How An FDA Official Looked at
"Freedom of Choice" in the Real World

Stephen Barrett, M.D.


Some people suggest that consumers should have more freedom to buy products that thre product that the FDA has determined are a risk to health. Instead or banning a risky product from the marker, these arguments run, the FDA should devote its primary efforts to educational programs and correct labeling about the risks so consumers would have the information they need to decide for themselves whether they want to take the particular risk. In 1979, in a talk to the Association of Food and Drug Officials in Washington, FDA General Counsel Richard M. Cooper explained why such a "freedom or choice" policy was unacceptable to the FDA [1].


"Freedom of choice" is a noble slogan. It comes to us, in Wordsworth's phrase, "trailing clouds of glory" from the liberal democratic philosophy of Locke, Jefferson, and John Stuart Mill; from the free market economics of Adam Smith; and from the First Amendment. The Free Exercise Clause guarantees us freedom of choice in religion; the Assembly Clause and the Petition Clause, together with the constitutional provisions for elections and the 14th, 15th, 19th, 24th and 26th Amendments, guarantee us freedom of choice in politics; and the Free Speech Clause and the Free Press Clause guarantee us freedom of choice in ideas generally. Why, then, should we not also have freedom of choice in goods and services, and particularly in foods and drugs?

The economic argument for freedom of choice is clear and powerful. The free market economy operates like evolution: products appear; those that adapt to meet consumer demand survive and flourish; those that do not disappear. Consumers know their own needs better than anyone else does. Producers of goods learn those needs through trial and error. If consumers have adequate information about the products offered them, they will select those that best satisfy their needs. Thus, if freedom of choice is allowed to prevail, consumers will, over the long term, achieve the highest possible level of satisfaction. The greatest satisfaction of the greatest number is the very purpose of economic society.

Freedom of choice is a powerful idea also because it embodies notions of individual autonomy that run deep in western culture and that have flowered in particular abundance in the divergent lifestyles of this decade. Mill argued for freedom on the ground that it promotes truth. Liberal economists argue for freedom on the ground that it promotes efficiency. Some theologians and moral philosophers have argued, however, that freedom is essential to the religious or moral life. Saint Augustine, for example, in explaining why freedom of choice is a good that comes from God even though it can be turned to bad use, said: "it [is] not possible to do rightly except by free choice of will, and . . . God [has] given it . . . for this purpose [2] The more extreme autonomists argue that freedom of choice is an end in itself: that the exercise of free choice, using our rational powers, is the exercise of the distinctively human faculty; and that to restrict the area for freedom of choice is to diminish our humanity.

Primarily for these reasons, writers on food regulation have favored increased use of warnings instead of bans as a general strategy for resolving issues of food safety. Peter Barton Hutt, one of our most knowledgeable and thoughtful commentators on food and drug law, has argued:

For those substances for which there is a moderate risk and no safer alternative, and individual choice is feasible, the best approach may well be to permit the individual consumer to make a fully informed choice on the basis of his or her own perceptions of benefit, rather than to propose an arbitrary societal determination of benefit on all our citizens. . . . [T]he determination of what each individual concludes to be an acceptable risk, or an acceptable level of uncertainty is intensely personal and is based upon deeply felt beliefs and human values that perhaps cannot and should not be dictated by any government [3].

Other writers have expressed similar views [4].

It is no reflection on these writers to note that "freedom of choice" is also a banner being unfurled by others with less disinterested motives. Freedom of choke is a rationale for keeping on the market products that would otherwise be banned. Those who have an interest in selling those products naturally do not disdain the rationale.

If you want to sell an anti-cancer drug such as Laetrile that doesn't work and that presents certain risks, you don't defend it on the ground that its therapeutic benefits outweigh its risks. Instead, you proclaim: "Freedom of choice!" The same is true of saccharin. Now that the National Academy of Sciences has put its imprimatur on the findings that saccharin is a carcinogen, that its impurities have no demonstrable role in its carcinogenicity, and that it has essentially no demonstrable benefits [5], the public policy debate has shifted from the realm of science to the realm of philosophy and arguments for freedom of choice are looming much larger in that debate. If you make a good product—one that is safe and effective—you can promote and defend it by pointing to its merits. But when all arguments on the merits fail, the last refuge of the marketer is "freedom of choice." [6]

