HHS NEWS

U.S. Department of Health and Human Services

P98-15                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Print Media:       301-827-6242
April 24, 1998                
                              Consumer Inquires: 800-532-4440

FDA PROPOSES RULES TO MAKE CLAIMS FOR DIETARY SUPPLEMENTS MORE INFORMATIVE, RELIABLE AND UNIFORM

In response to recommendations made by the Commission on Dietary Supplement Labels, the Food and Drug Administration today proposed rules to give consumers better information about dietary supplements by making the labeling of these products more reliable and uniform. The proposal, which defines certain permitted and prohibited types of labeling claims for dietary supplements, will not affect the availability of these products or consumers' access to them.

In addition to the new proposal, the FDA today is also responding to the report of the Commission on Dietary Supplement Labels. (See the separate fact sheets on the new proposal and the response to the Commission report.) The Commission was an independent panel of experts mandated by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and appointed by President Clinton to study and make recommendations on the regulation of label claims and statements for dietary supplements, including procedures for evaluation of such claims.

Under DSHEA, dietary supplements may carry "structure/function" claims -- claims that a product may affect the structure or functioning of the body -- but not claims that they can treat, diagnose, cure or prevent a disease.

Today's proposal defines the criteria for the structure/function claims that DSHEA permits and the disease claims that it prohibits, and provides examples for both categories.

The law allows, without FDA's authorization, claims that are truthful and not misleading about the effect of a dietary supplement on the structure or function of the body for maintenance of good health and nutrition. Under the proposal, such permissible structure/function claims can state, for example, that the product "promotes regularity," "helps maintain cardiovascular health," or "supports the immune system."

The proposal also identifies many types of so-called "disease claims" that are prohibited under DSHEA. In general, these claims state or imply benefits for a disease, which the proposal in part defines as any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of signs or symptoms. Under the proposal, dietary supplements that expressly or implicitly claim to diagnose, treat, prevent or cure a disease continue to be regarded as drugs, and have to meet the safety and effectiveness standards for drugs under the Food Drug and Cosmetic Act (FDCA). Examples of such prohibited disease claims for a dietary supplement include "protects against cancer," "treats hot flashes," and "reduces nausea associated with chemotherapy."

The proposal also describes various means -- such as product names, vignettes, graphics and citations -- by which a dietary supplement could make or imply a disease claim prohibited under DSHEA.

"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," said William Schultz, FDA's Deputy Commissioner for Policy. "By clarifying for manufactures what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices."

Today's proposal and FDA's response to the Commission's report will be published next week in the Federal Register. The agency welcomes written comments and recommendations on the proposed criteria and other aspects of the proposal, and will accept such communication for the next 120 days. The agency will also accept written comments on its response to the Commission on Dietary Supplement Labels. All comments should be addressed to:

   Dockets Management Branch (HFS-456)
   Food and Drug Administration
   12420 Parklawn Dr., Room 1-23
   Rockville, MD 20857

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