcomed and a long-overdue decision," Erika Sward, assistant vice president of advocacy for the American Lung Association, told Axios.
• "FDA should have acted years ago, but if it acts now and we do more to educate young people, this is a reversible epidemic," Matt Myers, president of the Campaign for Tobacco-Free Kids, told Axios.

Background: A 2016 FDA rule required makers of tobacco products to submit applications for products made after 2007.

• A court ordered the FDA to make decisions by September 2021. After the agency missed the deadline, the American Lung Association and other advocacy groups and pediatricians successfully sued to speed up the process.
• Now, all e-cigarette manufacturers have to show products are "appropriate for the protection of public health," per the FDA.
• Congress also recently gave the FDA the authority to regulate synthetic nicotine products, which are subject to the same application requirements.

Flashback: The FDA banned Juul flavored products as part of a bigger crackdown on flavored vapes, prompting many teens to use disposable e-cigarettes and menthol-flavored products that are still sold.

• From February 2020 to February 2022, disposable e-cigarette sales increased by 215.4%, data from the CDC Foundation show, and more than half of youth who reported smoking in 2021 used disposable e-cigs.
• Public health groups say it's important for the FDA to finally have a clear, consistent policy on vaping, without loopholes.

The other side: The e-cigarette industry is worried regulators will take a carte blanche approach to policing its products.

• Juul's application process involved nearly two years of submitting data and evidence to the FDA, WSJ reported, and industry leaders say its data was sound.
• "If that level of science isn't sufficient, it begs the question of what is," Tony Abboud, executive director of the Vapor Technology Association, told Axios.
• E-cigarette industry groups are calling on the FDA to go after bad actors that are skirting the review process.
• The industry also claims its products are used successfully to wean adult smokers off cigarettes, and that removing e-cigarettes from the market will force people to return to cigarettes again.
• "FDA's staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history," American Vapor Manufacturers Association President Amanda Wheeler said in a statement.

Context: Juul's rise in popularity from 2017 to 2019 coincided with more than a million teens getting hooked on nicotine, while flavored vape cartridges and pods were still available.

• A study in Pediatrics assessed found most new tobacco use during that time was among teens using e-cigs.
• "There was no evidence that [older] smokers were using them," John Pierce, one of the study authors, told Axios.

What's next: The FDA still has many products to review and a bipartisan group of lawmakers in Congress is calling on the agency to expedite the process and take aim at addictive products marketed towards teens.

The bottom line: If Juul is pulled from the market, health risks to youths will have trumped arguments for using e-cigarettes as cessation products.