#149  

 September 1996




Demon Tobacco

by Doug Bandow

 

Introduction

Political crusades tend to be most successful when directed against an enemy of one sort or another. To promote the public interest is tough. To attack someone who is seemingly obstructing the public interest is far easier. Now the Clinton Administration, having already run through the gamut of usual suspects -- pharmaceutical companies, insurance firms, doctors, gun owners, government critics, talk show hosts, Republicans, and religious activists, to name only a few -- is now attempting to demonize the tobacco industry.

To be sure, the tobacco giants make easy targets. It is hard to find a medical researcher who believes that cigarettes are safe. Few habits are dirtier or smellier. And the industry's professed concern for individual liberty seems driven more by profits than by principle.

Nevertheless, fundamental issues of principle are at stake. The administration's campaign against tobacco is misguided, even dangerous. Cigarette smoking may be bad, stupid, and even self-destructive, but millions of Americans nevertheless exercise their freedom and choose to smoke, puffing one billion cigarettes a day. To seriously restrain such a pervasive behavior would require something approaching prohibition -- which would, of course, simultaneously violate Americans' most basic liberties and prove to be utterly unworkable, just like the ban on alcohol more than 60 years ago.

Nanny-in-Chief

Although President Clinton's anti-tobacco proposal avoids outright prohibition, it would move Uncle Sam ever closer to the role of nanny-in-chief, prepared to regulate whatever and whenever it believes people are acting stupidly. The campaign would restrict the freedom of American adults to smoke, a right possessed, and exercised, by people throughout human history. Indeed, the measure would enshrine as law the principle that government may treat adults as children if it believes doing so is necessary to protect children. The proposal also would infringe the First Amendment through its restrictions on advertising.

Equally important are several practical considerations. Today the federal government tries to do almost everything. Unfortunately, it performs many of those tasks, including its most important ones, badly: decades of battling drugs have failed to stem the demand for and supply of illicit substances; turning local crimes into federal offenses has had no impact on the crime rate; a host of regulatory initiatives, from environment to health, have proved to be unintentionally counterproductive and unnecessarily expensive; and school standards have plummeted even as federal educational funding has risen. There is no reason to expect Washington to do a better job at stopping underage smoking, something better suited to the states, which themselves have achieved only modest success. Worst of all is the idea of assigning responsibility for the tobacco war to the Food and Drug Administration (FDA). For years the FDA has lagged behind its government counterparts in other industrialized nations in approving life-saving drugs, leading to needless patient suffering and death. The agency needs many things, but another task to divert its attention from its supposed raison d'etre is not one.

Administration Battle Plan

The administration is nothing if not ambitious in its tobacco battle plan. Explains President Clinton, "We can save countless lives of our young people. We can give them the future that we imagine when we look into the bright faces of these children who are here." (His eloquent pleas notwithstanding, he refused to abandon his beloved cigars as a symbol of his commitment to curbing smoking. )

The FDA has proposed to ban most cigarette self-service displays and vending machines. No sales could be made from packages that are either open or contain less than 20 cigarettes. The agency's prospective rules regarding advertising and promotion are equally intrusive. The FDA is seeking to prohibit any advertising not specifically authorized, brand-name event sponsorships, free product distributions, use of brand names on non-tobacco products (such as lighters), use of non-tobacco brand names on tobacco products, advertising in publications with more than 15 percent (or more than two million) of their readers under 18, and outdoor advertising within 1,000 feet of playgrounds or schools. Advertising would be largely limited to black text on a white background, and required to include a second warning statement, all the while announcing "cigarettes -- a nicotine delivery device." The FDA would restrict logos in racing events, mandate that six major tobacco companies undertake an advertising campaign to discourage smoking by children, and prosecute firms for "misleading" advertising based on "omissions" or a lack of "balance." Washington would impose new responsibilities on manufacturers, distributors, and retailers to ensure compliance with federal regulations. Violations would be either a misdemeanor or a felony, would not require guilty intent, and could be punished by an injunction, product seizures, and fines.

The agency's draft regulations drew a record 710,000 letters, most of them negative, and 2,000 pages of industry comments. The FDA's final rules included slight modifications, but the entire matter will ultimately be decided by the courts and perhaps Congress.

