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The Slow Demise of FDA Censorship
The Slow Demise of FDA Censorship

Recent Court Cases on Health Claims that Define the Scope of Speech Rights for the Manufacturers and Distributors of Herbs and Other Dietary Supplements

by Jonathan W. Emord

Summary: Certain herbs, like saw palmetto, have physiological effects upon the body that are useful in mitigating or preventing disease and health-related conditions. Even in the presence of credible scientific evidence supporting claims for such products, the Food and Drug Administration has often censored them, denying manufacturers of such products the right to inform consumers of truthful and nonmisleading health information. The loss of that information harms consumers. Indeed, in certain instances it may be responsible for the worsening of human health. This article provides a detailed history of recent federal court decisions that spell a new day for those who wish to communicate on dietary supplement product labels and in labeling truthful and nonmisleading health information concerning the effects of herbs and other nutrients upon disease.

[Editor's note: Just before presstime, on July 11, 2003, the U.S. Food and Drug Administration announced plans to allow "qualified health claims" for foods and dietary supplements under the Nutrition Labeling and Education Act of 1990, the subject of much of the article below. HerbalGram will cover the new FDA policy in a future issue.]

For decades the U.S. Food and Drug Administration (FDA) censored nutrient-disease relationship claims (so-called "health claims") with impunity. Agency scientists and officials have long believed it was FDA's unique role to determine for Americans what is in their own best interest and to deny them access to information on how nutrients, and foods in general, could affect disease, reasoning that less-than-certain information of this kind could result in dangerous self-medication by consumers. The era of censorship with impunity is now coming to a close. A new era of agency respect for the First Amendment* appears in the offing.1 Nevertheless, legal battles against FDA censorship of claims concerning a nutrient's effect on existing disease continue.

* The First Amendment is part of the Bill of Rights, the first 10 amendments to the U.S. Constitution ratified in 1791. The First Amendment reads, "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances."

As explained in greater detail below, in 1999 the U.S. Court of Appeals for the District of Columbia (D.C.) Circuit held in Pearson v. Shalala that FDA violated the First Amendment by denying all health claims except those backed by near-conclusive proof of a nutrient-disease relationship. Although at first unwilling to comply with that decision,2 FDA became chastened by three lower federal court orders that demanded immediate compliance, repeatedly finding agency noncompliance incompatible with the Court of Appeals' orders. Indeed, the lower court (Judge Gladys Kessler presiding) imposed injunction after injunction on the agency to prevent continued acts of censorship.3

The federal courts have made it clear that if a statement is true, or is capable of being rendered so through the addition of a disclaimer, the FDA has no power under the First Amendment's free speech provision to censor the statement (even if FDA believes scientific evidence inconclusive or not fully supportive of the claim, or that consumers cannot be trusted to act responsibly if they receive the claim). At first FDA was quite reluctant to follow the Court's decision. A change of administration brought new officials to the agency in late 2002, like Commissioner Mark B. McClellan, M.D., Ph.D., Associate Commissioner Lester M. Crawford, and Chief Counsel Daniel E. Troy, all of whom share a profound respect for the need to comply with the Court's orders. While that respect has led FDA to allow a series of nutrient-disease prevention claims, it has not led FDA to change its position on claims of a nutrient's effect on an existing disease (so-called "treatment" claims). With respect to the latter, FDA still refuses to allow them to be made as health claims for dietary supplements. FDA will only allow such claims for drugs, following approval of new drug applications. That position of the agency, however, is now the subject of litigation in the federal courts. In Whitaker v. Thompson, now pending before the U.S. Court of Appeals for the D.C. Circuit (the same court that held against FDA health claim suppression in Pearson v. Shalala), the court will decide whether FDA may constitutionally suppress a claim associating consumption of saw palmetto (Serenoa repens (W. Bartram) Small, Arecaceae) extract with a reduction in the symptoms of benign prostatic hyperplasia (BPH).

FDA originally justified its claim bans with anti-fraud and with health and safety rationales.4 It largely ignored the implications of its actions on First Amendment-protected freedom of speech.5 Touted as a means to end fraud and enhance health and safety, FDA's censorship never produced those effects;6 it may well have encouraged fraud and diminished health and safety. By denying consumers access to truthful and nonmisleading information about how nutrients affect disease, FDA may well have created an environment where fraud could flourish uncontested by truthful health information and may well have sacrificed public health. Hucksters depend upon ignorance to defraud consumers. Consumers armed with accurate health information are less likely to be victimized by fraud than those denied that information and are also more apt to make health-enhancing market choices.7 Conversely, consumers unaware of the actual effects of nutrients are more apt to believe falsehoods about those products and less likely to make health-enhancing market choices.

