The Food and Drug Administration (FDA) has authorized Juul Labs to keep its electronic cigarettes on the market, a major reversal after the agency completely banned the company’s products in 2022.
The agency said Thursday it will allow the sale of Juul’s original e-cigarette device as well as refill cartridges in tobacco and menthol flavors. The move followed “an extensive scientific review” that showed the benefit to adult smokers outweighed the risk to young people or adults who don’t smoke.
FDA said Juul submitted evidence showing high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored Juul products.
“While today’s actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they FDA approved,” the agency said.
FDA’s decision marks the latest chapter for a company so popular it was once synonymous with vaping. But as more young people began using its fruit flavored products, federal scrutiny grew.
Juul has denied allegations that it marketed its e-cigarettes to children and teens.
The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market “would be appropriate for the protection of the public health.”
The agency suspended the order about two weeks later to conduct an internal review of “scientific issues” in the company’s application.
Despite the pause, FDA’s actions nearly bankrupted the company. The e-cigarette maker also subsequently paid $1.7 billion to resolve thousands of lawsuits alleging the company aggressively marketed its e-cigarettes to young people and fueled a vaping crisis.
The FDA considered Juul’s appeal for two years and in 2024 formally rescinded the ban, putting the company’s application back under scientific review.
All electronic cigarette products are required by law to have FDA authorization to be legally marketed, and the companies must submit scientific evidence of public health benefits.
“Today’s FDA authorization of JUUL products marks an important step toward making the cigarette obsolete,” K.C. Crosthwaite, Juul Labs’s CEO, said in a statement.
“We strongly support FDA’s role in regulating tobacco and nicotine products,” Crosthwaite continued. “Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly.”
Still, Juul is no longer the juggernaut it once was and has lost significant market share amid rising competition, including from e-cigarettes illegally imported from China.
But antitobacco groups said they were dismayed by FDA’s decision, saying it risks a reversal of recent progress in reducing youth e-cigarette use.
“It is a big step in the wrong direction to authorize sales of the product that was responsible for this public health crisis in the first place,” said Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids.
“There is no question that this crisis was driven by Juul’s sleek, easy-to-hide products, which were sold in enticing flavors, including menthol, were marketed in ways that appeal to kids and delivered massive doses of nicotine that can quickly addict kids,” Richardson added.
The American Lung Association (ALA) similarly blamed Juul for the spike in youth vaping.
“This is a serious misstep,” Ranjana Caple, senior manager of federal advocacy for ALA, said in a statement. “Juul is responsible for the youth vaping epidemic, and its products have hooked a generation of kids on nicotine. Authorizing these products signal a stunning failure to protect public health.”
