Pearson v. Shalala
1999 U.S. App. LEXIS 464, 334 U.S. App. D.C. 71, 164 F.3d 650 (1999)
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Rule of Law:
The government cannot prohibit potentially misleading health claims on dietary supplements without considering less restrictive alternatives like disclaimers, and an administrative agency must provide a clear definition for its regulatory standards to avoid arbitrary and capricious action.
Facts:
- Dietary supplement marketers Durk Pearson and Sandy Shaw submitted requests to the Food and Drug Administration (FDA) to authorize four specific health claims for inclusion on their supplement labels.
- The proposed claims were: (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," and (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."
- The FDA's regulations require pre-approval for health claims on dietary supplements, authorizing a claim only if there is "significant scientific agreement" among experts that the claim is supported by available evidence.
- The FDA rejected all four of Pearson and Shaw's proposed claims, concluding that the existing scientific evidence was inconclusive and did not meet the "significant scientific agreement" standard.
- In rejecting the claims, the FDA did not consider Pearson and Shaw's suggestion that the claims be permitted with corrective disclaimers, such as stating that the evidence was inconclusive.
Procedural Posture:
- Durk Pearson and Sandy Shaw, along with two health care advocacy organizations, sought relief in the United States District Court for the District of Columbia, challenging the FDA's rejection of their health claims on constitutional and statutory grounds.
- The District Court rejected their various constitutional and statutory challenges.
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Issue:
Does the FDA's refusal to permit health claims on dietary supplements without "significant scientific agreement," and its failure to consider appropriate disclaimers for potentially misleading claims, violate the First Amendment's commercial speech protections, or does the FDA's failure to define "significant scientific agreement" violate the Administrative Procedure Act?
Opinions:
Majority - Silberman, Circuit Judge
Yes, the FDA's outright prohibition of health claims that lack "significant scientific agreement" without considering less restrictive alternatives like disclaimers, and its failure to define what constitutes "significant scientific agreement," violate the First Amendment and the Administrative Procedure Act, respectively. The court found that health claims lacking "significant scientific agreement" are not inherently misleading and therefore fall under the protection of commercial speech, subject to the Central Hudson test. While the government's interests in public health and preventing consumer fraud are substantial, an outright ban on potentially misleading claims fails the "reasonable fit" prong of Central Hudson because less restrictive means, such as prominent disclaimers, were not considered and could often suffice to mitigate potential consumer confusion. The court emphasized that the First Amendment doctrine generally prefers disclosure over suppression, citing Bates v. State Bar of Arizona, Peel v. Attorney Registration and Disciplinary Comm'n, and 44 Liquormart, Inc. v. Rhode Island. Furthermore, the FDA's failure to articulate a concrete definition for "significant scientific agreement" constitutes arbitrary and capricious action under the Administrative Procedure Act, as an agency must provide a satisfactory explanation and definitional content for the standards it applies to regulate private conduct. The court remanded the case for the FDA to reconsider the health claims and either approve them, approve them with appropriate disclaimers, or ban them with proper justification after defining its standard.
Analysis:
This case significantly clarifies the application of commercial speech doctrine to health claims on dietary supplements, establishing a precedent that government agencies cannot unilaterally ban potentially misleading claims without first considering less restrictive measures, such as disclaimers. It reinforces the principle that while the government has a substantial interest in preventing consumer fraud and protecting public health, these interests must be balanced against First Amendment rights through narrowly tailored regulations. The ruling also underscores the Administrative Procedure Act's requirement for agencies to provide clear, defined standards, ensuring transparency and preventing arbitrary decision-making. Future cases involving government regulation of commercial speech, particularly in areas affecting public health, will likely look to Pearson for guidance on the necessity of exploring disclosure as an alternative to outright prohibition.
