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Perrigo opposes FDA proposed phenolphthalein ban due to lack of human data.

This article was originally published in The Tan Sheet

Executive Summary

FDA PHENOLPHTHALEIN BAN NOT SUPPORTED BY EXISTING DATA, PERRIGO maintains in comments on the agency's recent proposal to reclassify the OTC stimulant laxative ingredient from Category I (generally recognized as safe and effective) to Category II (not generally recognized as safe and effective) and to list phenolphthalein as a nonmonograph ingredient. The agency's Sept. 2 proposal is based on National Toxicology Program data suggesting phenolphthalein's carcinogenic potential in rodents ("The Tan Sheet" Sept. 1, p. 1).
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