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PEARSON v. SHALALA

No. 98-5043, 98-5084.

164 F.3d 650 (1999)

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.

United States Court of Appeals, District of Columbia Circuit.

Decided January 15, 1999.

Attorney(s) appearing for the Case

Jonathan W. Emord, Burke, VA, argued the cause for appellants. With him on the briefs were James S. Turner, Bellevue, WA, 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.

SILBERMAN, Circuit Judge:

Marketers of dietary supplements must, before including on their labels a claim characterizing the relationship of the supplement to a disease or health-related condition, submit the claim to the Food and Drug Administration for preapproval. The FDA authorizes a claim only if it finds "significant scientific agreement" among experts that the claim is supported by the available evidence. Appellants failed to persuade the FDA to authorize four...

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