WINSTON-SALEM, N.C. — R.J. Reynolds Vapor Co. (RJR Vapor) can keep marketing two menthol styles of its top-selling electronic cigarette Vuse, at least temporarily.
The federal Fifth Circuit Court of Appeals issued a temporary stay on March 20 after the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) on March 17 for two menthol cigarette products currently marketed by RJR Vapor under the Vuse Solo brand. They are the Vuse Replacement Cartridge Menthol 4.8 percent G1 and the Vuse Replacement Cartridge Menthol 4.8 percent G2.
As a result of the MDOs, RJR Vapor was not allowed to market or distribute these products in the United States, or it risks FDA enforcement action, before the court issued its stay.
In general, companies may resubmit applications or submit new applications to address the deficiencies for the products that are subject to the MDOs, as Convenience Store News previously reported.
RJR Vapor is a subsidiary of Winston-Salem-based Reynolds American Inc., which is an indirect subsidiary of British American Tobacco (BAT).
Following the FDA's decision, a BAT spokesperson said the company is disappointed in the agency's decision and intended to seek a stay of enforcement immediately, and "will pursue other appropriate avenues" to allow Vuse to continue offering its innovative products to adult nicotine consumers aged 21-plus without interruption.
However, the appeals court's decision this week allows the products to stay in the marketplace, reported the Winston-Salem Journal.
"We are pleased that the Fifth Circuit court has granted our motion to issue a temporary administrative stay allowing for Vuse to continue offering Vuse Solo Menthol 4.8 percent to adult nicotine consumers [aged] 21-plus without interruption," Reynolds said in a statement to the news outlet. "We remain confident in the quality of all of Reynolds' applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health."
When reviewing premarket tobacco product applications, the FDA is required to consider products' risks and benefits to the population as a whole, including users and non-users.
In its decision, the FDA determined that Reynolds' application lacked "sufficient evidence" to "demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health," which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Earlier this year, the agency also issued two MDOs for menthol vapor products marketed by RJR Vapor — the Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.
Reynolds may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
In a statement, Brian King, director of the FDA's Center for Tobacco Products, said that "the science has guided — and will always guide — the FDA's decision making on premarket tobacco product applications, including today’s marketing denial orders."
More on the FDA's Ruling
As of March 17, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the United States.
In May 2022, RJR Vapor gained FDA authorization for six Vuse Vibe and Vuse Ciro e-cigarette products, allowing the products to legally marketed in the United States. However, the agency issued MDOs "for multiple other Vuse Vibe and Vuse Ciro e-cigarette products," added the Winston-Salem Journal.
In October, the FDA approved the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1 and Vuse Replacement Cartridge Original 4.8 percent G2, making it the first electronic nicotine system to get the greenlight under the premarket application pathway.
However, the FDA rejected at that time submissions for 10 flavored Vuse Solo products, saying it "is still evaluating" the company's application for menthol-flavored products for Vuse Solo.
TD Cowen analyst Vivian Azer said the FDA's latest ruling on the Vuse menthol products was not surprising, given the agency previously denied Japan Tobacco's application for Logic menthol in October.
"It increasingly looks like a modified-risk tobacco product pathway may be the only viable pathway for companies to commercialize mentholated nicotine products," Azer said. "With the FDA still focused on elevated youth vaping incidence, and with characterizing flavors still widely available through disposable e-cigarettes, we would be surprised to see any company received [authorization] on menthol vapor."
Azer cautioned that the FDA is on track to publish deeming regulations to ban menthol in combustible cigarettes in the U.S. this year. Yet analysts said it could take several years before any menthol cigarette ban would work its way through the federal court system.
"As a reminder, the agency has issued 16 modified-risk tobacco product applications across combustible cigarettes, heat-not-burn and snuff, all of which received approval for menthol variants," Azer said.