Aloe Definition Clarification In Laxatives Final Rule Requested By AHPA, IASC
This article was originally published in The Tan Sheet
Executive Summary
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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Aloe, Cascara Sagrada Safety In Laxatives Still Needs Supporting Data – FDA
Data on aloe and cascara sagrada from the German Commission E monographs, World Health Organization reviews and the National Toxicology Program are insufficient to support the safety and efficacy of the ingredients in OTC laxatives, FDA concludes in a July 3 letter to the American Herbal Products Association
Cascara sagrada laxatives
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)...
Cascara sagrada laxatives
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...