On January 24th, the United States Food and Drug Administration (FDA) issued marketing denial orders (MDOs) for RJ Reynolds Vapor Co's open-system product, Vuse Vibe Tank Menthol 3.0%, and its closed-system product, Vuse Ciro Cartridge Menthol 1.5%. The statement from the FDA prohibited the marketing of these products by the company.
The director of the FDA Tobacco Products Center, Brian King, previously stated that the FDA is committed to assessing new tobacco product applications based on public health standards. These standards consider the risks and benefits of tobacco products for the entire population. There is not enough scientific evidence to prove that the potential benefits of e-cigarette use for adults who smoke outweigh the risks for teenagers who start and use them.
According to a statement, existing evidence suggests that non-tobacco flavored e-cigarettes, including menthol, pose known and substantial risks in terms of appeal, absorption, and use among young people. In contrast, data shows that tobacco-flavored e-cigarettes do not have the same appeal to young people and thus do not pose the same level of risk. Data from the 2022 National Youth Tobacco Survey shows that Vuse is the second most popular e-cigarette brand among young people, and menthol e-cigarettes are more popular among young people than traditional tobacco flavors.
According to a report by Tobacco Reporter, Morgan Stanley has stated that Vuse Vibe and Vuse Ciro, two e-cigarette products by BAT's RJRV subsidiary, only account for a small portion of BAT's overall e-cigarette sales in the US. "If it chooses to appeal, we expect its products to remain on the market as the appeals process proceeds, resulting in minimal/no operational impact," the investment bank wrote in a report to investors while assessing the impact of the latest MDO. Morgan Stanley also added that the MDO provides another example of the FDA's reluctance to approve menthol-flavored e-cigarettes, as the agency has only approved tobacco-flavored e-cigarettes so far. The financial institution also noted that the FDA has granted pre-market tobacco product applications for the menthol variant of IQOS and modified risk tobacco product names, which could make it one of the few low-risk menthol alternatives on the market.
According to Morgan Stanley, the FDA's objective is to issue a final rule banning menthol cigarettes by August 2023. However, given the anticipated industry litigation, the actual implementation may take five to six years.
Further Reading:
Conversation with FDA: Exploring the future of e-cigarettes in America" - Online conference announcement.
The US FDA endorses the ban on menthol-flavored cigarettes in a seminar, highlighting the difference between menthol flavor and mint flavor.
The FDA has received over 6 million market applications with extremely low approval rates.
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