The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. The action is part of an ongoing agency review of antibacterial active ingredients and would not apply to hand sanitizers, wipes or antibacterial products used in health-care settings.
Noting that although many consumers generally view antibacterial products as effective tools to help prevent the spread of germs, FDA cites a lack of evidence that they are any more effective at preventing illness than washing with plain soap and water and observes that some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks such as bacterial resistance or hormonal effects.
“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” said FDA Microbiologist Colleen Rogers. “There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.” Rogers also asserts that laboratory tests that have historically been used to evaluate the effectiveness of antibacterial soaps do not directly test the effect of a product on infection rates. That would change with FDA’s current proposal, which would require studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap. Additional details about FDA’s commitment to assess the safety and efficacy of these products appear in Issue 15 of this Report. See FDA News Release, December 16, 2013; Federal Register, December 17, 2013.