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FOR IMMEDIATE Release
No Real World Evidence Tying Antimicrobial
Products to Antibiotic Resistance, FDA Told WASHINGTON, D.C. - September 3, 2003 - The use of topical antimicrobial wash products does not contribute to antimicrobial resistance, according to the latest comprehensive scientific literature provided to the Food and Drug Administration (FDA). The information was submitted by The Soap and Detergent Association (SDA) and The Cosmetic, Toiletry, and Fragrance Association, which filed three sets of comments to the agency as it develops a Final Monograph (FM) for Over the Counter (OTC) Health-Care Antiseptic Drug Products. The SDA/CTFA coalition reminded FDA that in 1997, an independent review panel convened by the agency reported that resistance was not an issue under current conditions of topical antimicrobial product usage. The latest research shared with the agency reiterates that conclusion, said the Coalition. "In recent years, several national, regional, and inter-governmental agencies (British House of Lords, European Commission, WHO, among others) have reviewed the available data on antimicrobial resistance. None have identified resistance associated with the use of topical antimicrobial products as a concern under current conditions of use," said the Coalition. The Coalition also provided additional data on the benefits of healthcare professional products published since the Coalition's 2001 submission on that subject. Additionally, the Associations said that FDA should be open to receiving new data on the benefits of antimicrobial products beyond the recent deadline for submitting additional comments and data. ### CTFA is the national trade association representing the cosmetic, toiletry and fragrance industry. Founded in 1894, CTFA has an active membership of approximately 300 companies that manufacture or distribute the vast majority of finished personal care products marketed in the United States. CTFA also includes approximately 300 associate member companies, including manufacturers of raw materials, trade and consumer magazines, and other related industries. The Soap and Detergent Association (www.cleaning101.com) is the non-profit trade association representing manufacturers of household, industrial and institutional cleaning products; their ingredients; and finished packaging. SDA members produce more than 90% of the cleaning products marketed in the U.S. SDA is located at 1500 K Street, NW, Suite 300, Washington, DC 20005. ###
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