Write the FDA--Dietary Supplement Regs

[Joan E. Medlen]

>FOOD AND DRUG ADMINISTRATION

>FOR IMMEDIATE RELEASE        

>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. (Separate fact

>sheets on the new proposal and the response to the Commission report are

>attached.) 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 willalso 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

>

>