Supreme Court Overturns Saccharin Ban

FDA must bear burden of proof

WASHINGTON, Dec. 9—In a surprise move today, the Supreme Court struck down a controversial ban on saccharin by the Food and Drug Administration. The decision is expected to have sweeping long-term consequences for American consumers and for the future of food and drug regulation in the United States.

The Supreme Court heard arguments in the case on October 23, and legal experts expected the Court to uphold the FDA's ban, relying on a history of court decisions affirming the government's power to regulate food safety. Instead, the Justices, in a 5-to-4 decision, held that the section of the Food, Drug and Cosmetic Act under which the FDA acted is unconstitutional.

One of the major producers of saccharin says that its product will be back on market shelves within several weeks. The makers of other food products that have been banned in the past are expected to appeal the FDA's rulings soon. And although legal experts have not yet analyzed the Court's decision, one prominent economist who has studied drug regulation by the FDA predicts that the decision will have a spill-over effect on over-the-counter and prescription drugs, increasing Americans' average life expectancy by several years.

The Court's opinion in the case was written by Chief Justice James Madison, who was joined by Justices Jefferson, Hamilton, Jay, and Adams. FDA officials are unwilling to comment on the Court's surprise move, saying that they have not yet seen the text of the Court's opinion. Because of the wide-ranging implications of this ruling, the opinion is reproduced here in full. (Justices T. Roosevelt, F.D. Roosevelt, J.F. Kennedy, and E.F. Kennedy filed a dissenting opinion, not published here.)

OPINION OF THE COURT The federal Food, Drug and Cosmetic Act (FDCA) prohibits interstate commerce in any "adulterated or misbranded" food, drug, device, or cosmetic. The act specifies that an adulterated food is any food that is or contains an unsafe food additive. Under the "Delaney clause" of the FDCA, any food additive must be deemed unsafe if it is found, when ingested or after appropriate food safety tests, to induce cancer in man or animals. The Food and Drug Administration (FDA) is charged with administration of this act. The questions for decision are (1) whether the demands of the Delaney clause are impossible to satisfy, (2) whether the clause breaches due process of law under the Fifth and Fourteenth Amendments by presuming that all food additives shown to be carcinogenic (cancer-inducing) under certain conditions are also so under normal conditions of human use, and (3) whether the clause breaches due process of law by presuming harm, rather than safety, until proven otherwise.

I The case arises out of a seizure action taken by the FDA against claimant, Saccharine Sweets, Inc. In a notice published in the Federal Register (June 10, 1981), the FDA stated that it had been determined, through administrative review of available animal and human studies, that the sugar substitute saccharin is a carcinogen. The FDA thereupon ordered a ban on its use as a food additive.

When claimant failed to withdraw its product, "Saccharine Sweets," from sale, the FDA proceeded with libel of information action, charging that the res, 14,203 packages, more or less, of claimant's product is adulterated within the meaning of the FDCA. The specific adulteration charged is violation of the so-called Delaney clause of section 409(c)(3)(A): "That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals.…" Claimant's product was seized by FDA agents on June 28, 1981, under section 304(a)(1): "Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into…interstate commerce…shall be liable to be proceeded against…on libel of information and condemned in any district court…within the jurisdiction of which the article is found."

The claimant admits in its answer that the product was shipped in interstate commerce. It denies, however, that its product is adulterated as charged and urged that the District Court find the Delaney clause unconstitutional on several counts. The District Court instead upheld the seizure and ordered the condemnation of claimant's product. The Court of Appeals affirmed the decision. We granted certiorari to review this case because it raises important constitutional issues. We reverse.

II The Delaney clause now permits the FDA to prohibit the manufacture, distribution, and use of a food additive if it determines, through administrative review of available animal or human studies, that the additive is carcinogenic under certain conditions, including administration of high doses to test animals. In Bell v. Goddard (1966), the court stated that the Delaney clause "is generally intended to prohibit the use of any additives which under any conditions induce cancer in any strain of test animal."1 Hence, this clause does not permit any "risks-benefits analysis," any weighing of risks against benefits, by the potential users of an additive. If an additive is found to cause malignant changes in any animal fed the additive in any amount (any dose per day), then that additive cannot be allowed in any quantity in our nation's food supply.2 The FDA has maintained, furthermore, that not only the Delaney clause, but the general food safety provisions, required a ban on saccharin.3

In 1977 the FDA presented evidence to Congress that saccharin causes excess (above the normal rate) bladder cancers in male rats when fed to them at high doses, either 5 percent or 7.5 percent of their diet.4 For a person weighing 154 pounds, this is the equivalent of consuming 800 "diet" drinks a day, or about 0.4 pounds of saccharin a day, for an entire lifetime. Although animal tests at lower doses have produced no excess cancers, some medical experts urge that carcinogens, unlike toxic substances, may produce effects even at very low doses. As Dr. Guy R. Newell of the National Cancer Institute has stated:

