FDA Denies Menthol-Flavored Products From R.J. Reynolds Vapor

Vuse Vibe, Vuse Ciro affected by latest PMTA decision
R.J. Reynolds Vapor Co.
Logo/R.J. Reynolds Vapor Co.

Update: The U.S. Fifth Circuit Court of Appeals, New Orleans, granted R.J. Reynolds Vapor Co. a temporary administrative stay on Jan. 25 for the marketing denial order (MDO) for Vibe, a company spokesperson told CSP Daily News. This means retailers can continue to sell the Vuse Vibe Tank Menthol 3%. The Vuse Ciro Cartridge Menthol 1.5% is not on the market currently, therefore, that order was not stayed.

The Food and Drug Administration issued marketing denial orders (MDOs) for two menthol-flavored e-cigarette products from R.J. Reynolds Vapor Co. The currently marketed products include the Vuse Vibe Tank Menthol 3% and the Vuse Ciro Cartridge Menthol 1.5%.

The company must not sell or distribute these products in the United States, or it risks FDA enforcement action, the agency said Tuesday. A spokesperson from R.J. Reynolds Vapor Co. told CSP Daily News it plans on challenging the denials. 

Several Vuse Vibe, Vuse Ciro and Vuse Solo products in original flavors had already been authorized by the FDA in 2021 and 2022, but the menthol flavors remained pending at the time that those marketing granted orders (MGOs) were issued. 

“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 (CTP). “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.”

After reviewing the premarket tobacco product applications (PMTA) for the menthol products, the FDA determined they lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the standard used to judge applications required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Nontobacco flavored e-cigarettes, including menthol, have a known and substantial risk with regard to youth appeal, uptake and use, the FDA said, while tobacco-flavored e-cigarettes do not pose the same degree of risk. Given these differences, applicants need to provide robust evidence to demonstrate that using their menthol flavored e-cigarette products are likely to promote a complete switch or significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products, the agency 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,” King said.

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 agency said. The first was Puff Bar, according to the survey.

Vuse Vibe is a large capacity, closed-tank system e-cigarette, and Vuse Ciro is a clear cartridge-based system with an innovative ceramic wick. Retailers should contact R.J. Reynolds Vapor Co. with any questions about products in their inventory, the FDA said. 

The Winston-Salem, North Carolina-based tobacco company said it intends to seek a stay of enforcement immediately and will pursue other avenues to allow Vuse to continue offering its products to adult nicotine consumers aged 21 and older without interruption.

“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,” a company spokesperson said. “This decision is especially troubling given FDA’s ongoing efforts to ban menthol cigarettes. Taken together, these decisions and actions threaten to deprive menthol smokers of innovative and potentially less harmful alternatives that appeal to their preferences.”

Reynolds said it remains confident in the quality of its applications and believes there is ample evidence for the FDA to determine that the marketing of these products is appropriate for the protection of public health. 

In October, the FDA denied several menthol-flavored e-cigarette products from Logic Technology Development LLC, Teaneck, New Jersey. They were the first menthol vape products to receive a marketing decision based on full scientific review from the agency, but the FDA later issued an administrative stay on the MDO.

The FDA is trying to ban the sales of menthol cigarettes, with a final rule anticipated in August

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