There is some analogy, however. Although in regulating foods and drugs the govern­ment does not have a duty to overcome the effects of its past wrongful actions, it does have a duty to take positive action to protect the public. A system of freedom of choice that consistently led to large numbers of people dying from poisonous foods and harmful drugs would simply not be acceptable. It was to prevent such occurrences that food and drug regulation was created in the first place. Moreover, consumers of foods and drugs—like the parents of schoolchildren In New Kent Count—are subject to a variety of influences when making decisions. We need not be prepared to find that those influences render the decisions "unfree" in order to be able to conclude that in light of those real-world influences a policy of freedom of choice is not an adequate discharge of the government's responsibility.

Freedom of choice is a fundamental value in our society, and is enormously important to our system of government, our economic prosperity, our progress in science and the arts, and the maintenance of our way of life. Nevertheless, other values are also important, and freedom of choice has not been allowed to override them in all circumstances. The First Amendment says Congress "shall make no law respecting" certain freedoms of choice, but Congress has made many laws respecting them, and most have been upheld. Freedom of religion is not absolute [7], nor is freedom of speech [8],nor is freedom of the press [9]. Until very recently, it was thought that there is no freedom of commercial speech at all [10]. and even now the scope of that freedom is highly uncertain.

In the realm of foods and drugs, as Mr. Hutt has ably shown, our political tradition is not one of unbridled freedom of choice, but rather one of very considerable, and in this century pervasive, regulation to protect the interests of consumers. For centuries, the common law, with the aid of statutes, has sought to protect consumers from "unwholesome" food, from the use of false weights and measures in the sale of food, and from the use of false pretenses [11].

Whether or not these examples of protective intervention by government can be squared with the classical economists' rationale for freedom of choice is immaterial. The fact is that even if free market competition could solve the problems of unwholesome food and deceptive practices, our society has not been willing to pay the price for that kind of solution.

Evolutionary solutions may bring progress and protect individual autonomy, but they take enormous amounts of time and are enormously costly. Evolution works, but no one ever said it is cost-effective. We have not been satisfied to leave it to consumers to find out for themselves which retailers sell unwholesome food or use deceptive practices and then to transfer their patronage elsewhere. We have not been satisfied to leave it to consumers to find out which foods and drugs will kill them, blind them, or otherwise harm them. Without government intervention, it would take too long to remedy the defects of the market; new defects would continually arise; and too many unnecessary deaths, illnesses and economic losses would occur. In the realm of food and drugs, we have not accepted the rules, of laissez-faire and caveat emptor. Instead, we have countenanced a degree of protective regulation that we would not accept in the realm of ideas.

Could not the same degree or at least a tolerable degree of protection be achieved by providing information rather than by prohibitions on new products and bans on old ones? That is the question I want to examine now.

It is an important question. Mr. Hutt argues that in at least a substantial number of circumstances consumers should be "permitted to make their own judgments about risks on the basis of complete and accurate information about the hazards involved [12]. The National Academy of Sciences recommends that educational programs and labeling strategies play a much larger role in food safety policy, and that bans be used much less frequentl [13]. Any social policy that gives a critical role to free choice critically depends on the availability of adequate information and the ability of the decision-makers to understand it and act on the basis of it.

But can the real world provide what the policy requires? The National Academy has summarized some of the reasons for thinking it cannot:

Many difficulties arise from attempts to provide risk informa­tion to the public. First, it is not easy to convey warnings about small and ambiguous risks. People have difficulty conceptualizing small-probability hazards, and abstract statistical information is much less compelling than concrete information. Second, the scientific basis for assuming the presence of food risks is often subtle and vulnerable to public skepticism. High dosage studies in rats fall in this category. Third, there is a danger that the public is satiated with health danger warnings, and would pay little attention to any given warning because of an increasing perception that; for example, 'everything causes cancer.' Fourth, public trust in the actions of government appears to have declined over the last ten years, and lack of credibility of government-sponsored information may limit its effectiveness [14].

