How harm reduction, illicit markets, and regulatory gridlock are reshaping the future of nicotine policy in the United States
By Dave Dobbins, Principal Dobbins Consulting
It is now clear that reduced-risk nicotine delivery products such as e-vapor and nicotine pouches are accelerating declines in demand for cigarettes. One need only follow the earnings calls of major cigarette manufacturers in the United States to confirm this fact. Bonnie Herzog, an analyst with Goldman Sachs with an expertise in tobacco products, predicts ongoing declines of cigarette volume year over year through 2035 at roughly a 40% higher rate than between 2016 and 2024, resulting in a 63% decrease in cigarette sales between now and 2035.
However, Herzog predicts almost all the lost volume in cigarettes will be replaced by products with much lower risk than cigarettes such as nicotine pouches and vapor. In other words, the demand for nicotine will persist, but the risk of death and disease will be greatly reduced. On its face this seems like an obvious triumph for public health, but ironically there is an important segment of tobacco control advocacy that views this result as unacceptable.
For many years, tobacco control has focused on reducing and preventing smoking. This was a sensible goal; the cigarette is the country’s leading cause of preventable death. The emergence and popularity of reduced risk nicotine delivery options complicated the issue by separating nicotine delivery from the hazards of smoking. Both e-vapor and nicotine pouches were developed outside of the cigarette business and were very quickly adopted by consumers. Both present a small or undetectable fraction of the toxins present in cigarette smoke.
The popularity of these products presents an opportunity and a threat. Unfortunately for the development of policy around reduced risk alternatives, the first product to develop mass popularity in the United States was the e-vapor device Juul, and it became disproportionately popular with young people. Prior to the eruption of Juul in 2018 and 2019, the conversation in tobacco control around reduced-risk products had included consideration that the technology might serve as a substitute for adult cigarette smokers that would greatly reduce disease and death. Now, the major lobbying groups in United States tobacco control, the Campaign for Tobacco Free Kids, American Heart Association, American Lung Association, and American Cancer Society Cancer Action Network (“the Prohibitionists”) are all aligned in the view that all non-medicinal nicotine products should be banned. This is despite the enormous reductions in youth e-cigarette use in the years after 2019, continued low rates of youth nicotine pouch use, and youth cigarette use of 1.4% in 2024, a number that was unimaginable even ten years ago.
Youth Concerns to Broad Policies
The Prohibitionists advocate for bans of flavored nicotine products, taxation at very high levels for all nicotine products without consideration of relative risk, eliminating menthol and virtually all nicotine from combusted products, resistance to all FDA authorizations of reduced risk products, and to efforts by manufacturers to communicate true facts about relative health risks. At an international level, tobacco control leaders and the WHO, funded by Bloomberg Philanthropies, just as the Prohibitionists are in the US, call for all out bans on reduced risk products and laude countries that adopt such prohibition policies. Last year, prohibition advocates supported a UN Declaration on Noncommunicable Diseases that treated all nicotine products the same without recognizing the huge differences in risk of those products. The declaration thankfully failed to gain consensus, but the idea has not gone away.
This absolute resistance to reduced risk consumer nicotine products can no longer credibly be based on a concern that lower risk nicotine products will create a “gateway” to smoking that will result in increased youth smoking rates. In fact, the opposite has occurred and the introduction of reduced risk products has coincided with youth smoking rates dropping to previously unimaginable lows. While it is a universal goal to prevent youth nicotine usage, it is a reasonable hypothesis that reduced-risk products diverted some youth who otherwise may have taken up smoking.
Instead, calls for nicotine prohibition appear to be motivated by a belief that no entity should be able to sell nicotine for a profit because it is a dependence-inducing drug. Calls for nicotine prohibition are also motivated by a desire for retribution against cigarette companies. Lastly, the Prohibitionists argue that new reduced risk products are a ruse designed by manufacturers to hook a new generation of young people regardless of whether they progress to cigarette use.
The Prohibitionists rarely are held to account for the costs of the policies they recommend, but for policy makers to appropriately evaluate their suggestions they should be required to “show their work” regarding the impact of those policies on public health and society. While the Prohibitionists may feel their policy program is virtuous, that does not determine how the policies will play out when deployed in the real world. After all, sometimes the road to hell is paved with good intentions.
Lessons From Global Experiments
The first question nicotine prohibitionists must answer is why it will work for nicotine when it has failed to significantly reduce the supply of any other psychoactive drug. Instead, the reaction to prohibition has always been the development of illicit markets to address consumer demand. In fact, this is happening with nicotine in places where prohibition policies have been put in place. Bhutan’s attempted to ban tobacco products in 2010 but withdrew the measure in 2021 because of resulting criminality and black markets, and public outrage at attempts to enforce the law. In Australia vapor is illegal as a consumer product and the tax rate on cigarettes is so high that it is functionally a prohibition measure. The result has been a transfer of tobacco supply to criminal gangs that use violence to intimidate legitimate retailers and to protect territory from other gangs.
