FDA regulation of tobacco

The following are the submitted comments from TobaccoHarmReduction.org regarding the U.S. FDA regulation of tobacco (see FDA page). We decided to post them here for easy access by interested readers since we think they contain useful observations that may not be widely presented anywhere else.

We are writing to urge the FDA, as part of its new authority over tobacco products, to actively support tobacco harm reduction (THR), rather than interfering with or ignoring it. Because the scientific facts about THR are well-known and likely to appear in other comments, we will simply summarize them and move on to less obvious points. More details and links to summary documents can be found at our website, TobaccoHarmReduction.org.

-There are nicotine products that are proven to be about 99% lower risk than smoking (Western smokeless tobacco of either the American or Swedish style) and others that are strongly believed to be roughly as low risk though there is no direct evidence of the exact magnitude of the risks (pharmaceutical nicotine, a.k.a. NRT; electronic cigarettes).

-Smokers who switch to these products, even if they continue to use them for the rest of their lives, get health benefits that are barely different from quitting nicotine entirely.

Most smokers do not know that switching to smokeless tobacco or other low-risk products is such a good option. There is an active campaign to tell smokers that the only options are to quit or die, which keeps many from switching. This persists despite the fact that switching to a low-risk product and using it for a lifetime is, on average, lower risk than continuing to smoke for just a few more months (see: Phillips CV, Harm Reduction Journal, 2009, for the calculations that produce that estimate).

With that background, we would like to focus on three observations that are not so well known:

1. It seems extremely likely that fifty years from now, unless an even better substitute drug is invented, a substantial portion of the world’s population (perhaps as much as one-third of those who can afford it) will use nicotine in low risk forms. There will still be some smokers, but far fewer than there are today. What is not yet predictable is how long smoking will remain the dominant form of nicotine use in particular societies, a question that hinges substantially on public policy decisions.

2. The FDA is very skilled in many areas of science, but should avoid exceeding its core skills, mission, and mandate to engage in social engineering. The political actors who dominate quasi-scientific discourse around tobacco will try to steer the FDA’s tobacco policy toward actively pushing the moralistic social engineering goal of eliminating all self-administration of nicotine, regardless of health or welfare concerns.

3. Companies that make nicotine products, including many of the major tobacco companies, will be the biggest engines of innovations in reducing the health effects of smoking if they are pushed toward and allowed to go in that direction.

Regarding point 1., nicotine is so vilified that many people do not even pause to think about its benefits. This is quite strange given that such a large portion of the population chooses to use it despite the costs and is quick to espouse its virtues. Nevertheless, the benefits are great and range from medication for clinical-level psychiatric disorders, self-treatment for subclinical or undiagnosed (including depression, schizophrenia, post-traumatic stress, attention deficit), and a mild drug to promote pleasure, relaxation, focus, productivity, and alertness. While the FDA does not officially recognize these benefits, any honest scientist or casual observer of the human condition cannot help but recognize them. Moreover, nicotine is quite simple to produce and acquire. Thus, we can confidently predict that many people throughout the world will choose to use nicotine indefinitely.

What happens in the near term in the United States, however, is not so predictable. If the government policy discourages THR, by interfering with the introduction of low-risk products or by communicating to the public that all nicotine products are similarly unhealthy, smoking prevalence might continue to slowly creep down. But there is reason to expect that nothing other than a heavily-enforced prohibition would cause the last 10-15% of the population to give up the benefits they get from nicotine. The only proven method of reducing smoking prevalence much below what it now is in the U.S. is substitution of a low risk alternative. If such substitution is discouraged in the U.S., THR will likely not catch on until it is well-established elsewhere in the world, resulting in tens of thousands of needless deaths every year.

Inaccurate scientific claims about the risks from smokeless tobacco and other low-risk products can discourage switching. So do literally true but obviously misleading claims like the warning that smokeless tobacco “is not a safe alternative to smoking”, which most people read as “equally unhealthy”. This message tells nicotine users that they might as well smoke rather than using low-risk alternatives. On the other hand, if the FDA gives consumers honest information about comparative risks, or even just allows manufacturers to freely provide such accurate information, widespread switching – which is roughly as good as abstinence from the perspective of life-threatening disease and much better for many people in terms of psychological conditions and general welfare – is likely to begin almost immediately.

