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FDA wants more stringent rules for antibacterial soaps

The U.S. Food and Drug Administration (FDA) has issued a proposal [1] 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.

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 (liquid soaps) and triclocarban (bar soaps) - could pose health risks, such as bacterial resistance or hormonal effects,” the FDA explains.

Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, the FDA believes there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk. 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.

A public comment period has been opened for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.

The FDA’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure 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.

Antibacterial soaps - Proposed rule

Antibacterial soaps - Proposed rule

Footnotes

[1] “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record; Proposed Rule”, Food and Drug Administration, Department of Health and Human Services, 21 CFR Parts 310 and 333

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