We begin our discussion on the smoking controversy by asking you to consider the following question: Which is more important to you, health or liberty?

Assume these values are mutually exclusive from a public- policy point of view. Let's phrase the question another way: Which do you value more, freedom from coercion by a paternalistic governmental authority at the possible expense of possible poor health--or freedom from disease or poor health at the expense of being denied pursuit of certain behaviors and activities you find enjoyable despite their risk?

Consider our question in still another way: Is it more noble to secure individual liberty at the risk of harming ourselves than to allow someone else to make decisions about risky activities for us? If this is the case, then we see that liberty and responsibility, again from a public policy point of view, are positively correlated. To be sure, the more liberty people exercise, the more responsible they must be. The inverse is also true: The more responsible people are, the more liberty they can experience.

If the opposite is true, i.e., if it is more noble to be healthy and protected from increased probability of harm, then the correlation between liberty and responsibility is still a positive one. When we give up our freedom to engage in risky behaviors we must be regarded as less responsible. We become "infantilized" by authority. We assume or are assigned a social role of metaphorical children--even though we are actually adults. Government then becomes our metaphorical parents. We cannot increase liberty by decreasing responsibility and vice versa. While the inverse to our equation is true, the converse is false.

In fact, there is no "right" answer to the question we are posing to you here. The question is a moral one requiring an answer based on personal values. Individual morality is a heterogeneous quality in the population at large, not a homogeneous one. The answer to our question, it seems to us, is "it depends." It depends on whether one is willing to accept the consequences of one decision or another. We are interested in the arguments supporting one answer or another in light of the different consequences integral to one path or another. We ask you to consider this question in light of the smoking controversy we face today.

THE IMPORTANCE OF STUDYING TOBACCO REGULATION
Smoking policy presents a unique opportunity to study political, economic, legal, and social aspects of health and health behavior. The demonization of the tobacco industry coupled with the medicalization of addiction, and the high financial stakes involved in liabilities cases and revenue losses, are virtual gold mines for analysis and debate.

The recently proposed regulation of smoking and tobacco products by the U.S. Food and Drug Administration (FDA) takes diverse forms. These include increasing restriction of smoking in public and private domains, requirements of health warnings on cigarette packages, anti-smoking publicity campaigns, prohibitive taxation strategies, age-restrictive vending regulation, and sanctions on advertising. The FDA has asserted that it has a legitimate scientific and legally justifiable basis for regulating nicotine, and thereby all tobacco products containing nicotine. A federal court has upheld this authority --U.S. District Court Judge William Osteen ruled on April 25, 1997 that tobacco products fit the federal definition of a drug, and in so doing he cleared the way for the potential regulation of those products by the FDA. (He also gave the tobacco companies a slight victory, however, in ruling that the government could not restrict cigarette advertising.) Judge Osteen's ruling was reversed by the U.S. Court of Appeals for the Fourth Circuit on August 14, 1998 (1).

Moreover, a plethora of litigation has been launched against the tobacco industry by a conglomerate of state attorneys general successfully seeking compensation for the health care costs incurred by smoking. The tobacco companies have agreed, in part, to pay for such costs, among many other concessions (see on-line, http://www.tobaccoresources.com). Public policy is being crafted to reduce mortality and morbidity associated with the use of tobacco. But should the elimination of smoking even be a goal in a free society? Where should the line be drawn between public dissemination of accurate information and the legislation of morality in the form of propaganda?

Tobacco control is the exertion of power by government grounded in the implied health preferences of the nonsmoking majority. By societal nature, we are bound to affect others when we exert our preferences. Rights, depending on ideological perspective, are therefore viewed as either ensured or infringed upon by tobacco control. Various tobacco control initiatives have different goals. Some initiatives aim at reducing public exposure to smoking behavior--protecting "us" from "others." Some strategies attempt to protect "us" from "ourselves" (included here are even the inclinations we may have toward smoking) through tobacco taxation and regulation of tobacco as an addictive substance. Still other regulations are designed to dismantle the tobacco industry's public image by restricting advertising.

