Issue Date: July 4, 2016
FDA requests safety data on hand sanitizers
Manufacturers who market over-the-counter hand sanitizers in the U.S. would have to submit data to FDA on the safety and effectiveness of certain active ingredients in their products, under a rule proposed by FDA last week. Millions of consumers use these products daily to help reduce bacteria on their hands when soap and water are not available. FDA wants to learn more about the long-term safety of daily exposure to three ingredients: ethyl alcohol, isopropyl alcohol, and benzalkonium chloride. Ethyl alcohol is used in 90% of all consumer hand sanitizers, FDA says. The proposed rule would not require manufacturers to remove hand sanitizers from the market, but companies would have to show that their products are safe and effective at reducing bacteria on skin. “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, director of the FDA’s Center for Drug Evaluation & Research.
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