Other reasons could be added. We could point to the substantial portion of our population who are functionally illiterate—who cannot read, or cannot understand, or cannot make purchasing decisions on the basis of information on labels [15]. We could point to children and teen-agers, who buy substantial quantities of food, including diet soda [16]. We could point to the many people who live in institutions or eat in restaurants; they never see the labels on the food they eat there.

Moreover, the U.S. population includes millions of people whose language is other than English and who have difficulty with English. See, e.g. U.S. Department of Commerce, Bureau, of the Census, Language Usage in the United States: July, 1975 (Current Population Reports, Special Studies, Series P-23, No. 60 (Revised), July, 1976).

We could point to the millions and millions of dollars spent on advertis­ing on television and radio, billboards and signs, in newspapers, magazines, and subway cars. These ads show beautiful, healthy people smiling and having fun and emphasize the tastiness and attractiveness of foods. How can a line of government prose buried in a package label compete with all that for a fair share of a consumer's time and attention?

Finally, in the case of drugs, the long, sad history of quackery and of orthodox medical remedies that didn't work testifies to the need for scientific standards and some government controls over the pharmaceutical marketplace. The Supreme Court has now recognized this need once again in the Laetrile case [17].

I shall focus on foods, where the argument for freedom of choice is made most insistently. To see what broad freedom of choice on safety matters in the real world of foods would mean, we shall leave the philosophers of freedom of choice in their offices and studies, and shall venture into a supermarket. We may also seriously doubt that food processors really would be willing to put on their products the kind of information a freedom-of-choice philosophy would require. We shall, however, put those doubts aside.

I frequently do the shopping for my family. I do it after work, when I am rather worn down; or on the weekend, when I am more relaxed. Some­times I take my children with Irie. When I enter a supermarket I do not expect to make BIG, LIFE-AND-DEATH DECISIONS; and I am not mentally or emotionally prepared to do that.

It normally takes me about an hour or so to reach the check-out counter. I am concerned about quality and, on a civil servant's salary, I have to be concerned about price. My hour includes some time comparing different kinds of products and different brands of the same product from the perspectives of quality and price. I generally don't choose products on the basis of safety; I simply don't worry about that; I have enough trouble making sure of freshness and price and keeping my kids from running all over the store. And, for the most part, I simply buy the same items week after week, without thinking too much about it and without examining the fine print on labels. I certainly don't do my food shopping on a zero-base principle by re-examining each and every food purchasing decision.

Shopping is a chore, but it's not really unpleasant (except for the price increases every week). The store is bright and clean; the foods are attrac­tively packaged; choosing foods from the shelves is modestly enjoyable. And the whole process doesn't take very long; I'd much rather spend my free time with my wife and kids, playing basketball or tennis, taking walks, reading, and so on. That's how I shop today.18

Let us go then, you and I, on a shopping trip to the future world of the freedom-of-choice supermarket. I have learned from the TV that the government no longer tries to prevent very many risky substances from getting into food. The point is reinforced by a sign over the supermarket door(required by law): Abandon confidence in the food supply, all you who enter here.

When I enter the store, I know that somewhere inside those thousands of jars and can sand boxes are substances that are risky, but that were approved because they provide economic benefits to farmers and food processors or to their employees or to towns where they have mills or plants. Others were approved because members of the public perceived them to have benefits although these benefits could not be scientifically demonstrated. Still others were approved to protect my personal au­tonomy, for which I thank the free market philosophers. So now safety is something I've got to be concerned about along with quality and price.

I'm not paranoid, and I don't worry more than the average person. But I don't want to buy food that will harm my wife and kids or that will harm me. Fortunately, the new system of freedom-of-choice food safety regulation pursues an "information strategy." All the foods in the supermarket contain a logo that signifies high risk, moderate risk, or low risk. The high risk logo, I know, is a skull-and-crossbones. The other two logos I sometimes confuse in my mind, even though I saw them on TV a couple of nights ago. I'm in luck, however, because my store has posted a sign explaining the logos.

Early on, it was found that the logos didn't mean much to people. Surveys showed that the simple message- "high risk," "moderate risk," or "low risk"-merely produced an attitude of "So what?". In addition, people were confused because some traditional foods that they had been eating all their lives, and their parents and grandparents before them, were labeled "high risk;" and new foods they'd never heard of and that had lots of chemicals in them were labeled "low risk."

