Court Finds FDA Rejection of Truthful Health Claims Unconstitutional

On January 15, 1999, the U.S. Court of Appeals held that the FDA acted unconstitutionally in its rejection of four specific health claims that dietary supplement manufacturers Durk Pearson and Sandy Shaw wanted to place on their products' labels.

What does this decision really mean? Are manufacturers now free to make any kind of health claim they wish as long as they include appropriate disclaimers?

Information in this article is based on the published court opinion.

Free speech and advertising

The U.S. Court of Appeals stated that "truthful advertising related to lawful activities is entitled to the protection of the First Amendment." However, government can impose restrictions when advertising is potentially misleading. Since almost any statement can be potentially misleading, the question becomes: What kinds of restrictions are allowable, under the law? At least three laws and many court decisions affect the kinds of restrictions that the government can place.

Health claims: Who can make them?

A health claim is a statement that a particular substance has an impact upon a disease. Until the mid-1980s, only drugs were allowed to make such a claim -- and any product that did make such a claim was automatically categorized as a drug. (According to legislative definition, any product that is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" is a drug.)

In the past, the FDA took a very stringent position on health claims. Statements that a food could prevent a particular disease were viewed as a claim that the food was a drug -- and the FDA said it would prohibit sale of that food until a new drug application had been approved. Thus, the question of whether a particular product is a drug or a dietary supplement has very significant consequences, both for the manufacturer and the consumer.

In the mid-80s, however, companies began making health claims on food without seeking new drug approval -- and in 1987, the FDA issued regulations that sanctioned this practice. In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA), which allowed health claims on foods if these claims were certified by the FDA as supported by "significant scientific agreement." The Dietary Supplement Health and Education Act (DSHEA) of 1994 created a similar niche for allowing health claims by dietary supplements.

Criteria for approval of health claims

DSHEA specifically allows dietary supplements to make "structure/function" claims. However, in order to print a health claim on the label of a dietary supplement, that claim must be submitted to the FDA for preapproval. The FDA approves only those claims that have "significant scientific agreement" among experts that the claim is supported by the available evidence. (The FDA has approved only two such health claims on dietary supplements.)

What criteria are the FDA allowed to use for approving or rejecting these health claims? This question lies at the heart of the Pearson and Shaw lawsuit. Pearson and Shaw claimed that the criteria the FDA used in rejecting their health claims was both unconstitutional -- violating both the First and Fifth Amendments -- and illegal under the Administrative Procedure Act (APA). The First Amendment protects free speech. The Fifth Amendment and the APA require that laws and regulations be clearly defined in order to be observable and enforceable.

Is the health claim inherently misleading?

Judicial decisions have held that advertising that is inherently misleading can be prohibited altogether. The FDA argued that health claims lacking "significant scientific agreement" are inherently misleading.

The appeals court characterized the FDA's argument as saying that health claims that lack significant scientific agreement have such an "awesome" and "hypnotizing" influence on consumers that they become unable to exercise any judgment at the point of sale, and therefore are bound to be misled. The appeals court rejected this argument as "almost frivolous."

Can government prohibit health claims that are potentially misleading?

The FDA also argued that health claims on dietary supplements are potentially misleading for two reasons. Consumers would find it hard to verify these claims on their own. Also, consumers might assume that the government has approved such claims.

Disclaimers are often used in advertising to clarify or qualify statements that are potentially misleading. For example, a statement that "The FDA has not approved these health claims" might be an adequate disclaimer for the second concern in the paragraph above.

Pearson and Shaw offered to use disclaimers with their health claims. The FDA rejected this offer and argued in court that the government is not required to accept disclaimers but can instead prohibit any claims that lack "significant scientific agreement."

When can government restrict commercial speech?

The appeals court cited several court cases in stating that information that is potentially misleading may not be prohibited altogether "if the information can be presented in a way that is not deceptive."

In particular, the Central Hudson case [477 U.S. 557, 566 (1980)] established that government schemes for regulating commercial speech that is potentially misleading must meet three specific guidelines.

Basically, the appeals court found that the FDA's choice of suppressing health claims that lack "significant scientific agreement" was not a direct advancement of consumer health -- although it could be considered a direct advancement of protection against consumer fraud. But the appeals court then said, "The difficulty with the government's consumer fraud justification comes at the final Central Hudson factor: Is there a reasonable fit between the government's goals and the means chosen to advance those goals?"

Is the FDA's refusal to consider disclaimers a "reasonable fit"?

The issue is whether the government is allowed to prohibit a potentially misleading statement if providing additional information (such as a disclaimer) will satisfy the requirement for a "reasonable fit" between government ends and means. The FDA maintained that commercial speech doctrine does not prefer disclosure over outright suppression -- but the appeals court disagreed.

FDA's grounds for rejection of health claims found unconstitutional

The appeals court cited several cases in which the Supreme Court "repeatedly [pointed] to disclaimers as constitutionally preferable to outright suppression." The Supreme Court has rejected the ideas that the public is too unsophisticated to understand the limitations of advertising, and that the public is better kept in ignorance than trusted with correct but incomplete information. The Supreme Court has also said that "the preferred remedy is more disclosure, rather than less."

For these reasons, the appeals court found that the FDA's rejection of these four health claims was unconstitutional.

Is the FDA now required to accept disclaimers?

The appeals court did not conclude that the FDA would be required to accept health claims with disclaimers. The appeals court said it would not presume to draft appropriate disclaimers for the four health claims, saying that this was the job of the agency.

The appeals court also said that if evidence against a particular health claim outweighed evidence supporting that claim, it was possible that the FDA could decide that this potential confusion was incurable by any disclaimer and might ban such a claim outright.

