FDA Authorizes Juul’s Updated E-Cigarette with Age-Verification System

Vaping company Juul Labs has received permission from the Food and Drug Administration (FDA) to sell an updated version of its e-cigarette. This new version features an optional age-verification system intended to prevent use by underage individuals. The FDA decision marks the first time Juul has been cleared to sell a new device since launching over a decade ago.

Due to rising concerns over teen usage, Juul has faced significant legal challenges, resulting in layoffs and a payout of about $3 billion in settlements. The new device will be marketed under the name Juul2, alongside updated tobacco and menthol cartridges. In the past, Juul discontinued popular flavors like mango, mint, and creme, which were favored by teens.

Juul CEO K.C. Crosthwaite has expressed plans to seek authorization to expand the company’s product offerings with more flavors catering to adult nicotine consumers. The FDA emphasizes that this authorization does not constitute an endorsement, and those who do not smoke should refrain from using Juul or any other e-cigarettes.

Research reviewed by the FDA shows that 20% to 50% of smokers who used Juul products stopped smoking at the end of six weeks. The success rates varied based on the flavors used. The FDA considers the benefits of reduced exposure to harmful chemicals in traditional cigarettes versus the risks posed to youths and non-users.

For marketing authorizations, the FDA requires evidence that new products present more benefits to public health compared to risks. The new Juul device offers an age verification option via an app, intended for users 21 and older, giving insights into product use and allowing locking to prevent unauthorized access.

The FDA has authorized various e-cigarettes to assist adult smokers in quitting or reducing cigarette consumption. Recently, fruit-flavored e-cigarettes were approved for adults, signaling a policy shift due to industry appeals. Juul no longer leads the e-cigarette market, now trailing Vuse, sold by Reynolds American, a company known for Camel and Newport cigarettes.

There has been a noted decline in teen vaping, with a shift away from Juul products. Teens who continue to vape tend to use disposable e-cigarettes from China, available in fruit and candy flavors.