FDA Allows Qualified Antioxidant/Cancer Health Claim

WASHINGTON--The Food and Drug Administration (FDA) authorized a new health claim, with appropriate disclaimer language, that was the subject of a petition to the agency. Emord & Associates served as counsel for the petitioners, who sought to use a health claim linking intake of antioxidant vitamins and a reduced risk of certain kinds of cancer.

FDA's final order follows a decision issued in December 2002 by the U.S. District Court for the District of Columbia. In the case, Whitaker et al v. Thompson et al, the court determined FDA could not suppress the health claim on first amendment grounds; the FDA appealed the decision, but withdrew its appeal March 28.

The claim reads: "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer." As ordered by the court, FDA reviewed disclaimer language suggested by the court and submitted by other parties. FDA offered three disclaimers to run with the claim.

* Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.

* Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive.

* FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.

In the notice to Emord, Christine L. Taylor, Ph.D., director of the Office of Nutritional Products, Labeling and Dietary Supplements at FDA's Center for Food Safety and Applied Nutrition (CFSAN) said the agency would exercise enforcement discretion with respect to antioxidant dietary supplements containing vitamin E and/or vitamin C that meet two criteria: the products must use one of the FDA disclaimers and recommended intake must not exceed the Tolerable Upper Intake Level (established by the Institute of Medicine) of 2,000 mg/d of vitamin C and 1,000 mg/d of supplemental alpha-tocopherol