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Robert BellRobert G. Bell, Ph.D. is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.

With the holidays rolling in, there will be lots of hugging and handshakes–and the use of antibacterial soap to keep the germs away. However, it appears the use of antibacterial soap (ABS) could be part of the problem by contributing to bacterial resistance to antibiotics. In addition, some of the ingredients commonly found in ABS may carry unnecessary human and environmental risks given that their benefits are unproven. According to Colleen Rogers, Ph.D., a lead microbiologist at the US Food and Drug Administration (FDA), there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water. Furthermore, ABS products contain chemical ingredients such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven. For instance, the Environmental Protection Agency regulates triclosan as a pesticide and is currently updating its assessment of its effects when used as a pesticide.

The laboratory tests that have historically been used in the effectiveness evaluation of ABS do not directly test the effect of a product on infection rates. The FDA’s current proposal would require studies to directly test the ability of an ABS to provide a clinical benefit over washing with nonantibacterial soaps. “New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. 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.

In response to the ABS issue, this week, the FDA issued a proposed rule that would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes, or antibacterial soaps that are used in health-care settings such as hospitals. The FDA is encouraging consumers, clinicians, environmental groups, scientists, industry representatives, and others to discuss and weigh in on the proposed rule. The comment period extends for 180 days. Until then, the FDA emphasizes that hand washing is one of the most important steps people can take to avoid getting sick and to prevent spreading germs to others. A good source for tips and information about benefits of appropriate hand washing is the Centers for Disease Control and Prevention (CDC).

Happy Hygienic Holidays!