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 disease

• Published in: The Journal of nutrition Vol. 135; no. 2; p. 354
• Main Author: Trumbo, Paula R
• Format: Journal Article
• Language: English
• Published: United States 01-02-2005
• Subjects: Cardiovascular Diseases - prevention & control; Heart Diseases - prevention & control; Neoplasms - prevention & control; Reproducibility of Results; Selenium; United States; United States Food and Drug Administration; Vitamin E; United States
• ISSN: 0022-3166
• DOI: 10.1093/jn/135.2.354

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.