FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

In December 2013, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to provide substantial data 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 this proposed rule, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

In its news release on the topic, the FDA states that: “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.”

Given the foregoing concerns, the FDA’s current position is that there should be a clearly demonstrated benefit from using these products to balance any potential risk. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the FDA 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.

In a joint statement, the American Cleaning Institute (“ACI”) and the Personal Care Products Council (“PCPC”) expressed the following opinion of the FDA’s proposed ruling:

“We are perplexed that the Agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products. In fact, in 2008, at industry’s request, FDA held a public meeting to discuss the data and industry asked FDA if the Agency required any further information. Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap.

Additionally, a review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap.

We intend to file comments to FDA reaffirming that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance. The ingredients used in antibacterial soap and washes have been evaluated and regulated by agencies and scientific bodies around the world. In some instances, these products have been found to be critical in the reduction of infection and disease.”

The FDA has encouraged consumers, clinicians, environmental groups, scientists, industry representatives and other to discuss and weigh in on the proposed rule and the data it discusses in the proposed ruling. 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.

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