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Epidemiological evidence needed to support antimicrobial product benefits, FDA says.

This article was originally published in The Rose Sheet

Executive Summary

ANTIMICROBIAL PRODUCTS MUST DEMONSTRATE SUPERIORITY TO BAR SOAP, FDA Anti-infectives division Microbiology Team Leader Albert Sheldon, PhD, said at a June 2-3 "Healthcare Continuum Model" Symposium co-sponsored by the Cosmetic, Toiletry and Fragrance Association and the Soap and Detergent Association in Washington, D.C. Sheldon maintained: "If you're going to sell the concept that because [a product] contains an antimicrobial [that product] will have superiority" over a regular bar soap, "then you should demonstrate that." CTFA and SDA submitted the HCCM to FDA June 15, 1995 as an alternative way to categorize antimicrobial ingredients under the agency's OTC health care tentative final monograph.



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