Antibacterial Soaps Safe & Effective? FDA Wants Proof

The FDA has proposed a rule that requires 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 do not demonstrate such safety and effectiveness under the proposed rule, these products would need to be reformulated or relabeled to remain on the market. This will not affect hand sanitizers, wipes, or antibacterial products used in healthcare settings.

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Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban which can also be found in some soaps labeled “deodorant.” There is some data available suggesting that long-term exposure to certain active ingredients found in antibacterial products (eg,  triclosan in liquid soaps and triclocarban in bar soaps) could pose health risks, such as bacterial resistance or hormonal effects.

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