Product claims serve to provide consumers with information about the product and can help them in determining which products are most appropriate for them. The Food & Drug Administration (FDA) regulates claims on dietary supplement product labels.
There are three basic types of legal claims permitted on the bottle for dietary supplements.
- Nutrient content claims.
These claims characterize the level of vitamins and minerals in the product (e.g., “a good source of vitamin C,” or “high in antioxidants”). FDA has issued new rules on product labels for foods and dietary supplements. These new rules will result in changes for some supplements specifically with regard to Recommended Dietary Allowances (RDAs) and percent of Daily Value, and therefore may result in changes in manufacturers’ recommendations on serving size for these supplements. In addition, as a result of these changes, some nutrient content claims may need to be revised. To reflect the latest nutrition science and changes in American diets. For example, in 2016, FDA established a Reference Daily Intake (RDI) of 550 milligrams of choline for adults. Learn more about changes to labeling via our Be Label Wise site.
- Structure/function claims.
These claims describe the basic benefits of the product on a particular structure or function in the body (e.g., “helps support healthy joints,” or “maintain strong bones”). As mandated by the regulations, these claims must also include a statement on the label that advises “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” When you see that statement on a product label, it simply means that the manufacturer is following the law.
- FDA-authorized health claims or qualified health claims.
These claims describe the relationship between a substance and reduced risk of a disease (such as calcium and vitamin D in relation to osteoporosis). Unlike nutrient content claims and structure/function claims, FDA must review the scientific evidence for a health claim and approve its use. It’s important to note that FDA maintains a distinction between “reducing the risk” of a disease, which it views as an appropriate health claim for supplements if approved by the agency, and “prevents” disease, which is not legally allowed, and which FDA views as a disease claim that can only be made by an approved drug.
For more information on product label claims, visit FDA’s website.
CRN members, contact our scientific and regulatory affairs staff with questions.
