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Cascara sagrada laxatives

This article was originally published in The Tan Sheet

Executive Summary

AHPA "intends to submit a review document within the next several weeks that will evaluate the relevance" of published data pertaining to "the potential mutagenicity, genotoxicity and carcinogenicity of cascara sagrada ingredients," trade association tells FDA. In Oct. 28 submission, AHPA includes "eight summaries of literature searches conducted over the past several months" on cascara sagrada bark that were "not previously considered" by FDA's OTC Drug Products staff or agency's advisory review panel on OTC laxatives. Group is seeking a stay of Nov. 5 effective date of final rule classifying cascara sagrada, aloe as Category II laxative ingredients (1"The Tan Sheet" June 17, 2002, p. 7)...

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Cascara sagrada

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)...

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FDA's final rule on aloe and cascara sagrada does not properly distinguish between aloe used in OTC drug laxatives and aloe vera gel used in foods and dietary supplements, AHPA and the International Aloe Science Council say in a 1citizen petition

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