U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
April 20, 2001

Letter Regarding Completion of Review of a Health Claim that Was the Subject of the Pearson Court Decision

Dear Mr. Emord:

I notified you by letter on March 30, 2001, that the Food and Drug Administration (FDA) expected to complete its review of a health claim for antioxidant vitamins with respect to cancer (Docket No. 91N-0101) by April 20, 2001.

The agency has continued to work intensely on the review of the antioxidant vitamins claim, and this review has continued to be the highest priority for the staff involved. Regrettably, I must inform you that we were unable to complete the final review and concurrence process by April 20, 2001. The agency will need more time to complete this process.

As I explained in earlier letters, FDA's review of the claim for antioxidant vitamins with respect to cancer has been complicated by the large number of new human studies that were conducted since FDA's original 1991-93 review. Further complicating the agency's review is the fact that the proposed claim addresses relationships between a number of antioxidant vitamins and a number of different types of cancers. FDA is closely examining the evidence regarding the relationship between each antioxidant vitamin and each cancer. The review of each such relationship has brought forth issues that have required additional evaluation of the science. The scientific and management staff have been working diligently on the review, and we expect that the agency's response will be over sixty pages in length. Further, some of these same scientific and management staff were involved earlier in responding to your correspondence with respect to other proposed claims. Despite several lengthy internal conferences over the past three weeks, all these factors have prevented us from achieving closure and meeting the April 20, 2001, deadline.

We are continuing to work as hard as we can to finalize the antioxidants review. We believe we can complete the final stages of review and issue our decision by May 4, 2001. The agency sincerely apologizes for this further delay. We appreciate your ongoing patience.

Hypertext updated by dav 2001-MAY-21