Paternalism Run-Amok

The administration's stated desire to protect children is, of course, laudable. Government has long attempted to help parents shield kids from dangers normally attendant adult life. State prohibitions on the sale of cigarettes to minors is an example of such a policy.

But President Clinton's program, while nominally addressed to children, will affect adults as much or even more. Its proposals are not, in fact, primarily directed at the phenomenon of kids buying cigarettes, which is already against state laws across the nation. Rather, the Clinton administration is seeking to prohibit promotional activities that have at best an indirect impact on children smoking--race sponsorships and logos on t-shirts, for instance. Indeed, the collective impact of all advertising on the rate of smoking by minors appears to be quite modest. As Jerry Taylor, director of natural resource studies at the Cato Institute, observes: "Every single study of teen and preteen smoking -- including those conducted by the World Health Organization and academic researchers around the world -- finds that peer pressure, adolescent rebellion and the never-ending quest of kids to be 'cool' are the reasons children smoke." Advertising, in contrast, does not appear to be a major factor. Indeed, a greater proportion of kids smoke in some nations, like Norway, where advertising is banned, than in America. And teen consumption of marijuana has also been rising of late -- without any advertising.

Politically Popular Excuse

In fact, protecting children seems to be merely a politically popular pretext for the administration's action. Observes former FTC chairman Michael Pertschuk, by focusing on kids Dr. Kessler "completely neutralized the industry's argument that the goal was prohibition." This emphasis on paternalism also improves the FDA's chances of successfully defending its rules in court, since judges are more willing to accept interference with commercial speech for this reason.

However, administration officials almost certainly proposed controls on the color of advertising, convenience sales (like through the mail), sports sponsorships, use of tobacco and non-tobacco brand names on various products, and the like because such steps would combat adult smoking while being plausibly directed against tobacco consumption by children. Even the prohibition on cigarette advertising near schools and playgrounds would limit the freedom of adults more than it would protect kids. After all, children travel all over -- to movie theaters, ball parks, malls, churches, and most everywhere else that adults congregate. Thus, cigarette advertising-free zones would do little to shield students from tobacco ads. But they would banish tobacco ads from some sections of town. Kippy Burns of the Outdoor Advertising Association of America, complains that the prohibition is "not a fair balance. In many areas, it would blanket an entire community."

More generally, the rules establish the principle of ever-greater restrictions on cigarette advertising. And such costly controls are likely by themselves to reduce the availability of cigarettes for adults. For instance, the Target discount retail chain announced that it would stop selling cigarettes because of the new federal rules. Carolyn Brookter, a company spokesman, explained that "it costs lots of money to retrofit stores to put cigarettes behind counters and to service tobacco customers." Nor is Target likely to be the only seller to so decide. Matthew Smith of Leo J. Shapiro & Associates, a Chicago market-research company, explains that "The bottom line is, fewer stores will be selling cigarettes, no matter how it shakes out."

As a result, in its attempt to protect children, Uncle Sam is effectively treating adults like children. (Such paternalism is not unique: public health officials also complain when they perceive cigarette companies are targeting women, as if the latter are more vulnerable to commercial entreaties than are men. ) Because many kids wear t-shirts adults will not be able to buy t-shirts emblazoned with a tobacco brand name. Because some children might watch a televised sports event, no adults will be able to see brand-name sponsorship of sporting events. (Indeed, some lower-budget Nascar races may fold, since they are heavily dependent on revenue from tobacco sponsors. ) Because all children walk the streets, no adult can receive a free cigarette sample. These sort of restrictions constitute a dramatic departure from traditional tobacco regulation, which attempts to protect kids by prohibiting their use of cigarettes, rather than by limiting everyone's access to cigarettes and cigarette advertising.

As important as is the task of protecting children, that does not excuse federal overreaching as a kind of nanny-in-chief. The Clinton administration's proposals are draconian, intrusive, and ill-suited to the supposed goal of reducing smoking by kids. Helping to inform adults and children alike of the dangers of smoking is useful but old news; attempting to ration access to cigarettes through inconvenience and ignorance, in contrast, exceeds government's proper role.

