Under the law, manufacturers of dietary supplement have three different categories of claims that can be used for dietary supplements: health claims, structure/function claims, and nutrient content claims. Of course, all of these claims must be truthful and not misleading. FDA provides more information on the types of claims that can be used on conventional foods and dietary supplements.
- Health claims describe the connection between a nutrient or food substance and reduced risk of a disease or health-related condition and are regulated by the FDA. FDA can authorize a health claim in one of the following three ways:
• Authorized Health Claim— These claims result from an extensive review of the scientific literature and the determination that the nutrient/disease relationship is well established. There must be significant scientific agreement among qualified experts regarding the relationship between the nutrient and the disease. An example of a health claim is: “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers”. FDA has prepared a Guidance for Industry: A Food Labeling Guide, which provides a summary of approved health claims for food and dietary supplement labels.
• Authoritative Statements—The Food and Drug Administration Modernization Act of 1997 allows health claims based on authoritative statements from a scientific body of the U.S. government or the National Academy of Sciences. Currently, this type of claim cannot be used for dietary supplements.
• Qualified Health Claims— When the strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation, a qualified health claim may be allowed. As with a standard health claim, qualified health claims are reviewed for accuracy and to ensure that they are not misleading to consumers. The Agency permits their use provided they are accompanied with appropriate disclaimers to ensure their truthfulness. - Nutrient content claims describe the level of a nutrient in a food or dietary supplement. For example, a supplement containing at least 200 milligrams could carry the claim “high in calcium.” Percentage claims for dietary supplements, used to describe a percentage level of a dietary ingredient for which there is no established Daily Value, are another category of nutrient content claims. A summary of the rules for use of nutrient content claims can be found in the FDA Guidance on Food Labeling.
- Structure/function claims are statements that describe the role of a nutrient or a dietary supplement intended to affect the structure or function of the body, the mechanism of how it helps to maintain that structure or function, or general well being. Because FDA does not pre-clear structure/function claims, they must be accompanied by the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” An example of a structure/function claim is: “Ginseng will help maintain your natural energy.”