It seems reasonable on an intellectual basis to assume that there may be a threshold of dose below which no toxic effect would occur. I say this because in all the situations that we know about, there is a dose response relationship. However, there are no experimental procedures available that allow us to establish such a threshold below which we can be absolutely certain that there is no population at risk. A concern for the public health requires on our part that for estimating risk for humans, it is appropriate to assume no threshold, at least until such time as a threshold can be demonstrated and measured.5

Two major court decisions have adopted this position with respect to pesticide residues in food. In Environmental Defense Fund, Inc. v. HEW (1970), the court concluded:

[W]e think the events of the late 1950's indicate administrative action entirely consistent with, if not required by, Congress' expressed intent. At that time, Secretary Fleming indicated that there was no scientific basis for determining a "safe" residue level for a chemical known to produce cancer in experimental animals. Under such conditions, it would obviously be impossible to meet the congressionally imposed burden of establishing the safety of a residue of such a pesticide.6

Again, in Environmental Defense Fund, Inc. v. EPA (1975), the court held that

[the EPA] Administrator's failure to determine a threshold level of exposure to aldrin/dieldrin does not render his determination improper, for he had concluded that the concept of a threshold exposure level has no practical significance where carcinogens are concerned. This is due in part to the irreversibility and long latency period of carcinogens. "[W]here the matter involved is as sensitive and fright-laden as cancer, " and the statute places the burden [of proving safety] on the registrant, we shall not, assuming a substantial showing of danger, require the Administrator to make impossible proofs. In reviewing administrative actions, courts "cannot fairly demand the perfect at the expense of the achievable."7

These two decisions thus held that congressional intent in legislation on pesticide residues in food places the burden of proving safety on those who wish to hold that there is a safe tolerance or threshold, even though it is granted that this burden is, scientifically, impossible to meet. Indeed, the FDA's own food additive regulations state that "[i]t is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance."8

We find that the attempt to demonstrate a safe tolerance or threshold is not merely a present scientific impossibility but is actually an absolute impossibility. Even if a manufacturer presents "statistically significant" evidence that there is no harm at a certain level, the FDA can always argue, without producing any evidence of harm, that this evidence is insufficient to show with "absolute certainty that there is a threshold below which an additive is harmless. Since no one is omniscient, no one can be absolutely certain that someone, sometime, under some conditions, will not be harmed through the use of a food additive.

On the other hand, we take judicial notice of the fact that it is possible to show that an additive is harmful below a purported tolerance or threshold. This can be done simply by producing one animal or human who has been harmed at a dose below the presumed threshold or by producing "statistically significant" positive results in a group of animals or humans showing harmful effects below the presumed threshold.

For these reasons, we grant claimant's impossibility defense, which rests on numerous court decisions that have declared statutes void if it is impossible to meet their demands. "The imperfection of the law will not render it void, unless it is so imperfect as to render it impossible to execute it."9 "Though a law is imperfect in its details, it is not void, unless it is so imperfect as to render it impossible to execute it."10

This position has been upheld with respect to thresholds of harm. In Lone Star Gas Co. v. Kelly (1942), a personal injuries damage suit resulting from a gas stove explosion wherein negligence of Lone Star Gas Co. was alleged in that it had failed "so to odorize its gas that a person with an ordinary sense of smell could detect the presence of gas at the time and place of the explosion," the court held:

While it probably was not so intended by the [Railroad] Commission [of Texas], the[ir] order dearly calls for odorization although gas may be present only in infinitesimal proportion, in quantity so minute as to be wholly inconsequential and utterly without dangerous potentialities to the user, but which can never be definitely determined by the one charged with the obligation to perform. The law does not demand the impossible or the vain. If it attempts to do so it is unreasonable and the attempt is void. Below what proportion in the union of gas and air is the presence of the gas harmless? At what proportion in the union does the presence become discoverable because of the malodorant? Conversely, below what proportion is its presence not so discoverable? Obviously these questions are open to debate, and that is sufficient to invalidate the order."11

We agree that if a law attempts to demand "the impossible or the vain" and, in particular, demands that a threshold be demonstrated, then "it is unreasonable and the attempt is void." We thereby declare section 409(c)(3)(A), the Delaney clause, of the Federal Food, Drug and Cosmetic Act to be void.