Proponents of increased smoking regulation who favor restriction of smoking in public places emphasize the collective right of nonsmokers to be free from the effects of smoking or the behavior of smokers. This position rests on acceptance of the scientific reports of the federal Environmental Protection Agency (EPA) conclusively associating second-hand smoke with adverse respiratory health effects. Economic analysts have addressed second-hand smoke as an externality leading to market failure and tend to steer away from criticism of second-hand smoke regulation. For regulation proponents, it follows, then, that the government should issue regulations protecting the health of nonsmokers and limiting the behavior of smokers. It is further asserted that agencies (especially the U.S. Department of Health and Human Services) should enforce rules governing smoking in what pro-regulationists consider public places, i.e., restaurants, workplaces, and theaters, in an attempt to guarantee the implied health rights of nonsmokers. An example of this approach is the recent prohibition of smoking in private restaurants in California to protect workers from second-hand smoke. Allies in these endeavors include various professional health organizations (e.g., the American Public Health Association) and an array of citizen-action groups. Anti-regulation advocates, however, have interpreted liberty to imply just the opposite, declaring the rights in question to be those of smokers rather than nonsmokers. Their arguments rely on the constitutional ideal of avoiding government intrusion in, and the restriction of, personal behavior. Anti-regulators claim that especially in the circumstance of restaurants, as private rather than public establishments, government intrusion is unconstitutional. These assertions, voiced most strongly by the tobacco industry and various smokers' rights groups (often funded by the tobacco industry), cite studies rejecting EPA findings that second-hand smoke is a health risk. Accordingly, there is debate over "good" and "bad" science--leaving many people with questions over what to believe. U.S. District Court for the Middle District of North Carolina Judge William L. Osteen rejected the EPA's claim that second-hand smoke was a known carcinogen in an important case decided on July 17, 1998. (2)

THE VOLUNTARY NATURE OF ADDICTION
The debate about smoking rights and regulation also rests on the meaning of addiction. Groups and individuals supporting government regulation of tobacco products contend that nicotine ixperts disagree. By definition, addiction refers to behavior. Consequently, it is voluntary. Involuntary "behavior" is not behavior--it is pathological, e.g., an epileptic seizure. The distinction between behavior and disease is important in public policy considerations. Smoking is a behavior. Cancer is a disease. The former refers to mode of conduct, deportment. Behavior is the expression of choice. Disease is defined through signs, tests, physiological lesions, and chemical imbalance.

BEHAVIOR VERSUS DISEASE
The distinction between behavior and disease is also crucial when we consider the difference between what tobacco smoke does to the body and how the smoke gets into the body. The former is concerned with physical and chemical interactions. Tobacco products are inert substances. They cannot purposefully invade a person's body. The latter refers to conduct, volition. People choose to purchase, ignite, and inhale the smoke from tobacco products. We must keep these distinctions in mind throughout the course of our discussion. Smoking policy is fraught with controversy, and we must agree on terms and issues at hand in order to communicate meaningfully.

Again, the facts about smoking behavior do not appear to support the assertion that addictive behavior is involuntary. People quit smoking all the time. Most people quit on their own, without help from others (Fiore et al., 1990). And many people moderate their smoking, i.e., they only smoke one or two cigarettes, at specific times and places, without developing an uncontrollable desire to smoke more (Hennrikus et al., 1996, Gilpin et al, 1997). If adults start smoking because they choose to do so, and moderate their smoking because they choose to do so, and quit smoking--sometimes after fifty years of smoking heavily--because they choose to do so, doesn't it seem reasonable to conclude that people who continue to smoke after many years--even when they know they are suffering health consequences by their behavior--are choosing to do so?

Since smoking is voluntary, isn't it accurate to conclude that the controversy surrounding smoking rights and regulation is a political, not a strictly medical one? Smoking is a behavior based on personal choice and values. Thus, the regulation of smoking behavior through institutional control such as government, is, in fact, the regulation of individual choice and behavior.

Since behavior indeed refers to mode of conduct, and the control of conduct can occur in only one of two ways--through internal or external control--then smokers and nonsmokers can either control themselves or be controlled by others. How many people would credit the federal government for their personal decision not to smoke? They probably would prefer to take responsibility for not smoking themselves because it is dehumanizing to abdicate their responsibility for not smoking to others.

