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)