Thus, the burden of persuasion must be thrown on the FDA as plaintiff in the present case to show either that there is not a threshold for the carcinogenicity of saccharin or else that the product in question, "Saccharine Sweets," contains saccharin at a level above the threshold of safety. Although this may be difficult to demonstrate, it is not impossible. Moreover, mere difficulty in a given case to find proof to establish plaintiff's cause does not obviate the necessity of furnishing it.12 Again, that a fact essential to a party's case is unavailable does not relieve the party from his burden of proving such essential fact.13

III The dissenting opinion in this case criticizes our finding that the Delaney clause should be declared void because it is impossible to rebut its presumption that all food additives shown to be carcinogenic under certain conditions (including high doses to test animals) are also so under normal conditions of human use. The dissent holds that the majority opinion is not in line with the trend of recent court decisions, and it calls upon the argument in Mr. Justice Rehnquist's dissent in Vlandis v. Kline (1973), in which Chief Justice Burger joined:

There will be, I fear, some ground for a belief that the Court now engrafts the "close judicial scrutiny" test onto the Due Process Clause whenever we deal with something like "permanent irrebutable presumptions." But literally thousands of state statutes create classifications permanent in duration, which are less than perfect, as all legislative classifications are, and might be improved on by individualized determinations.14

These Justices also held, following Justice Douglas, that

[t]he doctrine that [formerly] prevailed…—that due process authorizes courts to hold laws unconstitutional when they believe the legislature has acted unwisely—has long since been discarded. We have returned to the original constitutional proposition that courts do not substitute their social and economic beliefs for the judgment of legislative bodies, who are elected to pass laws.…[Thus,] the fact that a generally valid rule may have rough edges around its perimeter does not make it unconstitutional under the Due Process Clause of the Fourteenth Amendment: "…It is enough that there is an evil at hand for correction, and that it might be thought that the particular legislative measure was a rational way to correct it."15

Thus, the dissenting Justices argue that since the legislative purpose of the Delaney clause is to protect the American public from things against which they cannot adequately protect themselves, the irrebutable presumption of this clause lies within constitutional bounds of due process of law. They further note that it has long been held that

[w]herever the character of a measure is precautionary it operates on persons, things or conditions no matter whether in every individual case the precaution is necessary or not. The principle is that where a measure could not be enforced without uniformity, the individual interest must yield to this requirement. Thus in the case of vaccination it would not be possible to inquire or discover whether each child vaccinated was predisposed toward small-pox.…The danger being general, a measure would be defeated in its beneficial effect, if the question of its necessity could be raised in each particular case.16

Against this line of reasoning followed in the dissent, we are inclined to agree with the majority opinion of Vlandis v. Kline:

Statutes creating permanent irrebutable presumptions have long been disfavored under the Due Process Clause of the Fifth and Fourteenth Amendments. In Heiner v. Donnan [1932]…the Court stated that it had "held more than once that a statute creating a presumption which operates to deny a fair opportunity to rebut it violates the due process clause of the Fourteenth Amendment."17

We maintain that claimant is here "denied a fair opportunity to rebut" the Delaney clause presumption that there are no thresholds of carcinogenicity since it is impossible to rebut this presumption, when it is taken as a general presumption, even though it may well be false with regard to specific food additives.

We have been presented evidence of a great deal of medical dispute on this issue, and we are not convinced that the FDA has shown the possibility of harm, "an evil at hand for correction," for which there is thereby the necessity for "precautionary measures." Even Ernst Freund, who was largely sympathetic to state regulations in his famous work The Police Power (1904), maintained that "[t]he freedom of medical science requires that under the sanitary power no exclusive standards of medical treatment be established, as long as there is respectable scientific dissent from the correctness of the theories which the state might seek to establish."18 In the instant case of "Saccharine Sweets," we find that there is this "respectable scientific dissent" from the state's view that there are no thresholds of carcinogenicity, and we maintain that the product's manufacture and use, particularly by diabetics and the weight-conscious, cannot be restrained under the police power. For these reasons and others noted below, we hold that each food additive case must be tried on its own merits.

We also wish to distinguish the situation presented here from those in which the rights of other parties are involved, as is the case with contagious diseases. It is quite understandable why there was such an increase in public health and safety measures after Pasteur's discoveries concerning infectious diseases and the germs that spread them.19 When we are dealing with contagious diseases, we can well agree with the dissenting opinion that there is scientific justification for "utilitarian" approaches, such as quarantines and vaccinations, that protect the interests and rights of third parties.

We differ from the dissent, however, in its attempt to apply this line of reasoning to disorders of a personal and noncontagious nature. The dissenting Justices argue that the Delaney clause protects the interests of the human population, but they ignore the fact that statistical studies do not necessarily have any direct relevance to the individual. It is well known that in many cases there are major physiological differences in human beings, so that what is harmful or beneficial for one may very well not be so for another. Indeed, we take judicial notice of the fact that this is the origin of normal distribution (bell-shaped) curves showing individual responses to particular substances.

