FDA Authorizes Juul’s E-Cigarettes, Reversing Ban That Nearly Bankrupted Firm
Regulator allows firm’s original vaporizer and refill cartridges in tobacco and menthol flavors to remain on U.S. market
- U.S. regulators have authorized Juul Labs to keep its e-cigarettes on the U.S. market after a federal ban in 2022.
- The FDA authorized Juul’s original vaporizer and refill cartridges, determining their benefit to adult smokers outweighed any public-health risks.
- Juul is now the No. 3 e-cigarette brand in the U.S., holding about 18% of e-cigarette sales in U.S. stores.
U.S. regulators have authorized Juul Labs to keep its e-cigarettes on the U.S. market, according to people familiar with the matter. The decision breathes new life into the vaping company after a federal ban in 2022 pushed it to the brink of bankruptcy.
The Food and Drug Administration gave a green light to Juul’s original vaporizer, along with refill cartridges in tobacco and menthol flavors, the people familiar with the matter said. The decision means that regulators determined that the products’ benefit to adult cigarette smokers outweighed any potential public-health risks.
The FDA’s decision—five years after Juul first submitted its products for federal review—follows a period of tumult for the company.
Juul was once a vaping juggernaut and one of the most valuable startups in America. But in 2022, the FDA ordered Juul to halt its sales because of unresolved questions related to the toxicology data Juul had submitted in its application to remain on the U.S. market.
The FDA ban, though it was quickly paused, sent Juul into a financial tailspin as the company attempted to settle thousands of lawsuits alleging that the company had marketed its addictive devices to children and teens. The company narrowly averted bankruptcy and its workforce shrank to a fraction of its former size.
Marlboro maker Altria Group, which in 2018 paid $12.8 billion for a minority stake in Juul, divested five years later at a near-total loss. The FDA considered Juul’s appeal for two years and in 2024 formally rescinded the ban, putting the company’s application back under scientific review and opening the door for federal clearance.
Juul has denied allegations that it marketed its e-cigarettes to children and teens. The company agreed to a $1.7 billion legal settlement covering more than 5,000 lawsuits.
Juul is now the No. 3 e-cigarette brand in the U.S., after Vuse and Geek Bar. Juul represents about 18% of e-cigarette sales in U.S. stores tracked by Nielsen, according to a Goldman Sachs analysis.