Under the current administration, which is committed to "putting credible, science-based information in the hands of consumers,"8 FDA seems willing to comply with the federal court orders, but will that compliance be complete? In at least one area, that of claims concerning the effect of a nutrient on an existing disease, the answer appears to be no. There FDA censorship continues as it had before the Pearson decision; consequently, the battle for First Amendment freedom continues. The battle centers on whether FDA will allow consumers to receive information about how foods and food ingredients, including dietary supplements, affect existing diseases and their symptoms. FDA takes the position that such claims are not allowable as health claims, but only as "drug claims," by which FDA means that no one may be allowed to make such claims on foods and on dietary supplements without first obtaining FDA new drug approval for the products. That approval is a virtual impossibility. The cost of the new drug approval process ranges from a conservative low of $200 million to a high of $800 million or more. Most foods and most dietary supplements are unpatentable, so even were food or supplement companies wealthy enough to file a new drug application for a product, few, if any, could recoup their investments in the market, lacking the monopoly protection that patents provide. Moreover, few could afford to leave their present distribution and market channels and market products anew as drugs.

FDA has historically viewed scientific information destined for consumer markets as a potential enemy: either a possible source of sophistication beyond the reach of the average consumer that could beguile, or a source of truth so profound that consumers could not be trusted to act rationally with it. The agency has long viewed itself as the nation's ultimate authority on the interpretation of science, the first and last determiner of what nutrient-disease and nutrient content information may appear on the labels and in the labeling of the commercial goods the agency regulates. In the exercise of health claims regulation,9 FDA has heeded precious few external voices - whether from leading scientists of the world* or from other federal public health agencies.**

* Each health claim filed with the agency has been accompanied by a scientific report from leading experts who study the nutrients in question.

** For example, in 1992, the Centers for Disease Control and Prevention (CDC) recommended that all women of childbearing age be informed of the need to consume 0.4 mg of folic acid daily to reduce a woman's risk of neural tube defects by an estimated 50 percent (CDC. Morbidity and Mortality Weekly Report, September 11, 1992). FDA at first refused to follow CDC by authorizing a claim for folic acid and neural tube defects. It finally changed its position in March 1996 only after the Pearson litigation began (which included this claim until FDA relented). See Senate Report 105-43, "Food and Drug Administration Modernization and Accountability Act of 1997," 49-50 (1997). In addition, despite CDC's determination that elevated homocysteine levels were an independent risk factor for vascular diseases in 1999 (CDC. Morbidity and Mortality Weekly Report, November 12, 1999), FDA refused to recognize it as such and to permit a B6, B12, and folic acid claim for vascular disease risk reduction due to those nutrients' accepted homocysteine-lowering effects until after Julian M. Whitaker, M.D., and others sued the agency in 2001. Compare Letter from FDA to Jonathan Emord denying B6, B12, Folic Acid/Vascular Disease claim, November 30, 1999, to Settlement Reached for Health Claim Relating B Vitamins and Vascular Disease, May 15, 2001 found online at < ~dms/ds-hclbv.html>.

Folic Acid and the Health Consequences of Censorship

The paradigmatic example of how FDA censorship can affect public health arose during the administration of former Commissioner David Kessler, M.D. Dr. Kessler, and several of the agency's top scientists, believed folic acid was not adequately proven to be a safe and effective means to reduce the incidence of neural tube defects (NTDs). NTDs (e.g., spina bifida) are horrific and often lethal conditions afflicting about 5,000 live births annually in the United States. Despite overwhelming scientific evidence that 0.4 mg of folic acid did reduce the incidence of NTDs by 40 percent to 50 percent, and the endorsement of the U.S. Public Health Service and the U.S. Centers for Disease Control and Prevention for a folic acid/neural tube defect risk reduction claim, Dr. Kessler maintained (until the winds of political and legal change became unbearable for him) that there was not "significant scientific agreement" among qualified experts that folic acid could safely reduce the risk of neural tube defects and that there existed a risk (unproven then and now) that those consuming folic acid may mask a vitamin B12 deficiency. On those grounds, he suppressed the folic acid claim for more than a year, finally relenting to demands from U.S. Senator Orrin Hatch (R-UT) and then Congressman (now Governor) Bill Richardson (D-NM) on the eve of a U.S. Senate Labor and Human Resources Committee hearing (at which Dr. Kessler would have been made to account publicly for his refusal to allow the claim.)10

The U.S. Senate Committee on Labor and Human Resources investigated FDA's refusal to allow the folic acid claim, while Durk Pearson, Sandy Shaw, the American Preventive Medical Association, and Citizens for Health sued the agency for its refusal. At the conclusion of its deliberations, the Senate Committee observed:

In September, 1992, the Public Health Service issued a recommendation that all women of child-bearing age have adequate folic acid to prevent against birth defects. The Centers for Disease Control had made a similar recommendation one year before. Despite these two recommendations, and despite the fact that the FDA participated in the PHS proceedings leading up to the announcement, FDA did not issue a regulation proposing approval of a health claim for folic acid until October, 1993, one week before the committee's hearing on dietary supplements.

