Write the FDA--Dietary Supplement Regs
Joan E. Medlen
jmedlen at teleport.com
Sat Apr 25 09:41:09 PDT 1998
>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
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