The Food and Drug Administration (FDA) has authorised Juul Labs to market its vapes and tobacco and menthol-flavoured pods in the U.S.
The ruling marks a significant development for the company, which has faced years of regulatory scrutiny, lawsuits, and financial difficulties, as well as a broader shift in how the agency evaluates vaping products.
The FDA said in a statement on Friday that after reviewing updated data submitted by Juul, it determined that the products meet the agency’s standard for marketing.
The authorisation applies to the company’s Juul device, along with its Virginia tobacco and menthol pods, both in 5.0 per cent and 3.0 per cent nicotine strengths.
‘Appropriate for the protection of public health’
The FDA said: “The agency determined that the marketing of these products is appropriate for the protection of public health.” It added that the decision reflects “a rigorous scientific review” of toxicological and behavioural data.
The FDA emphasised that the products are not approved as safe, nor are they authorised for use by youth or people who do not already use tobacco.
Instead, the authorisation is based on evidence that Juul’s products could help addicted adult smokers switch from cigarettes. This is a key aspect of the agency’s regulatory framework under its pre-market tobacco product application (PMTA) process.
An ‘important moment for harm reduction’
In a statement, Juul Labs CEO K.C. Crosthwaite said: “We appreciate the FDA’s decision and now look forward to re-entering the market to offer adult smokers an alternative to combustible cigarettes. This is an important moment for harm reduction, especially for the millions of adult smokers who continue to use deadly cigarettes.”
The decision comes two years after the FDA initially denied Juul’s PMTA in June 2022, ordering the products off the market.
That order was quickly paused by a federal court, and the FDA later placed the denial under internal review. On Friday, the agency formally rescinded the 2022 denial and issued marketing granted orders (MGOs) in its place.
Anti-vaping groups criticised the move, with some arguing it could reverse progress in reducing youth use of vapes. But Crosthwaite said the company has taken extensive steps to prevent underage access.
“We remain committed to preventing underage use, while also advancing the opportunity for harm reduction for adult smokers,” he said.
Strict marketing rules
The FDA said it will continue to monitor Juul’s products post-market, and the company must adhere to strict marketing and sales restrictions as part of its authorisation.
Juul is now one of just two companies legally allowed to sell menthol-flavored vaping products in the U.S.
In January, the FDA approved the nicotine pouch brand ZYN for US sale in ten flavours and two nicotine strengths.
“To receive marketing authorisations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products said at the time.
