FDA Postpones Antioxidant Claim Decision...Again

WASHINGTON-On Dec. 22, the Food and Drug Administration (FDA) notified the Pearson v. Shalala petitioners that it has again postponed issuing a decision on their proposed antioxidant/cancer health claim until Feb. 23, 2001. FDA cited the quantity of research to be analyzed as the reason for the second delay. In a letter to Emord & Associates, FDA stated, "The agency's review has been complicated by the fact that the proposed claim addresses relationships between antioxidant vitamins and a number of different types of cancer. Each of these multiple relationships needs to be evaluated individually." In addition, FDA reiterated the fact that there are numerous new studies that need to be reviewed before it can render its decision.

The agency's scientific team is also reviewing a claim regarding an association between vitamin E and its effect on cardiovascular disease. The U.S. District Court for the District of Columbia agreed to extend FDA's deadline for issuing a decision concerning this claim until Jan. 12, 2001. For more information, visit www.fda.gov.