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article imageAre antibacterial soaps effective, safe? Prove it, says FDA

By Paris Hughes     Dec 17, 2013 in Health
The U.S. Food and Drug Administration (FDA) are now questioning the efficacy and safety of antibacterial soaps, suggesting that they may not kill as many germs as previously thought, and may even pose some health risks to consumers.
FDA proposed a new rule Monday, in which manufacturers of antibacterial hand soaps and body washes may be required to prove that their products are safe for long-term use, and are more effective at killing germs and preventing disease than plain soap and water.
“We want companies to actually test these products so that consumers that purchase them have a sense whether there is really any benefit at all over plain soap and water,” Sandra Kweder, deputy director of the office of new drugs at FDA’s Center for Drug Evaluation and Research said in USA Today.
Kweder also explained that, under the new rule, manufacturers would also have to provide additional data on their products to verify that they are “generally recognized as safe for use”— or GRAS—a term used for the list of ingredients used in many foods and products that have been proven safe.
If companies are unable to provide adequate data to confirm their efficacy and safety, antibacterial soap products would have to be relabeled or reformulated in order to remain on the market.
The proposed rule will not extend to alcohol based hand sanitizers, wipes or antibiotic sanitizing products used in hospitals and other health care settings, according to the FDA.
A joint statement from the American Cleaning Institute and the Personal Care Products explained that they were “perplexed that the Agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided date and information about the safety and efficacy of these products.”
Both continued to explain that manufacturers had provided “significant” information on the efficacy and safety of antibacterial soaps to the Agency for 20 years. As the American Cleaning Institute continues to stand by their convictions that they gave the FDA numerous reports and studies showing effectiveness of their products, the FDA states a different view.
“Consumers assume that by using antibacterial soap products they’re protecting themselves and their families from illness—but we don’t have evidence that they’re better than simple soap and water,” Kweder said.
Proposed requirements for companies to provide evidence of safety and effectiveness of antibacterial products came about as the FDA became increasingly concerned about the contents in antibacterial soaps and their effects on humans. Many antibacterial soap products contain triclosan, which may cause infertility, early puberty and other hormonal issues, according to evidence from animal studies. Based on studies conducted on rats, thyroid hormone levels decreased after long-term exposure, according to Kweder. Whether long-term exposure to triclosan could greatly impact the health of humans is still not yet confirmed however, Kweder explained, as human studies require an extended time period, making data collection “very difficult”.
According to the agency, the studies "are of concern to FDA as well, and warrant further investigation to better understand how they might affect humans."
Also, regular, long-term use of antibacterial soaps products may also create super bacteria that will become resistant to anything available on the market, added Dr. Brian Koll, an infectious disease expert at Beth Israel Medical Center in New York.
“The concern is development of drug resistance so that makes our bacteria stronger,” Koll said for CBS News.
Ultimately, the FDA still recommends hand washing with soap and water as the best protection against dangerous germs and illness.
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” Kweder added in a press release. “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.”
“For the majority of us at home, old fashioned soap and water that’s used effectively are just as effective. There are no benefits to an antibacterial product at home,” Koll added.
The FDA will give companies and manufacturers until December 2014 to submit the adequate data and studies to prove the efficacy and safety of their products. They are hoping to finalize the proposed rule and determine, from data provided, whether products are considered “generally recognized as safe and effective” by September 2016.
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