Guide to Dietary Supplements : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

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 1998 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.

Fraudulent Products

Consumers need to be on the lookout for fraudulent products. These are products that don't do what they say they can or don't contain what they say they contain. At the very least, they waste consumers' money, and they may cause physical harm.

Fraudulent products often can be identified by the types of claims made in their labeling, advertising and promotional literature. Some possible indicators of fraud, says Stephen Barrett, M.D., a board member of the National Council Against Health Fraud, are:

Claims that the product is a secret cure and use of such terms as "breakthrough," "magical," "miracle cure," and "new discovery." If the product were a cure for a serious disease, it would be widely reported in the media and used by health-care professionals, he says.

"Pseudomedical" jargon, such as "detoxify," "purify" and "energize" to describe a product's effects. These claims are vague and hard to measure, Barrett says. So, they make it easier for success to be claimed "even though nothing has actually been accomplished," he says.

Claims that the product can cure a wide range of unrelated diseases. No product can do that, he says.

Claims that a product is backed by scientific studies, but with no list of references or references that are inadequate. For instance, if a list of references is provided, the citations cannot be traced, or if they are traceable, the studies are out-of-date, irrelevant, or poorly designed.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.