Absent approval of a health claim by the FDA, it was illegal for manufacturers or retailers to advise the public about the benefits of folic acid, even though those benefits had been endorsed by the leading Federal public health agencies.11

Upon review of that same evidence three years later, the same committee found FDA squarely to blame for neural tube defect births that could have been prevented by prompt allowance of the folic acid/neural tube defect risk reduction claim:

The history of the folic acid and neural tube defects health claim dramatizes the critical need for [passage of the FDA Modernization Act]. In 1992, the Centers for Disease Control and Prevention (CDC) issued the following recommendation to women of childbearing age, aimed at reducing the risk of pregnancies affected by neural tube defects:

All women of childbearing age in the United States who are capable of becoming pregnant should consume 0.4 mg of folic acid per day for the purpose of reducing their risk of having a pregnancy affected with spina bifida or [other neural tube defects].

- The CDC estimated that this recommendation could reduce the number of cases of spina bifida and other neural tube defects in the United States by 50 percent.

Despite the significant scientific agreement among qualified experts concerning the evidence supporting the recommendation, manufacturers of foods containing folic acid were prohibited from making claims about the benefits of folic acid in reducing the risk of neural tube defects until FDA approved the claim through a notice and comment rulemaking procedure.

Without appropriately accounting for the CDC recommendation, FDA promulgated a rule in January 1993, prohibiting claims concerning the relationship. In the wake of controversy concerning FDA's action, and despite the absence of any change in the scientific evidence, the Agency reversed course, proposing to authorize such claims in October, 1993. Final regulations authorizing the claim were promulgated in March 1996. Undoubtedly, many children suffered from preventable neural tube defects as a result of FDA's delay in authorizing health claims based on the 1992 CDC recommendation. [Emphasis added.]12

Although Congressional angst reached a fever pitch in response to FDA's refusal to allow the folic acid/neural tube defect claim, the world fundamentally changed for the FDA as a result of a series of judicial, not political and not legislative, decisions. Those decisions repeatedly held FDA censorship of health claims unconstitutional under the First Amendment and enjoined FDA from doing so. The world changed further when a new administration arrived in 2002, including Commissioner McClellan, Associate Commissioner Crawford, and Chief Counsel Troy. Those officials have dedicated the agency to fulfillment of the First Amendment mandate given FDA by the federal courts. Although it would be a hasty generalization to conclude at this early date that FDA's days of censorship are over, it may now be said with confidence that addressing First Amendment issues has become obligatory for agency censors as a result of the new leadership at the agency.

Pearson v. Shalala I

A bellwether of health claims regulation until 1999, FDA censorship first met the superior and countervailing force of the American Constitution when the U.S. Court of Appeals for the D.C. Circuit decided Pearson v. Shalala.13 In that landmark decision, written for the Court by Senior Judge Laurence H. Silberman, the Court of Appeals for the D.C. Circuit held that FDA violated the First Amendment by censoring four health claims, held that FDA had to favor disclosure of information over suppression as the operative rule in health claims review, held that claims not passing FDA's scientific standard would nevertheless have to be allowed if they could be rendered nonmisleading with disclaimers, and held that FDA had to rely on disclaimers as a less restrictive alternative to censorship in all instances except the extremely rare circumstance in which a claim was backed by no credible scientific evidence.14

The Pearson I Court began its First Amendment assessment quoting In re R.M.J., 455 U.S. 191, 203 (1982): that the government "may not place an absolute prohibition on - potentially misleading information - if the information also may be presented in a way that is not deceptive."15 The Pearson I Court explained the importance of the presumption at some length and the fact that the burden cannot be met except upon adduction of empirical evidence of misleadingness (a complete ban is only appropriate if the government "demonstrate[s] with empirical evidence that disclaimers - bewilder consumers and fail to correct for deceptiveness"16).

Under Pearson I and its progeny, before resorting to censorship, FDA must determine based on empirical evidence that the claim before it (not the nutrient-disease relationship per se or in the abstract) cannot be rendered nonmisleading through the addition of a reasonable disclaimer. Every disclaimer that could be used to eliminate a proven potential to mislead must be carefully assessed. Only after establishing that no disclaimer can cure that proven potential may the FDA suppress the claim.

