An FDA guide to dietary supplements

FDA Consumer, Sept-Oct, 1998 by Paula Kurtzweil

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 tree 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 marketed. While the manufacturer first 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.