First Amendment Endangered

The FDA's proposed ban on cigarette advertising is also a hackneyed strategy. Canada banned tobacco advertising, only to have a court void the prohibition last year. Also in 1995, Russian President Boris Yeltsin outlawed all tobacco advertising. Yeltsin simply issued a decree, rather like the unilateral approach of the Clinton administration. The Yeltsin government also acted for the same basic health reasons as did President Clinton. "We have been saying for years that as long as the most popular man in Russia is the Marlboro Man, we can't even begin to do much about the wretched health of the nation," explained Dr. Galina Perfilyeva, a medical analyst and proponent of the ban.

Although U.S. courts typically apply a somewhat lower standard of First Amendment protection to advertising, they have found commercial speech to fall within the Constitution's protection. And rightly so. Free economic speech is vital for a capitalist economy. Advertising provides information, and markets work best with informed consumers. Indeed, limits on ads -- relating, say, the price of eyeglasses, a typical restriction -- have almost always been imposed as anti-competitive measures to enrich one interest group or another.

That the Clinton Administration's goal is paternalistic rather than protectionist does not make its proposed restrictions any less obnoxious. Advocates of censorship are almost always well-intentioned. One could, in fact, construct superficially appealing arguments for banning ads for liquor and beer, luxury or sports cars, furs, chocolate, non-eco-friendly goods, beef, dairy products, clothes made by foreign workers, anything produced in China, exhorbitantly priced athletic shoes, and more. All are "bad" by some measure. Why shouldn't Washington "protect" people from hearing about them?

Purpose of the First Amendment

But the purpose of the First Amendment was to prevent political majorities from suppressing unpopular speech, irrespective of why it was unpopular (were the speech popular, of course, constitutional protections would be unnecessary). And that includes so-called commercial speech. To make an exception for cigarettes -- to let Washington decide where billboards may be erected, how brand names may be used, the lawfulness of sports sponsorships, what may be printed on t-shirts, and the appropriate color of advertising, and to mandate contrary advertising -- is to make a huge exception to a basic right. Indeed, Barry Lynn of the American Civil Liberties Union warns that this sort of "'words only' approach [to advertising] is really nothing short of a ban in sheep's clothing, providing potential consumers with virtually nothing to alert them to the existence of lawful tobacco products. It is apparently intended to censor speech by having tobacco advertisements become as dull as many speeches on the floor of Congress." Ordering a business to spend untold millions (the FDA originally proposed forcing the entire industry to cough up $150 million, before limiting its mandate to six firms and dropping the specific dollar figure) to essentially attack itself invades the core values of the First Amendment by compelling speech in which someone disagrees.

Forcing the industry into collective confession, rather like a typical violation of the Fifth Amendment's prohibition against self-incrimination, is not even necessary to yield funds for anti-smoking campaigns. Groups like the American Cancer Society have created the National Center for Tobacco-Free Kids and contributed some $31 million for a national advertising program which will be directed by the ad firm of Porter/Novelli. Pharmaceutical companies that sell nicotine gum and patches also advertise extensively.

If implemented, the Administration's broad-breadth exception to normal free speech protections would likely be limited neither to cigarettes nor to regulations motivated by good intentions. If the federal government gains the power to micro-manage product advertising, it could do so for any and every industry. If the First Amendment means anything, it prohibits this kind of control.

Existing Regulation Ignored

Listening to the debate over the Clinton Administration's proposals might lead one to believe that tobacco was today virtually unregulated. That is, of course, not the case. From beginning to end cigarettes are subject to a series of disparate government controls. The Department of Agriculture, for instance, maintains production quotas for tobacco, an archaic holdover from the New Deal. Every state restricts the sale of cigarettes to minors; some regulate the use of vending machines. Many are currently debating strengthening their controls by, for instance, requiring presentation of photo ID's to purchase cigarettes. Numerous localities and some states limit smoking in public areas, including parks, while the federal government does the same in some agency buildings and on private commercial aircraft. Congress has banned cigarette advertising in the electronic media and mandated inclusion of health warnings on cigarette labels and ads. The Federal Trade Commission has long been empowered to regulate advertising. In 1992 Congress passed legislation requiring states to improve their enforcement efforts to prevent teen smoking or lose federal grants. Taxes by local, state, and federal governments account for roughly 40 percent of the price of cigarettes -- in fact, it is hard to find a more highly-taxed product in America. Voluntary private restrictions, too, are growing more severe: the 3M Media company recently announced that it will no longer lease billboards to advertise tobacco products.

