The U.S. Food and Drug Administration (FDA) denied premarket tobacco product applications (PMTA) for our Vuse Solo Replacement Cartridge Menthol 4.8%.
- This denial does not impact the legal status of Vuse Alto’s PMTA, which is awaiting further review by FDA.
- This denial also does not impact the prior marketing authorizations for the Vuse Solo Power Unit and Vuse Solo Replacement Cartridge Original 4.8%.
We are disappointed in this decision. We are pursuing appropriate legal avenues in order to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption. Although we disagree with the FDA’s decision, we remain committed to working alongside the agency to create A Better Tomorrow™.
Thank you for your patience as we navigate this process. We will continue to provide important updates as additional information becomes available.
The Vuse Team