June 1, 2000
Saw Palmetto Seeks Health Claim
WASHINGTON--A health claim (docket #99P-3030) submitted to the Food and DrugAdministration (FDA) on May 25, 1999 requested that FDA authorize a health claim fordietary supplements containing saw palmetto (n-hexane lipidosterolic extract from Serenoarepens) and its effects on benign prostatic hyperplasia (BPH). The petition set forththe claim: "Consumption of 320 mg daily of saw palmetto extract may improve urineflow, reduce nocturia and reduce voiding urgency associated with mild benign prostatichyperplasia (BPH)."
The case is Julian M. Whitaker, M.D., et al v. Donna E. Shalala; the action wassubmitted on behalf of organizations such as the American Preventive Medical Associationand Pure Encapsulations Inc.
The current motion asks that a health claim for an existing disease (BPH) be applied tosaw palmetto products. Wording in health claims walks a fine line, and the saw palmettoclaim could be characterized as treating a disease, mitigating a disease or both. Afterthe FDA reviewed the proposed health claim for saw palmetto, it concluded that claimsabout effects on existing diseases do not fall within the scope of the health claimprovisions in 21 U.S.C. 343(r) and therefore cannot qualify for an authorized healthclaim from the FDA. The only substance that can receive a claim to treat a disease is adrug, which means that saw palmetto would have to be tested as a drug to receive theproposed claim.
The plaintiffs planned to file a motion for summary judgment on June 13, opposingmemoranda shall be filed on or before June 27 and reply memoranda on or before July 7. Formore information, call (202) 466-6937.
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