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FDA questions safety, effectiveness of hand sanitizers

July 6, 2016
by Nicole Stempak, Senior Editor
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Hand sanitizers were originally intended for use when soap and water wasn’t available. Disinfecting gels and hand wipes are convenient, thought to help reduce bacteria on hands and prevent the spread of germs at work, school, restaurants, doctors’ offices and other public places.

Outbreaks and superbugs — or at least the possibility of them — have helped the sanitizer industry grow the past 20 years. Now the U.S. Food and Drug Administration wants to make sure they’re effective and safe for repeated daily use.  

“These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in a press release. “To do that, we must fill the gaps in scientific data on certain active ingredients.”

The FDA has issued a proposed rule requesting manufacturers provide additional scientific data about how topical consumer antiseptic rubs are absorbed by the body, especially in pregnant women and children. Manufacturers have been asked to study whether three active antibacterial ingredients — alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride — show up in blood or urine, which could indicate the chemicals may affect the reproductive system or the production of hormones.

“We need to get this additional information so if there are situations where caution is warranted we can label that or inform the public,” Woodcock says.

The request is part of a larger Over the Counter Drug Review of 22 decades-old antiseptic chemicals that have never had a comprehensive federal review, including antibacterial soap. Under current regulations, manufacturers can make broad claims about their products’ effectiveness in killing germs.

The proposed rule will be open for public comment for six months, and companies will have one year to submit the requested information. 



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