Vuse Menthol Refills Denied Marketing

Two of the earliest vape devices to be approved by the FDA (Food and Drug Administration) through the PMTA gateway (Pre-Market Tobacco Application) have had their menthol flavored refills denied. Both the Vuse Vibe and the Vuse Ciro devices have had refills rejected. Both devices’ tobacco flavored pods have been approved by the FDA.

The FDA has delayed making a decision on any menthol flavored vapes for a while, likely due to plans to implement a menthol ban across all tobacco products. This decision would be the first time the FDA has officially made a judgment on a vaping product with flavor as the reason for rejection. Though many other flavored products were rejected from market approval, those vape products were technically not rejected due to their flavors. They were rejected because their applications failed to provide enough evidence to prove their benefits to adult smokers outweighed the harm they posed to youth vapers. 

An official ban on menthol products has not been passed, only proposed. Menthol is a flavor that was historically allowed in cigarettes, despite most flavors being banned. Given the history of menthol, its preference amongst Black tobacco users, and lack of news regarding which direction the FDA would take towards menthol vapes, the rejection of menthol pods is notable news. Additionally, the FDA has always used wording that made it clear they saw e liquids as flavored vapes, tobacco flavored, and menthol flavor.

However, the following statement makes it clear the FDA will likely reject any menthol flavored vapes in the future. 

“Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, 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.”

Generally, the current FDA administration leans anti-vape. With the rejection of Vuses’s menthol vape refills and the statements made during the associated press release, it is unlikely that any menthol vape flavors will be issued approvals. For now, the most possible pathway to legal vapes is in one of the many court battles between vape companies and the FDA. 

References: 

FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard 

FDA Proposes Rule Prohibiting Menthol Cigarettes - NCI