The Pearson I Court explained that disclaimers not only correct for what the Court termed "misleadingness" by informing consumers of scientific inconclusiveness but also of adverse reactions that may occur to some who use a dietary supplement, writing, "- [T]he government's interest in preventing the use of labels that are true but do not mention adverse effects would seem to be satisfied - at least ordinarily - by inclusion of a prominent disclaimer setting forth those adverse effects."17 It is thus not enough to justify suppression that at some dose level or in some contexts a nutrient may cause an adverse reaction. That, too, is reason for a disclaimer, not censorship.

The Pearson I Court relied heavily on First Amendment precedent in crafting its decision, delving into the philosophical underpinnings for the requirement that the claims in issue be protected from government suppression. Repeatedly in its decisions over the last two and a half decades, the U.S. Supreme Court has emphasized that full and faithful implementation of the First Amendment leads inexorably to preservation of a free and open idea and information marketplace and that, while imperfect, the free idea market nevertheless serves as the best engine for advancement, innovation, and truth discovery. To be sure, the Court loathes censorship and prior restraint, particularly when predicated on the paternalistic notion that those in government know better than the average individual how best to pursue that individual's own self interest. The constitutional presumption favoring disclosure of information over its suppression is a strong one therefore, arising from the well-accepted and often cited conclusion of the Court that under the First Amendment commercial speech doctrine, there is no legitimate role of government in censoring, let alone restricting access to, truthful information.

The Court of Appeals had little difficulty rejecting FDA's justifications for refusing to rely on disclaimers as a less speech restrictive alternative to censorship. It unceremoniously rejected each of the agency's justifications. It rejected the notion that a claim not backed by "significant scientific agreement" was by that fact alone inherently misleading and could lawfully be censored, reasoning that a claim could be true and protected under the First Amendment even if it failed to satisfy the agency's chosen scientific standard.:

As best we understand the government, its first argument runs along the following lines: that health claims lacking "significant scientific agreement" are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous. See Peel [v. Attorney Registration and Disciplinary Comm'n of Illinois], 496 U.S. 91, 105 (1990) (rejecting paternalistic assumption that the recipients of a letterhead are "no more discriminating than the audience for children's television"). We reject it.18

The Court held FDA's scientific standard arbitrary and capricious under the Administrative Procedure Act because it was largely undefined but, the Court reasoned, even were FDA able to define a standard for health claims review, that could not serve as a lawful basis upon which to reject a health claim, writing: "[E]ven if 'significant scientific agreement' were given a more concrete meaning, appellants might be entitled to make health claims that do not meet that standard - with proper disclaimers."19

The Court also rejected the notion that unless information is scientifically certain, it will mislead consumers and cause them to waste their resources, writing:

Because it is not claimed that the product[s] [are] harmful, the government's underlying - if unarticulated - premise must be that consumers have a limited amount of either attention or dollars that could be devoted to pursuing health through nutrition, and therefore products that are not indisputably health enhancing should be discouraged as threatening to crowd out more worthy expenditures. We are rather dubious that this simplistic view of human nature or market behavior is sound, but, in any event, it surely cannot be said that this notion - which the government does not even dare openly to set forth - is a direct pursuit of consumer health; it would seem a rather indirect route, to say the least. See Bates v. State Bar of Arizona, 433 U.S. 350, 375 (1977) ("We view as dubious any justification that is based on the benefits of public ignorance."); cf. 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996) (opinion of Stevensw, J., joined by Kennedy, J., and Ginsburg, J.) ("The First Amendment directs us to be especially skeptical of regulations [of indisputably non-misleading information] that seek to keep people in the dark for what the government perceives to be their own good.").20

The Court of Appeals understood FDA to have a high First Amendment burden of proof to justify censorship and meant to reverse FDA's penchant for denying the public access to nutrient-disease relationship information. To satisfy its high constitutional burden, FDA could not rest on a determination that a claim failed to meet some FDA-decreed objective or subjective scientific standard or a determination that use of the claim could result in some members of the public engaging in behavior FDA found inappropriate. Rather, FDA had to find empirical evidence that a claim was inherently misleading and that no disclaimer could be used to eliminate the misleading connotation. If the science supporting a claim was inconclusive, if only a minority of scientists endorsed it, or if there remained controversy in the scientific community concerning it, those qualifications were precisely the kind that the Court expected FDA to write into disclaimers. Pearson I has therefore made it incumbent upon FDA in the discharge of its constitutional duties to stand aside, permitting as much information as possible to reach the public and relying on reasonable disclaimers as its primary corrective mechanism because that mechanism is invariably a less speech restrictive alternative to outright suppression.

