The Impact and Limits of the Constitutional Deregulation of Health Claims on Foods and Supplements - Margaret Gilhooley

• Citation: Vol. 56 No. 2
• Publication year: 2005

The Impact and Limits of the Constitutional Deregulation of Health Claims on Foods and Supplements: From Dementia to Nuts to Chocolate to Saw Palmettoby Margaret Gilhooley^*

I. Introduction

The Food and Drug Administration ("FDA") recently issued an enforcement policy identifying the types of health claims in the disclaimers that are constitutionally permitted on foods and dietary supplements.' In 1990 Congress required that before a company could make a health claim on a food product, the FDA must approve the claim as based on significant scientific agreement.' While the 1990 law gave the FDA discretion to establish a lesser standard for nutritional supplements than for food products,³ the FDA chose to apply the same standard. Thus, claims on nutritional supplements had to be supported by significant scientific agreement.⁴ Supplement marketers successfully challenged this requirement in Pearson v. Shalala.⁵ In Pearson the United States Court of Appeals for the District of Columbia held, based on the First Amendment, that the government could not suppress claims that lacked significant scientific agreement when disclosures were sufficient to prevent consumer confusion.⁶ The court suggested that the FDA consider the use of disclaimers, such as a warning that the claim was inconclusive, but left the exact language of the disclaimers to the FDA.⁷ Moreover, the court suggested that product claims made contrary to the weight of the evidence might be barred when the potential for deception could not be cured by disclaimers.' A district court later found that claims with disclaimers may not be barred if there is credible evidence for them.⁹ The FDA has now identified the types of claims and disclaimers it will accept for foods and supplements."

The FDA's enforcement policy for health claims warrants analysis not only for its adequacy in protecting consumers, but also as an example of constitutional deregulation. The application of commercial speech principles to food and drug law is one of the most important recent developments in the field, and the implications are still emerging.

The FDA's enforcement policy details the claims that can be "qualified"" by a disclaimer in categories that range from B to D.¹² Some may be puzzled by the lack of an A or F grade. The A category is for claims that have significant scientific agreement, like the claim for oat fiber in Cheerios. Such A category claims do not need to be qualified by a disclaimer. The F category would be for claims that are so weak that they are precluded.¹³ To make its determinations, the FDA uses an "evidence-based rating system" for evaluating scientific evidence, a system adapted from the American Dietetic Association¹⁴ to assign claims into their respective rankings.

This Article focuses on the following claims, which are supported by various levels of scientific evidence:

•Manufacturers of nutritional supplements containing phospha-tidylserine¹⁵ can make a D-type claim that "very limited and preliminary scientific research suggests" that the supplement may reduce the risk of cognitive dysfunction or dementia in the elder-ly.¹⁶ The supplement must also contain language that the "FDA concludes that there is little scientific evidence to support this claim."¹⁷

*Manufacturers of antioxidant vitamins can make a C-type claim that "some scientific evidence suggests" that consumption of antioxidant vitamins may reduce the risks of certain forms of cancer, but the "FDA has determined that this evidence is limited and not conclusive."¹⁸

*Companiesthat sell walnuts can make a claim that "[s]upportive but not conclusive research shows that eating 1.5 ounces per day" in

a low fat diet and "not resulting in increased caloric intake" may reduce the risk of heart disease."

This Article explores some important points about these claims. First, the claims on the label do not bear the actual letter category or grade identified in the guidance and press release.²⁰ Second, the D claim is strikingly weak and clearly raises the issue about what test is appropriate for precluding claims. Third, the disclosures for all the claims need improvement. Lastly, in the case of nuts, the FDA, for the first time, is allowing a claim for a food as opposed to a nutritional supplement. The greater impact on the public from health claims on foods warrants special attention.

