FDA asks antibacterial soap makers to prove effectiveness

smhantibacterialloresDo you make sure to buy antibacterial soap, thinking it will protect you and your family from germs and illness?

The U.S. Food and Drug Administration says there is no evidence the soaps are any more beneficial than regular soap and water. Today, the agency issued a proposed rule to 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. If companies don’t demonstrate this, their products would need to be  reformulated or relabeled to remain on the market.

The proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The FDA said in a release, “Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, 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.”

The FDA urged people to continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer with at least 60 percent alcohol should be used. More information on hand-washing is available here.

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