WINSTON-SALEM, N.C. — The U.S. Court of Appeals for the Fifth Circuit granted R.J. Reynolds Vapor Co. (RJRV) an emergency administrative stay of enforcement. The move temporarily puts on hold the U.S. Food and Drug Administration's (FDA) marketing denial order (MDO) for Vuse Alto Menthol Pods.
As a result of the court's decision on Oct. 13, the vapor products will remain on backbars across the country. RJRV will now take steps to obtain a formal stay and challenge the FDA's MDO of the premarket tobacco product application (PMTA) for Vuse Alto Menthol Pods, according to the company.
Based in Winston-Salem, RJRV is British American Tobacco's (BAT) U.S. indirect subsidiary.
"As previously communicated, we are confident in the quality of RJRV's applications, which were informed by years of scientific study and research, and we believe that these applications contained ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of the public health," Reynolds Marketing Services Co. (RMSC), a subsidiary of Reynolds American Inc., wrote in a letter to its retail and wholesale customers.
"RJRV's Vuse Alto submissions shared foundational science with the applications for Vuse Vibe, Vuse Solo, and Vuse Ciro, which received marketing granted orders for tobacco flavors and represent the broadest portfolio of marketing authorizations provided to any company in the U.S.," it added. "While a stay is in effect, Vuse Alto Menthol Pods remain available for sale. RMSC and RJRV will continue marketing these products, and RMSC will also continue supporting all active retail and wholesale programs and initiatives for the vapor category."
As Convenience Store News reported on Oct. 13, the FDA issued MDOs for Vuse Alto's Menthol and Mixed Berry products. The agency is still reviewing RJRV's Vuse Alto Rich Tobacco and Golden Tobacco products.
"According to the FDA, the sole ground for this arbitrary decision was the absence of long-term consumer switching data for these products. This is a capricious decision, considering a year-long data package was presented at the Food & Drug Law Institute Tobacco & Nicotine Regulatory Product Science Symposium on March 30, 2023 with FDA in attendance," said BAT Chief Strategy & Growth Officer Kingsley Wheaton, who added the company will publish a summary of the data on its website.
BAT noted the applications build on the science submitted in the earlier PMTA submissions to the agency with respect to Vuse Solo, Vuse Vibe and Vuse Ciro, which were granted marketing authorization in original flavors in October 2021 and May 2022.