FORMAL VERSUS INFORMAL SOCIAL CONTROLS
Under what circumstances are institutional forms of social control legally acceptable?

"No matter how carefully rights are drawn and assigned, there remains some potential for conflict. The fact that my preferences extend to your behavior over activities that are well within your defined rights, and vice versa, insures that my satisfaction is influenced by the way that you behave and that your satisfaction is also affected by my behavior." (Buchanan, 1986, pp. 108-109)

James Buchanan's insight reveals a central focus of the debate surrounding tobacco control. Buchanan alludes to the level of interaction inherent in any social environment.

"Liberty" can be viewed as the foundation for either pro- or anti-tobacco regulation arguments. Often the two terms "liberty" and "rights" are used interchangeably, which, to a number of philosophers is a mistake. For the purposes of this discussion, liberty represents either the "preferences" which smokers wish to assert by smoking, or those which nonsmokers wish to assert by being free from smoke. Rights, according to traditional rule of law ideology, are constitutionally appointed entitlements, politically secured by the intentions of the Founding Fathers, and now subject to a great deal of interpretation. Since nowhere in the Constitution was smoking or tobacco explicitly mentioned, there has been an enduring dispute surrounding those issues.

Furthermore, as rights are claimed or established, either for nonsmokers or smokers, it is assumed that the opposing group will accept the responsibility of according the other those rights--either by not smoking or by tolerating smoking. In fact,

"with respect to these debates over competing "rights" to smoke or not smoke, most economists would not pose the issue in this manner. What we are seeking is an efficient outcome, not the preservation of assigned rights in a situation in which there is no market exchange. Determining the optimal smoking "rights" outcome involves establishing the benefits and costs of different forms of restriction. This approach takes the problem out of its more strident and inconclusive ideological context in which the debate has been waged." (Viscusi, 1992)

Ultimately, the debate over tobacco regulation continues to challenge any conclusions regarding liberty and rights, pitting the interests, expressed through their preferences, of smokers and nonsmokers against each other indefinitely.

HARM TO SELF VERSUS HARM TO OTHERS
We must, for purposes of clarity and accuracy in our discussion, differentiate here between harm to oneself versus harm to others. The primary controversy concerning the right to smoke is focused on whether individuals should be free to harm themselves. Let us agree that no one has the legal right to pursue liberty at the expense of others. Liberty at the expense of others is criminal behavior. Our issue here is this: Do smokers have a right to harm themselves, when they harm no one but themselves? As Lysander Spooner wrote, "vices are not crimes."

The problem we confront next has to do with drawing the line on what constitutes harm. Some argue smokers incur greater health care costs. Who should bear the burden of those costs? If smoking does incur greater costs, and those costs are passed on to nonsmokers in the form of higher health insurance premiums and/or higher taxes to fund Medicare and Medicaid, doesn't that constitute (economic) harm to others? If such is in fact the case, it seems, at first glance, smokers should bear the burden of those expenses.

But that conclusion seems simplistic to us and may set an unfair precedent. If smoking is willful, and responsibility for the consequences of smoking behavior belongs to the smoker, i.e., the health-cost consequences, an equitable health care policy would necessarily discriminate against other people who engage in willful activities incurring greater health care costs. It has been suggested that the health insurance industry could play an integral and interesting role in tobacco regulation. A libertarian approach could advocate the potential for deterrence of smoking by the private sector through assigning smokers to higher risk categories and higher premiums (Halpin and Schauffler, 1993). Public health advocates have sought allies among the health insurance companies by including smoking cessation benefits in health plans. By shifting the costs of their behavior directly to smokers, it is assumed that economic disincentives would significantly reduce smoking rates. Obviously, the large numbers of un- and underinsured smokers would present a large problem under this model, since they would probably not be subject to the same incentive system, and even more low-income smokers would be priced out of the insurance market altogether.

