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Disclaimers May Be "Subterfuge" For Disease Claims, PhRMA Exec Warns

This article was originally published in The Tan Sheet

Executive Summary

FDA should be cautious in allowing a disclaimer statement that could mislead consumers into believing dietary supplements can cure or prevent disease, a PhRMA rep maintained at FDA's Aug. 4 public meeting on the regulation of supplement structure/ function claims in Washington, D.C.

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FDA Narrowed "Disease" Definition Expands Structure/Function Claims

Dietary supplement manufacturers will be able to make expanded structure/function claims on product labeling under an FDA final rule published in the Jan. 6 Federal Register. The rule clarifies the distinction between structure/function and disease claims by reverting to the older, narrower definition of "disease" used in the Nutrition Labeling & Education Act.

Botanicals

FDA guidance on OTC and Rx botanical drugs could be released this fall, Center for Drug Evaluation & Research Office of New Drug Chemistry Acting Director Yuan-yuan Chiu, PhD, says at the National Institutes of Health "Symposium on Complementary and Alternative Medicine in Chronic Liver Disease" Aug. 24. The guidance, in the works since 1994, is under review by FDA regulatory policy staff and legal counsel (1"The Tan Sheet," May 4, 1998, p. 7). Also, FDA's structure/function claims rule could be made final internally in September, Chiu says. The proposed rule's provisions on the definition of "disease," common conditions associated with natural states and implied disease claims were the subject of an Aug. 4 public hearing (2"The Tan Sheet" Aug. 9, pp. 6-10)

Dietary Supplement Labels With Graded Levels Of Support Suggested To FDA

A five-class system for dietary supplement labels would effectively convey the level of existing scientific support for a product's structure/function claims, Botanical Enterprises CEO Floyd Leaders, PhD, suggests in recent comments to FDA.

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