More specifically, we note that three possible situations have been presented in the medical literature with regard to infectious diseases:

(a) A person's "natural" resistance is so high relative to the "potential" virulence of the infectious agent that overt disease will not occur in any case.

(b) A person's natural resistance is in such delicate balance with the potential agent virulence that other physiological factors in the person will determine to a greater or lesser extent the frequency and/or severity of overt disease.

(c) A person's natural resistance is so low in relation to the potential agent virulence that overt disease will result regardless of other physiological factors present in the individual.20

Situation (c) characterizes a general epidemic where few, if any, members of the population have developed sufficient levels of natural resistance to a given pathogenic agent. This case is the one for which governmental intervention under the police power is appropriate. Since saccharin, however, is generally regarded as a "weak" carcinogen,21 if it is even considered one at all, the instant case is similar to case (a) or (b), where individual physiological differences play a significant role.

In the present case of saccharin, the strongest medical evidence supporting the FDA's ban is a recent Canadian study on humans. Using 632 persons with bladder cancer, 480 males and 152 females, and the same number of matched controls, this study found a statistically significant 60 percent increase in the risk of bladder cancer in males who used saccharin.22 On the other hand, females in this study had a 40 percent decrease in the risk of bladder cancer associated with saccharin use, a result that "just barely missed" being statistically significant.Even without knowing why this is so, the question immediately presents itself, Why not allow at least females to use saccharin? Again, there are literally thousands of diabetics who must restrict their caloric and sugar intake, and thousands more over-weight individuals and their doctors who are willing to testify that they require saccharin to maintain their weights at acceptable levels and that for them the risks of getting cancer are far outweighed by the benefits of restricting their caloric intake, primarily from sugar, to avoid obesity and subsequent cardiovascular risks.24 We also note, on this point, that there is some medical evidence that obesity may predispose some people to major forms of cancer, such as breast, colon, and endometrial cancers, so that these persons may well be at greater risk of developing cancer by not using saccharin.25

We find that the Delaney clause not only creates an irrebutable presumption against thresholds, as noted previously, but also creates one concerning the applicability of statistical animal or human studies to specific individuals or human populations (in this case, especially women, diabetics, and the overweight). Although it is within the power of the legislature to establish presumptions of law that are irrebutable, statutes that declare one fact conclusive evidence of another material fact in controversy are unconstitutional if the former is not, in and of itself, by virtue of its own force, conclusive.26 In this case, we hold that the carcinogenicity of saccharin at high doses is not conclusive evidence of its harm at the amounts contained in claimant's product, "Saccharine Sweets." Again, we find that, owing to individual and perhaps unique responses to saccharin consumption, the Delaney clause breaches due process of law by attempting to set up a general presumption of harm concerning an entire human population of diverse individuals. It therefore cannot be permitted to stand.

IV Finally, we find that the Delaney clause breaches due process of law by presuming harm, rather than safety, until and unless proven otherwise. Against this holding, the Government and the dissenting opinion argue that this presumption of the Delaney clause is in line with other statutes protecting the public health. They maintain that, under the police power, the Government must only show that a product is adulterated and not that it is harmful to anyone's health.27 They also point to Chief Justice Burger's dissent in Eisenstadt v. Baird (1972):

So far as I am aware, this Court has never before challenged the police power of a State to protect the public from the risks of possibly spurious and deleterious substances…Moreover, a statutory classification is not invalid "simply because some innocent article.. . may be found within the proscribed class." …[I]f the Constitution can be strained to invalidate the Massachusetts statute…we could quite as well employ it for the protection of a "curbstone quack," reminiscent of the "medicine man" of times past, who attracted a crowd of the curious with a soap box lecture and then plied them with "free samples" of some unproven remedy28

The dissenting opinion also relates a long history of laws and court decisions, especially in the areas of negligence and public health and safety, that place the burden of proof on the defendant because of (a) the complexities of life originating from the Industrial Revolution; (b) the desire to expedite trials and reduce the costs of litigation;29 (c) the greater knowledge and ability of the defendant to produce evidence;30 and, most importantly, (d) certain social policies designed to protect the public health. Thus, it has been held that the placement of the burden of proof is generally a question of policy and fairness.' And the dissent notes, moreover, that the power of the state to make uniform and impartial changes in the rules of evidence with regard to the burden of proof is practically unrestricted.32

Finally, the dissent points to specific court decisions on carcinogens and thresholds of harm. In Environmental Defense Fund, Inc. v. HEW (1970), for instance, the court of appeals held:

Before any pesticide-chemical residue may remain in or on a raw agricultural commodity, scientific data must be presented to show that [it]…is safe from the standpoint of the food consumer. The burden is on the person proposing the tolerance or exemption to establish [its] safety.33

