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Cascara sagrada laxatives

This article was originally published in The Tan Sheet

Executive Summary

CDER Ombudsman James Morrison should "intercede and facilitate" a meeting between AHPA, Division of OTC Drug Products to discuss data on cascara sagrada, trade group says in Sept. 12 letter. OTC division denied association's earlier request to discuss May 9 final rule classifying ingredient as Category II in OTC laxative products. AHPA also has asked FDA to stay rule's Nov. 5 effective date (1"The Tan Sheet" June 17, 2002, p. 7). Separate petition submitted by Arnall Golden & Gregory (Atlanta) requests that FDA withhold enforcement action against manufacturers of cascara sagrada laxatives pending publication of laxatives final monograph. Petition also suggests FDA could consider "imposing certain labeling restrictions relating to the product's use" to keep such laxatives on the market...
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