FDA Authorizes Juul To Sell E-Cigarettes In The US

Juul Labs Inc. received authorization from the Food and Drug Administration to sell its e-cigarettes in the US.

The FDA said in an email that it had authorized Juul’s e-cigarette device along with tobacco and menthol-flavored refill cartridges in both 3% and 5% nicotine strengths, following a review through the agency’s premarket tobacco product application process. Sweet and fruity flavors remain off the market.

Closely held Juul was once the dominant player in US e-cigarettes, thanks to its sleek, USB-style device and flavored nicotine pods. Its products have remained available in the US during the FDA review, but its growth has been hobbled by accusations it was targeting underage users. In 2022, Juul agreed to pay $1.2 billion to settle thousands of lawsuits tied to youth vaping.

The FDA authorization is “a very important milestone” for the company and its mission “to make the cigarette obsolete,” Juul Chief Executive Officer K.C. Crosthwaite said in an interview.Juul submitted more than 110 scientific studies to support its application and sees its products as a tool for adults looking to quit cigarettes. Bloomberg's Sabah Meddings reports.

Juul provided evidence showing its tobacco and menthol products comply with federal tobacco laws and help adult smokers switch from cigarettes, the FDA said. That included a two-year study showing high rates of smokers switching to Juul’s tobacco and menthol flavors.

The decision doesn’t mean the products are safe or “FDA approved.” The agency said it will keep a close eye on Juul’s marketing to ensure it doesn’t target underage users.

Vaping use is climbing faster than smokers are quitting cigarettes, according to recent data from the US Centers for Disease Control and Prevention. The number of US adults who exclusively smoke cigarettes decreased by 6.8 million between 2017 and 2023, according to a CDC report released earlier this year. However, approximately 7.2 million adults started exclusively using e-cigarettes, according to the study.

The FDA has authorized the sale of only a small number of vaping products — all with tobacco or menthol flavors — from a handful of companies. That’s left the door open for a flood of illicit products, particularly flavored disposable vapes from China, which are thriving in convenience stores and online. Regulators have struggled to keep up.

“There’s a significant number of illicit operators that have not gone through this process,” Crosthwaite said.

Juul also competes with companies including British American Tobacco Plc and Altria Group Inc., which previously owned a stake in Juul.

Altria shares slipped 1.8% at 12:07 p.m. in New York trading on Thursday, erasing an earlier gain. British American Tobacco stock fell 1.6% in UK trading.

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