Juul Has a New High-Tech Vape and Hopes the FDA Won’t Ban It

Juul Labs is seeking U.S. authorization for a next-generation vaporizer, while the e-cigarette maker waits for word on whether its current products can stay on the market.

Juul’s new device, already available for sale in the U.K. and Canada, has age-verification capabilities and prevents the use of counterfeit or unauthorized third-party refill cartridges, the company said. Juul’s latest application to the Food and Drug Administration, submitted this week, includes just one flavor—Virginia Tobacco—with a nicotine concentration of 18 mg per mL, the same concentration Juul sells in the U.K. and Canada. 

Juul said the application for its new device avoids the technical issues that last year led the FDA to order Juul’s existing products off the market, a ruling that threw the company into limbo and pushed it to the brink of bankruptcy. The FDA banned Juul’s products because Juul hadn’t sufficiently answered the agency’s questions on the toxicology data the company had submitted in an application for its original vaporizer to remain on the market. The FDA put the ban on hold while the company appealed. The appeal is pending. Juul has told the FDA that the agency’s unresolved questions could have been cleared up in “a mere phone call.”

Juul said it hasn’t yet decided whether to market the new vaporizer in the U.S. under the Juul brand or a different name.

All e-cigarette manufacturers are required to submit new vaping products for FDA review before they can be sold in the U.S. Juul said it submitted scientific research this week to demonstrate that its new device, like its original one, exposes users to fewer carcinogens than cigarettes and that the benefit of helping adult smokers switch to a safer alternative outweighs the potential harm of hooking young people on nicotine. 

Juul said it hopes the new device—which generates more aerosol in each puff and delivers nicotine more consistently—will appeal to adult cigarette smokers who have tried and rejected other e-cigarettes or who have never tried them.

Juul has been conducting research on other flavors for potential submission to the FDA, including menthol and complex flavors that combine tobacco or menthol with fruity notes. In the U.K., Juul sells complex flavors such as autumn tobacco, which contains apple flavoring. Juul’s new refill cartridges can be configured so that menthol or other flavored versions must be unlocked by an age-verified user before use—a feature intended to allay regulators’ concerns about flavors that are popular among children and teens.

Juul said it is taking a “shots-on-goal” approach to its FDA submissions, presenting a range of products to regulators in the hopes that at least some of them pass muster. 

“We have designed a technological solution for two public health problems: improving adult smoker switching from combustible cigarettes and restricting underage access to vapor products,” said Kirk Phelps, Juul’s chief product officer.

Juul’s new device won’t work with counterfeit or unauthorized Juul-compatible refill pods, which several years ago became a problem for regulators when they flooded the U.S. market with fruity flavors that were appealing to children. An accompanying app allows vapers to track their use and the device’s location. Personal usage data captured by the app will remain private and won’t be collected by the company, Juul said.

The new device has better temperature controls that minimize the presence of toxic substances in its aerosol, the company said. Juul said it is still studying how much nicotine the new device yields in each puff—and how that compares with other vaping products on the market. Juul said the device yields less nicotine per puff than a traditional cigarette.  

Juul’s research includes a study that followed about 100 cigarette smokers for six months after they first bought the new device in the U.K. At the six-month point, nearly 33% had switched from cigarettes to the Juul device.

U.S. regulators began to crack down on the vaping market in 2018 when Juul’s sleek vaporizers became a teen status symbol and underage vaping surged. Youth use of e-cigarettes—and Juul’s popularity among young people—has since dropped. Middle-school and high-school students who vape now prefer disposable brands such as Elf Bar.

Write to Jennifer Maloney at [email protected]