Pearson Injunction Against FDA Denied By Federal Judge
This article was originally published in The Tan Sheet
Executive Summary
A preliminary injunction against FDA requested by the Pearson v. Shalala plaintiffs was denied May 24 by D.C. federal court judge Gladys Kessler. An appeal was filed May 26 by Emord & Associates (Washington, D.C.).
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Pearson claims
FDA will make a final determination by Oct. 10 on the four proposed health claims, CFSAN says in a July 14 update on its 2000 program priorities. In light of the impending deadline, the Pearson plaintiffs say they are withdrawing their appeal of a D.C. federal judge's decision denying their motion to force the agency to allow immediate use of the four claims with appropriate disclaimers (1"The Tan Sheet" June 5, p. 14). CFSAN also announces a Nov. 24 deadline for determining whether health claims with qualifying disclaimers may be made for vitamin E/heart disease and vitamin B/vascular disease. The agency previously denied the two claims, finding they did not meet its significant scientific agreement standard (2"The Tan Sheet" Jan. 24, p. 10)
Whitaker v. Shalala
FDA "has adduced no empirical evidence" supporting its assertion that a health claim for saw palmetto and benign prostatic hyperplasia would cause men with prostate cancer to delay treatment, undermine drug approval system protections or diminish research incentives, dietary supplement sellers say in a summary judgment motion filed June 13 in D.C. federal court. The Whitaker plaintiffs assert FDA, in a May 26 decision denying the claim, improperly attempted to reclassify saw palmetto as a drug and failed to review the petitioners' scientific evidence concerning the botanical's safety (1"The Tan Sheet" June 5, p. 14)