Antimicrobials and Antibacterial Information
The Facts on Antibacterial Products and Antibiotic Resistance
This issue brief was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. The paper summarizes research demonstrating there is no real world evidence linking the use of topical antimicrobial products to antibiotic resistance.
Research published in the Centers for Disease Control and Prevention (CDC) journal Emerging Infectious Diseases (October 2005) finds that the use of antibacterial cleaning products does not lead to a "significant increase in antimicrobial drug resistance after one year, nor did it have an effect on bacterial susceptibility to triclosan." You can find the research paper online at http://www.cdc.gov/ncidod/EID/vol11no10/04-1276.htm.
Study Finds "Negative Correlations" Between Biocide Usage, Antibiotic Resistance
An independent study published in the October 2004 Journal of Applied Microbiology reports finding "negative correlations" between biocide usage and antibiotic resistance. The study was funded by SDA and The Cosmetic, Toiletry, and Fragrance Association.
Data from a separate SDA-contracted study were statistically analyzed by British researcher Dr. Ronald W. Lambert to look for correlations among specific groups of clinical bacterial isolates with regard to their susceptibilities to clinically relevant antibiotics and common antimicrobials.
The results of this study indicated that increases in the antibiotic resistance of strains of Staphylococcus and Pseudomonas were not caused by increases in their biocide resistance.
"From the analyses of these clinical isolates it is very difficult to support a hypothesis that increased biocide resistance is a cause of increased antibiotic resistance either in Staph. aureus or in Ps. Aeruginosa," the author stated.
"The observation of negative correlations between antibiotics and biocides may be a useful reason for the continued use of biocides promoting hygiene in the hospital environment," he concluded.
Researchers: Antibiotic Risk Overstated on Antibacterial Cleaning Products
The risks of antibacterial resistance developing from the use of antibacterial cleaning products may well have been overstated and that health and hygiene are being compromised as a result. That's the conclusion of an article published in the May 2004 issue of Microbiology Today by University of Manchester (UK) researchers Peter Gilbert and Andrew McBain.
Professors' McBain and Gilbert also presented research at the 104th General Meeting of the American Society for Microbiology (ASM) in New Orleans in May 2004. That research, according to an ASM news release, shows that "the risk of bacteria developing antibiotic resistance after exposure to the biocide triclosan may not be as great as previously believed."
Research Shows No Association Between Triclosan Usage, Antibiotic Resistance
A scientific review on the use of triclosan (a common ingredient in antibacterial soap) -- published in the April 2004 Journal of Antimicrobial Chemotherapy – stated that "comprehensive environmental surveys have not demonstrated any association between triclosan usage and antibiotic resistance."
The paper, written by researcher Denver Russell of the Welsh School of Pharmacy at Cardiff University, can be viewed online at http://jac.oupjournals.org/cgi/reprint/dkh171v1.pdf.
Study: 'No Convincing Evidence' on Triclosan, Antibiotic Resistance Link
"While biocides may lead to antibiotic resistance in the laboratory, it does not necessarily equate to the development of such resistance in the natural or clinical environment."
That's the conclusion of a scientific review performed by noted researcher Denver Russell in a piece published in the journal Lancet Infectious Disease (Vol. 3, December 2003).
Link to abstract:
http://www.thelancet.com/journals/laninf/article/PIIS1473309903008338/abstract [registration required]
A study in October 2003 Journal of Applied Microbiology "refutes widely publicized, yet unsupported, hypotheses that use of antibacterial products facilitates the development of antibiotic resistance in bacteria from the home environment."
Research from the September 2003 issue of Applied and Environmental Microbiology reported that the "emergence of antibiotic resistance through triclosan in the kitchen is highly improbable."
Study abstract: http://aem.asm.org/cgi/content/abstract/69/9/5433
September 2003 American Society of Microbiology news advisory: http://www.eurekalert.org/pub_releases/2003-12/asfm-tft121103.php
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).
Link to formal comments submitted to FDA, August 27, 2003: http://www.fda.gov/ohrms/dockets/dailys/03/Sept03/090303/75n-0183h-c000084-01-vol167.pdf
A paper presented at the March 2003 annual meeting of the Society of Toxicology summarized research examining triclosan and antibacterial resistance.
The research, presented by the scientific consulting firm Cantox Health Science International, found that:
"Based on the totality of the data, there is no compelling evidence suggesting that triclosan usage has contributed towards the development of resistance to triclosan or triclosan-antibiotic cross-resistance in the clinical setting or the home environment."
F urther, the paper states that "current levels of triclosan usage in cosmetic products are considered safe, and based on available data, not expected to select for antimicrobial resistant bacteria."
In June 2002, a European Commission Scientific Steering Committee completed a comprehensive and thorough scientific review and analysis of data on antibiotic resistance regarding triclosan, the most commonly used antibacterial ingredient in consumer products.
The panel reported that "There is no convincing evidence that triclosan poses a risk to humans or to the environment by inducing or transmitting antibacterial resistance under current conditions of use."
On September 17, 2002, the European Commission’s Scientific Committee on Cosmetic Products and Non-food Products Intended for Consumers (SCCNFP) endorsed the Scientific Steering Committee’s findings and recommendations.
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Benefits of Antimicrobial/Antibacterial Cleaning Products
Benefits of Topical OTC Antimicrobial Products
This issue brief was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. The paper summarizes research describing the benefits of over-the-counter topical antimicrobial products, including bars, liquids, gels and wipes.
Endorsements for Consumer Topical Antimicrobial Products
This document was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. This summary describes examples of official regulations, guidelines or recommendations for the use of topical antimicrobial products in general population (non-healthcare) settings or situations.
Study: Antimicrobials most effective in removing bacteria
A study published in the American Journal of Infection Control (March 2005) found antimicrobial soap ingredients to be the "most efficacious" in removing bacteria from hands.
University of North Carolina news release, March 10, 2005: "Study: soap and water work best in ridding hands of disease viruses" http://www.unc.edu/news/archives/mar05/rutala031005.html
A comprehensive review of scientific research and literature is overwhelmingly supportive of the benefits of topical antimicrobial products in interrupting infection in invasive situations, interrupting disease transmission to oneself and others in non-invasive situations, as well as reducing the numbers of bacteria on the surface of the skin.
Much of this information has been transmitted to the U.S. Food and Drug Administration by a coalition consisting of The Soap and Detergent Association and The Cosmetic, Toiletry, and Fragrance Association.
Part of the Coalition’s August 2001 submission to the FDA showcased benefits in home, institutional and clinical settings
SDA-CTFA FDA petition-8.27.01-SECTION 2-benefits.pdf
2001 SDA-CTFA Submission-AppdxA.pdf
Additional studies on product benefits were showcased in an August 2003 Coalition petition:
SDA/CTFA comments, Food and Drug Administration, August 27, 2003: Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products. New Data Shows Additional Benefits From healthcare professional products: http://www.fda.gov/ohrms/dockets/dailys/03/Sept03/090303/75n-0183h-c000080-01-vol160.pdf
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Cleaning for Health -- antibacterial products for extra protection against germs
Frequently Asked Questions About Bacterial Resistance and Antibacterial Products
SDA/CTFA Presentation, Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting, October 20, 2005, Silver Spring, MD: Technical presentations and materials outlining the safety and benefits of topical antmicrobial consumer products
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