Particularly important are state laws governing the sale of cigarettes to minors, which already address the alleged purpose of the FDA's new campaign. Smoking by minors was recognized as a problem more than a century ago. In fact, some critics charged that cigarettes, in contrast to cigars and pipes, were created with the express purpose of enticing children (and women) to use tobacco. By 1890, 26 states had banned the sale of tobacco to minors; early in the next century, 14 states had gone so far as to outlaw cigarette sales entirely. Since then states have moved back to a more reasoned position, prohibiting sales only to children, though the age varied by state until Congress set 18 as a national standard in 1992.

Porous Prohibitions

Obviously state prohibitions are porous: Last year, the University of Michigan reported that 18.6 percent of eight-graders smoke and 31.2 percent of high school seniors were puffing away. Children found it easier to purchase cigarettes in 1993 than in 1989. These facts are both appalling and astonishing. Appalling because kids obviously pay so little attention to the risks of smoking. Astonishing because state laws are obviously unable to prevent a large number of minors from smoking.

Equally astonishing, though, is the belief that shifting the problem to Washington would improve matters. Cigarette sales, like street crimes, are the sort of activities that can only be controlled at the local level. And localities and states are already struggling mightily over how to improve enforcement. Unless the FDA is prepared to loose a swarm of tobacco investigators across the nation and clog federal courts from California to New York with prosecutions, it is not going to be able to make more than a marginal difference in the sale of cigarettes to minors. Already many states monitor tobacco sales, undertake sting operations, and the like. And kids still find friends to buy for them and stores to sell to them.

The FDA proposals most likely to have some effect -- the virtual ban on vending machines and draconian controls over advertising -- also would have the greatest impact on adults. Moreover, they are the kind of issues that have traditionally seemed best decided outside of Washington. Getting rid of vending machines, at least in unsupervised places open to children (unlike, say, bars), makes a lot of sense, but is quintessentially a local question. We all ultimately lose a bit of our freedom if we allow policy to be set nationally by an unaccountable federal bureaucracy. So, too, with advertising questions. Why must the number of feet between a school and a tobacco advertisement be decided nationally? And why must any government at any level decide what color may be tobacco advertisements and how cigarette brand names may be used on t-shirts and other products?

Foolishly Trusting the FDA

Although the FDA wants to regulate most everything, it can't. James Phillips, the FDA's former chief investigator, complains that in early 1994 he couldn't talk to administrator David Kessler about any number of pressing issues because of the latter's fixation on tobacco:

For the better part of the Spring of 1994, Dr. Kessler spent virtually all of his time on cigarettes. I can recall several instances in which I tried to contact Dr. Kessler on important matters and was told by his secretary that if my topic was anything other than cigarettes, the Commissioner would not have time for me.

In fact, Dr. Kessler has long been noted for his ambitious attempts to expand agency power and acquire positive press. Among his more notorious crusades was the seizure of orange juice named "Fresh Choice" for not being "fresh." The fact that the juice carton noted it was made from concentrate and consumer surveys showed that people did not believe it was freshly squeezed did not deter the FDA from destroying 12,000 gallons of perfectly good orange juice. Tobacco regulation was another Kessler priority, well before the President announced his program last year.

The issue is not just the administrator. It is also the FDA bureaucracy as a whole. For three decades the agency has demonstrated a willingness to stifle the development of even life-saving drugs and devices as it steadily expanded its authority through legislative enactment and regulatory interpretation. Typical of the FDA's imperialistic ambitions is its assertion, originating before the President's proclamation last year, of authority over cigarettes as "nicotine delivery devices," even though cigarettes predated the FDA and were never placed under the agency's authority by Congress.

Discouraging Drugs and Devices

Much has been said and written of the FDA. There is little doubt, however, that today the FDA simultaneously discourages the development of new medical products and increases their cost. So poor is its performance that Lydia Verheggen, director of health policy at Citizens for a Sound Economy, complains that "compliance with federal law is not always an FDA priority since the agency has chosen to employ selective observance of the law."

