"I've never seen anything like it. The calls range from diabetics and people with weight problems almost plaintively asking what they can do now, all the way to zealots demanding that they have total freedom to decide what they're going to put in their bodies.…"
—Unidentified FDA Spokesman March 17, 1977
The Food and Drug Administration's proposed ban on saccharin raises once again the question of the relationship between the citizen and the State. In March the FDA announced a ban on saccharin, effective July 1, based on tests in which rats fed the equivalent of 1000 cans of diet soda per day developed bladder cancer. In making its decision the FDA ignored vast amounts of evidence from studies of humans which fails to indicate any link with bladder cancer. Dr. Kurt Isselbacher of Harvard Medical School cites studies of 20,000 people dating back to 1935; Dr. Irving Kessler of Johns Hopkins has conducted controlled studies of 1000 saccharin and cyclamate users, with similar findings. Yet so rigid are the laws under which the FDA operates that it was legally required to ban saccharin based on the rat experiments.
The FDA dates its existence to 1906 and passage of the Pure Food and Drugs Act, aimed at protecting consumers from fraud and mislabeling. The law was strengthened in 1938 by the Food, Drug, and Cosmetic Act, which required manufacturers to test new drugs for safety and report the results to the FDA. That law also gave the agency the power to remove from the market drugs it could prove unsafe. The FDA has similar power over food additives like saccharin. In 1958 the agency's control over food additives was substantially increased when Congress passed an amendment authored by one James Delaney of New York. That amendment, which bears Delaney's name, states that "no additive shall be deemed to be safe if it is found…after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." Under this law the FDA is required to ban any substance which can be shown to cause cancer in laboratory animals, regardless of the quantity ingested, the lack of similar evidence in humans, and the extent of benefits afforded humans by use of the substance. Even today the Delaney clause is hailed by many natural food adherents as a landmark in consumer protection legislation.
The fundamental premise underlying FDA regulation of drugs and food additives is control. The agency's approach (and that of the Congress) attempts to guarantee the safety of the substances under its jurisdiction. To do this, it adopts hypercautious methods aimed at making certain that no one may use potentially risky substances. If millions of people must forego various benefits in exchange for this guaranteed security…well, those are the breaks, folks.
You can see the same thinking at work in the FDA's approach to effectiveness testing. Under the 1962 Kefauver/Harris amendments, the agency requires drug manufacturers to prove not just the safety but also the effectiveness of every new drug. Economist Sam Peltzman has demonstrated that the FDA's hypercautious approach to this mandate has cut in half the number of new drugs being introduced, doubled their cost, and led to thousands of deaths and illness that could have been prevented by earlier introduction of life-saving new drugs (many of which are available abroad).
Once again, by seeking to guarantee that drugs are effective, the FDA precludes people's options, making choices for them that they might not have made for themselves. The alleged cancer treatment Laetrile offers another poignant example, as do Federal laws preventing even terminal cancer patients from receiving heroin or LSD for relief from excruciating pain.
Ultimately the issue boils down to the following: who is to be responsible for one's (potentially risky) choices—the individual or the State? Most people agree that individuals have the right to take such risky actions as going swimming, driving automobiles, going skiing, hang-gliding, smoking cigarettes, and drinking liquor. Each of these is potentially lethal, yet is considered within an individual's competence to choose. How much less risky is deciding to drink a can of diet soda—especially if one is a diabetic? But even in cases where the action may not appear rational to an observer—using "quack" remedies, taking heroin, playing Russian roulette—by what right is anyone justified in interfering with an individual's freedom of choice? Either one is free to take risky or irrational actions with his own life or one lives only at the sufferance of the State. In the latter case the concept of freedom is meaningless.
"What you say is all well and good," defenders of the FDA will argue, "but it neglects the fact that the average person lacks the knowledge to assess the risks of drugs and food additives. He may not even know he's being exposed to food additives. How can people make proper choices if they lack the necessary information?" Indeed, they cannot, but this fact hardly justifies the FDA's attempt to make their choices for them.
In a free society no such entity as the FDA would exist, but there would still be a need for information on the risks and benefits of various substances—drugs, food additives, chemicals, etc. It is quite likely that various specialized consumer information services would exist to meet the demands for information of various groups of people—health food fans and average consumers concerned about foods, physicians seeking feedback on the effects of prescribed drugs, industrial unions seeking to protect their members from harmful substances. Each constituency would seek certain kinds of information, and would presumably be willing to pay for it.
We do not yet live in a free society, of course. And although we are, today, much plagued by the FDA, it seems politically impossible to abolish it. Complain as they might about bans on saccharin, Laetrile, and the like, most people are still terrified of another Thalidomide incident and can't yet conceive of depending on marketplace institutions as sources of protection. It remains a source of security to them to have Big Brother FDA in Washington blessing their food and drugs.
But if abolishing the FDA is not yet in the cards, a radical change in its functions could move us substantially in the direction of a marketplace solution. Congress should remove from the FDA all power to coerce, leaving the agency strictly as a source of information. No longer could the FDA compel manufacturers to conduct tests or fill out mountains of forms, no longer could it ban products that people desire from the marketplace. It would merely compile and make available information on safety and effectiveness—whether submitted by manufacturers, universities, independent labs, or others. In so doing it would serve as a prototype for the more specialized commercial information services that would subsequently develop. In order to prevent unfair competition with these services, the costs of this revamped FDA could be met via a system of user charges for the information, rather than from tax revenues.
Making choices that involve risk is the essence of human liberty. The FDA violates this human liberty every day by its arbitrary actions and decisions. If abolishing the FDA altogether has a ghost of a chance, we should advocate it. But if we conclude that people need a government security blanket a while longer, stripping the FDA of its coercive power would still be a major step forward. Limiting the agency's role to providing information would restore vital freedom of choice to every American.
This article originally appeared in print under the headline "Saccharin and Human Liberty".