WHO IS RESPONSIBLE?
If we consider smoking behavior involuntary, then to hold smokers responsible for the consequences of their behaviors seems equivalent to punishing persons for self-inflicted crimes they did not commit. Who is responsible then? Many people today, notably those favoring governmental regulation of nicotine, assert the responsibility belongs to the tobacco industry. The U.S. Department of Health and Human Services ranks tobacco use as the single most preventable cause of mortality in the United States. Tobacco use is a leading cause of diseases of the heart and blood vessels; chronic bronchitis and emphysema; and cancers of the lung, larynx, pharynx, oral cavity, esophagus, pancreas, and bladder, as well as respiratory infections and stomach ulcers. Some argue that smoking behavior is involuntary and that smokers should be held accountable for the greater share of health care costs resulting from smoking. "Sin tax" policies are ways of holding smokers accountable for the consequences of their behaviors and simultaneously are designed to discourage people from smoking. Yet these policies seem contradictory, too.

If smoking is regarded as involuntary, i.e., the result of an addiction that causes an individual to lose the ability to stop smoking, then the attempt to discourage smoking by making smokers pay higher prices for cigarettes and related tobacco products seems to be a cruel and unusual punishment. The Americans with Disabilities Act (ADA) should, at least theoretically, protect smokers against such policies. Obviously, smokers can be discouraged by high prices only if smoking is voluntary behavior. If, on the other hand, smoking is involuntary, high prices will not discourage smoking and will penalize smokers for behaviors they cannot control.

Faced with these apparent contradictions, proponents of tobacco regulation, rallying to the defense of children, assert government must protect children from becoming smokers. This, they often argue, should be done by enforcing age minimums on the sale of tobacco products to minors, eliminating advertising directed toward children, educating children about the dangers of smoking, and so on. Here is a question we must answer in light of these assertions and the policies that are implemented because of them: Who are the more appropriate persons to teach children about the possible dangers of smoking, parents or government? Again, this seems to us to be an ethical issue. Most would answer that parents are the proper persons to do so. However, many tobacco regulationists believe they know what is better for children than the children's own parents. Don't parents have the right to teach their children as they see fit?

Clearly the danger in tobacco regulation is the creation of what has come to be known as the "slippery slope": When government mandates personal behavior in one area, what areas of personal conduct can be immune from regulation? Benevolent paternalism has been shown historically to be a road to serfdom. If smoking is banned or regulated because of the dangers it poses, what's next? High-fat diets?

As Morris E. Chafetz has remarked elsewhere, one-third of the population does everything "right," i.e., behaves in health- enhancing ways, complies with recommendations made by health care professionals, and still dies early. One-third of the population does everything "wrong," i.e., behaves in unhealthy ways, refuses to comply with health recommendations, and lives long and meaningful lives. Everyone else seems to fall somewhere in-between. We don't know why some people get cancer and others don't. We also don't know what the consequences of tobacco regulation may be. Yet, just as it seems there is a high probability that increased smoking will lead to increased health problems, there seems to be a concomitant risk that increased control of conduct by others, notably government, will lead to abuse of power. Where paternalism, under the masquerade of "public health," imposes formal social controls, informal ones, i.e., relational and self-controls, are the morally, if not legally, appropriate ones.

The validity of some of these conclusions, however, has come under great scrutiny in recent years as confidential tobacco industry files--the Brown and Williamson documents--have been made public, documenting significant differences between public industry statements and private industry knowledge of health risks associated with tobacco use. These documents, released by a "whistle blower" (formerly a Brown and Williamson employee), documented the results of tobacco industry research initiatives and their intentional release of contradictory information.

BACK TO THE FUTURE
In light of the current smoking controversy, which is more important, health or liberty? Much has been written to support the medicalization of smoking and the criminalization of the tobacco industry. Most anthologies and books presenting arguments against regulation are dismissed as tobacco-industry apologia, if not funded by the tobacco industry itself. We believe the soundness of an argument should not be dismissed simply on the basis of who supported the publication of these views. If that were the case, one should simply dismiss the arguments for regulation because they come from the federal government.

The bottom line is this: We are each responsible for the consequences of our actions, whether we favor health at the expense of liberty, or vice versa.

