FDA's review of scientific evidence for health claims

Under the Federal Food, Drug, and Cosmetic Act health claims on foods or dietary supplements must be authorized by the FDA. Health claims describe the relationship between a food, food component, or dietary supplement and reducing the risk of a disease or health-related condition. Under interim guidance and enforcement discretion, certain qualified health claims have been provided for on foods and dietary supplements; these claims contain language to qualify the quality and strength of scientific evidence to support the claim because they are not based on significant scientific agreement, which is the standard for health claims authorized by the Federal Food, Drug, and Cosmetic Act. In order to meet its statutory responsibility for evaluation of health claims, the agency has developed guidelines for review of scientific evidence in support of a health claim.