Enforcing Pearson v. Shalala (Pearson II, Pearson III, and Whitaker I)

Even after the Court of Appeals' remand order, FDA continued to censor the very claims the Court held protected by the First Amendment. In Pearson v. Shalala II,21 the U.S. District Court for the District of Columbia held unconstitutional under the First Amendment FDA's continuing refusal to allow the following health claim (held protected by the First Amendment in Pearson I) to appear on the label and in the labeling of folic acid containing dietary supplements: "0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form." The Court enjoined FDA from enforcing a second, post-Pearson I order denying the claim and ordered FDA to come up with "one or more alternative disclaimers which may be chosen by designers, sellers, and manufacturers of dietary supplements" for use on folic acid-containing dietary supplements.22 The Court found FDA noncompliance with Pearson v. Shalala I wholly unjustified, writing: "[I]t is clear that the FDA simply failed to comply with the constitutional guidelines in Pearson. Indeed, the agency appears to have at best, misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals Opinion."23 The Court found that FDA "continually refused to authorize the disclaimers suggested by the Court of Appeals - or any disclaimer, for that matter - ."24 The Court reiterated that inconclusiveness in science does not justify banning a claim backed by credible evidence. In such circumstances the First Amendment protects the speech in issue and the government must rely on the less restrictive alternative of more speech, in the form of a disclaimer, to cure any potential misleadingness:

[A]s the Pearson opinion strongly suggests, the FDA may not ban the Folic Acid Claim simply because the scientific literature is inconclusive about whether synthetic folic acid is superior to naturally occurring folate. - The question which must be answered under Pearson is whether there is any "credible evidence" that synthetic folic acid is superior to naturally occurring food folate. - There clearly is such evidence, as the FDA itself acknowledged. Consequently, the agency erred in concluding otherwise. In short, even if the FDA's criticism of the sub-claim is valid, this criticism does not make the Claim inherently misleading; rather, it suggests the need for a well-drafted disclaimer, which the FDA has steadfastly thus far refused to even consider.25

The Court emphasized that FDA could not suppress health claims with impunity but had to satisfy a very high First Amendment burden of proof to show that suppression was constitutional; indeed, in no instance would suppression be allowed when disclosure could serve as a less restrictive alternative:

In sum, the FDA has simply failed to adequately consider the teachings of Pearson: that the agency must shoulder a very heavy burden if it seeks to totally ban a particular health claim. With respect to the two disclaimers which the Pearson Court suggested might cure all potential misleadingness, the FDA did not consider one of them at all, and summarily rejected the other in a single sentence. Nor did the FDA "demonstrate with empirical evidence that disclaimers similar to the ones" suggested by the Court of Appeals would "bewilder consumers and fail to correct for deceptiveness." Indeed, the FDA did not consider any other disclaimers, except for "The FDA has not evaluated this claim," a disclaimer no one has suggested and which is obviously inaccurate.26

The FDA refused to accept this second decision and moved to have it reconsidered by the trial judge, despite the absence of new evidence, new law, or clear error warranting reconsideration. In Pearson v. Thompson27(Pearson III), the Court denied the government's motion, finding the motion further evidence of the FDA's "reluctance to fully comply with Pearson I... ."28 Significantly, the Court used this opportunity to reiterate that FDA could not justify censorship of a health claim simply because it deemed the evidence in support of the claim insubstantial. Rather, FDA would have to produce specific evidence that contradicted the very claim in issue and would have to show that the contradictory evidence substantially outweighed the evidence in support of the claim. In the end, only if the evidence for the claim was patently incredible by comparison to the evidence specifically against it, could the claim be censored. In all other circumstances, the claim would have to be allowed (with disclaimers performing the role of qualifying the relative level, quality, and quantity of evidence for the claim). The Court wrote:

With respect to Defendants' request for clarification, which asks under what circumstances the FDA may totally ban a health claim, this issue is adequately addressed when Pearson II is considered in conjunction with Pearson I. Pearson I indicates that "the FDA [may] impose an outright ban on a claim where evidence in support of the claim is qualitatively weaker than evidence against the claim - for example, where the claim rests on only one or two old studies" or "where evidence in support of a claim is outweighed by evidence against the claim." Pearson II fleshes out the term "against": "The mere absence of significant affirmative evidence in support of a particular claim - does not translate into negative evidence 'against' it - ."29

While from the outside looking in, one would find it hard to believe that after three decisions condemning FDA censorship (one from the U.S. Court of Appeals and two from the U.S. District Court) the FDA would continue along its speech suppressive course; that is precisely what the agency did. Rather than heed the Courts' orders and permit an antioxidant/cancer risk reduction claim (e.g., "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer."), properly disclaimed (e.g., "The scientific evidence in support of this claim is inconclusive."), the FDA chose censorship once again, resulting in a second court battle on that claim, a claim already held protected by the First Amendment in Pearson I.

