On October 12, the United States Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Company for six flavored vaping products: three menthol-flavored and three mixed berry.
To date, the mere 23 vaping products authorized under the FDA’s Premarket Tobacco Product Applications (PMTA) pathway have all been manufactured by big companies with the resources to compile the substantial scientific submissions required—Reynolds included.
But what makes the latest rejections unsurprising is the fact that, years into its PMTA process, the FDA has still not authorized any non-tobacco flavored vapes.
Though flavored vapes remain on shelves in many parts of the US, sales occur in a legal gray area at best, with some calling for harder crackdowns.
The FDA’s stance on flavors seems clear, even if the agency denies imposing a de facto flavors ban.
Studies show that vape flavors are really important to people who switch from cigarettes. Yet public health bodies and public consciousness, if not the data, firmly associate the availability of flavors with youth-vaping uptake. And the FDA’s stance on flavors seems clear, even if the agency denies imposing a de facto flavors ban.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, Ph.D., director of the Office of Science at the FDA’s Center for Tobacco Products. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”
However, in 2022 Filter broke the story that leadership at the FDA’s Center for Tobacco Products (CTP) had pressured CTP scientists to reverse their initial recommendation to authorize menthol vaping products (manufactured, in that instance, by Logic, a company owned by Japan Tobacco International). This, together with the pattern of PMTA denials and authorizations, suggests a political agenda against flavored vapes at the FDA.
The role of menthol vapes as a harm reduction option would seem especially pertinent at a time when the FDA is expected to move forward with a deeply controversial plan to ban menthol cigarettes.
Meanwhile, evidence of the harm reduction value of vape flavors in general continues to build. A study published in the Harm Reduction Journal on October 14 considered the preferences of more than 69,000 US adults who vape, the largest ever survey of its kind. This research, its authors concluded, “identified the importance of non-tobacco flavors in e-cigarette use initiation and sustained use, and their potential contribution to smoking cessation and relapse prevention.”
Fruit and dessert flavors were among the most popular for people switching from cigarettes, and participants considered such options “particularly helpful” to them in avoiding a return to smoking. Just 15 percent were using tobacco-flavored vapes, which respondents considered less helpful in keeping them off cigarettes.
“Identifying the factors that can promote the transition to tar-free products and accelerate eradication of smoking among adults is of utmost significance,” Dr. Riccardo Polosa, professor of internal medicine at the University of Catania, Italy, and one of the study authors, told Filter. “One such factor is the inclusion of various flavors.”
“Within this context,” he continued, “fruit as well as dessert/pastry/bakery and candy/chocolate/sweet flavors emerge as key elements that can aid adult smokers in their cessation efforts and contribute to reducing relapse rates.”
If the FDA presses ahead with a national menthol cigarettes ban, such rejections beg the question of what it expects the millions of people who smoke them to do.
Research and anecdotal reports indicate that many people who quit cigarettes with vapes don’t want to contend with the constant reminder of smoking that a tobacco-flavored product may present.
Three of the six Reynolds products that just received MDOs were menthol-flavored. And if the FDA presses ahead with its national menthol cigarettes ban, such rejections beg the question of what it expects the millions of people who smoke them to do—other than migrate to the booming illicit menthols market that opponents of the ban say it would create.
Dr. David T. Levy, professor of oncology at Georgetown University School of Medicine, has studied the potential public health impacts of a menthols ban, and was an author of research published in the Tobacco Control journal in April.
“My research indicates that, in the event of a menthol cigarette and a cigar flavor ban, a large portion of smokers will quit cigarette and cigar use, many of whom are likely to switch to e-cigarettes,” Levy told Filter.
However, “if non-tobacco-flavored e-cigarettes are not available,” he continued, “I expect that many of those who would have switched to e-cigarettes are likely to continue to smoke non-menthol cigarettes or non-flavored cigars.”
That makes the case for flavors in general. But in particular, wouldn’t it make sense to permit harm reduction products that most closely resemble the banned cigarettes? Even if some people preferred different options (perhaps for the same reason as those avoiding tobacco flavors), it seems logical that menthol vapes might help others in switching.
“The FDA’s denial of all menthol e-cigarette applications to date could backfire,” Dr. Michael Pesko, professor of health economics at the University of Missouri, told Filter.
Pesko is among the authors of another recent study, looking at the effect of vape-flavor restrictions on tobacco product sales (currently available online prior to peer review).
“Our findings from state and local e-cigarette flavor restrictions find that cigarette sales sizably increase when flavors are restricted from e-cigarettes, likely offsetting any public health gains,” Pesko continued. “A more rational policy from a public health perspective is to make menthol available in e-cigarettes while working to eliminate it from cigarettes.”
“Given our findings linking flavor restrictions to increased cigarette sales, I am concerned about the path FDA is headed down.”
Dr. Abigail S. Friedman, associate professor at Yale School of Public Health and another author of that study, has similar worries.
“Given our findings linking flavor restrictions to increased cigarette sales, I am concerned about the path FDA is headed down,” she told Filter.
“FDA is required to evaluate whether each individual product is ‘appropriate for the protection of public health,’ she continued. “But microeconomics tells us that an individual product’s effects on behavior depend not just on the product’s characteristics and costs, but also on the alternatives available in the market.”
These concerns add up to growing conviction that the FDA’s continued rejection of all flavored vapes, including menthols, cannot be considered “appropriate for the protection of public health.”
The Influence Foundation, which operates Filter, has received grants from Reynolds American, Inc. Both The Influence Foundation and the Center of Excellence for the acceleration of Harm Reduction (CoEHAR), founded by Dr. Polosa, have received grants from the Foundation for a Smoke-Free World. Filter‘s Editorial Independence Policy applies.