A Policy Experiment is Worth a Million Lives

by Lynn T. Kozlowski

(Published in Issues Winter edition 2016 with credits to LTK and Issues)

Smoking cigarettes is a public health disaster in the United States and the rest of the world. Every year, around 500,000 smokers die prematurely, and the Surgeon General considers smoking the single largest preventable cause of death in the United States. But not all tobacco products are alike in the risks they bring to users and those around them. This diversity of ways to deliver nicotine to the user offers regulatory pathways to reducing—perhaps radically—the toll of smoking. Policy experiments at the state level could allow governments to explore and learn from these pathways, but the dominant, hard-line anti-tobacco ideology may stand in the way of implementing the necessary regulations.

Since 2007, an ever-expanding variety of electronic cigarettes have reached the market (although some of them in fact look nothing like cigarettes). These devices are popularly and generically known as “vape,” “vaping products,” and, by researchers, as Electronic Nicotine Delivery Systems (ENDS). Tobacco combustion products are the cause of virtually all of the serious health risks from cigarettes. ENDS do not burn tobacco. Rather, they use electricity to heat solutions that often contain nicotine, allowing the user to inhale nicotine-infused water vapor. Public Health England, whose mission is to “protect and improve the nation’s health and wellbeing, and reduce health inequalities,” supports the estimates that vaping is 95 percent less dangerous than cigarettes. The evidence is even stronger for oral smokeless tobacco products, such as Swedish snus, with one recent epidemiological review concluding that snus was 99 percent less dangerous than smoking. Unlike so many debates over relative risk (such as those relating to dietary choices or chemical food additives), which often hinge on very small differences between risks, or very large uncertainties, there is no doubt that the risks of vape and snus are dramatically lower than for smoking. The question is how to craft policies that take advantage of these differences to achieve public health benefits. The first step toward addressing that question is simply to acknowledge that the deadlier smoked products are widely and legally available to adult consumers—and that this reality won’t change anytime soon.

And the bans play on

It is commonly said of cigarettes that if they had been submitted to the Food and Drug Administration (FDA) for drug review, they never would have been allowed on the market. True enough. History did not allow us to make that choice (and if it had, we probably would have regretted it, as the lessons of Prohibition suggest). In any case, U.S. tobacco law does not allow the banning of tobacco products. Even though it discourages youth access, FDA regulation preserves adult access to these products, free from encumbrances such as being available by prescription only (as might be the case for other dangerous, pharmacologically-active products). Yet some anti-tobacco forces such as the Centers for Disease Control and Prevention (CDC) are disinclined to acknowledge or make the public aware of significant differences in product risk. They stress that all tobacco and nicotine products are “not safe” and worry that any “safer” tobacco product might lead to worsening of the total public health costs of tobacco use. The European Union, with the exception of Sweden, still bans smokeless tobacco. Most regulatory bodies seem driven by the belief that all tobacco products should be regulated uniformly. Although the FDA does not currently have jurisdiction over e-cigarettes, it is seeking it.

The perspective I take here is that given the reality of cigarette availability, it is a serious analytical and policy mistake to view all tobacco products as similar when they are so different. The zeal to stamp out tobacco products needs to be tempered by regulatory and market realities that offer no prospect of eliminating tobacco products. Policies and positions that would prefer the banning of tobacco products are an irrelevant distraction from those aimed at managing the product options that do exist in ways that might deliver big public health gains.

With the variety of non-combustion tobacco products now available, promising policy alternatives emerge from a “harm reduction” perspective. Harm reduction is essentially pragmatic rather than absolutist. For smoking, it means encouraging less harmful products as substitutes for the more harmful ones. The rapidly growing popularity of ENDS offers the potential to use these products as an important tool to reduce smoking, especially as evidence mounts that vape can compete with cigarettes in the marketplace. Harm reduction would happen in two fundamental ways: when individuals who would have become smokers choose instead to use a less harmful product like vape or snus, or when people who already smoke are able to substitute the less harmful product for cigarettes.

Skepticism among regulators and public health activists about harm reduction is not without reason. In the 1960s, lower-tar cigarettes were marketed as “light” and “mild” and were broadly perceived as safer than regular cigarettes, even though they offered little to no reduction in harm for individual smokers. “Harm reduction” does not occur if the substitute product is not really safer! Today, FDA rules require evidence that a claim of harm reduction not lead to net negative public health outcomes. And although E-cigarettes and smokeless tobacco products are significantly less dangerous than cigarettes, empirical questions remain about the possible net public health effects of promoting non-combusted tobacco and nicotine products. Just as trying beer and liking it could increase the chances of someone moving on to try liquor, one commonly voiced concern is that vape or snus might act as a new gateway into smoking by offering a safer nicotine product that leads its users toward unsafe use of cigarettes. To date, however, evidence supporting the idea of ENDS or smokeless tobacco as causal gateways to frequent smoking for most users is very limited to non-existent. On the contrary, the rise in use of vape by youth in the United States (much of it experimental rather than habitual) has been accompanied by further drops in cigarette smoking. In Sweden, many years of research has failed to detect a causal gateway between snus and cigarettes.