In 1962 Congress voted to slow down the drug approval process and have the FDA certify drugs for effectiveness as well as safety. In just five years, the average FDA review time for pharmaceuticals more than tripled. Drug development costs more than doubled between the 1960s and the 1980s, in large part due to the FDA. They now average $445 million. This is an especially heavy burden on firms that survive only by creating a few successful products from many, many research dead-ends. (Of every 4,000 compounds tested, only one ends up being marketed, and barely 30 percent of those make any money. )

Indeed, product development has slowed as FDA power has expanded. The U.S. generally introduced new drugs more speedily than did Great Britain through 1965. But it was Britain that enjoyed the lead, an estimated 15 months, between 1966 and 1971. More than half of the 204 new drugs introduced in America between 1977 and 1987 were sold first in Britain. Barely one-fifth of Britain's 186 new drugs first appeared in the U.S. Sadly, the greatest time lags in America occurred in the approval of pharmaceuticals to treat cancer, heart conditions, and other deadly diseases. Incredibly, it took twice as long to win approval for new drugs in America than in other industrialized nations by the early 1990s. Six of every ten new drugs and vaccines approved in the U.S. between 1990 and 1994 were available first overseas.

FDA Casualties

FDA dawdling does not just cut corporate profits. It also kills people. According to Robert Goldberg of Brandeis University, "By a conservative estimate, FDA delays in allowing U.S. marketing of drugs used safely and effectively elsewhere around the world have cost the lives of at least 200,000 Americans over the past 30 years." The agency's casualty list is a long one. Alzheimer's patients were long denied access to the drug THA, even when it was available in other nations. The agency dithered while patients with kidney cancer begged for access to Interleukin-2. AIDS patients, too, sickened and died as the FDA assessed the cost-effectiveness of drugs such as AZT. People suffering from serious cardiovascular conditions waited years for Washington to okay beta-blockers; Science magazine charged that the agency had "not only egg on its face but blood on its hands."

The FDA has created similar barriers to the introduction of medical devices -- band-aids, nuclear magnetic resonance machines, and more than 40,000 other products. Over the last decade applications for approval of new products and changes in existing products have piled higher and higher at the FDA. Approvals fell steadily from 1989 to 1992, before rebounding slightly in 1993. The number of 510(k) applications, for simple devices, pending for 90 days or more rose from two to 713 between Novembers 1991 and 1992. The average review time ran 216 days in 1994, dipping to a still ridiculous 185 in early 1995, after the Republican takeover of Congress. More complex goods wait literally years -- 823 days, on average, in 1994 -- for approval. Yet the FDA actually tightened its control in response to industry criticism, that is, until the 1994 election, and increasing congressional concern over agency dithering.

Again, patients suffer the most. People with serious conditions ranging from coronary disease to ligament injuries would benefit from new and improved medical products, if they were available. Typical of the FDA obstruction is its refusal to approve the Ambu CardioPump, thought by many doctors to increase the likelihood of surviving a heart attack by as much as 50 percent. The device, manufactured in Denmark and required equipment on ambulances in Austria, is completely safe. The only argument against it is that it may not save many lives. But how better to test it than to allow its use? Complains analyst Alexander Volokh, it is as if the FDA put up a sign that said "Do not resuscitate."

The agency is also the nation's leading book-burner. Despite the First Amendment, the FDA strictly regulates device and drug advertising. Explains Administrator David Kessler, advertising for "nonapproved uses" of drugs "is prohibited even if these uses are supported by studies in the medical literature." Yet up to half of all drugs, and 90 percent of those used in pediatrics, are prescribed for off-label uses. Drugmakers don't seek formal approval for new uses because doing so requires running the same approval gauntlet, and the agency takes even longer -- up to two years -- to okay secondary uses.

Killer Rules

These rules also kill. Paul Rubin of Emory University warns that tens of thousands of people may be dying annually from the FDA's ban on aspirin producers advertising the benefits in combatting heart disease. Two-thirds of oncologists surveyed by the Competitive Enterprise Institute complained that the agency's campaign against sharing information on how drugs can treat multiple forms of cancer had made it more difficult for them to care for their patients. Says Dr. Larry Norton, head of breast oncology surgery at the Memorial Sloan-Kettering Cancer Center: "If I had to use drugs for their approved uses only, half my patients would be dead."

