Tobacco

FDA Denies Menthol Vuse Solo

R.J. Reynolds Vapor parent company British American Tobacco says it will seek a stay
R.J. Reynolds Vapor Co.
Image/R.J. Reynolds Vapor Co.

The Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products from R.J. Reynolds Vapor Co.’s Vuse Solo brand.

The Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2 must be removed from retailer’s shelves, and the company risks enforcement from the FDA if they continue to distribute them in the United States, the agency said.

However, a spokesperson from British American Tobacco (BAT), which R.J. Reynolds Vapor Co. is a subsidiary of, told CSP Daily News Friday morning that it plans to immediately seek an enforcement stay, which would allow products to continue being sold pending further review.

“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes,” BAT said. “FDA’s decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials. 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.”

After reviewing R.J. Reynolds Vapor Co.’s premarket tobacco product applications (PMTAs), the FDA said the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health. Evidence submitted by the Winston-Salem, North Carolina-based tobacco company did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smoker relative to tobacco-flavored e-cigarettes, the FDA said.

“The FDA is a data-driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, director of the FDA’s Center for Tobacco Products. “The science has guided—and will always guide—the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”  

R.J. Reynolds Vapor Co. may resubmit its applications or submit new applications to address the deficiencies for the products subject to these MDOs, the FDA said. Retailers should contact the company with any questions about products in their inventory, the agency said.

The FDA had previously also issued MDOs for R.J. Reynolds Vapor Co.’s Vuse Vibe Tank Menthol 3% and the Vuse Ciro Cartridge Menthol 1.5%. The decision was later stayed. Several Vuse Vibe, Vuse Ciro and Vuse Solo products in original favors have been authorized by the FDA.

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.

The 2022 National Youth Tobacco Survey also showed Vuse to be the second most common brand youth e-cigarette users reported “usually” using, the FDA said.

To date, the FDA has made determinations on more than 99% of the nearly 26 million deemed tobacco products for which applications were submitted.

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