Since one of the premises of freedom-of-choice is informed decision-making, the government attempted to solve this problem by requiring that additional information be provided to consumers. At one point this approach did get out of hand: some bureaucrat took seriously the notion that consumers should be permitted to make their own judgments about risks on the· basis of complete and accurate information about the hazards involved, and the government started to require that the packages of all high risk products contain a "brief and succinct" explanation of the principles of toxicology. But, after a lawsuit, that approach was abandoned. Now, a "reasonable" amount of information is provided. Here are some examples of statements on food packages:

"This product contains a substance that has been found to cause cancer in rats."

"This product contains a· substance that has been found to cause cancer in one species of mice and that is positive in 3 out of 5 screening tests." ·

"This product contains a substance that has been found to cause cancer in rats, but the effect was barely significant statistically. The product has also been found to cause reproductive effects in monkeys."

"This product contains a substance that, when given in high doses in laboratory animals, has been found to cause cancer. There is no epidemiological evidence that it causes cancer in humans."

"This product contains a substance that causes toxic effects in animals, but there is no accepted way to estimate its risk to humans."

"This product contains one substance that has been found to cause cancer in rats and another that has been found to cause cancer in two species of mice."

"This product may contain a contaminant that is a potent carcinogen."

"This product contains a substance that has raised concerns about whether it causes cancer or interferes with the body's immune system. It is known to combine with other substances to form a potent carcinogen. However, certain kinds of products without this substance may present a risk of botulism if they are not handled properly."

"This product contains a substance that has been found to cause cancer, but the U.S. Government has determined that the risk of cancer it presents is acceptable.".

"This product contains a substance that has been found to cause cancer, but the U.S. Government has determined that the sub­stance is an essential nutrient, necessary for maintaining life."

In the aisles the shoppers come and go, talking of angiosarcomas.

I do do many things in my life that I suppose are relatively risky, but I have no idea what the statistical risks are and I hardly ever think about them. As I wheel my shopping cart down the aisles, I pick out packages from the shelves to see whether there is any safety information I should be aware of. I have to check every package I consider buying because you never know what it will sav. Then I have to think about all those descriptions of risk, figure out what they really mean, and decide which risks my wife and kids and I should take. The most intense agony comes when I have to decide whether to pay more for a product that seems less risky. .

Swarms of foods carry some sort of risk information—even the fresh fruit and vegetables, due to pesticides. (Do I dare to eat a peach?) I had not know the information strategy had undone so many. And it's never easy to make these risk decisions. Some people talk as though I carry around in my head a set of risk-benefit decision rules and a set of food safety indifference curves, but I don't.

Standing there in the aisle trying to make these important decisions isn't easy because people are always rushing past you, grabbing things from in front of you or asking you to step aside. The kids yank at my sleeve and ask whether they can buy this candy or that cake, or they complain that they're bored. At least I don't have to carry an infant with me when I shop, as I used to do.

Shopping is no longer any fun at all. I certainly don't enjoy ma king those decisions. I'm never satisfied that I've made them correctly. I never feel that I have enough information, but I don't know that more information would make it any easier. Some theorists talk as though I'm able to process an indefinite quantity of information about every one of the large number of consumption decisions I make in the supermarket. But the advertisers know that isn't true. And, even with the quite small amount of risk information that is provided on the packages, my shopping seems to take forever. I'd much rather spend my limited time on this earth doing other things.

I leave it to you to judge, given a social policy of freedom-of-choice, how much of my description of the freedom-of-choice supermarket is impossible fantasy. I will, though, make one claim for it-that it illustrates how freedom of choice philosophers have lost their sense of proportion and how they fundamentally misconceive and misapply our society's strong but selective commitment to individual autonomy and freedom of choice.

We are committed to freedom of choice in the important matters of life, about which we believe individual autonomy should govern. In religion, in morals, in politics, in arts, sciences and ideas generally, we believe that people should be free to choose as their inner lights guide them. We believe that people do not need or want to be protected from the risk of error in such matters, and that the history of governmental efforts to say what is error and to seek to prevent it demonstrates that such efforts are the essence of tyranny. We also believe that people should be free to make fundamental decisions about their lives-where to live, where to work, whom to marry, whether to have children, how to spend free time, and so on. Here, too, we as a society believe with St. Augustine that the value of free choice outweighs all the harms and unhappiness that may result from decisions that may prove to have been wrong.