Another concern is that vaping might help smokers cope with restrictions against smoking in the workplace or other public places and therefore act as a kind of crutch for people who might otherwise try to quit. But even if smoking alternatives did create some (as yet unknown) health risk, it would require an enormous increase in the percentage of the public using non-combustion tobacco products to come close to equaling the harm caused by cigarettes and other combusted products. At this point, the focus on research and analysis should not be on the public health risks of harm reduction, but on the policy alternatives that could best deliver public health benefits.

When should you choose your poison?

All cultures make some distinction between adolescence and adulthood with respect to rights and privileges of consuming risky products and engaging in risky activities. The age of “adulthood” varies around the world and differs for different products and activities. And of course good judgment is a quality of the individual as much as one’s age; we have all known wise 16-year-olds and foolhardy 30-year-olds. Thus, there is inevitably a degree of arbitrariness in age-based qualifications. Federal law allows licensed firearms dealers to sell handguns to 21-year-olds and rifles to 18-year-olds. Americans can enlist in the military, an admittedly unsafe enterprise, at age 18, or at 17 with parental consent. In contrast, U.S. law penalizes states that allow people under the age of 21 to purchase alcoholic beverages. (For most other nations, the legal purchase age is 18.)

The precautionary bias that treats all tobacco products the same obscures an opportunity to reduce the most dangerous form of tobacco use and its costs to society.

Setting an age for legal purchase of tobacco products has been a standard practice in modern tobacco control. But what’s the right age, and for what types of tobacco products? Well-heeled from tobacco industry fees, the FDA commissioned the Institute of Medicine (IOM) in 2013 to conduct a study of the “public health implications of raising the minimum age of legal tobacco sale to 19, 21, or even 25 years old.” The IOM experts used statistical models to identify a kind of “sweet spot” for the age of access to be 21 and judged that this policy would have valuable public health effects on smoking prevalence and deaths and disability from smoking.

Ironically, the FDA Family Smoking Prevention and Tobacco Control Act itself does not permit the federal government to raise the legal age for purchase of tobacco products beyond 18 years. Fortunately, states and localities are free to set their own minimum age of purchase, which for most states is 18. A few states have set the age of legal purchase to 19, and in June 2015, Hawaii became the first state to increase the tobacco sale age to 21. Eighty localities, most notably New York City, have set the legal sale age to 21. Several other states, including California, are now considering increasing the age to 21. Setting the purchase age at 25 would offer even more protection against recruitment to smoking, but clearly there would be complaints from retailers about the more complex rules and significant political challenges to being able to pull off such a large departure from the current standards for the age of purchase of dangerous adult products.

The IOM report notes in its summary: “The committee assumes that the MLA [minimum legal age] will be increased for all tobacco products, including nicotine delivery systems (ENDS), and that the intensity of enforcement will be the same for all tobacco products.” Indeed, the momentum in the United States has been, when in doubt, treat all tobacco products as equally dangerous. For example, Hawaii treated ENDS just like cigarettes when raising the legal purchase age to 21.

The IOM committee raised concerns about ENDS as a possible gateway to cigarettes, but it also acknowledged that vaping could prevent or delay recruitment to smoking in some adolescents or young adults who would otherwise start smoking. The committee notes: “Presumably FDA and state policy makers will take these possibilities into account in setting the MLA and will carefully monitor the promotion and use of ENDS, especially by adolescents and young adults.” This presumption that FDA and state policy makers will actually evaluate the various possibilities may be overly optimistic, in light of the common regulatory party line that all tobacco products should be treated as if they were simply unsafe and even equally risky.

Yet, the flexibility that states have to adopt different legal purchase ages for tobacco, combined with the increasing availability and market penetration of non-combustion tobacco products, provides an unparalleled opportunity for quasi-experiments that can test the contributions of harm reduction policies to public health, with the potential for saving literally millions of lives in the long run. Such quasi-experiments, in fact, proved valuable for alcohol regulation, where the de facto standard legal drinking age of 21 was arrived at, in part, by comparing the experience of different state age limits. As more states consider raising the age of legal tobacco purchase, now is the time for public health scientists, policy makers, and activists to consider selectively and differentially raising the legal purchase age of tobacco and nicotine products according to their risks to health.

