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Dietary Supplement OTC Monograph Claims Opposed By CSPI

This article was originally published in The Tan Sheet

Executive Summary

FDA should "modify language" in the structure/ function claims final rule to "prohibit dietary supplements from carrying the same claims as those that are approved for over-the-counter (OTC) drugs," the Center for Science in the Public Interest states in a March 30 citizen petition.

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Pregnancy claims

Amendment of the structure/function claims final rule to prohibit statements concerning edema associated with pregnancy is requested by CHPA in a citizen petition filed with FDA May 11. The trade group asks the agency to issue a regulation requiring label statements on certain dietary supplements pertaining to their use by women who are pregnant or nursing, and calls on CFSAN to develop a guidance on the "scientific basis for assessing the potential for possible effects of dietary supplements on reproduction/development and the scope and nature of safety-related evidence that is needed to support a structure/function claim for conditions associated with pregnancy and nursing." CHPA suggests FDA use the association's voluntary pregnancy/nursing labeling program, announced in March, as a basis for creating a regulatory framework (1"The Tan Sheet" March 27, p. 3)

Certain OTC Drug Monograph Claims May Be Structure/Function Claims - FDA

Some OTC drug monograph claims may be acceptable dietary supplement structure/function claims, FDA concludes in the final rule on supplement claims criteria published in the Jan. 6 Federal Register. However, others would be disease claims if used on supplement products, the agency adds.

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