Senna laxative further Ames testing would not resolve safety -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
SENNA AMES MUTAGENICITY NEW TESTING NOT NECESSARY, FDA says in a letter to Purdue Frederick recently made available by the agency. FDA still intends to reclassify several stimulant laxative ingredients, including senna, from Category I (safe and effective) to Category III (more data needed). However, the agency points out, "there are sufficient Ames test data in the literature showing that the senna extracts emodin, chrysophanol and aloe-emodin are positively genotoxic, while sennosides A and B are negative," the letter states. "Therefore, no new Ames testing for senna is necessary."
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