FDA Consumer

FDA moves toward consistent supplement claims – new proposals for labeling of dietary supplements

FDA moves toward consistent supplement claims – new proposals for labeling of dietary supplements – Brief Article

Labeling claims about the health benefits of dietary supplements would be more reliable and uniform under an FDA proposal that establishes criteria for product label claims.

The proposed rule, published in the April 29, 1998, Federal Register, specifically defines two types of potential claims: “structure-function” claims, which describe how a product may affect the body’s structure or functioning, and disease claims, which relate the product to its role in the treatment, diagnosis, cure, or prevention of disease. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), structure-function claims are allowed, while disease claims are not.

FDA’s proposal follows a report from the presidential Commission on Dietary Supplement Labels, an independent panel of experts charged under DSHEA with recommending measures for regulating dietary supplement claims. The proposal would not affect the availability of dietary supplements or consumers’ access to them.

DSHEA allows manufacturers to use, without FDA authorization, structure-function claims that are truthful and not misleading. Under FDA’s proposal, prohibited disease claims include those that imply or state that the product:

* has an effect on a specific disease or class of diseases. For example, the claim “protects against the development of cancer” would not be allowed, but the claim “helps promote urinary tract health” would be allowed as a structure-function claim.

* is in a drug class that is intended to be used to diagnose, mitigate, treat, cure, or prevent a disease. Thus, claims that describe a product as an “antibiotic,” “antiseptic” or “antidepressant” would not be allowed, while the terms “energizer” and “rejuvenative” would be.

* is a substitute for or augmentation of a drug or other medical therapy. For example, the claim “herbal Prozac” would not be allowed.

* has a role in the body’s response to disease or carriers of disease. For example, the claim “supports the body’s ability to resist infection” would not be allowed, but the claim “supports the immune system” would be allowed as a structure-function claim.

Also, manufacturers may not make or imply a disease claim in product names, graphics, citations, or other means.

If finalized, the proposed rule would require manufacturers to remove unacceptable disease claims from dietary Supplement labels or meet the safety and effectiveness standards for drugs under the Federal Food, Drug, and Cosmetic Act.

The public has until Aug. 27 to send written comments on the proposed rule to FDA, Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857.

The Federal Register is available in some libraries and at ohrms/dockets/98fr/fr98menu.htm on FDA’s Website. The proposal can be viewed as a pdf file by clicking on the date 4/29, then Docket No. 98N-0044.

COPYRIGHT 1998 U.S. Government Printing Office

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