Health claims describe a relationship between a food substance (a food, food component, or dietary supplement ingredient) and reduced risk of a disease or health-related condition. There are three ways in which the U.S. Food and Drug Administration exercises its oversight in determining which health claims may be used on a label or in labeling for a conventional food or dietary supplement.
First, the 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative.
Second, the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research. These claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification fails to include all the required information.
Third, as described in FDA’s guidance (“Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements”), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. FDA issues a letter of enforcement discretion if it finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers. The letter specifies the qualifying language that should accompany the claim and describes the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling.
Unlike health claims, dietary guidance statements and structure/function claims (see NPA’s fact sheet) are not subject to premarket review and authorization by FDA.
Sources
- “Label claims for conventional foods and dietary supplements” (FDA resource)
- “Interim procedures for qualified health claims in the labeling of conventional human food and human dietary supplements” (FDA resource)
- “Guidance for industry: Notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body” (FDA resource)
- “Authorized health claims that meet the significant scientific agreement (SSA) standard” (Includes list of approved health claims) (FDA resource)
- “Questions and answers on health claims in food labeling” (FDA resource)
- “Guidance for industry: Evidence-based review system for the scientific evaluation of health claims” (FDA resource)
- “Guidance for industry: A food labeling guide” (updated January 2013) (FDA resource)
- Nutrition Labeling and Education Act of 1990
- Food and Drug Administration Modernization Act of 1997