The FDA recently prevailed in limiting the scope of the constitutional deregulation of health claims for treatment of disease for the supplement saw palmetto.²¹ The D.C. Circuit Court of Appeals accepted the agency's statutory interpretation that health claims include disease prevention claims, but not disease treatment claims and determined that such a limit does not violate commercial speech.²² In light of that decision, this Article considers the constitutional permissibility of allowing disease-prevention health claims for only those supplements that are "nutritional," a limitation found in the statute.²³ If such a limit were recognized, non-nutritional supplements, such as St. John's Wort, could make structure and function claims, as Congress has allowed, but not disease-related health claims without meeting the drug approval requirements.²⁴ Exploring this issue will require consideration of the complex regulatory scheme for dietary supplement This Article also examines the need for reform to ensure that the non-nutritional supplements are safe, as well as the relevance of the FDA's guidance on the support for qualified health claims to the support needed for the structure and function claims statutorily allowed for dietary supplements. Currently, these supplements can include only structure and function claims.²⁶ This Article considers the complexity of the different approaches to health claims and, structure and function claims for supplements and notes points where reform is most needed.

This Article primarily focuses on the FDA's new guidelines for the types of qualified claims it will accept. This Article also examines the restraints placed on the FDA by the constitutional grounds that underlie the new policy. Part II provides background on the legislation governing the use of health claims and on the judicial decisions recognizing constitutional protections for claims with disclaimers and rejecting efforts to preclude claims. Part III assesses the FDA's new enforcement policy for claims on supplements with respect to the test for barring claims and the framework for providing better disclaimers. Part rV separately examines the enforcement policy for foods and the existence of specific legislative standards for the claims on foods. Part V examines the judicial decision finding that it is statutorily and constitutionally permissible to prevent supplements from containing disease treatment health claims and to require the products with such claims to meet the drug approval requirements. Part VI concludes by reflecting on the types of reforms that are most needed in the regulation of supplements and the importance of Congress's role, notwithstanding the constitutional deregulation that has occurred.

11. Background on Statute, Litigation, and Evolution of FDA Policy

A. Statutory and Regulatory Provisions for Health Claims

At one point the FDA did not allow companies to display any explicit health claims on foods because it viewed them as drug claims.²⁷ Manufacturers that made a drug claim bore the burden of supporting the claim with "adequate and well-controlled investigations" and obtaining agency approval before sell of the drug.²⁸ Meeting the strict standards for drug approval is often not feasible for the manufacturers of food products.

Foods, as commodities, are more difficult to protect under patent or intellectual property rights, which support extensive research.²⁹ Additionally, health claims often relate to disease prevention, and these effects may need difficult and expensive long-term population studies to be fully adequate.³⁰

The FDA began to reconsider its approach in the 1980s when the National Cancer Institute discovered that fiber could reduce the risk of cancer.³¹ The FDA proposed rules that would have allowed nonmis-leading health claims on foods when supported by the weight of the evidence.³² However, food manufacturers abused the proposed rules by advertising health claims about foods with nutritional drawbacks, such as an advertisement about the value of vitamin A in butter.³³

In response to these concerns, in 1990 Congress enacted a law that allowed health claims for foods, but only if the FDA determined that "based on the totality of publicly available scientific evidence . . . there is significant scientific agreement, among experts . . . that the claim is supported by such evidence."³⁴ The significant scientific agreement standard is viewed as a proxy for the type of support that experts believe is needed in a field where long-term testing is not always feasible.³⁵ While the statute authorized health claims on foods only if supported by substantial scientific agreement, the law left it to the FDA to decide what procedures and standards should apply to "nutritional" supple-ment ~ . The FDA, by regulation, applied the same standards to supplements as it applied to foods.³⁷

B. Litigation

1. Pearson u. Shalala

In Pearson u. Shalala,³⁸ a marketer of supplements sought to make health claims that antioxidant vitamins may reduce the risk of cancer. The FDA refused to allow the marketer to do so because of the lack of significant scientific agreement for the claim. The research revealed such an effect for fruits and vegetables containing these vitamins but not for the vitamins themselves. The FDA believed the vitamin might only be a marker for other constituents in the food that produced the claimed effect.³⁹ The FDA also rejected the alternative of allowing the claim with a disclaimer that the "FDA has determined that the evidence supporting the claim is inconclusive."⁴⁰

The D.C...