ALEXANDRIA, Va.—R. J. Reynolds Vapor Company, an indirect subsidiary of BAT, yesterday received marketing authorization from the U.S. Food and Drug Administration (FDA) for certain Vuse Ciro and Vuse Vibe products that will allow them to remain on the market in the United States. The approvals build on the prior marketing granted orders by the FDA in October 2021 for Vuse Solo products in original flavor.
The FDA issued marketing granted orders for Vuse Vibe and Vuse Ciro original flavors. Menthol remains under review and can remain on market pending a decision from the agency, BAT said in a news release. The FDA issued a denial for the applications of other flavors not currently marketed or sold in the U.S., in line with prior-issued FDA industry guidance. BAT is reviewing the FDA’s decision on those applications to determine next steps.
“These authorizations represent the broadest portfolio of Market Authorizations provided to any company in the U.S. for Premarket Tobacco Product Applications (PMTA),” Dr. David O’Reilly, director of scientific research, BAT, said. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products.
“We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications,” Dr. O’Reilly said.
“Our corporate purpose is clear: to build A Better Tomorrow by reducing the health impact of our business. We are committed to Tobacco Harm Reduction and believe our portfolio of scientifically substantiated reduced-risk products*† can play a critical role in delivering it. As part of this commitment, we will continue to work with FDA to support access and choice for adult consumers.”
BAT noted that the PMTAs submitted by R. J. Reynolds Vapor Company in 2020 included rigorous scientific studies for Vuse Vibe and Vuse Ciro, building on the data submitted in the U.S. business’s first PMTA submission to the FDA for Vuse Solo, which won marketing approval in October 2021 for its original flavor.
Vuse Alto remains under review and will continue to be available for adult nicotine consumers. The Vuse Alto PMTA was submitted nearly a year after Vuse Solo, and five months after Vuse Vibe and Ciro, and those applications share foundational science, BAT said.