FOOTNOTE (TO TITLE).
1. Schaler, J.A. and Schaler, M.E. (Eds.) (1998). Smoking: Who has the right? Amherst, N.Y.: Prometheus Books. Reprinted by permission of the publisher.

NOTES.
1. On August 28, 1996, the FDA published a final rule entitled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." Cigarette and smokeless tobacco manufacturers, convenience store retailers, and advertisers (the plaintiffs) challenged the FDA's legal authority in the U.S. District Court for the Middle District of North Carolina at Greensboro and Winston-Salem, William L. Osteen, Sr., District Judge, to regulate and restrict tobacco products in this manner. Their lawyers argued that Congress has withheld from the FDA the jurisdiction to regulate tobacco products and that the Federal Food, Drug, and Cosmetic Act does not permit the FDA to regulate tobacco products either as drugs or as devices (cigarettes were labeled "nicotine- delivery devices" by the FDA). Judge Osteen held that Congress did not "[intend] to withhold from FDA" the jurisdiction to regulate tobacco products. He also concluded the FDA had the authority to regulate tobacco products under the device provision of the Act and that the FDA lacked the statutory authority to restrict advertising of tobacco products. Plaintiffs appealed Judge Osteen's ruling. On August 14, 1998, the U.S. Court of Appeals for the Fourth Circuit reversed Judge Osteen's decision stating "For the purposes of these appeals, plaintiffs do not dispute the factual findings of the FDA. Based on our review of the record and the relevant legal authorities, we are of opinion that the FDA lacks jurisdiction to regulate tobacco products . . . [A]ll of the FDA's August 28, 1996 regulations of tobacco products are thus invalid . . . This is not a case about whether additional or different regulations are needed to address legitimate concerns about the serious health problems related to tobacco use, and particularly youth tobacco use, in this country. At its core, this case is about who has the power to make this type of major policy decision. As the Supreme Court has previously stated about a different agency and its enabling statute, neither federal agencies nor the courts can substitute their policy judgments for those of Congress . . . Accordingly, we do not, indeed cannot, pass judgment on the merits of the regulatory scheme proposed by the FDA . . . [T]he FDA has exceeded the authority granted to it by Congress, and its rulemaking action cannot stand . . . We are thus of opinion that Congress did not intend to delegate jurisdiction over tobacco products to the FDA. Accordingly, the judgment of the district court is REVERSED." (Opinion written by Judge Emory H. Widener Jr., Circuit Judge, U.S. Court of Appeals for the Fourth Circuit, August 14, 1998; Brown & Williamson Tobacco Corporation et al. v. Food & Drug Administration et al. From 1998 U.S. App. LEXIS 18821). Two FDA regulations are still in effect: Tobacco products may not be sold to anyone under 18 years of age and retailers are required to check photo IDs of purchasers under age 27 (The Nation's Health, Volume 28, No. 8, 1).