In Whitaker v. Thompson (Whitaker I),30 the Court evaluated FDA's decision to refuse, on remand, to allow a claim associating consumption of antioxidant vitamins with a reduction in the risk of certain forms of cancer. In holding FDA's censorship unconstitutional under the First Amendment and enjoining FDA's rule suppressing the claim, the Court explained in the greatest detail to date that FDA was utterly powerless to suppress a health claim unless under no circumstances the claim could be rendered nonmisleading through use of a disclaimer. The Court explained:

Specifically, Pearson I identified two situations in which a complete ban would be reasonable. First, when the "FDA has determined that no evidence supports [a health] claim," it may ban the claim completely. - Second, when the FDA determines that "evidence in support of the claim is qualitatively weaker than evidence against the claim - for example, where the claim rests on only one or two old studies," it may impose an outright ban. - Even in these two situations, a complete ban would only be appropriate when the government could demonstrate with empirical evidence that disclaimers similar to the ones [the Court] suggested above ["The evidence in support of this claim is inconclusive" or "The FDA does not approve this claim"] would bewilder consumers and fail to correct for deceptiveness.

Thus, two conclusions emerge from a close reading of Pearson I. First, the Court of Appeals did not rule out the possibility that disclaimers would not be able to correct the inherent misleadingness of some claims. Second, the Court stated that any complete ban of a claim would be approved only under narrow circumstances (i.e., when there was almost no qualitative evidence in support of the claim and where the government provided empirical evidence proving that the public would still be deceived even if the claim was qualified by a disclaimer).31

With Whitaker I, First Amendment protection for credible nutrient/disease relationship claims appears well-established. However, as revealed in Whitaker II, that protection applies only in the context of claims about a nutrient reducing the risk of, or preventing, a disease. The Court has held the First Amendment not violated when FDA refuses to evaluate health claims that concern the effect of a nutrient on an existing disease (i.e., a so-called "treatment" effect). That decision, Whitaker v. Thompson32 (Whitaker II), is now on appeal. The appeal will determine whether sellers of an unpatentable herbal dietary supplement, saw palmetto, may inform consumers of the truthful and nonmisleading fact that the herb (usually in extract form) affects symptomology of benign prostatic hyperplasia (BPH).33 The case calls into question basic First Amendment tenets. The outcome will determine whether FDA may censor all health claims that accurately convey an unpatentable nutrient's effect on an existing disease (a so-called "treatment" effect).

Challenging Whitaker II

Neither the plain language of the Nutrition Labeling and Education Act (NLEA) nor the intent of Congress as articulated by key committees, bill sponsors, or members reveal any evidence that the health claims definition found in 21 U.S.C. § 343(r)(1)(B) limits the scope of nutrient-disease relationship claims to disease prevention claims. To the contrary, the plain language permits the filing of health claims that "expressly or by implication - characterize the relationship of any nutrient - to a disease or a health-related condition."34 Despite that fact, the FDA prohibited review of a truthful and nonmisleading saw palmetto/BPH claim on the basis that the health claims provision did not contemplate permitting a claim concerning an effect on an existing disease. The claim is documentable and supportable by a large body of generally accepted scientific and medical research, enough in fact to possibly qualify for the "significant scientific agreement" standard, which would not be necessary to permit claim use under the Pearson precedent.35,36

FDA's decision not to permit this claim to be processed as a dietary supplement health claim under NLEA (this is significantly different from a structure/function claim under the Dietary Supplement Health and Education Act of 1994, which does not require FDA preapproval) left only one alternative for the petitioners: to seek new drug approval (NDA) for the supplement as a condition precedent to making the claim. New drug approval would cost at least $58 million according to the economic expert retained by the petitioners. Neither the petitioners nor any other company that makes saw palmetto could afford such an exorbitant cost. Moreover, even if a company could afford the cost, the fact that the nutrient is unpatentable ensures that none would file. It would be impossible to recoup that extraordinary investment (relatively modest in comparison to the cost of patentable new chemical entity drugs, whose NDA costs can run in the hundreds of millions of dollars, such costs being recoupable with exclusive marketing rights deriving from the patent and other statutory protection). Moreover, the petitioners would be sorely disadvantaged because they would also incur the costs of transforming themselves from dietary supplement to drug manufacturers, the latter operating in a new market with an entirely different distribution system. Despite those costly, indeed practically prohibitive, burdens on the right to communicate a truthful message, neither the FDA nor the U.S. District Court for the District of Columbia felt compelled to evaluate the claim under the First Amendment standards applicable to state suppression of speech.

