FDA authorizes Juul Labs to market Juul2 vaping device

  • Juul Labs received FDA authorization for Juul2 and tobacco- and menthol-flavored pods.
  • 19.9%-34.6% of tobacco-pod users and 28.4%-49.3% of menthol-pod users stopped smoking.
  • The FDA said benefits for adult smokers outweighed menthol-product risks, including youth appeal.

Juul Labs received Food and Drug Administration authorization to market its Juul2 e-cigarette device and tobacco- and menthol-flavored pods. The privately held vapor company submitted tens of thousands of pages of scientific evidence with its 2023 application. The FDA said its review found that a substantial proportion of adult smokers completely switched from combustible cigarettes to the authorized products, with six-week complete-switch rates ranging from 19.9% to 34.6% for tobacco-flavored pods and 28.4% to 49.3% for menthol-flavored pods. Juul2 is designed to provide more consistent vapor and nicotine delivery and includes thermal technology, a Pod ID chip and a smartphone app for users 21 and older. The authorized pods contain 18 mg/mL of nicotine, equivalent to a 1.5% to 1.6% concentration. The FDA determined that the benefit to adults who smoke outweighs the risks of the menthol product, including youth appeal.

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