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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowThe Food and Drug Administration on Thursday reversed a ban on e-cigarette products made by Juul Labs, the company widely identified as making the product that ignited the youth vaping craze.
The decision will not immediately affect consumers—Juul products have remained on store shelves as the company appealed the FDA’s initial June 2022 decision to banish the products.
The FDA said Thursday that the move to rescind the ban was made in light of court cases involving the vaping industry and because the agency has since “gained more experience” with scientific issues involving e-cigarette products. The agency stressed that the move was not an approval of Juul’s requests to market products but instead returns those applications to the status of pending review.
The agency’s move involving one of the industry’s leading players comes as the Supreme Court is scheduled on June 20 to privately discuss for the first time whether to weigh in on conflicting lower-court decisions involving FDA regulation of e-cigarette products for other companies.
The vaping industry—which casts e-cigarettes as less risky alternatives to smoking—has long decried how the FDA’s Center for Tobacco Products handles requests to legally market products. The agency, citing risks to public health, has denied approvals for thousands of e-cigarette products in recent years while approving just 23.
But courts have split on whether the FDA has acted fairly in denying applications to companies.
In January, a divided U.S. Court of Appeals for the 5th Circuit ordered the FDA to reconsider its decision prohibiting two companies from marketing their e-cigarette products. In a stinging decision, the majority said the agency sent manufacturers on a “wild goose chase” of requirements for applications.
“The FDA has been having a hard time defending its approach to vaping products,” said Jonathan H. Adler, a professor of administrative law at Case Western Reserve University. “The agency has been overwhelmed and sloppy.”
The FDA is asking the Supreme Court to accept the case, saying the lower court’s decision “has far-reaching consequences for public health and threatens to undermine” the agency’s regulatory powers. Vaping manufacturers, in turn, are asking justices to settle the legal issues.
Juul is not a part of those cases but remains the highest-profile manufacturer of e-cigarettes, which emerged as a major public health concern during the past decade. Juul’s popularity skyrocketed after it introduced a sleek vaping device with fruity flavors in 2015. The company’s marketing featured young models on websites and social media, and spurred the growth of the vaping industry while prompting backlash from parents and health officials who blamed Juul for a surge in teenage vaping.
In June 2022, the FDA ordered Juul products off shelves after saying it had worries about the e-cigarette device as well as pre-filled cartridges in menthol and tobacco flavors. Regulators said they had concerns about “insufficient and conflicting data” about damage to DNA and potentially harmful chemicals leaching from the company’s cartridges.
After Juul filed a lawsuit in federal court, the FDA paused its ban pending further review of the company’s application.
Juul said in a statement Thursday that it remains confident that a “full review of the science and evidence” will show its products are safe for the public. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process,” the company said.
The Campaign for Tobacco-Free Kids on Thursday criticized the FDA’s decision, urging the agency to “finish its review and again deny marketing applications for all Juul products.”
“Juul’s history shows that its products are highly appealing to kids, and it cannot be trusted to act responsibly,” CEO Yolonda C. Richardson said in a statement.
States and others have sued Juul over its marketing tactics, resulting in more than $1 billion in settlements. The company is also seeking FDA approval of a vape device that requires age verification.
Meanwhile, illegal disposable vape cartridges from China have flooded the United States, prompting criticism of the FDA by lawmakers and tobacco companies.
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