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FDA raises questions about ‘data gaps’ regarding safety, effectiveness of hand sanitizer

A charity group gives free hand sanitizer to people to protect against Middle East Respiratory Syndrome in Seoul in June 2015. (Ahn Young-joon/AP)

The colorful gels have become the front lines in our fight against germs. Antiseptic hand sanitizers in greens, blues and reds are now ubiquitous in schools, workplaces and hospitals. They are must-haves in moms' pocketbooks. And they have been distributed in West Africa to fight Ebola and in South Korea against Middle East Respiratory Syndrome.

Although these products were designed to be used when old-fashioned soap and water aren't available, many people use them multiple times a day even when a sink is nearby under the belief that they are killing more bacteria.

The Food and Drug Administration says the problem is that we still don't have enough information to know whether these products present unknown safety and efficacy concerns, and on Wednesday, the agency asked manufacturers to provide scientific data for three active ingredients: alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride. They are looking for information that the ingredients are safe, effective and reduce bacteria on skin. The FDA's request also applies to hand wipes.

The FDA emphasized that it does not mean it believes the products are ineffective or unsafe, and it is not asking for any consumer hand sanitizer products to be removed from store shelves at this time.

"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. To do that, we must fill the gaps in scientific data on certain active ingredients,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA expressed particular interest in information about repeated exposure and use by children and pregnant women. It noted that "emerging science" suggests that detection of antiseptic ingredients in the blood or urine is higher than previously thought in full body exposure.

The agency's request is part of a massive inquiry of 22 chemicals that fight bacteria and that has set the $30 billion industry against some scientist groups that are concerned that the ingredients, which linger in the environment and can be absorbed by the body, may not work as advertised and may be contributing to antibiotic resistance.

In September, the FDA is expected to announce a decision on antibacterial soaps and whether they are safe and more effective than soap and water. The companies that make the products are concerned that if the FDA decides against them, they will have to relabel and reformulate the products.

FDA wants more proof that antibacterial soaps actually work

The two major industry groups — the American Cleaning Institute and the Personal Care Products Council — have said they have the data to show their products are safe and effective and dispute the idea that they may be contributing to creating superbugs. They said that scientific evidence points to prescription antibiotics and animals we eat as the cause. They have also warned that a ban on antibacterial soap, gels, wipes and other cleaning tools would pose a serious public health risk, leading to increased incidence of infection and disease.

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