FDA Rejects Two Vuse Menthol Vaping Products
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for RJ Reynolds Vapor Co.'s Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%. Consistent with the authority granted by Congress, the FDA said it remains committed
The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for RJ Reynolds Vapor Co.'s Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%. <\/span><\/div>
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“Consistent with the authority granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on public health standards that consider the risks and benefits of tobacco products to the entire population,” said Brian King, director of the FDA's Center for Tobacco Products. “The applications for these products did not provide sufficient scientific evidence to demonstrate that the potential benefits to adult smokers outweigh the risks of initiation and use by youth.”<\/span><\/div>
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“Existing evidence indicates that non-tobacco flavored e-cigarettes, including menthol-flavored e-cigarettes, pose known significant risks in terms of appeal, uptake, and use among young people; in contrast, data suggest that tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same level of risk,” the FDA wrote in a statement.<\/span><\/div>
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“Given these existing differences in youth risk, applicants must provide robust evidence to demonstrate that the use of their menthol-flavored e-cigarette products may facilitate complete switching or significantly reduce adult smokers' use of combustible cigarettes, rather than merely promoting tobacco-flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most commonly reported brand among youth e-cigarette users who said they “usually” use it.”<\/span><\/div>
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“Today's decision relates to the specific applications submitted for FDA review,” King said. “Applicants have the responsibility to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standards have been met. In this case, the evidence provided did not meet that standard.”<\/span><\/div>
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When assessing the impact of the recent MDO on RJRV's parent company BAT, Morgan Stanley noted that Vuse Vibe and Vuse Ciro account for only a small portion of BAT's total e-cigarette sales in the U.S. <\/span><\/div>
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The investment bank wrote in a report to investors: “If it chooses to appeal, we expect its products to remain on the market as the appeal is ongoing, resulting in minimal/no impact on operations.”<\/span><\/div>
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Morgan Stanley stated that the MDO provides another example of the FDA's reluctance to approve menthol e-cigarette flavors. To date, the agency has only approved tobacco-flavored e-cigarettes. <\/span><\/div>
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The financial institution also noted that the FDA has approved the premarket tobacco product application and modified risk tobacco product designation for the menthol variant of IQOS, which may make it one of the few menthol reduced-risk alternatives on the market. <\/span><\/div>
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According to Morgan Stanley, the FDA aims to release the final rule banning menthol cigarettes in August 2023, but considering anticipated industry litigation, final implementation may take five to six years. <\/span><\/div>