What a difference a year (or two) could make

Why not keep the legal purchase age for ENDS and snus at a lower age than for cigarettes? Multiple options for age differentials could be explored empirically. One could, for example, set ENDS or snus at 18, and move cigarettes to 19, 20, or 21. The need is to try to determine the benefits of pushing the age for cigarettes above that for products that are much less dangerous. If some state or other jurisdiction were to differentially set the age of legal purchase with consideration to the dramatic differences in health risks, this could permit more than hypothetical data to be collected for future consequences of various tobacco products—with an emphasis above all on reducing the use of cigarettes. One suggestive historical study compared smoking prevalence in states that did not restrict access to vape with those that had already set the purchase age for vape at 18; those states that had not yet set an age limit showed somewhat greater reductions in smoking prevalence in 12- to 17-year-olds. This finding provides preliminary support for the idea that differential age of purchase might have benefits for public health.

Those who are inclined toward a “ban them all” approach should also recognize the potential benefits that differential age limits could have on addressing the contribution of cigarette smoking to growing health disparities in the United States. Twenty-four percent of adults without high-school diplomas are smokers; for the college-educated, the number drops to nine percent. Twenty-nine percent of adults living below the poverty line are smokers; in the rest of the population, only 16 percent smoke. The mentally ill are especially susceptible, with smoking rates of 36 percent, versus 21 percent for those without mental illness. “Hard to reach” populations may not hear or respond to public health warnings or changing social norms. But even those who are not receiving regular health care, advice from health care professionals, and constructive social pressure from work and friends, will get the message from structural changes like a variable age of legal purchase that could help to delay or prevent the use of cigarettes among those who have been hard to reach with other tobacco control methods.

Setting the legal age of purchase is an important decision that sends a message about risk to all consumers. It is a powerful message, but it has never been completely effective in preventing underage use of products. Despite efforts to educate and restrict, adolescence is a time for recruitment to risky activities: unprotected sexual activity, smoking, drinking, and other recreational drug use. As poet Richard Wilbur observed, a dangerous activity can be “made safe by rashness.” Neuroscience research and behavioral research on adolescence has made it clear that adolescents have the cognitive abilities to understand messages and lessons about risk, but this information has little effect on their inclinations toward risk-taking until they mature beyond adolescence (which biologically is most likely after age 25). Differential access to tobacco products offers the potential of influencing choices by this “hard to reach” (but in a very different sense) group that might deflect them from smoking during the crucial rash years of adolescence.

Lumping all tobacco and nicotine products in the same standard ignores the considerable differences in harm to users or bystanders caused by different products. The science-base for setting the age at the same point is slight, and the evidence for a very high magnitude of differential risks is substantial. If some states allowed the purchase of snus and vape at an earlier age than the purchase of cigarettes, would smoking decline overall? Would smoking-related health problems in those states decline relative to states that regulate all tobacco products uniformly? We can’t know the answer to these questions until we do the experiment, but if we fail to do the experiment we miss the opportunity for potentially major public health benefits. Importantly, the potential that differential smoking ages would lead to unanticipated net public health harms seems very small. Yet if such harms did begin to emerge, the mistake could easily be corrected by moving the legal age for vape and snus up to the age for cigarettes. And if the benefits of harm reduction policies began to make themselves felt, then other states could adopt differential age limits as well.

There is a kind of timidity of purpose and failure of analysis that would treat sticks of dynamite and firecrackers as if they each should be subject to the same restrictions on use. The FDA tobacco products division has given a priority to do research on the use of low-nicotine, low-addiction cigarettes as a means to discourage the use of cigarettes. This has been viewed as a way to productively push cigarette smokers to less dangerous tobacco products. But states and municipalities have at their fingertips, as it were, an opportunity to move immediately and decisively beyond the serious limitations of federal tobacco law and develop a possible new way to reduce the harm of tobacco use. The precautionary bias that treats all tobacco products the same obscures an opportunity to reduce the most dangerous form of tobacco use and its costs to society—costs that are increasingly borne by those who are already unhealthy, uneducated, and poor. If the states are, as Louis D. Brandeis, former associate justice on the U.S. Supreme Court, called them, “the laboratories of democracy,” now is the time for them to initiate policy experiments that could help the nation take the next major step in reducing one of its worst public health scourges.

Lynn T. Kozlowski is a professor of community health and health behavior, and former dean of the School of Public Health and Health Professions, at the University at Buffalo, State University of New York.