It took the 1994 election, but now even the FDA acknowledges that its record has not been perfect. David Kessler has taken the lead in touting his agency's speedier approval of drugs and devices. But he has inflated the FDA's progress through statistical legerdemain, leaving the agency's record one of continuing failure. Moreover, Kessler's promise to do better is suspect: the FDA's new-found commitment to reform seems only as deep as the Republican majority on Capitol Hill is large. There is no reason to believe that the administrator has abandoned his desire to expand his agency's power.

And if he succeeds in doing so, if the agency is allowed to grab vast power over an entirely new industry, the device and drug approval processes will inevitably suffer. To effectively police the retail advertising and distribution of tobacco would require enormous resources. States already try to do so, with only intermittent success; indeed, it is their relatively high failure rate that is currently driving federal proposals to regulate. But Washington is far less capable of dealing with the issue. Any serious FDA campaign will almost certainly reduce the already inadequate attention given to speeding pharmaceuticals and other medical products to the market. Administrator Kessler told a Senate Committee earlier this year that his agency cannot expedite drug approvals: "I want to get drugs out, but we want to be thorough and don't want to sacrifice progress made over the years." Such alleged thoroughness will take even longer if the FDA shifts its focus to cigarettes.

Conclusion

Overall, long-term cigarette use has been falling amongst adults and children alike. Teen smoking alone in 1993 was down 62 percent from 1979 and 17 percent from 1990. Smoking by children fell both in terms of absolute numbers and population rates during these periods. These positive trends obviously can suffer -- and have recently suffered -- short-term reversals, but they suggest that in general the government's current stance has managed to preserve people's freedom to smoke while encouraging them to make the "right" decision not to do so. There is no justification for the Clinton administration's radical shift in traditional policy and extreme expansion of government power.

Of course, too many kids still smoke. But Washington does not have the ability to solve a problem that states have found to be intractable or the right to substitute Big Brother for their families. The Administration's proposal is bad from the standpoint of principle: Washington should not treat adults like children in a vain effort to protect the latter. The federal government certainly should not sacrifice important First Amendment values on the dubious claim that doing so will solve a problem endemic to America since its creation, underage smoking.

The practical objections to the Administration measure are equally serious. Tobacco is already one of America's most heavily regulated products; additional controls by the FDA are unlikely to have any more than a marginal impact on the smoking rate of children or adults. Finally, the FDA has more important work to do, like hurrying the approval of potentially live-saving devices and drugs. To sacrifice the lives of thousands of people who could be saved with new pharmaceuticals and medical devices in a quixotic crusade against smoking would make sense only to an ideologue.

In the end, the tobacco battle is over prohibition and power, not children. The ultimate goal of regulatory proponents is obvious. In response to industry proposals that local merchants require a picture ID for cigarette purchases, Robin Brown, spokesman for the San Diego chapter of the American Cancer Society, opined: "We'd prefer that they don't sell tobacco at all to anybody." The FDA seems determined to fulfill this objective, and to do so, conveniently enough, by expanding its own power. This isn't the first time that the agency has used a "crisis" to gain influence: after the drug thalidomide caused birth defects, Congress greatly enhanced the FDA's authority, even though the agency's new powers would do nothing to prevent a similarly dangerous drug from entering the market. Nor are the current tobacco regulations likely to be the agency's final bid for more power. After a decent interval, the FDA will almost certainly declare that its regulatory efforts--assuming they survive both congressional and court challenges--have failed, as they inevitably will, to curb teen smoking. Administrator Kessler, or whoever replaces him, will then propose even more draconian steps. And so on.

Smoking is a dumb habit, a stupid behavior, a foolish action -- but not the government's responsibility to prevent. Rather, the responsibility for smoking, and quitting, lies with the individual. It is not government's job to save people from themselves, especially when doing so would infringe their freedom, limit the constitutional guarantees for the rest of us, and end up hurting and probably killing patients now waiting for the FDA to fulfill its other responsibilities.

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Doug Bandow is a syndicated columnist with the Copley News Service and Senior Fellow at the Cato Institute in Washington, D.C. A former Special Assistant to President Reagan, he is the author of "The Politics of Envy: Statism as Envy."



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