In the view of the petitioners, the FDA simply ignored the First Amendment in its decision. The U.S. District Court based its First Amendment decision on a hasty generalization unsupported by commercial speech precedent. Under the governing Central Hudson37 four-part test, the first inquiry is to discern whether the speech in issue concerns an unlawful activity. If so, then it may be banned outright. The District Court made the mistake of defining the speech here in issue (a health claim) as concerning an unlawful activity (the filing of an ungranted health claim petition), but the filing of a health claim petition, even an ungrantable one, is a perfectly legal action. Were the filing of a petition seeking a government approval an "illegal" activity within the meaning of Central Hudson, it would have been impossible for any party to have ever won a commercial speech case against the government, to have ever surmounted the first prong. That is because at this level of abstraction every pleading defined post hoc as seeking ungrantable relief from government censorship would be ipso facto an illegal action. It would thus be entirely within the government's power to define out of existence all First Amendment protection for commercial speech. In every prior commercial speech case decided against the government, the government's proscription against speech did not define an "illegal activity" within the meaning of Central Hudson. No, the government's speech proscription was the very fact in issue. Thus, the Court erred by deciding the case on an erroneous interpretation of the first prong of Central Hudson and by thereafter not applying the remaining three parts of the Central Hudson test. Were it to have applied all four parts of the test, the Court should have found under the last part an obvious less speech restrictive alternative to the extraordinary burden placed upon the claim by the demand that a new drug application be filed as a condition precedent for the utterance of truthful speech in the market. The obvious less restrictive alternative of a health claim petition is one not proscribed by statute and one that comports fully with the First Amendment requirement placed upon FDA by Central Hudson and its progeny.

Moreover, the Court ignored its obligations under what is known as the "avoidance doctrine" - a constitutional rule of construction that our Supreme Court expects to be followed when it is possible to interpret statutory language to avoid a constitutional issue. In this case, the First Amendment issue could have been avoided in its entirety were the Court to have interpreted the statute in accordance with its plain meaning. Deference to an administrative agency taking a contrary interpretation in such instances is forbidden.38 Yet that is precisely what the Court did.

This case is now pending before the U.S. Court of Appeals for the D.C. Circuit. Resolution of the case will likely trigger a petition to the U.S. Supreme Court from the losing party, seeking that Court's review. Ultimate resolution of this case will determine whether companies that manufacture unpatentable nutrients will enjoy the freedom to inform consumers of accurate, known disease treatment effects of these nutrients. If the Court sides with the government, those truths will remain locked out of the marketplace for the foreseeable future because no company will be able to afford the high cost of the drug approval process as a condition precedent to telling the public the truth. Furthermore, few would be willing to abandon established markets, enter costly new drug markets and fight for new drug distribution channels. As with Pearson v. Shalala I, this case, Whitaker v. Thompson III, will determine whether the right to communicate a truthful and nonmisleading message will survive the contrary will of the FDA.

Ensuring Freedom of Informed Choice

It has become a truism that eternal vigilance is the price of freedom. Those individuals who, and companies that have fought the FDA to ensure freedom of informed choice have paid the price, and others also will have to guard against a loss of liberty attendant to FDA's regulatory encroachment on free speech rights. Commissioner McClellan, Associate Commissioner Crawford, and Chief Counsel Troy are all committed to ensuring freedom of informed choice, but they stand in contrast to an entrenched bureaucracy originally responsible for unconstitutional health claims suppression. While disease prevention claims are now enjoying the benefits of the new administration's labors to implement Pearson v. Shalala, the task of protecting truth remains unfulfilled so long as the saw palmetto/BPH claim and others like it remain effectively suppressed by the agency. Once again, parties have turned to the courts for relief from government censorship. As before, so now freedom hangs in the balance.

Jonathan W. Emord is a principal with Emord & Associates, P.C. in Washington, D.C. Mr. Emord practices constitutional and administrative law before the federal courts and agencies. He served as the lead counsel in Pearson v. Shalala and each of the other three federal court decisions holding FDA suppression of health claims unconstitutional under the First Amendment. He also represented Dr. Jonathan V. Wright before the U.S. Department of Justice. He is also the author of Freedom, Technology, and the First Amendment (Pacific Research Institute for Public Policy, 1991).


1. On December 18, 2002, FDA Commissioner Mark B. McClellan, M.D. announced that henceforth FDA would "make available more and better information about foods and dietary supplements to help American consumers prevent diseases and improve their health by making sound dietary decisions." See Anon. FDA Announces Initiative to Provide Better Health Information for Consumers. FDA News, Dec. 18, 2002. The initiative is a dramatic departure from preceding agency history which was characterized by claim suppression. In the words of the U.S. Court of Appeals for the D.C. Circuit: "FDA appears quite reluctant to approve health claims on dietary supplements." Pearson v. Shalala, 164 F.3d 650, 654 n.3 (D.C.Cir. 1999).

2. See Pearson v. Shalala, 172 F.3d 72 (D.C. Cir. 1999) (wherein FDA unsuccessfully sought rehearing of the Court's decision).

