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01/24/2023

FDA Denies PMTAs for Two Vuse Menthol Products

R.J. Reynolds Vapor Co. plans to challenge the agency's marketing denial orders.
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SILVER SPRING, Md. — The Food and Drug Administration (FDA) continues to work through the premarket tobacco product applications (PMTAs) for vapor products, most recently denying the submissions for two Vuse menthol products.

On Jan. 24, the agency issued marketing denial orders (MDOs) for two menthol electronic cigarette products currently marketed by R.J. Reynolds Vapor Co. (RJR Vapor). The currently marketed products include the Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.

With the MDOs, RJR Vapor cannot market or distribute these products in the United States, according to the FDA; however, the company may resubmit applications or submit new applications to address the deficiencies for the products.

"Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole," said Brian King, director of the FDA's Center for Tobacco Products. "The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use." 

 

Winston-Salem. N.C.-based RJR Vapor, a subsidiary of Reynolds American Inc., plans to challenge the MDOs.

"We are disappointed in FDA's decision to issue MDOs for two Vuse products — the Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent. Reynolds intends 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," said a spokesperson for British American Tobacco (BAT).

Reynolds American is an indirect subsidiary of BAT.

"We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA's decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials," the spokesperson added. "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 PMTAs, the agency evaluates, among other things:

  • A tobacco product's components;
  • Ingredients;
  • Additives;
  • Constituents;
  • Design;
  • Harmful and potentially harmful constituents and health risks; and
  • How the product is manufactured, packaged and labeled.

After reviewing the PMTAs for the two Vuse products, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products 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.

According to the agency, existing evidence demonstrates that non-tobacco flavored electronic cigarettes and vapor products, including menthol flavored e-cigarettes, "have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk."

Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported "usually" using, the FDA added.

"Today's decision pertains to the specific application submitted for review by FDA," King said. "It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard." 

Previously, the FDA issued marketing authorization for several products in products in RJR Vapor's portfolio. In May 2022, the agency gave the greenlight to Vuse Vibe and Vuse Ciro original flavors. The decision came about seven months after the FDA authorized Vuse Solo products in original flavor to remain on the market.