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FDA: ‘Vast Majority’ Of Antibac Soaps Need Reformulation Under Final Rule

This article was originally published in The Rose Sheet

Executive Summary

FDA/CDER’s Teresa Michele says the “vast majority” of roughly 2,100 consumer antibacterial soaps on the market contain at least one of 19 antimicrobial ingredients banned from OTC use under an FDA final rule. Industry, which suggests the agency is overstating the rule’s impact, is focused on delivering supporting data for three active ingredients still pending before FDA for GRASE use in the category.

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