Cascara sagrada

Executive Summary

FDA should maintain inclusion of cascara sagrada bark in OTC laxatives monograph for adult use, while "use by children at the current recommended dose should be reconsidered" based on toxicity studies on emodin, The Toxicology Group says. In a report submitted to FDA by AHPA Dec. 19, NSF subsidiary presents safety conclusions for cascara based upon National Toxicology Program reports on toxicity of phenolphthalein, a Category II ingredient, and emodin, a constituent of cascara. "The structure of phenolphthalein and those of cascara sagrada's constituents are significantly dissimilar so that there is little reason to think that toxicity concerns for phenolphthalein should be extrapolated for cascara sagrada preparations," NSF division says. AHPA's submission is part of its citizen petition requesting FDA reconsider Category II designation for cascara (1"The Tan Sheet" Nov. 4, 2002, In Brief)...