Today, the FDA rescinded its June 2022 Marketing Denial Orders (MDOs) for the JUUL System and placed our applications back into scientific review. We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.
We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.
These products (the JUUL device and Virginia Tobacco and Menthol JUULpods in 5.0% and 3.0% nicotine concentration) will remain on the market during this review.
For additional information, see the FDA’s press release issued this morning.
December 19, 2023
Juul Labs has taken another important step in its path forward to introduce novel technologies that provide adult smokers an alternative to combustible cigarettes…
October 4, 2023
At a time when underage use of JUUL products has been cut by 95%, while usage of illicit disposable vapes from China is skyrocketing, it is disappointing to see the Florida Attorney General direct her state’s resources to suing Juul Labs.
September 28, 2023
This week, Juul Labs Chief Regulatory Officer, Joe Murillo, delivered remarks at the 76th Tobacco Science Research Conference, where he discussed the current state…