The FDA Center for Tobacco Products today denied marketing applications from R.J. Reynolds for menthol refills used in its Vuse Vibe and Vuse Ciro vape devices. The CTP action marks the second time the agency has issued a marketing denial order (MDO) for menthol vaping products based solely on the flavor itself.
“Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk about 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,” the FDA said in a press release.
"Applicants must present strong evidence to show that using their menthol-flavored e-cigarette products is likely to encourage a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products, given the existing differences in youth risk."
The CTP approved the sale of the Vibe and Ciro devices in May of last year, along with tobacco-flavored refills for each. The agency stated that the menthol refills were still being looked into at that point. In the convenience store/gas station vaping market sector, neither Vuse device holds a sizable market share. (Regarding Reynolds' highly well-liked Vuse Alto gadget and its refills, the FDA has not acted.)
As of right now, the FDA has not approved any bottled e-liquid or open-system (refillable) goods in any flavor other than tobacco for use in vaping devices. Manufacturers used the FDA's premarket tobacco application (PMTA) procedure to submit millions of items for assessment.
Reynolds intends to take menthol MDO to court.
Similar to Reynolds, Logic, a producer of vape devices, was granted FDA approval this spring for both its Pro and Power models and refills that taste like tobacco. But in October of last year, the FDA issued orders denying Logic's menthol refills for those devices. The business swiftly contested the MDO, and a federal appeals court granted a temporary stay of the order.
R.J. Reynolds intends to pursue legal recourse. "intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products," the firm said in a statement released today.
With varying degrees of success, dozens of smaller vaping businesses have appealed FDA refusal orders in federal courts around the nation. Triton Distribution was given permission to rehear its unsuccessful appeal last week before the Fifth Circuit Court of Appeals.
Documents from CTP that were made public during Logic's lawsuit revealed that, following the OS's first recommendation to approve Logic's menthol refills, the office of CTP Director Brian King exerted pressure on the center's Office of Science (OS) to modify its stance. Alex Norcia of Filter broke the news for the first time in December of last year.
The OS first "concluded that the existing literature supports that menthol-flavored cigarette smokers show a preference for menthol-flavored ENDS relative to tobacco-flavored ENDS," according to one of the internal FDA letters that Norcia disclosed. The OS and the director's office had been in discussions regarding the menthol issue for months. However, in July, not long after King became CTP director, the OS changed its mind and accepted Logic's menthol product application.
The new cotton candy is menthol.
In 2021, the FDA authorized a small number of unpopular tobacco-flavored items and issued MDOs for almost all vaping products with flavors other than tobacco and menthol. The majority of tobacco and menthol PMTAs are still being reviewed. There was conjecture that the organization will approve certain menthol items to serve as substitutes for those who use menthol cigarettes, which the FDA plans to outlaw.
The CTP made a clear distinction between menthol and other non-tobacco flavors when it announced the first MDOs for vape devices with flavors other than tobacco and menthol. "When compared to other non-tobacco-flavored ENDS products, the scientific review of menthol ENDS raises unique considerations," the FDA stated.
However, the FDA has now changed its position on menthol, as seen by the papers that were made public in Logic's court documents. Brian King, the new director of CTP, has long opposed vaping and has brought with him the viewpoint of his allies at anti-vaping tobacco control organizations such as the Campaign for Tobacco-Free Kids and Truth Initiative, which holds that flavors are just a ruse to get kids addicted to nicotine. For them, the only good flavor is dead, whether it be the gummy bear and cotton candy flavors they despise or just plain menthol.
King and the prohibitionist wing of tobacco control are ungratefully attempting to cross everything off their wish list at once, as they are on the point of eliminating the independent vaping industry, eliminating the majority of nicotine from cigarettes, and outlawing menthol smokes. The future of menthol and all nicotine usage may end up in the courts under a presidential administration that is open to such laws.