Again, in Environmental Defense Fund, Inc. v. EPA (1975), it was held that the Federal Insecticide, Fungicide, and Rodenticide Act

does not require the [EPA] Administrator to establish that the product is unsafe, but places "[t]he burden of establishing the safety of a product…at all times on [the producer]."34

We cannot agree with this line of argument. As the majority of this Court held in Eisenstadt v. Baird (1972) against the view that "contraceptives are immoral as such":

Such a view of morality is not only the very mirror image of sensible legislation; we consider that it conflicts with fundamental human rights. In the absence of demonstrated harm, we hold it is beyond the competency of the State.35

Again, the concurring opinion of Justices White and Blackmun in the same case held that in the absence of

facts demonstrating that the hazards of using vaginal foam are common knowledge or so incontrovertible that they may be noticed judicially… we could not sustain appellee's conviction.…[T]o sanction a medical restriction upon…a contraceptive not proved hazardous to health would impair the exercise of the constitutional right [to privacy].36

We believe that there is no reason why this same position should not also be accepted with regard to the food safety laws. As the court of appeals held in Hess & Clark v. FDA (1974), a case involving an FDA revocation of its previous approval of animal feed drugs containing diethylstilbestrol (DES):

The statute does not say that because a drug leaves residues, it is unsafe per se. We think it implicit in the statute that when the FDA proposes to withdraw an approval because new evidence shows the drug leaves residues, it has an initial burden of coming forward with some evidence of the relationship between the residue and safety to warrant shifting to the manufacturer the burden of showing safety.37

Following these decisions, we hold that the FDA as plaintiff must present evidence to demonstrate harm before it can revoke its long-time approval of saccharin as a food additive—before it can remove it from its "generally recognized as safe" (GRAS) list and prohibit claimant from selling its product.38

We also believe that this position is more in line with long-established legal principles. The most fundamental rule, dating back to Roman law, is that "the burden of proving a fact is on the party who asserts it, and not on the party who denies it,"39 which has been upheld in American courts many times.40 Again, the following rules on legal presumptions are usually held:

(a) No one shall be called on to prove a negative, or be put on his defense, without sufficient evidence against him having been offered, which, if not contradicted or explained, would be conclusive evidence of his wrongdoing.41 Thus, failing the presentation of such evidence, there is no necessity to raise a defense. And, as William Best observed, this rule is derived from "the very nature of things and grounds of one's belief," and it has been adopted into the jurisprudence of every "enlightened country."42

(b) The burden of proof rests upon the party who asserts the affirmative of the issue.43 For example, in a case involving the question whether work was properly done,

the proper test is to which party would be successful if no evidence at all were given.…[S]upposing no evidence were given on either side, the defendant would be entitled to the verdict, for it was not to be assumed that the work was badly executed; and consequently that the [burden of proof] lay on the plaintiff.44

This position has been generally adopted in American courts.45 The side that would be unsuccessful if no evidence were given, if no one said anything, has the burden of proof. Thus, in this case, if nothing were said in the trial court, then it is to be assumed that the product is not causing harm to anyone. The affirmative of the case is the position that "there is at least one person being harmed by this product," while the negative is that "no one is being harmed by it."

Moreover, we do not take this decision on the placement of the burden of proof lightly, since "[i]n all kinds of litigation it is plain that where the burden of proof lies may be decisive of the outcome."46 The rule fixing the burden of proof is important in the administration of justice, and it constitutes a substantial right of the party on whose adversary the burden rests, so that it should be carefully guarded and rigidly enforced.47 In this regard, it has been commonly held that the burden of proof is always upon the plaintiff to prove the essential elements of his cause of action48 and that the defendant's right to have the plaintiff bear the burden of proof upon the whole case is a substantial right of which the defendant should not be deprived.49

We also lay stress on the famous position of Thayer and Wigmore on this issue. Concerning rebutable presumptions, those presumptions that merely presume one side of the issue to be true or false until proven otherwise, Thayer held that the "burden of proof never shifts," so that it always lies throughout the trial upon the party who had it at the beginning.50 To this doctrine must be added the Thayer-Wigmore "discovery" that the so-called burden of proof is actually made up of two burdens. The first is the "burden of persuasion," which has about the same meaning as previously given to burden of proof. The second is the "burden of going forward" with one's evidence to prevent the trial judge from directing the trier of fact (usually a jury) to return a verdict for the other party.51

Given this distinction, although the "burden of going forward" with one's evidence may shift between the defendant and plaintiff throughout a trial,52 the doctrine that "the burden of proof never shifts" means that the ultimate "burden of persuasion" always lies on the party who has the affirmative of the issue at the start.53 And we have already concluded that the FDA has the affirmative to show that there is at least one person who is harmed by the use of claimant's product.

