Antibacterial soap makers would need to prove efficacy under proposed FDA rules

December 16, 2013

Manufacturers of antibacterial hand soaps and body washes would have to prove that their products are safe to use over time and perform better than ordinary soap and water to keep them on the market, according to regulations proposed Monday by the Food and Drug Administration.

Agency officials said scant evidence exists to suggest that antibacterial soaps are any more effective at preventing illnesses than washing with old-fashioned soap and water. In addition, the agency said some data suggest that long-term exposure to some of the ingredients in antibacterial products, such as triclosan in liquid soaps and triclocarban in bar soaps, actually could pose health risks such as bacterial resistance or hormonal effects.

“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,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement Monday. “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.”

The agency’s proposal does not affect hand sanitizers, wipes or other antibacterials used in hospitals and other medical facilities.

Still, the eventual change could affect products that have become ubiquitous in grocery stores and pharmacy aisles and are used by millions of Americans each year. Almost any soap labeled “antimicrobial” or “antibacterial” contains at least one of the ingredients included in a list the FDA intends to oversee.


There is some evidence antibacterial chemicals may pose health risks. (Bigstock)

Monday’s proposal doesn’t require companies to pull any antibacterial soaps from the market at the moment. But if it is finalized, manufacturers will have to give the agency data backing up any antibacterial claims. If not, they will have to reformulate or relabel them.

Still, it’s likely to be a long time before that happens. The FDA will accept public comments on its proposal for the next 180 days, and companies will have a one-year period to submit data and information to the agency.

Brady Dennis is a national reporter for The Washington Post, focusing on food and drug issues.
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