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Symposium: Nutrient Disease Relationships: Closing the Scientific Knowledge Gap

The Level of Evidence for Permitting a Qualified Health Claim: FDA’s Review of the Evidence for Selenium and Cancer and Vitamin E and Heart Disease¹

Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD 20740

²To whom correspondence should be addressed. E-mail: PaulaTrumbo{at}fda.gov.

Health claims are authorized for the labeling of foods when there is significant scientific agreement among qualified experts on the evidence for a relationship between a food or food component (substance) and a disease. Qualified health claims are permitted when there is less scientific evidence for a substance-disease relationship, therefore requiring qualifying language. The evidence for a relationship between vitamin E and heart disease and selenium and cancer was reviewed by the U.S. FDA. It was determined that there was insufficient evidence to permit a qualified health claim for vitamin E and cancer, whereas there was some evidence for permitting a qualified health claim for selenium and cancer. The rationale for these conclusions is discussed below.

KEY WORDS: • qualified health claims • vitamin E • selenium

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