News Masthead


September 3, 2003 12:12 PM

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.

You can view more detailed information on the safety and effectiveness of antibacterial products on ACI’s Antibacterial Information page, at