Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)

You may also be interested in...



FDA Prohibition of Saw Palmetto/BPH Treatment Claim Upheld by Court

FDA's decision to deny a health claim linking saw palmetto extract to the treatment of benign prostatic hypertrophy symptoms was upheld by a Washington, D.C. federal court in a Jan. 3 decision

FDA Prohibition of Saw Palmetto/BPH Treatment Claim Upheld by Court

FDA's decision to deny a health claim linking saw palmetto extract to the treatment of benign prostatic hypertrophy symptoms was upheld by a Washington, D.C. federal court in a Jan. 3 decision

FDA Prohibition of Saw Palmetto/BPH Treatment Claim Upheld by Court

FDA's decision to deny a health claim linking saw palmetto extract to the treatment of benign prostatic hypertrophy symptoms was upheld by a Washington, D.C. federal court in a Jan. 3 decision

Related Content

Topics

UsernamePublicRestriction

Register

PS091341

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel