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Health benefit claims
January 1999

In addition to the new labeling rules, several rules previously issued by the FDA are in effect.

Structure-function claims (claims that the supplement maintains healthy or normal structures or functions of the human body) may be included, such as "maintains bowel regularity." They must be accompanied by a statement that the claim "has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

No disease claims (see "health claims" in the glossary) may be included unless approved by the FDA. Which claims may be approved is a subject of continuing debate. An imporant court ruling remanded the FDA to reconsider several health claims that it had previously rejected; the court held the FDA's action was an unconstitutional restriction of free speech.

To learn about this court ruling, see also: Court Finds FDA Rejection of Truthful Health Claims Unconstitutional (DSQI News: March 1999).



More about reading the label:

New labeling rules in effect

Health benefit claims

Ingredients and recommended dosages

Dosage units

Dosage amounts

Expiration date

Lot number

Dissolution and bioavailability

Certification claims

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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.