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FDA Issues Proposed Rule for Antibacterial Soaps

Companies must show that their products are better than plain soap and water (December 16)

The FDA has 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 are 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 agency’s action is part of a larger, ongoing review of antibacterial active ingredients to ensure that these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

Millions of Americans use antibacterial hand soap and body wash products. 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 in liquid soaps and triclocarban in bar soaps — could pose health risks, such as bacterial resistance or hormonal effects.

Source; FDA; December 16, 2013.

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