When we come to choices among foods, however, the claims of individual autonomy are very different. Certainly the government shouldn't tell me what to eat; that would be unthinkable. Free exercise, however, is a quite different matter. The banning of food additives cannot be compared to the banning of religious sects or political parties or literary clubs. Mr. Hutt contends, however, that decisions about foods raise "the most basic questions of personal beliefs and human values [19]. I simply disagree.

When Patrick Henry said, "Give me liberty or give me death," he wasn't talking about the composition of foods. Some things in life are vastly more important than others. Our human dignity, our distinctively human faculties, our spiritual, moral, political, emotional, interlectual, aesthetic and social values are expressed in decisions about religion, politics, art, science, and the course of our lives. But, in general, they are not expressed in decisions about additives in foods.

I enjoy consumption about as much as the next person, but I am quite content to leave it to the government to decide on safety grounds what substances may not be added to the food I eat, or what pollutants may not be added to the air I breathe (should there be freedom of choice in pollutants?), or what defective parts may not be included in the engines of airplanes I fly in. In general, I believe that when the government bans an additive or a pollutant or a defective part, it doesn't interfere with my ability to live in accordance with my personal beliefs and values.

I say "in general" because there are exceptions. There are some substances that are peculiarly important and that people feel strongly about. Such substances are, as a practical matter, unbannable. Examples are alcohol and tobacco. I suspect we are learning that saccharin—or, at least, the last non-nutritive sweetener- is a third. In this democracy, if a majority of the people (as reflected by their elected representa­tives) want to go on consuming these substances, they should be able to.

But the public demand for these substances that have special appeal does not justify any general argument that the centerpiece of food safety policy should be freedom of choice. I submit that, as to the generality of risks that may arise in the food supply, the public wants protection, not information and not freedom of choice. 20 People would rather spend their time and energy on the areas of life where freedom is really important and not have to worry about the toxicology of the food supply. Indeed, freedom of choice on food safety matters would distract time and energy away from activities that are expressions of far more important freedoms.

The general and strong presumption in food safety policy should be for protection and against freedom of choice. 21 Where the public registers its determined preference to keep a particular risky substance in the food supply, our democratic political system can and should find a way to keep it in. I would expect such cases to be quite rare.

Footnotes

  1. This paper was presented at the 83rd Annual Conference of the Association of Food and Drug Officials, Washington, D.C., June 20, 1979.

  2. S. Augustine, De Libero Arbitrio Voluntatis, Bk. 11, Ch. xviii, p. 77 (Sparrow trans. 1947). See also, e.g., I. Kant, Foundations of the Metaphysics of Morals 59, 64-83 (Beck trans. 1959).

  3. P. Hutt, Public Policy Issues in Regulating Carcinogens in Food, 33 Food Drug Cosmetic L.J. 541, 556 (1978).

  4. See, e.g., R. Havender, Ruminations on a Rat: Saccharin and Human Risk, Regulation, March/April, 1979, at 11;Rutherford v. United States, Regulation, March/April, 1979, at 17; Rutherford v. United States, 438 F. Supp. 1287, 1298-1301 (W. D. Okla. 1977), aff'd on other grounds, 582 F.2d 1234 (10th Cir. 1978, rec'd, 47 U.S.L.W. 4724 (U.S. June 18, 1979).

  5. Assembly of Life Sciences/Institute of Medicine/National Research Council/National Academy of Sciences, Saccharin: Technical Assessment of Risks and Benefits (Nov. 1978).

  6. Some light on freedom of choice is shed by Green v. County School Board, 391 U.S. 430 (1968), which involved the use of freedom of choice as a means for desegregating the schools of rural New Kent County, Virginia. The county population was about equally divided between blacks and whites, and they lived side by side without residential segregation. Prior to 1954, the county operated two schools, one in the eastern part for all grades of whites and the other in the western part for all grades of blacks. Under the regime of segregation, buses used criss-crossing routes to take children to and from school. The county schools could easily have been desegregated by drawing a line down its middle and using one school for the early grades for both races and the other school for the later grades. That solution also would have reduced busing.