3. See Pearson v. Shalala, 130 F.Supp.2d 105 (D.C.D.C. 2001); Pearson v. Thompson, 141 F.Supp.2d 105 (D.C.D.C. 2001); Whitaker v. Thompson, 2002 U.S.Dist. LEXIS 25299 (D.C.D.C. 2002).

4. See, e.g., Pearson v. Shalala, 164 F.3d at 655 (fraud rationale); 164 F.3d at 656 (safety rationale).

5. See, e.g., Pearson v. Shalala, 164 F.3d at 654 (explaining that when the Plaintiffs presented FDA with First Amendment argument in favor of use of disclaimers as less speech restrictive alternatives to censorship, "FDA declined to consider [that] alternative ").

6. See, e.g., Pearson v. Shalala, 164 F.3d at 659 (rejecting government conjecture of public harm as an insufficient substitute for proof that the harms recited are real and that the restrictions will in fact alleviate the alleged harms to a material degree).

7. Ippolito PM, Pappalardo JK. Advertising Nutrition & Health: Evidence from Food Advertising 1977-1997. Bureau of Economics Staff Report, Federal Trade Commission, September 2002.

8. Anon. FDA Announces Initiative to Provide Better Health Information for Consumers. FDA News. Dec. 18, 2002.

9. Under the NLEA, 21 U.S.C. § 343(r)(1)(b), a claim of a relationship of a nutrient to a disease or a health-related condition may not appear on the label or in the labeling of a dietary supplement or conventional food unless pre-approved by the FDA. That pre-approval process requires, in the case of foods (by statute, 21 U.S.C. § 343(r)(3)) and dietary supplements (by regulation, 21 U.S.C. § 343(r)(5)(D)) that FDA find "based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate [the] claims, that the claim is supported by such evidence."

10. See generally Pearson v. Shalala, 164 F.3d at 654 (D.C.Cir. 1999) ("A - folate-neural tube defect claim supported by appellants - that consumption of folate reduces the risk of neural tube defects - was initially rejected but ultimately approved for both dietary supplement and food labels. - The parties disagree on what caused the FDA's change of position on this claim. Appellants contend that political objections - Senator Hatch was one of the complainers - concentrated the agency's mind. The FDA insists that its initial denial of the claim was based on a concern that folate consumption might have harmful effects on persons suffering from anemia, and that its concern was alleviated by new scientific studies published after the initial denial of the claim.").]

11. Senate Report 103-410, "Dietary Supplement Health and Education Act of 1994" (October 8, 1994) at 16.

12. Senate Report 105-43, "Food and Drug Administration Modernization and Accountability Act of 1997" (July 1, 1997) at 49-50.

13. 164 F.3d 650 (D.C.Cir. 1999) ("Pearson I").

14. FDA asked for rehearing of the case, but its request was denied in an 11-0 opinion of the entire Court of Appeals for the D.C. Circuit. See Pearson v. Shalala, 172 F.3d 72 (D.C.Cir. 1999).

15. 164 F.3d at 655.

16. 164 F.3d at 659-660.

17. 164 F.3d at 659.

18. 164 F.3d at 655.

19. 164 F.3d at 654.

20. 164 F.3d at 656.

21. 130 F.Supp.2d 105 (D.C.D.C. 2001).

22. 130 F.Supp.2d at 121.

23. 130 F.Supp.2d at 112.

24. 130 F.Supp.2d at 114.

25. 130 F.Supp.2d at 118.

26. 130 F.Supp.2d at 118.

27. 141 F.Supp.2d 105 (D.C.D.C. 2001).

28. 141 F.Supp.2d at 108.

29. 141 F.Supp.2d at 112.

30. 2002 U.S.Dist. LEXIS 25299 (D.C.D.C. 2002).

31. 2002 U.S. Dist. LEXIS 25299, *27-*29.

32. 2003 U.S. Dist. LEXIS 777 (D.C.D.C. 2003).

33. The claim in issue reads: "Consumption of 320 mg daily of Saw Palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH)."

34. 21 U.S.C. § 343(r)(1)(B).

35. Wilt T, Ishani A, Stark G, et al. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA 1998;280(18):1604-9.

36. Wilt T, Ishani A, Stark G, et al. Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 2000;2:CD001423.

37. Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of N.Y., 447 U.S. 557 (1980).

38. See, e.g., Solid Waste Agency of Northern Cook County v. United States Army Corps of Engineers, et al., 531 U.S. 159, 173 (2001), citing De Bartolo Corp. v. Florida Gulf Coast Building & Constr. Trades Council, 485 U.S. 568, 575 (1988), "where an otherwise acceptable construction of a statute would raise serious constitutional problems, the Court will construe the statute to avoid such problems unless such construction is plainly contrary to the intent of Congress."