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

Pearson

This article was originally published in The Tan Sheet

Executive Summary

Plaintiffs seek preliminary injunction barring FDA from prohibiting use of antioxidants/cancer risk-reduction health claim until court decides on lawsuit's merits. Plaintiffs will accept "any reasonable short, succinct and accurate disclaimer to guard against potential misleadingness," according to motion filed in D.C. federal court Sept. 14. Emord & Associates asserts FDA's May 4 letter rejecting claim did not evaluate disclaimer language, as ordered in Pearson ruling. FDA's conclusions on ATBC study, other trials are "riddled with profound and basic errors of science," motion adds. Agency rejection cited ATBC data showing higher bladder, stomach cancer incidence with vitamin E (1"The Tan Sheet" May 14, p. 10)

You may also be interested in...



Antioxidants/Cancer Health Claim Contradicted By ATBC Study - FDA

Analyses from the 1994 Alpha-Tocopherol, Beta Carotene intervention trial raise "serious questions" about vitamin E's role in modifying cancer risk, FDA's Center for Food Safety & Applied Nutrition concludes May 4 in rejecting an antioxidant vitamins/cancer health claim.

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

People In Brief

Perrigo promotes in pricing, planning

Topics

UsernamePublicRestriction

Register

LL1129949

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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