The dissent urges, as noted above, that this holding goes against "the power of the state to make uniform and impartial changes in the rules of evidence with regard to the burden of proof [which] is practically unrestricted." But as this Court stated in Speiser v. Randall:

It is of course within the power of the State to regulate procedures under which its laws are carried out, including the burden of producing evidence and the burden of persuasion, "unless in so doing it offends some principle of justice so rooted in the traditions and conscience of our people as to be ranked as fundamental.54

We believe our position on burden of proof to be such a "fundamental principle of justice." Moreover, even though

the legislature may go a good way in raising…[presumptions] or in changing the burden of proof,…there are limits.…[I]t is not within the province of a legislature to declare an individual guilty or presumptively guilty of a crime.…[And] in civil cases too this Court has struck down state statutes unfairly shifting the burden of proof."55

With the burden of persuasion properly placed on the FDA, we also find that they have not satisfied this burden. We have already noted that the leading human study they rely upon showed mixed results with regard to males and females. And actually the positive results on males can also be questioned since the Canadian authors themselves noted that

[examination of the data showed substantial differences between cases and controls with respect to.. .occupational history, a record of bladder and kidney infections, smoking history, consumption of incident coffee, and the use of nonpublic water supply."56

Hence, even though these "confounding variables" were controlled for, there could well be "false positives" in this study, so that an increase in bladder cancer is attributable to something other than saccharin. On this point, although saccharin usage has increased greatly since World War II, there has not been a corresponding increase in the rate of bladder cancers. Indeed, since 60 percent of the increase seen in bladder cancers can be associated with increased smoking and occupational exposure of males to certain industrial chemicals, these factors, and not saccharin, appear to be of much greater concern.57

Another recent American study on 500 bladder cancer patients and matched controls found no significant differences in saccharin use between the two groups,58 and an editorial in a leading medical journal has observed that

[a]t least seven pertinent epidemiologic studies show that bladder-cancer mortality patterns…are not correlated with saccharin consumption and that diabetic patients have no excess mortality from bladder cancer despite their relatively high consumption of saccharin.…All of these studies may be criticized on several counts, the most serious being that they were too small.…However, neither this nor other criticisms explain why all the studies are negative.59

It has also been noted that if saccharin caused at least 10 percent of the 30,000 bladder cancer cases diagnosed each year, then this "should have been securely seen in these studies."60

Upon reviewing this available evidence, we conclude that the only thing the FDA has proved, if anything, is that an average male weighing 154 pounds may contract bladder cancer if he consumes 0.4 pounds (175 grams) of saccharin a day for an entire lifetime. But it has not been shown that saccharin causes cancer below this dosage, and especially at a dosage a person would receive by consuming the claimant's product, which meets the former interim FDA standard on saccharin of 30 milligrams per serving in processed foods. At this proportion, a person would have to consume about 6,000 servings per day of claimant's product to risk bladder cancer from the saccharin it contains. Moreover, since it has been known since at least 1911 that saccharin can disturb digestion in an amount of 300 milligrams to 1 gram each day,61 it is difficult to see how anyone could even begin to approach the required consumption of 175 grams per day in order to stand the reported increased risk of bladder cancer.

Hence, we find that the preponderance of evidence lies in favor of the claimant and therefore that the trial court's findings of fact are clearly erroneous. Since this is the standard test for appellate review,63 the judgment the claimant appeals from is reversed, and the cause is remanded with directions to dismiss the libel against and condemnation of claimant's product, "Saccharine Sweets." In the words of the vernacular, we hold that "where no harm has been shown, there is no foul."

[This is a fictional US Supreme Court opinion, although the citations are real. Both the opinion and the decision are purely imaginary in today's legal and social context, but the Justices could, legally, write it if they wanted to.]

Bruce K. Bell has a B.S. in physics and an M.A. in the history and philosophy of science. This article was prepared while Mr. Bell was a Reason Foundation summer research fellow.

Footnotes I. 366 F. 2d 177, 181 (7th Cir. 1966).
2. J. M. Coon, "The Delaney Clause," 2 Preventive Medicine 150 (1973).
3. Donald Kennedy's testimony, Hearings, Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce of the House of Representatives, 95th Cong., 1st sess., 64 (June 27, 1977).
4. Office of Technology Assessment, Congress of the United States, Cancer Testing Technology and Saccharin 20 (1977).
5. Hearings, supra note 3, at 44.

6. 428 F. 2d 1083, 1092 (D.C. Cir. 1970).
7. 510 F. 2d 1292, 1298 (D.C. Cir. 1975).
8. 21 C.F.R. 170.3(i).
9. Cochran's Heirs' Lessee v. Loring, 17 Ohio 409, 427 (1848).
10. Gordon v. State, 46 Ohio St. 607, 23 N.E. 63, 64, 6 L.R.A. 752. Compare also, Commonwealth v. Moir, 199 Pa. 534, 49 A. 351, 353, 85 Am. S.R. 801, 53 L.R.A. 837; Miller v. Belmont Packing & Rubber Co., 268 Pa. 51, 110 A. 802, 805; State v. LeBlond, 108 Ohio St. 41, 140 N.E. 491, 492; and People v. Briggs, 193 N.Y. 457, 86 N.E. 522, 523 (C.A. N.Y. 1908).

11. 140 Tex. 15, 165 S.W. 2d 446, 448 {1942).
12. Boxrud v. Ronning Machinery Co., 217 Minn. 518, 15 N.W. 2d 112 (1944).
13. Middletown Trust Co. v. Bregman, 118 Conn. 651, 174 A. 67 (1934).
14. 412 u.s. 441, 462.
15. 412 u.s. 441, 468, 465-466.

16. Freund, The Pollee Power: Public Policy and Constitutional Rights 26-27 (1904).
17. 412 u.s. 441, 446 (1973).
18. Freund, supra note 16, at 514.
19. F. Glaive, Pure Food and Drugs in California 59-60 (1957).
20. N.S. Scrimshaw et al., "Interaction of Nutrition and Infection," 237 American Journal of the Medical Sciences 383 (1959).

21. Office of Technology Assessment, supra note 4, at 22-23.
22. G.R. Howe et al., "Artificial Sweeteners and Human Bladder Cancer," Lancet 579 (Sept. 17, 1977).
23. W.R. Havender, "Saccharin in Suspense," Inquiry 22 (Nov. 26, 1979).
24. Donald Kennedy's testimony, supra note 3, at 78.
25. F.J. Rauscher, in "The Saccharin Ban: Risks vs. Benefits," American Enterprise Institute 5 (1977).

26. Compare Handy v. Delaware Trust Co., 285 U.S. 352, 76 L. Ed. 793, 52 S. Ct. 371; Heiner v. Donnan, 285 U.S. 312,76 L. Ed. 772, 52 S. Ct. 358; and Schlesinger v. Wisconsin, 270 U.S. 230, 70 L. Ed. 557, 46 S. Ct. 260, 43 A.L.R. 1224.
27. Commonwealth v. Pflaum, 236 Pa. 294, 84 A. 842, 845 (S.C. Pa. 1912); U.S. v. 716 Cases "Del Comida Brand Tomatoes," 179 F. 2d 174 (lOth Cir. 1950); and U.S. v. 1 Device Radiant Ozone Generator, etc., Notices of Judgement (No. 2987) issued June 1950 (W.O. Missouri).
28. 405 u.s. 438, 469, 472 (1972).
29. M. Shain, Res Ipsa Loquitur Presumptions and Burden of Proof, 2d ed. 161-62 (1974).
30. Garcia v. Industrial Accident Comm., 41 Cal. 2d 689, 263 P. 2d 8; Midwest Transfer Co. v. Preferred Accident Ins. Co., 342 Ill. App. 231, 96 N.E. 2d 228; Selma, R. & D. R. Co. v. U.S., 139 U.S. 560, 35 L. Ed. 266, 11 S. Ct. 638.

31. George v. Bekins Van & Storage Co., 196 P. 2d 637, subsequent opinion 33 Cal. 2d 834, 205 P. 2d 1037.
32. Johnson, Inc. v. Warden, 76 Cal. App. 2d 697, 173 P. 2d 838.
33. 428 F. 2d 1083, 1086-87 (D.C. Cir. 1970).
34. 510 F. 2d 1292, 1297 (D.C. Cir. 1975).
35. 405 u.s. 438, 453 (1972).

36. 405 u.s. 438, 464 (1972)
37. 495 F. 2d 975, 993 (D.C. Cir. 1974).
38. Saccharin has been used since the 1880s, first as an antiseptic and food preservative. Diabetics first used it in the mid-1880s, and the canning industry began using it as a sweetener in 1907.
39. Justinian, Digest, 22.3.2. An old Roman story nicely illustrates this early conception. Numerius, the governor of Narbonensis, was on trial before the Emperor Julian. He contented himself with merely denying his guilt, and there was not sufficient evidence against him to prove his guilt. His adversary, Delphidius, a "passionate man," seeing that the failure of the accusation was inevitable, could not restrain himself, and exclaimed, "Oh, illustrious Caesar! If it is sufficient to deny, what hereafter will become of the guilty?" To which Julian replied, "If it suffices to accuse, what will become of the innocent?" (From Ammianus Marcellinus, Rerum Gestarum, lib. XVIII, c.l.).
40. O'Neill v. Metropolitan Life Ins. Co., 345 Pa. 232, 26 A. 2d 898, 142 A.L.R. 735.