But we do not need to look abroad to see that prohibition does not work. In the United States, the FDA has not authorized a single flavored vapor device outside of tobacco and menthol. Yet they are ubiquitously available through unregulated black markets. Estimates are that over 70% of US vapor device purchases are illicit devices. And consumers have shown a clear preference for the features of devices in the illicit market. There have been significant seizures of illicit products and evidence of involvement of organized crime, such as Mexican cartels, but enforcement efforts have been unable to significantly impact supply just as they have been unable to significantly reduce supply of other drugs.
Second, to the extent that prohibition tactics work to reduce the supply of reduced-risk products, the inevitable result would be slowing the transition by smokers to those safer products. The grim math is that the Prohibitionists (whether consciously or subconsciously) appear willing to sacrifice lives in pursuit of eliminating “commercial” nicotine. All policies have tradeoffs, and by abandoning a focus on improving morbidity and mortality of people who smoke, excess deaths become the inevitable cost. Here the number of lives at stake is huge. When dealing with a population of 31 million people who smoke, a 5% change in switching over time is more than 1.5 million people smoking who otherwise would have switched. It may be that some advocates believe that the pursuit of a nicotine-free future is worth this sort of sacrifice, but they owe it to the public to be transparent about the tradeoffs.
Lastly, the goal of a society without “commercial” nicotine is based on a premise that people do not actually want nicotine but are tricked into using it by sophisticated marketing schemes and then become addicted or dependent and can never quit. It is certainly true that nicotine causes addiction and dependence. And advertising has undoubtedly played a part in the expansion and decline of cigarette use. However, nicotine does have hedonistic effects. For example, it improves cognitive function and moderates mood. Moreover, people have been seeking nicotine far before the advent of modern marketing. It became a major cash crop in the American South and was exported throughout the world by the 1700s. Even though they are now universally understood to cause chronic disease and illness, cigarettes are still smoked by over a billion people worldwide. Suffice it so say, there is little indication that demand for nicotine is going away in the foreseeable future.
So where does that leave a responsible government? First, while vastly reducing cigarette use is a desirable and achievable societal goal, it is highly unlikely that the elimination of all “commercial” nicotine sales is achievable. Governments that attempt to create a nicotine-free society will incur significant societal costs by prolonging smoking and shifting supply to illicit markets. If a government were to go so far as to commit to a “drug war” approach to a product like nicotine pouches, it is likely it would suffer significant reputational damage, and of course, the implementation of those enforcement strategies has its own costs that tend to fall largely on disadvantaged populations.
Once the Prohibitionists show their work, it is clear their program is impossible and destructive. The alternative is realistic regulatory measures to mitigate the risks of nicotine markets. This is how governments handle alcohol, gambling and other risky behaviors. An ideal nicotine regulatory regime would include harm reduction, but also would act to ensure product quality, limit youth use and access, and act as a trusted source of scientifically validated information. The United States currently has a structure of a nicotine regulatory regime, but the regulator has interpreted its statutory mandate to make actual regulation of the nicotine market impossible.
FDA Authority and Modern Regulation
We have heard many times from the leadership of the Center for Tobacco Products that it has simply been trying to apply the “appropriate for the public health” (APPH) standard it received from Congress in the Tobacco Control Act. However, the definition of APPH is broad, advising the agency to weigh the benefits of switching against the risks to nonsmokers. That should also include the risks of taking a regulatory approach that inevitably spawns multi-billion-dollar illicit markets that operate entirely outside the regulatory system.
CTP also must acknowledge the statutory deadlines in the Act. So far, they have been totally ignored. Reviews that should be complete within 180 days have routinely taken years. To get to a point where it can meet all its statutory obligations, CTP must switch its tobacco pre-market approval review to a much more pragmatic framework instead of the intensive multi-year review process it is currently doing on a product-by-product basis. Indeed, the statute appears to require such an approach. This should focus on real-world solutions, including:
• Establishment of baseline standards for products focusing on nicotine delivery and exposure to harmful and potentially harmful constituents
• Requiring manufacturers to register and comply with inspection
• Time, place, and manner of sale restrictions that protect youth
• Instituting a strong post-market surveillance system to ensure not only compliance but to monitor adverse events and unexpectedly high youth usage.
If a manufacturer can attest to following all these requirements, it should be allowed to market its products with the understanding that CTP has the power to revoke authorization in the event post-market surveillance uncovers problems.
This would create a regulatory system that could vastly increase manufacturer accountability to the regulator and increase the availability of regulated options for people who smoke to switch. It would also disincentivize and crowd out illicit markets. Ironically, this approach would also be more effective at dealing with youth use, the issue most emphasized by the Prohibitionists, because it allows the regulator to respond to upticks of youth use of products in cooperation with an accountable manufacturer.
The lack of regulatory authority over Juul was a major contributor to the fiasco in 2018-19. This system will not be perfect or without risk, but this is simply an area where that is an unachievable goal. Tradeoffs are inevitable. Surely, it is time to try a reality-based approach instead of pursuing an impossible goal that generates effects directly in opposition to the goals of the TCA.