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FDA clears Juul's age-gated e-cigarette

The FDA has permitted Juul Labs to sell an updated version of its vaping device, the Juul2, which includes an optional age-verification system.

The FDA has permitted Juul Labs to sell an updated version of its vaping device, the Juul2, which includes an optional...

Juul Labs received federal permission on Friday to sell an updated version of its e-cigarette. The Food and Drug Administration's decision allows the company to market a new device for the first time since its launch more than a decade ago.

The new device will be branded as Juul2. It will be sold alongside updated tobacco- and menthol-flavored cartridges. Juul CEO K.C. Croswaite stated the company plans to market the new system with a portfolio of flavors targeted to adult nicotine consumers, beyond just tobacco and menthol.

Regulators emphasized the announcement is not an approval or endorsement. The FDA stated that people who do not smoke should not use Juul or any other e-cigarettes.

FDA's Authorization Rationale

The FDA's determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes. This clearance is based on company studies reviewed by the agency.

Those studies showed between 20% to 50% of smokers who used Juul products were able to stop smoking at the end of six weeks. The quitting rates varied based on the flavors and nicotine strengths used.

Age Verification and Market Context

The new Juul2 device gives users the option to require age verification via an online app before the e-cigarette can be unlocked. This technology is designed to prevent underage use.

Juul is no longer the top-selling e-cigarette brand in the United States. It now trails Vuse, which is sold by tobacco giant Reynolds American.

Federal figures show teens have shifted away from Juul as part of a wider drop in vaping. Teens who continue to vape mostly use unauthorized disposable e-cigarettes imported from China, which come in fruit and candy flavors.

The FDA has authorized a handful of e-cigarettes to help adult smokers quit or cut back. In May, the agency cleared the first fruit-flavored electronic cigarettes intended for adult smokers, a major policy shift. In recent years, Juul has laid off hundreds of employees while paying roughly $3 billion to settle government and private lawsuits over teen use of its products.

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