U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 30, 2001

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

Dear Mr. Emord:

On February 23, 2001, I notified you by letter that the Food and Drug Administration (FDA) intended to complete its review of a health claim for antioxidant vitamins with respect to cancer (Docket No. 91N-0101) by March 30, 2001.

The agency has continued to work steadily on the review of the antioxidant vitamins claim, and this review has continued to be the highest priority for the staff involved. However, I must regretfully inform you that, although the response is in the final stages of review, the review process is still ongoing. The agency will need additional time to complete this process.

As I stated 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 in responding to your correspondence with respect to other proposed claims. These factors have prevented us from meeting the March 30, 2001, deadline.

We are continuing to work as hard as we can to finalize the antioxidants review, as Ms. Lewis-Eng of your firm was informed in a telephone conversation with a member of my staff on March 27, 2001. We believe we are now in the final stages of review. We now expect to be able to issue our decision by April 20, 2001. The agency sincerely apologizes for this further delay. The agency appreciates your ongoing patience.

Hypertext updated by kwg 2001-APR-10