This leads in to point 2. The steps necessary to promote THR and thus dramatically reduce the health burden from nicotine use (i.e., from smoking) are simply to provide honest scientific information and let people make an informed autonomous choice. Short of nicotine product prohibition (which is not allowed and would be a law-enforcement nightmare), this scientific honesty would also best fulfill the mission of serving the nation’s health and welfare. Health and welfare are not, however, the goals of many of the people who dominate the discourse on tobacco and nicotine use. The dominant activist faction makes it quite clear that their goal is to eliminate the use of tobacco (and, increasingly, other nicotine products like electronic cigarettes). They are unconcerned with the welfare effects of denying nicotine to those who benefit from it. Indeed, they are even unconcerned with health, making no distinction about whether nicotine is being used in a way that is clearly extremely harmful (smoking) or in ways that present minor risks, comparable to everyday hazards and consumption choices; they generally actively oppose THR.

This extremist faction will inevitably try to enlist or co-opt the FDA into supporting their goals. A key part of supporting that mission is discouraging the long-term use of low-risk nicotine products, even more than discouraging the use of high-risk products, because a consumer who knows he is using a low risk product – and who gets substantial benefit from doing so – is unlikely to be persuaded to quit entirely. His health risks will be minimal and the net welfare effects will be positive, but the extremist activists will consider him to represent a failure rather than a success because he is still choosing to use nicotine. Thus, they will try to steer the FDA into not providing accurate comparative risk information, discouraging the use of low-risk products far more aggressively than their real health risks warrant, and other acts of social engineering (i.e., manipulation of the population to do what they would not otherwise choose to do). Does the FDA really want to join other agencies of the U.S. government in participating in a “war on drugs” with all that implies for the Agency’s reputation and public image?

Regarding point 3., once it is recognized that harm reduction and low-risk products should be encouraged, it follows immediately that the innovators and manufacturers of such products are part of the solution. They might, of course, be part of the problem too. The FDA’s core missions leave little doubt that while food and drug manufacturers are tremendously beneficial sources of nutrition and treatment, they also need to be pushed in the right direction and forbidden from taking profitable but harmful actions. Thus, the FDA can extrapolate from the regulation of pharmaceutical companies to tobacco companies and other manufacturers of low-risk nicotine products (some of whom are pharmaceutical companies who could be encouraged to market their nicotine products as long-term substitutes rather than marginally useful cessation aids). The situation is quite similar: Those companies are the only source of the good products we should want to encourage the development and marketing of, but like most any organization will also often favor self-interest over social welfare.

Thus, regulation of various kinds of low-rise products is in order, though not regulations that are intended to strangle the companies or discourage innovation or marketing of low-risk products (as the FDA will be encouraged to pursue as noted above). Indeed, regulations that are designed to hurt companies rather than help consumers are very likely to backfire, and would likely encourage companies to retreat to their core business rather than trying to switch their cigarette customers to their low-risk innovations. Regulatory action that encourages manufactures to innovate and help consumers switch to low-risk products is perfectly aligned with doing good science and honestly communicating it, as well as standard government policy that tries to penalize and discourage health hazards and negative externalities.

In summary, regulating tobacco calls for recognizing that nicotine is a popular drug that it is a “lifestyle” consumption decision and/or self-treatment for many conditions that are not formally diagnosed, making it different from carefully controlled medical treatments for specific diseases. Demand will likely never be eliminated, and trying to eliminate it will take the FDA far beyond its mission and competencies. Like the products that FDA is experienced at regulating, the market will be dominated by major corporations; this should be recognized and turned into an asset rather than futilely resisted. Because this popular drug is caught up in so much politics, attempts at social engineering often overwhelm the good science. However, good science and honest provision of information will improve people’s health efficiently and without causing a net reduction in overall welfare.

Prof. Carl V. Phillips, MPP PhD
Paul Bergen, MLIS MSc
Karyn Heavner, MPH, PhD
Catherine Nissen, B.Sc.

The authors represent the TobaccoHarmReduction.org research group at the University of Alberta School of Public Health. The research group has benefited from an unrestricted grant to the UASPH from U.S. Smokeless Tobacco Company. Dr. Phillips consults on tobacco harm reduction to any interested organization, some of which are companies that sell products that will be affected by FDA actions, and is sometimes compensated for that work. No one other than the signed authors had any input into this statement or influence over its content.