    When the county developed its first desegregation plan a decade after Brown, however, it adopted freedom of choice: black parents and white parents could freely choose the school their children would attend. Under the New Kent County Plan, 15% of the blacks chose to attend the white school, and none of the whites chose to attend the black school. By the time the case reached the Supreme Court, the overwhelming majority of southern school districts undergoing desegregation were doing so by means of freedom-of-choice plans. No doubt, Locke's Second Treatise and Mill's On Liberty enjoyed new popularity throughout the South. The question before the Court was whether such plans constituted adequate desegregation.

    Defenders of freedom of choice argued that it was the very antithesis of segregation and racism. It avoided any assignment of children to schools on the basis of race. It affirmatively provided equal educational opportunity by giving black parents and white parents an equal opportunity to choose the educational environment for their children. Who could object to that?

    But the Supreme Court would have none of it. It held that; on the record before it, freedom of choice did not discharge the county school board's duty to end the dual school system left over from the era of segregation and to eliminate the vestiges of official racial discrimination "root and branch."

    The Court reached its decision without finding that the choice offered to the black parents was not really "free." There was evidence to that effect, but the Court "neither adopt(ed) it nor refuse(d) to adopt it." 391 U.S. at 440 n.5. The Court's unanimous opinion is vague and subject to a variety of interpretations. See Note, The Supreme Court, 1967 Term, 82 Harv. L. Rev. 63, 111-18 (1968). But it is safe to say that the Court recognized that, for all its philosophical appeal, freedom of choice in the real world of New Kent County, Virginia was not an adequate solution to the problem of achieving desegregation.

    Of course, Green is not directly applicable to the problems of freedom of choice that arise in food and drug regulation. There, the school board's duty did not end with mere non-discrimination; it had an affirmative duty to take positive action to extirpate the vestiges of its own prior unconstitutional policy of segregation. The court's holding was that a freedom-of-choice plan was not sufficient to discharge the latter duty.

    There is some analogy, however. Although in regulating foods and drugs the govern­ment does not have a duty to overcome the effects of its past wrongful actions, it does have a duty to take positive action to protect the public. A system of freedom of choice that consistently led to large numbers of people dying from poisonous foods and harmful drugs would simply not be acceptable. It was to prevent such occurrences that food and drug regulation was created in the first place. Moreover, consumers of foods and drugs—like the parents of schoolchildren In New Kent County—are subject to a variety of influences when making decisions. We need not be prepared to find that those influences render the decisions "unfree" in order to be able to conclude that in light of those real-world influences a policy of freedom of choice is not an adequate discharge of the government's responsibility.

  7. Reynolds v. United States, 98 U.S. 145 (1878).

  8. Schenck v. United States, 249 U.S. 47 (1919).

  9. Miller v. California, 413 U.S. 15 (1973).

  10. See Valentine v. Chrestensen, 316 U.S. 52 (1942); Bigelow v. Virginia, 421 U.S. 809 (1975); Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976).

  11. P. Hutt, The Basis and Purpose of Government Regulation of Adulteration and Misbranding of Food, 33 Food Drug Cosmetic L. J., 505, 506-09 (1978).

  12. P. Hutt, The Basis and Purpose of Government Regulation of Adulteration and Misbranding of Food, 33 Food Drug Cosmetic L.J. 505, 537 (1978).

  13. Institute of Medicine/National Academy of Sciences, Food Safety Policy: Scientific and Societal Considerations, pp. 9-9, 9-17, 9-25 (March 1979).

  14. ld., p. 7-14 (March, 1979). Two chapters later, the Academy recommended that "consumers ... be given the opportunity to play a larger role in food safety decisions." Id., p. 9-17. See also id., pp. 9-9, 9-25.

