FDA proposes rule to determine safety and effectiveness of antibacterial soaps

If safety and effectiveness cannot be demonstrated, these products would need to be reformulated or relabelled

The US Food and Drug Administration (FDA) is proposing to issue a 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. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market.

The move is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure that these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitisers, wipes, or antibacterial products used in healthcare settings.

The FDA says 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 studies have suggested 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.

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