The Food and Drug Administration (FDA) has approved marketing authorization for R.J. Reynolds’ (RJR) Vuse Alto device, as well as its Golden Tobacco and Rich Tobacco pod flavors.
The FDA had previously issued MGOs for the company’s Vuse Vibe, Vuse Ciro and Vuse Solo products in original flavor, in May 2022 and October 2021, respectively.
“We welcome the FDA’s decision to authorize RJR Vapor’s Vuse Alto device, as well as Golden Tobacco and Rich Tobacco flavors,” said Tadeu Marroco, chief executive, BAT — Reynolds Vapor Co.’s indirect parent company. “With authorizations for Alto, Vibe, Ciro and Solo, all in tobacco flavors, BAT now has the largest portfolio of vapor market authorizations provided to any U.S. organization for premarket tobacco product applications.”
Marroco also added that while this is a step in the right direction, he still feels that there are additional steps that should be taken.
“However, the success of these legal products is dependent on the FDA doing more to tackle a thriving illicit marketplace of vapor products, which are intentionally and systematically marketed to youth,” he continued. “By creating a future where a wide range of potentially reduced-risk products is accessible to adult smokers, we are taking a meaningful step towards Building a Smokeless World.”
While this decision now means the Vuse Alto device and Golden Tobacco and Rich Tobacco flavors have now been authorized, the company continues to challenge the MDOs for Alto’s Menthol and Mixed Berry flavors, which were issued in October 2023. Per court order, the FDA’s denial order for Alto Menthol products is stayed, meaning they remain available for adult nicotine consumers.
The PMTAs submitted by R. J. Reynolds Vapor Co. in 2020 included rigorous scientific studies for Vuse Alto, the company noted in a statement. These build on the science submitted in the U.S. business’s earlier PMTA submission to the FDA with respect to Vuse Solo, Vuse Vibe and Vuse Ciro.
