After a tumultuous regulatory journey, JUUL finally received the FDA greenlight.
The US Food and Drug Administration (FDA) has authorized the sale of Juul Labs’ tobacco and menthol-flavored e-cigarette products, according to a statement from the company. A spokeswoman for the Department of Health and Human Services said Juul Labs submitted robust data, including a two-year longitudinal study, demonstrating high rates of adult cigarette smokers who switched completely to JUUL.
Juul Labs’ chief executive officer K.C. Crosthwaite said FDA’s decision “validates our science and the efficacy in switching smokers.”
FDA’s clearance ends a two-year standoff over the company once blamed for igniting a national youth vaping epidemic and could reshape the regulatory landscape for nicotine products in the US. Once valued at US$13 billion, Juul Labs lost its top market spot after paying US$2.8 billion to settle lawsuits over its role in what FDA labeled a teen vaping “epidemic.”
Anti-tobacco advocates reacted angrily, arguing Juul’s sleek, easy-to-hide devices caused youth vaping to surge from 11.7% in 2017 to 27.5% in 2019. Yolonda Richardson of Tobacco-Free Kids warned “Authorizing the product that sparked this crisis is a big step backward.”
In a strongly worded statement issued by senator Dick Durbin, the Senate’s second-ranking Democrat and a longtime anti-nicotine zealot, said FDA’s reversal of its 2022 market denial for JUUL amounted to a betrayal of America’s youth.
“JUUL ignited this epidemic by addicting millions of children and lied about the harms of their vapes—resulting in being forced to pay states nearly US$1 billion for misleading promotion,” Durbin stated. “Despite this shameful history, the FDA ignored Juul’s disqualifying conduct, unleashing a wave of disease and addiction on America’s children.”
In a statement, Juul Labs claimed that the marketing order was an important milestone for the company and its consumers. “Over the past decade, our product design team in Silicon Valley has been working on the next generation of JUUL products to provide adults who smoke with preferred alternatives to cigarettes.
“[The] authorization of the JUUL System, including the market-leading tobacco-flavored vapor product in the US, enables us to submit applications with updates to the device and pod hardware with the goal of improving the user experience,” according to the statement. “And our new JUUL2 platform incorporates a suite of innovative technology …
“We have also developed a portfolio of adult-oriented flavors beyond virginia tobacco and menthol to provide adults who smoke with an increasing variety of options.”
The marketing order does allow the company to now submit applications with updates to the device and pod hardware. The JUUL2 platform, for example, includes built-in access control capabilities to prevent underage use.
Juul’s comeback comes as the agency faces mounting criticism for slow-moving product reviews and its failure to curtail the flood of unauthorized disposable vapes saturating the market.
Juul’s products were previously ordered off shelves in 2022, when FDA denied the company’s premarket tobacco product applications (PMTAs). The agency concluded that Juul Labs had not sufficiently demonstrated that its products were “appropriate for the protection of public health,” the legal standard required under the Tobacco Control Act.
But the company immediately appealed, and the ban was stayed just a month later, allowing the products to remain in the market pending further review. The announcement by FDA signals the agency has now found that Juul Labs’ revised applications for its tobacco and menthol-flavored pods and device meet regulatory standards.
This puts JUUL among a limited number of vaping products that have cleared FDA’s PMTA process, joining brands such as NJOY and certain other Reynolds and Altria offerings. The decision marks a significant moment in JUUL’s tumultuous regulatory journey. The company, once the undisputed leader of the US e-cigarette market, became the face of the teen vaping surge from 2017 to 2019.
By late 2019, Juul had voluntarily pulled most flavored pods from the market under pressure from lawmakers and regulators. The company’s market share plummeted amid lawsuits, Congressional hearings, and regulatory scrutiny. This recent authorization development has given the company a lifeline.
“Juul Labs markets responsibly and uses age-verification measures to ensure that our products are marketed to and used by adults. Currently, underage use of all vapor products is at the lowest point in more than a decade and reported underage use of JUUL products has decreased by more than 98% since 2019,” the statement says. “We support category-wide standards to limit access by those underage to all tobacco products.”
Critics argue that FDA has focused too heavily on legacy companies like Juul Labs while allowing a vast unregulated market to flourish. Some companies have waited years for decisions on PMTAs submitted in 2020 and 2021, while others were rejected without clear reasoning.
Lawmakers in both parties have pressured the agency to speed up reviews and prioritize enforcement against illegal products. In recent months, FDA has stepped up enforcement and requested more funding from Congress, including US$200 million earmarked specifically for vape-related enforcement in the Senate’s FY2026 appropriations bill.
FDA commissioner Marty Makary has also been granted new authority to detain and destroy illegal products at ports of entry. Still, legal and regulated companies continue to demand action from an agency that doesn’t seem to be listening.