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FDA Cancer Assessment Cmte. divided on phenolphthalein human carcinogenic potential.

This article was originally published in The Tan Sheet

Executive Summary

FDA CAC DIVIDED ON PHENOLPHTHALEIN CARCINOGENIC POTENTIAL TO HUMANS after reviewing information from the National Toxi-cology Program, industry and other FDAers at an April 2 meeting at the agency. FDA had asked the Carcinogenicity Assessment Committee, its in-house cancer study review group, to evaluate the validity of NTP animal data on the Category I laxative ingredient as well as the relevance of the data to human risk. The NTP studies had found "clear evidence of carcinogenic activity" in male rats and both sexes of mice, and "some evidence" in female rats.
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