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Soaps and body washes that are labeled "antibacterial" have now come under fire by the Food and Drug Administration, as the government agency has submitted a proposed rule that will require manufacturers of such products to prove they are safe for long-term use.
As part of a larger review by the Food and Drug Administration (FDA), manufacturers will also need to show how their products are more effective at preventing illness and the spread of infection than ordinary soap and water.
If such companies are unable to meet these requirements, they will need to reformulate or relabel their products, in order to keep them on the market.
"Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low," says Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER).
"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk," she adds.
Because of the widespread use of antibacterial soaps by the general public, the FDA cites health care groups and consumer groups that have convinced the agency to re-examine data on whether or not the ingredients in such products are "generally recognized as safe and effective."
In recent years, two of the main ingredients in antibacterial soaps, triclosan and triclocarban, have been analyzed closely in scientific studies.
One study, published in the journal Environmental Science and Technology, suggested that triclosan fuels the development of resistant bacteria in streams and rivers.
Still, other research has lauded the positive effects of antibacterial soaps. One study, for example, suggested these products may reduce MRSA infection rates in hospitals.
Representatives from the FDA say the proposed rule only covers antibacterial soaps and washes that are used with water, which means hand sanitizers, hand wipes or other agents that are used in health care settings are not being analyzed.
The agency says some data has suggested long-term exposure to ingredients like triclosan and triclocarban could pose risks, such as hormonal effects or bacterial resistance.
Additionally, the FDA notes there is currently no evidence that antibacterial soaps are any more effective than plain soap and water at preventing illness.
To continue marketing their products, manufacturers will need to show the FDA additional data on the safety and effectiveness of their soaps, including information from clinical studies.
The Environmental Protection Agency (EPA) has recently assessed triclosan and has concluded that the chemical is eligible for reregistration, "provided the measures and associated label changes identified in the RED [Reregistration Eligibility Decision] are implemented and required data are submitted," which is why the FDA is bringing antibacterial soaps under such scrutiny.
Dr. Sandra Kweder, from the Office of New Drugs at CDER, urges consumers to make educated choices about the products they use, adding:
"Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others."
Antibacterial soap products do not have to be removed from the market currently, and the public is invited to comment for 180 days.
Written by Marie Ellis
Copyright: Medical News Today
Not to be reproduced without the permission of Medical News Today.
FDA Release, accessed 17 December 2013.
Visit our Regulatory Affairs / Drug Approvals category page for the latest news on this subject.
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