  15. A recent study of adult functional competence reported that "approximately one-fifth of U.S. adults are functioning with difficulty." University of Texas at Austin, Industrial and Business Training Bureau, Adult Performance Level Project, Adult Functional Competence: A Summary 6 (1975). The conclusion was based on consideration of the following areas of knowledge and skills: occupational knowledge, consumer economics, government and law, health, community resources, reading, problem solving, computation, and writing. The report further commented: "In terms of the general knowledge areas, the greatest area of difficulty appears to be Consumer Economics . . . (S)ome 34. 7 million adult Americans function' with difficulty and an additional 39 million are functional (but not proficient) in coping with basic requirements that are related to Consumer Economics . . . . A greater proportion of people is unable to perform basic computations than the other skills. Approximately one-third of the population, or 39 million adults. functions with difficulty, and a little over one-fourth, or 29.5 million adults, is functional but not proficient in task performance on items requiring mathematical manipulation." Id., 6-1.

  16. In its report on saccharin, the National Academy of Sciences did not discuss how much saccharin is bought (not just consumed) by children and teen-agers, but it did conclude that the "greatest users (of saccharin) are now females in the child-bearing years (20-39-year age group) and males from birth to 9 years of age." Assembly of Life Sciences/Institute of Medicine, National Academy of Sciences, Saccharin: Technical Assessment of Risks and Benefits, p. 2-19 (Nov. 1978). The Academy also concluded: "The percentage of young children that consume saccharin is also rising. Young children consume fewer total milligrams per user than do older persons, but the amount per unit of body weight often surpasses the intake among adults, the same as one would find with other food components." Id. p. 2-18.

  17. United States v. Rutherford, No. 78-605 (U.S. June 18, 1979).

  18. In a recent survey, FDA asked respondents, "Aside from prices, please tell me about any particular problems, difficulties, or concerns which you have with food these days." About half the respondents (49%) reported no problems other than price; 14% mentioned adverse health implication; 8% thought food is not as fresh as it should be; another 8% mentioned labeling problems; and 3% had miscellaneous concerns. Nearly three-fifths of consumers, when asked directly about information on food labels, wanted full ingredient labeling. FDA, 1978 Consumer Food Labeling Survey (Summary Report), 3, 5 (May, 1979). There is no evident demand for additional information about risks.

    When FDA proposed to announce its defect action levels for foods (which limit, for example, the quantity of mold or' insect fragments that may be present in food), 37 F.R. 6497 (Mar. 30, 1972), it received more than 600 comments, about 98% of which were from consumers. FDA reported that most of these comments "objected to the existence of any level of defects in food or maintained that the levels allow an excessive amount of defects in food." 38 F.R. 854 (Jan. 5, 1973). It is safe to say that the public is not eager for· food package labels to disclose the number of insect fragments permitted in processed foods.

  19. P. Hutt, Public Policy Issues in Regulating Carcinogens in Food, 33 Food, Drug, Cosme­tic L.J. 541, 548 (1978).

  20. The public's views when asked about public policy toward carcinogens is ambivalent and complex. When asked about carcinogens generally, about¼ of the population favors a total ban, and '¾ favors letting people make their own decisions. When asked specifically about additives to foods and drugs, about 3/.a favor a ban on carcinogens, and ¼ oppose it. See Cambridge Reports, Inc., Public and Worker Attitudes Toward Carcinogens and Cancer Risk 42. 46, 47 (April, 1978} (prepared for Shell Oil Co.)

  21. I am, of course, referring to the policy toward risks that foods pose to the generality of the population and that under current law. would warrant a ban (e.g., risks of cancer, risks of acute poisoning). Foods that present risks only to a relatively small and relatively well-defined group within the population (e.g., people allergic to a particular additive, people on salt-free diets, people with certain nutritional diseases) warrant a different policy. In general, such people have been told by their doctors to avoid certain substances. Consequently, they are not looking for information with which to make complex risk-benefit decisions; they simply want a complete list of ingredients: if a food contains the substance to be avoided, they won't buy the food. Here, an information strategy is tolerably effective; although a ban would protect those who should avoid the substance but whose condition has not been diagnosed, it would impose an unacceptable loss on the rest of society. A recent survey by FDA found that among consumers who pay any attention to food labeling (apart from product information, brand name, and price) by far the most frequent use of labeling is use of the ingredients list to avoid particular substances thought to be harmful or hazardous. 'l'he ingredients most often mentioned were sugars (by far the number one item), salt, fats and oils, and preservatives. FDA, 1978 Food Labeling Survey (Summary Report), 6 (May, 1979)

This article was posted on December 27, 2019.