786 F. Supp. 2d 1
D.D.C.2011Background
- Plaintiffs design and license dietary supplement formulations and are industry groups; defendants include the FDA and DHHS secretary.
- Plaintiffs challenged FDA's June 19, 2009 decision denying several health claims linking vitamins C and E to reduced cancer risk on dietary supplement labels.
- FDA denied four claims entirely and allowed two as qualified claims with modified language, prompting a First Amendment challenge under Pearson I standards.
- The case sits within a line of prior Pearson/I Whitaker/Alliance decisions addressing whether disclaimers or bans are appropriate under Central Hudson and First Amendment doctrines.
- The court performs an independent constitutional review of the agency decision but defers to the FDA on its evaluations of scientific data.
- The court remands two of the qualified claims to the FDA for drafting precise disclaimers, and denies other relief.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the FDA's complete ban on four claims violated the First Amendment. | Credible evidence supported the claims; bans were impermissible. | No credible evidence; bans consistent with Pearson I framework. | Remanded for remand/reevaluation; partial vindication for plaintiffs. |
| Whether the FDA's use of its 2009 Guidance Document to assess credibility complies with Pearson I/Central Hudson. | Guidance provides reasonable framework for credibility; FDA applied it reasonably. | FDA's framework is consistent with controlling precedent and totality of evidence. | FDA's criteria deemed rational and appropriately applied. |
| Whether the FDA's modification of two qualified claims to separate, disclaimer-like language complied with the First Amendment. | Disclaimers should accompany claims without replacing the substantive claim. | Disclaimers are permissible within the qualified-claim framework. | Remanded for drafting precise disclaimers; complete substitution rejected. |
| What is the proper standard of review for a constitutional challenge to agency decisions on health claims under Central Hudson and Pearson I? | Independent constitutional review with deference only to scientific judgments. | Agency findings on scientific data deserve deference absent arbitrariness. | De novo constitutional review with deference to scientific interpretation. |
Key Cases Cited
- Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (First Amendment commercial speech framework for health claims; disclaimer preferred over outright bans when credible evidence exists)
- Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (Folio on evidence credibility and disclaimers in folic acid claim)
- Pearson v. Thompson, 141 F. Supp. 2d 105 (D.D.C. 2001) (Reconsideration of FDA methodology post-Pearson I)
- Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002) (Court found FDA failed to show least restrictive means to regulate potentially misleading claims)
- Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) (Remanded both outright bans and modified claims for precise, succinct disclaimers)
- Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980) (Multistep framework for commercial speech regulation)
- Western States Medical Center v. FOX, 535 U.S. 357 (2002) (Strict scrutiny of regulatory methods for restricted medical information)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (Agency interpretation of scientific data entitled to deference within expertise)