## Facts

- Dietary supplement marketers and allied organizations sought FDA authorization to use four proposed nutrient–disease “health claims” on dietary supplement labeling.
- The proposed claims asserted risk-reduction relationships involving antioxidant vitamins and cancer, fiber and colorectal cancer, omega-3 fatty acids and coronary heart disease, and higher-dose folic acid and neural tube defects.
- Under FDA regulations implementing the Nutrition Labeling and Education Act, health claims require FDA preapproval and must be supported by “significant scientific agreement” among qualified experts.
- The FDA denied authorization for each claim, concluding the evidence did not satisfy the “significant scientific agreement” standard and declining to approve the claims with disclaimers.
- Plaintiffs sued in federal district court alleging First Amendment, Administrative Procedure Act (APA), and due process violations; the district court upheld the FDA.
- Plaintiffs appealed to the D.C. Circuit.

## Issues

1. Whether the FDA violated the First Amendment by suppressing proposed dietary supplement health claims without considering whether disclaimers could cure potential misleadingness.
2. Whether the FDA’s failure to articulate an administrable standard for “significant scientific agreement” rendered its denials arbitrary and capricious under the APA and deprived regulated parties of fair notice.
3. Whether the FDA’s denials of the four claims were otherwise unlawful under the APA.

## Decision

- The D.C. Circuit reversed the district court.
- The court held the FDA’s refusal to consider disclaimers and its “outright suppression” of claims that were at most potentially misleading violated the First Amendment.
- The court held the FDA’s use of “significant scientific agreement” without a discernible, concrete standard was arbitrary and capricious under the APA and raised fair-notice concerns.
- The court remanded to the FDA to articulate a meaningful standard for “significant scientific agreement” and to reconsider the claims, including whether appropriately tailored disclaimers would avoid deception.

## Legal Principles

- Under Central Hudson, restrictions on truthful, lawful commercial speech must be reasonably fitted to a substantial governmental interest and not restrict more speech than necessary.
- Commercial speech that is potentially misleading generally may not be banned if disclaimers or qualifying language can render it non-misleading; disclosure is preferred over suppression.
- The FDA bears the burden to justify a ban by showing the claim is inherently misleading and not correctable by disclaimer; otherwise, the agency must consider allowing the claim with reasonable disclaimers.
- Under the APA, when an agency relies on a regulatory criterion as dispositive, it must articulate a workable standard and explain how the evidence fails to meet that standard; undefined standards that confer broad discretion risk being arbitrary and capricious and may fail to provide fair notice.

## Conclusion

The D.C. Circuit required the FDA to use less speech-restrictive measures for dietary supplement health claims when feasible, holding that potentially misleading claims ordinarily must be evaluated for disclaimer-based approval, and it required the agency to define and apply “significant scientific agreement” through a clear, reviewable standard on remand.


Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)