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Antimicrobial product benefits must be supported with epidemiological data, FDA says.

This article was originally published in The Tan Sheet

Executive Summary

ANTIMICROBIAL PRODUCTS MUST DEMONSTRATE SUPERIORITY TO BAR SOAP, FDA Division of Anti-Infective Drug Products Micro-biology Team Leader Albert Sheldon, PhD, said at a June 2-3 "Health Care Continuum Model" symposium co-sponsored by the Cosmetic, Toiletry & Fragrance Association and the Soap & Detergent Association. The groups submitted the HCCM at a July 29 OTC "feedback" meeting as an alternative way to categorize antimicrobial ingredients under the agency's OTC health care tentative final monograph. Addressing the audience, 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."
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