Finally, the appeals court was skeptical that the government could demonstrate empirically that a particular disclaimer "would bewilder consumers and fail to correct for deceptiveness," but they did not rule out the possibility.

The unarticulated standard of "significant scientific agreement"

Free speech was one of two major threads in the Pearson and Shaw lawsuit. They also claimed that the FDA's failure to define "significant scientific agreement" more specifically was an independent violation of the Fifth Amendment of the Constitution. They claimed the FDA's approach was so vague that it deprived them of liberty and property without due process.

Pearson and Shaw also claimed that the Administrative Procedure Act (APA) requires the FDA to develop a standard for acceptance or rejection of health claims that is much more concrete and specific than "significant scientific agreement."

The appeals court did not consider the constitutional issue here because it agreed with the appellants that the APA requires the agency to explain why it rejected their proposed health claims. The appeals court said that giving an adequate explanation "necessarily implies giving some definitional content to the phrase significant scientific agreement."

Basically, the government is not allowed to engage in arbitrary and capricious action. The appeals court stated, "It simply will not do for a government agency to declare -- without explanation -- that a proposed course of private action is not approved. To refuse to define the criteria it is applying is equivalent to simply saying no without explanation. It must be possible for the regulated [party] to perceive the principles which are guiding agency action."

The U.S. Court of Appeal's decision

1. The FDA must reconsider the appellants' four health claims because the reasons it gave for rejecting them are an unconstitutional violation of the appellants' First Amendment rights of free speech.
2. The FDA must also explain what it means by significant scientific agreement (or at least what it does not mean).

The decision of the appeals court to discuss the constitutional issue was highly unusual. They stated that they did so because the appellants might be entitled to make health claims with proper disclaimers even if those claims did not meet the standard of a fuller and more concrete definition of "significant scientific agreement". In other words, even if the FDA were to define "significant scientific agreement" more fully and specifically, Pearson and Shaw might still be entitled to make health claims that did not meet this standard as long as they used appropriate disclaimers.

Implications for quality

This decision is a clear victory for both producers and consumers. Producers will be able to include on their labels and product literature fuller information about the health benefits of their products. Consumers will have access to better, more extensive information about the scientific evidence about products they are considering. In the long run, this decision helps empower consumers to take charge of their own health.

Notes:

Each of the four health claims links the consumption of a particular supplement to the reduction in risk of a particular disease:

1. "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."

2. "Consumption of fiber may reduce the risk of colorectal cancer."

3. "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

4. "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."

In rejecting the first three claims, the FDA said that the evidence for these statements was based on consumption of foods containing these substances, not on consumption of the substances alone. In rejecting the fourth claim, the FDA merely stated that "the scientific literature does not support the superiority of any one source over others."

The three laws cited in this court case were the Administrative Procedures Act (APA), the Nutrition Labeling and Education Act of 1990 (NLEA), and the Dietary Supplements Health and Education Act of 1994 (DSHEA).

The Central Hudson [477 U.S. 557, 566 (1980)] guidelines that must be applied to government schemes for regulating commercial speech are:

1. The asserted government interest must be "substantial".
   
   On this point, the FDA presented two concerns: protection of public health and prevention of consumer fraud. The Supreme Court has said "there is no question that [the government's] interest in ensuring the accuracy of commercial information in the marketplace is substantial," and that government has a substantial interest in "promoting the health, safety, and welfare of its citizens."

2. The regulation must "directly advance the governmental interest asserted."
   
   The FDA did not claim that the dietary supplements in question were any kind of threat to consumers' health and safety. Instead, it argued that consumers' health is directly advanced by barring any health claims that were not approved by the FDA.
   
   The appeals court rejected this argument, saying that this strategy was only an indirect advancement of public health at best, and cited the Supreme Court's statement that "The First Amendment directs us to be especially skeptical of regulations ... that seek to keep people in the dark for what the government perceives to be their own good."
   
   The appeals court did find some merit in the idea that the FDA's regulatory scheme was a direct protection against consumer fraud. In essence, if some health claims on dietary supplements will mislead consumers, then requiring FDA preapproval and setting the standard extremely high (perhaps even impossibly high) will definitely prevent any confusion among consumers.

3. The fit between the government's ends and the means chosen to accomplish those ends must be "not necessarily perfect, but reasonable."
   
   However, the appeals court then said, "The difficulty with the government's consumer fraud justification comes at the final Central Hudson factor: Is there a reasonable fit between the government's goals and the means chosen to advance those goals?"
   
   This issue lies at the heart of Pearson and Shaw's constitutional challenge to the FDA's action. If a disclaimer satisfies the requirement for a "reasonable fit", then the more severe approach of suppressing the information altogether is a violation of the First Amendment protection of free speech.

The source of this article was the published court decision of the following case:

Argued December 1, 1998. Decided January 15, 1999
No. 98-5043
Durk Pearson and Sandy Shaw, American Preventive Medical Association, and Citizens for Health, Appellants
v.
Donna E. Shalala, Secretary, United States Department of Health and Human Services, et al., Appellees
Consolidated with
98-5084
Appeals from the United States District Court for the District of Columbia
(95cv01865)

Jonathan W. Emord argued the cause for appellants. With him on the briefs were James S. Turner and Betsy E. Lehrfeld.

Christine N. Kohl, Attorney, United States Department of Justice, argued the cause for appellees. With her on the brief were Frank W. Hunger, Assistant Attorney General, Wilma A. Lewis, United States Attorney, and Douglas N. Letter, Attorney, United States Department of Justice. Nancy T. Lord-Johnson was on the brief for amici curiae Direct Aids Alternative Information Resources, et al. David C. Vladeck, Allison M. Zieve, and Bruce Silverglade were on the brief for amici curiae American Cancer Society, et al.

Before: Wald, Silberman, and Garland, Circuit Judges