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

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.

Liquid soap

Triclosan, long targeted by NGOs for alleged health risks, is one of 19 ingredients that must be removed from consumer antibacterial soaps within a year under an FDA final rule released Sept. 2.

The rule, slated for publication in the Sept

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