By Kathleen Doheny
WebMD Health News
Reviewed by Arefa Cassoobhoy, MD, MPH
Dec. 17, 2013 -- Even though the FDA has asked makers of antibacterial soaps and body washes to prove the products are both safe and effective long-term, the products won't disappear from store shelves -- at least not at the moment.
The FDA's request is a proposed rule. That means makers can still sell their products while they give the FDA the information it requested.
Here's what else you may want to know about the FDA's action.
Q: Which products are affected?
The FDA's proposed rule covers only antibacterial hand soaps and body washes. The active ingredients include triclosan in liquid soaps and triclocarban in bar soaps.
Under the proposed rule, the makers of these products have to show they are safe for long-term, daily use. They must also prove they work better than soap and water to prevent illness and the spread of certain infections.
Most of these products are labeled as ''antibacterial" or "antimicrobial." They are sold over the counter.
Q: What about cleaning products?
Although many cleaning supplies also are marketed as antibacterial, the rule does not include them. It also does not affect hand sanitizers, wipes, or antibacterial products used in health care settings, where the infection risk is much higher.
Q: What are the specific safety issues and concerns?
- How well they work: According to the FDA, ''there is currently no evidence'' that antibacterial products work better at preventing illness than washing with soap and water.
- Bacterial resistance: Long-term use of soaps and washes with antibacterial chemicals could mean bacteria become resistant to these chemicals and are no longer killed or destroyed by them.
- Hormone disruption: Some research shows that the chemicals may interfere with hormones needed for normal brain and reproductive development.
Q: What does the research show about triclosan and triclocarban?
Studies about hormone disruption with the two ingredients have had mixed results, says Bruce Hammock, PhD, of the University of California, Davis. Many of these studies are on animals, not humans.
Triclosan is more concerning than triclocarban, he says. He sees the use of triclosan in antibacterial hand soap, which is typically used multiple times a day, as ''high-volume use of a chemical that has very little demonstrated benefit."
"My opinion is, there is so little benefit that any risk is unacceptable,'' he says of the antibacterial liquid soaps.
Triclocarban has mixed reviews, Hammock says. While some research has suggested that triclocarban could cause cancer, other research has found it could be an anti-inflammatory, which would be helpful, Hammock says.
Bottom line? "I don't think there is any data to support that [the antibacterial products] are better than soap and water," says Aaron Glatt, MD, a spokesman for the Infectious Diseases Society of America.
Q: What does the industry say?
The products are both safe and effective, says Brian Sansoni, a spokesman for the American Cleaning Institute. It issued a joint statement on Monday with the Personal Care Products Council in response to the proposed rule.
The statement reads, in part, that the industry ''has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap."
Two dozen studies have found that the products work to kill germs, it says.
The statement did not mention hormone disruption.
Q: What is the timeline for the FDA's proposed rule?
Public comments will be invited on the proposed rule until June 2014, followed by a time period to give companies a chance to submit new data and then a rebuttal period.
The FDA hopes to issue the final rule by September 2016.
Q: Does this proposed rule effectively ban these products?
According to the FDA, by the time the proposed rule is final, manufacturers who haven't provided convincing data must change the product's ingredients or remove the antibacterial claim.
Q: Until a final decision is made, what's the best advice for people now? Should they buy or not buy antibacterial soaps?
Glatt says there is no need to throw away anything you may have at home now. But he suggests that people not buy antibacterial soaps and body washes going forward: ''This is not a smart use of people's money at this point in time."
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SOURCES: Bruce Hammock, PhD, distinguished professor of entomology, University of California Davis Center for Vectorborne Diseases. Aaron Glatt, MD, spokesman, Infectious Diseases Society of America; executive vice president, Mercy Medical Center, Rockville Center, Long Island, N.Y. Statement, American Cleaning Institute and Personal Care Products Council, Dec. 16, 2013. News release, FDA. Andrea Fischer, spokeswoman, FDA.
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