Juul Labs can continue to sell its e-cigarettes and refill cartridges per a decision Thursday by the Food and Drug Administration.
According to an announcement on Juul’s website, the FDA determined that its e-cigarette device and pods — which come in tobacco and menthol flavors — are “appropriate for the protection of public health.”
Thursday’s authorization, first reported by The Wall Street Journal, marks the long-awaited conclusion to a multiyear FDA review that placed the products in regulatory limbo.
An FDA spokesperson said the authorization does not mean the products are safe or “FDA approved”; rather, Juul provided evidence demonstrating that its e-cigarettes met the legal standard for marketing new tobacco products in the U.S.
The spokesperson said the FDA must consider the risks and benefits to the U.S. population as a whole, including the benefits to adults who currently smoke cigarettes. Juul submitted robust data to show that high rates of adults switch from cigarettes to menthol- or tobacco-flavored Juul products, the spokesperson said.
“This is good news for the millions of Americans who still smoke cigarettes,” Juul Labs said in an online statement.
The company has positioned its products as an alternative to traditional cigarettes, which contain tobacco. Juul’s e-cigarettes are tobacco-free. However, they contain nicotine, the active ingredient in tobacco, which can be addictive. The chemicals in e-cigarettes have also been linked to lung and heart disease.
The FDA in 2022 ordered Juul to stop selling its e-cigarettes, citing a lack of evidence needed to assess their potential health risks. The decision followed a nearly two-year review of Juul’s application seeking FDA authorization, which is required by law for companies to market e-cigarettes.
At the time, the FDA under the Biden administration said there was “insufficient and conflicting data” about “potentially harmful chemicals leaching from the company’s proprietary e-liquid pods.” But the FDA suspended the ban less than two weeks later, telling Juul it could continue to sell its products while the agency carried out a review.
In June 2024, the FDA formally rescinded the ban and gave Juul’s application a “pending status,” opening the door for a potential authorization.
“We strongly support FDA’s role in regulating tobacco and nicotine products. Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products,” K.C. Crosthwaite, CEO of Juul Labs, said Thursday in a statement.
Many anticipated that the Trump administration would be more lenient with vaping regulations, given President Donald Trump’s comment on Truth Social during his second presidential campaign that he would “save vaping.” The Washington Post reported that the comment followed a private meeting with a leading vaping lobbyist.
Juul has faced controversy over its early marketing practices, which critics say targeted young consumers under 21. In 2021, the company settled a lawsuit over allegations that it marketed its wares to teens, agreeing to pay $40 million to the state of North Carolina. But Juul has denied that it deliberately tried to market its products to young people.
The use of e-cigarettes by U.S. middle and high school students has declined significantly in recent years. However, more than 1.6 million students still reported using them as of 2024.
Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, said the FDA’s decision on Thursday is “a big step in the wrong direction” and could reverse recent progress with reducing e-cigarette use.
“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,” she said.
