Whitaker v. Shalala
This article was originally published in The Tan Sheet
Executive Summary
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)
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