41. From Law Magazine (1831), as quoted in Shain, supra note 29, at 72.
42. W. Best, An Exposition of the Practice Relative to the Right to Begin and Reply in Trials by Jury 3 (1886).
43. Compare Lilienthal v. U.S., 97 U.S. 237, 24 L. Ed. 901; Omaha Hotel Co. v. Wade, 91 U.S. 13, 24 L. Ed. 917; and Arthur v. Unkart, 96 U.S. 118, 24 L. Ed. 768.
44. Best, supra note 42, at 20.
45. For instance, Cowen Co. v. Houck Mfg. Co., 249 F. 285, 161 C.C.A. 293 (1918); In re Hagan's Estate, 143 Neb. 459, 9 N.W. 2d 794, 154 A.L.R. 573 (1943); Colovos v. Gouvas, 269 Ky. 752, 108 S.W. 2d 820, 113 A.L.R. 871.

46. Speiser v. Randall, 357 U.S. 513, 525, 2 L. Ed. 2d 1460, 78 S. Ct. 1332.
47. Skyland Hosiery Co. v. American Ry. Express Co., 184 N.C. 478, 114 S.E. 823 (1922); Standard Accident Ins. Co. v. Cloutier, 92 N.H. 449, 32 A. 2d 684, 147 A.L.R. 626 (1943); O'Donnell v. Prudential Ins. Co., 58 Montg. 257 (Pa. Com. Pl. 1942).
48. Hauserv. Western Union Telegraph Co., 150 N.C. 557,64 S.E. 503 (1909); Amick v. Gooding Amusement Co., 243 F. Supp. 782 (D.C. S.C. 1966); Boyd v. Brown, 192 Va. 702, 66 S.E. 2d 559.
49. Hughes v. Atlantic City & S.R. Co., 85 N.J. Law 212, 89 A. 769, L.R.A. 1916A, 927 (1914).
50. Commercial Molasses Corp. v. New York Tank Barge Corp., 314 U.S. 104,86 L. Ed. 89,62 S. Ct. 156; Southern R. Co. v. Prescott, 240 U.S. 632,60 L. Ed. 836,36 S. Ct. 469; Lilienthalv. U.S., 97 U.S. 237, 24 L. Ed. 901.

51. Donovan v. St. Joseph's Home, 295 Ill. 125, 129 N.E. I (1920); Sellers v. Kincaid, 303 Ill. 216, 135 N.E. 429 (1922); Spilene v. Salmon Falls Mfg. Co., 79 N.H. 326, 108 A. 808 (1920).
52. Tower Grove Bank & T. Co. v. Duing, 346 Mo. 896, 144 S.W. 2d 69, 152A.L.R.I325; Judson v. Beehive Auto Serv. Co., 1360r.1,297 P. 1050, 74 A.L.R. 944.
53. Ranney v. Lewis, 182 Mo. App. 58, 167 S.W. 601 (1914); Clapper v. Lakin, 343 Mo. 710, 123 S.W. 2d 27 (1939); Stocking v. Johnson Flying Service, 387 P. 2d 312 (Mont. 1963).
54. 357 U.S. 513, 523, 2 L. Ed. 2d 1469, 78 S. Ct. 1332.
55. !d.

56. Hearings, supra note 3, at 56.
57. W.R. Havender, "Ruminations on a Rat: Saccharin and Human Risk," Regulation: AEI Journal on Government and Society 21 (Mar. I Apr. 1979).
58. !d., at 20.
59. K. J. Isselbacher and P. Cole, "Saccharin—The Bitter Sweet," 296 New England Journal of Medicine 1349 (June 9, 1977).
60. Havender, supra note 57, at 21.

61. State v. Empire Bottling Co., 261 Mo. 300, 168 S.W. 1176, 1177 (S.C. Mo. 1914).
62. C.C. Co. v. U.S., 145 F. 2d 462 (1944), on rehearing, 147 F. 2d 820 (5th Cir. 1945); U.S. v. 11¼ Dozen Packages "Mrs. Moffat's Shoo Fly Powders for Drunkenness," 40 F. Supp. 208 (W.D. N.Y. 1941); U.S. v. 88 Cases Bireley's Orange Beverage, Civil No. 4711 (D.C. N.J. 1949), reversed, 187 F. 2d 967; U.S. v. 5 Cases "Figlia Mia Brand," 179 F. 2d 519 (2nd Cir. 1950), cert. denied 339 U.S. 963.