Claims that tout a supplement’s healthful benefits have always been a controversial feature of dietary supplements. Manufacturers often rely on them to sell their products. But consumers often wonder whether they can trust them.
Under DSHEA and previous food labeling laws, supplement manufacturers are allowed to use, when appropriate, three types of claims: nutrient-content claims, disease claims, and nutrition support claims, which include “structure-function claims.”
Nutrient-content claims describe the level of a nutrient in a food or dietary supplement. For example, a supplement containing at least 200 milligrams of calcium per serving could carry the claim “high in calcium.” A supplement with at least 12 mg per serving of vitamin C could state on its label, “Excellent source of vitamin C.”
Disease claims show a link between a food or substance and a disease or health-related condition. FDA authorizes these claims based on a review of the scientific evidence. Or, after the agency is notified, the claims may be based on an authoritative statement from certain scientific bodies, such as the National Academy of Sciences, that shows or describes a well-established diet-to-health link. As of this writing, certain dietary supplements may be eligible to carry disease claims, such as claims that show a link between:
the vitamin folic acid and a decreased risk of neural tube defect-affected pregnancy, if the supplement contains sufficient amounts of folic acid
calcium and a lower risk of osteoporosis, if the supplement contains sufficient amounts of calcium
psyllium seed husk (as part of a diet low in cholesterol and saturated fat) and coronary heart disease, if the supplement contains sufficient amounts of psyllium seed husk.
Nutrition support claims can describe a link between a nutrient and the deficiency disease that can result if the nutrient is lacking in the diet. For example, the label of a vitamin C supplement could state that vitamin C prevents scurvy. When these types of claims are used, the label must mention the prevalence of the nutrient-deficiency disease in the United States.
These claims also can refer to the supplement’s effect on the body’s structure or function, including its overall effect on a person’s well-being. These are known as structure-function claims.
Examples of structure-function claims are:
- Calcium builds strong bones.
- Antioxidants maintain cell integrity.
- Fiber maintains bowel regularity.
Manufacturers can use structure-function claims without FDA authorization. They base their claims on their review and interpretation of the scientific literature. Like all label claims, structure-function claims must be true and not misleading.
Structure-function claims can be easy to spot because, on the label, they must be accompanied with 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.”
Manufacturers who plan to use a structure-function claim on a particular product must inform FDA of the use of the claim no later than 30 days after the product is first marketed. While the manufacturer must be able to substantiate its claim, it does not have to share the substantiation with FDA or make it publicly available.
If the submitted claims promote the products as drugs instead of supplements, FDA can advise the manufacturer to change or delete the claim.
Because there often is a fine line between disease claims and structure-function claims, FDA in April proposed regulations that would establish criteria under which a label claim would or would not qualify as a disease claim. Among label factors FDA proposed for consideration are:
- the naming of a specific disease or class of diseases
- the use of scientific or lay terminology to describe the product’s effect on one or more signs or symptoms recognized by health-care professionals and consumers as characteristic of a specific disease or a number of different specific diseases
- product name
- statements about product formulation
- citations or references that refer to disease
- use of the words “disease” or “diseased”
- art, such as symbols and pictures
- statements that the product can substitute for an approved therapy (for example, a drug).
FDA’s proposal is consistent with the guidance on the distinction between structure-function and disease claims provided in the 1997 report by the President’s Commission on Dietary Supplement Labels.
If shoppers find dietary supplements whose labels state or imply that the product can help diagnose, treat, cure, or prevent a disease (for example, “cures cancer” or “treats arthritis”), they should realize that the product is being marketed illegally as a drug and as such has not been evaluated for safety or effectiveness.
FTC regulates claims made in the advertising of dietary supplements, and in recent years, that agency has taken a number of enforcement actions against companies whose advertisements contained false and misleading information. The actions targeted, for example, erroneous claims that chromium picolinate was a treatment for weight loss and high blood cholesterol. An action in 1997 targeted ads for an ephedrine alkaloid supplement because they understated the degree of the product’s risk and featured a man falsely described as a doctor.