Chapter 16 - US regulation of food label claims

Abstract

There are three primary categories of food label claims under the United States laws that FDA enforces: health claims, structure/function claims, and nutrient content claims. Health claims describe a relationship of a food, food component, or dietary supplement in reducing the risk of a disease or health-related condition. Health claims must be evaluated and authorized prior to their use in food labeling. There are three ways by which FDA exercises its oversight in determining which health claims may be used in food labeling. One way is the issuance of authorizing regulations based on FDA’s conclusion that there is significant scientific agreement that the available scientific evidence supports the relationship. A second way is through a notification to FDA of a health claim based on authoritative statements from a scientific body of the US government or the National Academy of Sciences that ensues from that scientific body’s deliberative review of scientific evidence on the substance/disease relationship. The third way provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. Structure/function claims are food label statements that describe the role of a nutrient or dietary supplement ingredient to affect normal structure or function in humans. Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements. However, the Dietary Supplement Health and Education Act of 1994 established special regulatory procedures for the use of such statements on dietary supplement labels. Nutrient content claims are statements that characterize the level of a nutrient in a food. Nutrient content claims on food labels must be used in accordance with FDA authorizing regulations.