axios.com/2022/06/23/fda-juul-enforcement

The Food and Drug Administration is poised to sweep Juul e-cigarette products off store shelves, the Wall Street Journal reported on Wednesday, in what could be a major turning point for an agency that's taken a sluggish, at times disjointed approach to regulating the vaping industry.

Why it matters: The move, coming amid a push to cap nicotine in cigarettes, may signal the Biden administration is ready to try to put tobacco use behind us.

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....
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