title: 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.
abstract: 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.
authors.affiliation: Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD 20740, USA. PaulaTrumbo@fda.gov
authors.forename: Paula R
authors.initials: PR
authors.lastname: Trumbo
mesh_terms: D002318:Cardiovascular Diseases / Q000517:prevention & control; D006331:Heart Diseases / Q000517:prevention & control*; D009369:Neoplasms / Q000517:prevention & control*; D015203:Reproducibility of Results; D012643:Selenium; D014481:United States; D014486:United States Food and Drug Administration; D014810:Vitamin E
chemical_list: D014810:Vitamin E; D012643:Selenium