2. In Flue-Cured Tobacco Cooperative Stabilization et al. v U.S. Environmental Protection Agency (EPA) (4 F. Supp. 2d 435; 1998 U.S. Dist.), Decided July 17, 1998, the U.S. District Court for the Middle District of North Carolina, Winston-Salem Division, Judge William L. Osteen, lawyers for the tobacco industry argued against the EPA claim that Environmental Tobacco Smoke (ETS) was a Group A carcinogen, a designation meaning there is sufficient evidence to conclude ETS causes cancer in humans. Plaintiffs argued the "EPA exceeded its authority under and violated the restrictions within the Radon Research Act; EPA did not comply with the Radon Research Act's procedural requirements; EPA violated administrative law procedure by making a conclusion regarding ETS before it concluded its risk assessment, and EPA's ETS Risk Assessment was not the result of reasoned decision making." (1998 U.S. Dist. LEXIS 10986). The EPA denied this claim by the Plaintiffs and asserted "the administrative record . . . demonstrates reasoned decision making." (Ibid.). In his conclusion, Judge Osteen made the following ruling: "In 1988, EPA initiated drafting policy-based recommendations about controlling ETS exposure because EPA believed ETS is a Group A carcinogen . . . Rather than reach a conclusion after collecting information, researching, and making findings, EPA categorized ETS as a 'known cause of cancer' in 1989. EPA's Administrator admitted that EPA 'managed to confuse and anger all parties to the smoking ETS debate' . . . The Administrator also conceded, 'beginning the development of an Agency risk assessment after the commencement of work on the draft policy guide gave the appearance of . . . policy leading science . . . .' In conducting the Assessment, EPA deemed it biologically plausible that ETS was a carcinogen. EPA's theory was premised on the similarities between MS [mainstream smoke], SS [sidestream smoke], and ETS [environmental tobacco smoke. In other chapters, the Agency used MS and ETS dissimilarities to justify methodology. Recognizing problems, EPA attempted to confirm the theory with epidemiologic studies. After choosing a portion of the studies, EPA did not find a statistically significant association. EPA then claimed the bioplausibility theory, renominated the a priori hypothesis, [and] justified a more lenient methodology. With a new methodology, EPA demonstrated from the selected studies a very low relative risk for lung cancer based on ETS exposure. Based on its original theory and the weak evidence of association, EPA concluded the evidence showed a causal relationship between cancer and ETS. The administrative record contains glaring deficiencies. . . In this case, EPA publicly committed to a conclusion before research had begun; excluded industry by violating the Act's procedural requirements; adjusted established procedure and scientific norms to validate the Agency's public conclusion, and aggressively utilized the Act's authority to disseminate findings to establish a de facto regulatory scheme intended to restrict Plaintiffs' products and to influence public opinion. In conducting the ETS Risk Assessment, EPA disregarded information and made findings on selective information; did not disseminate significant epidemiologic information; deviated from its risk Assessment Guidelines; failed to disclose important findings and reasoning; and left significant questions without answers. EPA's conduct left substantial holes in the administrative record. While so doing, EPA produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes cancer. Because EPA exceeded its authority under the Radon Research Act and also failed the Act's procedural requirements, the court will direct the entry of judgment in favor of Plaintiffs' motion for summary judgment and vacate Chapters 1 thru 6 of and the Appendices to EPA's Respiratory Health Effects of Passive Smoking: Lung Cancer and Other disorders." (Opinion written by Judge William L. Osteen U.S. District Judge, 4 F. Supp. 2d 435; 1998 U.S. Dist.. LEXIS 10986). This ruling is important for several reasons, however, it is most likely to bear significantly on the authority of government to impose smoking restrictions in public and private places due to alleged carcinogenic effects of second-hand smoke.

REFERENCES
Buchanan, J.M. (1986). Politics and meddlesome preferences. In R.D. Tollison (ed.) Smoking and society: Toward a more balanced assessment (pp. 333-342). Lexington, MA.: Lexington Books.

Fiore, M.C., Novotny, T.E., Pierce, J.P, Giovino, G.A., Hatziandreu, E.J., Newcomb, P.A., Surawicz, T.S., and Davis, R.M. (1990). Methods used to quit smoking in the United States: Do cessation programs help? Journal of the American Medical Association, 263(20), 2760-2795.

Gilpin, E., Cavin, S.W., and Pierce, J.P. (1997). Adult smokers who do not smoke daily. Addiction, 92(4), 473-480.

Halpin Schauffler, H. (1993). Health insurance policy and the politics of tobacco. In R.L. Rabin and S.D. Sugarman (eds.) Smoking policy: Law, politics, and culture. New York: Oxford University Press.

Hennrikus, D.J., Jeffery, R.W., and Lando, H.A. (1996). Occasional smoking in a Minnesota working population. American Journal of Public Health, 86(9), 1260-1266.

Viscusi, W.K. (1992). Smoking: The risky decision. New York: Oxford University Press.

Jeffrey A. Schaler, Ph.D. is Fifth Column Editor of the PsychNews International. [jschale@american.edu]

Magda E. Schaler, M.P.H., received her B.A. degree in sociology with a program concentration in Law, Medicine and Health Policy from Brandeis University; and her M.P.H. degree from the Division of Health Policy and Management at Columbia University School of Public Health. She is currently a law student at Columbia University School of Law. [mes67@columbia.edu]