WINSTON-SALEM, N.C. — Several Vuse menthol vapor products will remain on the market despite a marketing denial order (MDO) from the U.S. Food and Drug Administration (FDA).
The U.S. Court of Appeals for the Fifth Circuit granted R.J. Reynolds Vapor Co. (RJRV) a permanent stay of enforcement on the FDA's MDO on Vuse Alto, Vibe and Solo Menthol Pods. As a result of this court action, these products will continue to be allowed on the market for sale, reported the National Association of Tobacco Outlets (NATO).
The permanent stay follows an emergency administrative stay of enforcement issued by the same court in October 2023.
The court also denied FDA's motion to transfer the case to another circuit. As result, the U.S. Court of Appeals for the Fifth Circuit will decide on the merits of the case, "which will likely take a significant amount of time," NATO added.
RJRV submitted to the FDA premarket tobacco product applications (PMTA) for numerous products. The agency granted marketing authorization to several products, including Vuse Solo, Vuse Vibe and Vuse Ciro in original flavors, in October 2021 and May 2022. However, it issued MDOs on flavored products, including for six flavored vapor products under the Vuse Alto brand. This included three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths, as Convenience Store News previously reported.
Decisions on other PMTAs from RJRV are still pending. When reviewing PMTAs, the agency evaluates, among other things:
- A tobacco product's components;
- Harmful and potentially harmful constituents and health risks; and
- How the product is manufactured, packaged and labeled.
Based in Winston-Salem, RJRV is British American Tobacco's U.S. indirect subsidiary.