The R.J. Reynolds Vapor Company Wins Temporary Stay Regarding Two Vuse Menthol Products

Herbie J Pilato

According to Convenience Store News (CSN), "R.J. Reynolds Vapor Co. (RJR Vapor) can keep marketing two menthol styles of its top-selling electronic cigarette Vuse, at least temporarily."

As CSN continued to report, "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," CSN noted, "...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)," CSN observed. "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."

"When reviewing premarket tobacco product applications," CSN also noted, "...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."

As CSN further documented, "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," CSN concluded, "...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.'"

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Herbie J Pilato is the author of several books about pop culture including RETRO ACTIVE TELEVISION, THE 12 BEST SECRETS OF CHRISTMAS, MARY: THE MARY TYLER MOORE STORY, TWITCH UPON A STAR, GLAMOUR, GIDGETS AND THE GIRL NEXT DOOR, DASHING, DARING AND DEBONAIR, and NBC & ME: MY LIFE AS A PAGE IN A BOOK, among others. He's also a TV writer/producer, and has worked for Reelz, Bravo, E!, TLC, and hosted THEN AGAIN WITH HERBIE J PILATO, the hit classic TV talk show (which premiered on Amazon Prime in 2019).

Los Angeles, CA

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