Claims That Can Be Made for Conventional Foods and Dietary Supplements
Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission.
I. Health Claims
Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. There are three ways by which FDA exercises its oversight in determining which health claims may be used on a label or in labeling for a food or dietary supplement: 1) the 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after FDA's careful review of the scientific evidence submitted in health claim petitions; 2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences; such claims may be used after submission of a health claim notification to FDA; and 3) the 2003 FDA Consumer Health Information for Better Nutrition Initiative 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. Such health claims must be qualified to assure accuracy and non-misleading presentation to consumers. The differences between these three methods of oversight for health claims are summarized below. Appendix C of The Food Labeling Guide contains a summary of those health claims that have been approved for use on food and dietary supplement labels. A Food Labeling Guide - Appendix C: Health Claims.
A "health claim" by definition has two essential components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. A statement lacking either one of these components does not meet the regulatory definition of a health claim. For example, statements that address a role of dietary patterns or of general categories of foods (e.g., fruits and vegetables) in health are considered to be dietary guidance rather than health claims, provided that the context of the statement does not suggest that a specific substance is the subject. Dietary guidance statements used on food labels must be truthful and non-misleading. Statements that address a role of a specific substance in maintaining normal healthy structures or functions of the body are considered to be structure/function claims. Structure/function claims may not explicitly or implicitly link the relationship to a disease or health related condition. Unlike health claims, dietary guidance statements and structure/function claims are not subject to FDA review and authorization. There are some regulatory requirements associated with the use of structure/function claims; see Structure/Function Claims.
NLEA Authorized Health Claims. The Nutrition Labeling and Education Act (NLEA) of 1990, the Dietary Supplement Act of 1992, and the Dietary Supplement Health and Education Act of 1994 (DSHEA), provide for health claims used on labels that characterize a relationship between a food, a food component, dietary ingredient, or dietary supplement and risk of a disease (for example, "diets high in calcium may reduce the risk of osteoporosis"), provided the claims meet certain criteria and are authorized by an FDA regulation. FDA authorizes these types of health claims based on an extensive review of the scientific literature, generally as a result of the submission of a health claim petition, using the significant scientific agreement standard to determine that the nutrient/disease relationship is well established.
Health Claims Based on Authoritative Statements. The Food and Drug Administration Modernization Act of 1997 (FDAMA) provides a second way for the use of a health claim on foods to be authorized. FDAMA allows certain health claims to be made as a result of a successful notification to FDA of a health claim based on an "authoritative statement" from a scientific body of the U.S. Government or the National Academy of Sciences. FDA has prepared a guide on how a firm can make use of authoritative statement-based health claims. This guide can be found at: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. FDAMA does not include dietary supplements in the provisions for health claims based on authoritative statements. Consequently, this method of oversight for health claims cannot be used for dietary supplements at this time. Examples of health claims based on authoritative statements may also be found at: A Food Labeling Guide - Appendix C: Health Claims.
Qualified Health Claims. FDA's 2003 Consumer Health Information for Better Nutrition Initiative provides for the use of qualified health claims when there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition. In this case, the evidence is not well enough established to meet the significant scientific agreement standard required for FDA to issue an authorizing regulation. Qualifying language is included as part of the claim to indicate that the evidence supporting the claim is limited. Both conventional foods and dietary supplements may use qualified health claims. FDA uses its enforcement discretion for qualified health claims after evaluating and ranking the quality and strength of the totality of the scientific evidence. Although FDA's "enforcement discretion" letters are issued to the petitioner requesting the qualified health claim, the qualified claims are available for use on any food or dietary supplement product meeting the enforcement discretion conditions specified in the letter. FDA has prepared a guide on interim procedures for qualified health claims and on the ranking of the strength of evidence supporting a qualified claim, see: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. Qualified health claim petitions that are submitted to FDA will be available for public review and comment. A listing of petitions open for public comment is at the FDA Dockets Management website. A summary of the qualified health claims authorized by FDA may be found at: Qualified Health Claims Subject to Enforcement Discretion. For more information see Qualified Health Claims.
II. Nutrient Content Claims
The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not "characterize" the nutrient level may be used to describe any amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium as being low and would therefore need to conform to the criteria of an appropriate nutrient content claim or carry a disclosure statement that it does not comply with the claim. Most nutrient content claim regulations apply only to those nutrients or dietary substances that have an established daily value: A Food Labeling Guide - VII. Nutrition Labeling. The requirements that govern the use of nutrient content claims help ensure that descriptive terms, such as high or low, are used consistently for all types of food products and are thus meaningful to consumers. Healthy has been defined by a regulation as an implied nutrient content claim that characterizes a food that has "healthy" levels of total fat, saturated fat, cholesterol and sodium. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe a percentage level of a dietary ingredient for which there is no established Daily Value. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." (See 21 CFR 101.13(q)(3)(ii)). A summary of the rules for use of nutrient content claims can be found in Chapter VI of The Food Labeling Guide. Examples of nutrient content claims can be found in Appendices A and B of The Food Labeling Guide: Appendix A: Definitions of Nutrient Content Claims and Appendix B: Additional Requirements for Nutrient Content Claims.
III. Structure/Function Claims
Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. However, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such claims for dietary supplement labels. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim. Further information regarding structure/function claims can be found in FDA's January 9, 2002 Structure/Function Claims Small Entity Compliance Guide. Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.
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