Why the Proposed US Vape Flavors Ban Risks Global Harm
At a higher level, it adds to the hysteria surrounding tobacco harm reduction internationally. As countries look to just a few examples of sane approaches to e-cigarette regulation, the United States has once again signaled that our regulatory agencies and public health bodies are in disarray. This could have devastating consequences in a world with 1.1 billion smokers, with over 8 million smoking-related deaths each year.
The president appears to have given in to the panic regarding adolescent vaping and vaping-associated pulmonary injury, or VAPI. The irony here is that experts have linked VAPI not to the use of e-cigarettes made by manufacturers registered with the Food and Drug Administration, but to the unregulated, THC-containing vaping devices sold on the illicit market. Yet Trump has decided that the only way to address the situation is to wrest control from the FDA and pursue a complete ban on non-tobacco flavored vapes—an approach almost guaranteed to expand the existing illicit market.
Our regulatory system is instrumental in setting international product standards and guiding worldwide perceptions.
The US is currently one of only a few countries with a regulatory pathway for allowing all types of reduced-risk products—including e-cigarettes, heat-not-burn products and snus—to be available as alternatives to combustibles. Rather than banning e-cigarettes, like India or Australia, or putting restrictive nicotine limits on e-cigarettes, like the European Union, the US committed to regulating individual products based on measurable and projected public health impact.
No matter the magnitude of tensions between the US and the international community, our regulatory system is still instrumental in setting international product standards and guiding worldwide perceptions.
The US therefore has the chance to provide an enormously influential example of how to approach the regulation of innovations with huge potential to improve global public health. If the US takes a thoughtful approach to approval and regulation processes—and avoids knee-jerk decisions like the proposed ban—it could demonstrate how to keep alternative nicotine delivery products available to adult smokers while limiting access and appeal to nonsmokers and adolescents.
The FDA’s approach to e-cigarette regulation is far from perfect, but to its credit, the agency continues to acknowledge vaping’s potential to reduce harm to public health. The United Kingdom’s National Health Service and others have found vaping to be at least 95 percent less harmful than smoking. And the FDA declared in a recent civil case related to e-cigarette regulation, “Some of these products may have a net positive effect on public health at a population level” and “it is likely that some ENDS products may reduce harm at the individual level.”
Flavors can serve as a stimulus for Pavlovian conditioning, helping smokers gradually transition.
Mounting evidence indicates that non-tobacco flavored vaping products help adult smokers transition away from cigarettes. Studies as well as anecdotal evidence show that many adult vapers prefer non-tobacco or menthol flavors to tobacco flavors. This preference is not just a product of enjoyment—flavors have a powerful influence in helping smokers dissociate the behavioral aspects of smoking from the taste of tobacco.
Vaping products designed to taste like fruits or sweets allow smokers to transition some of their smoking-related behaviors to a product distinctly different from tobacco- or menthol-flavored cigarettes. As a result, flavors can serve as a type of stimulus for Pavlovian conditioning, helping smokers more gradually transition away from combustible cigarettes and potentially all tobacco products. Banning non-tobacco flavored e-cigarettes, of course, will prevent this progress.
Not only will a ban on flavored vaping products harm adult smokers, it may have unforeseen effects on adolescents and young adults. Proposing such a ban requires considering how this demographic will adapt to flavored vapor products becoming unavailable. For those who have developed a nicotine dependency, banning flavored products will not prevent them from vaping unflavored products—or worse, transitioning to combustible cigarettes or flavored cigars and cigarillos, which remain available under the proposed ban.
Sunk Costs and Rational Steps
Trump’s latest move also interrupts the FDA’s effort to design and test a process for evaluating the safety and public health impact of all alternative tobacco products. The FDA has been working diligently to develop a pathway for approving the sale of alternative tobacco products that were unregulated prior to the Family Smoking and Tobacco Control Act, which involves evaluation through a Premarket Tobacco Product Application.
Of course, many believe the FDA’s consideration of whether each individual product meets the public health standard of not being attractive to non-smokers to be an unreasonably high bar for entry into the marketplace. (After all, if a newer product is considered to be at least 95 percent less harmful than an existing product, should it matter if a few people find it alluring?)
But circumventing this process to ban all flavors—including mint and menthol—before the FDA can fully implement it ignores not only the guidance of the specialists at the Center for Tobacco Products, but the immense resources that the agency has already dedicated to developing a workable strategy. As such, the administration’s move highlights its willingness to dismiss actual and sunk costs in favor of flashy and unilateral policy changes.
A ban is not supported by current research, does not address concerns over adolescent use, and has the potential to set tobacco control back significantly.
Policymakers and the public are clearly demanding action against vaping products. However, many more effective options for preventing youth access are available. For instance, raising the minimum age of purchase for all tobacco products to 21 is a practical first step—oddly one that meets much resistance among lawmakers. Deterring retailers from selling to underage patrons by instituting meaningful penalties will also be vital to the success of this reform.
Additionally, the FDA should remove from the market all unregistered products and those that entered the market after the deeming rule went into effect. This would eliminate a significant number of products that are already being sold illegally.
But let’s be clear: A ban of flavored vaping products is not supported by current research, does not address concerns over adolescent use, and has the potential to set tobacco control back significantly.
And again, tobacco control is not limited to the United States. Moving to ban a whole class of products without conducting impartial scientific due diligence and evaluation sets a dangerous precedent for the world.
In our haste to battle an “epidemic” that has been overstated, we may inadvertently assure that the national and global scourge of combustible cigarettes endures.