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FDA questions safety of antibacterial soaps

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Antibacterial soaps are popular these days; many use them on a regular basis with the belief that they reduce the risk of infection. However, on December 16, the Food and Drug Administration (FDA) published a proposed rule that would require makers of antibacterial hand soaps and body washes to demonstrate that their products are both safe and more effective than soap and water in preventing infection and the spread of bacteria.

The FDA notes that every day, antibacterial soaps and body washes are used at home, work, school, and in other public settings. Inasmuch as so many individuals use them on a regular basis, the agency is of the opinion that there should be clearly demonstrated benefits to balance any potential risks. It notes that, at present, no evidence exists that supports the benefits of antibacterial soaps for preventing illness over washing with plain soap and water. In addition, antibacterial soaps contain chemicals, such as triclosan and triclocarban, which may have unnecessary health risks. Thus, the FDA published a proposed rule on its website that would require manufacturers to provide additional data supporting the safety and effectiveness of their products. The proposed rule addresses only antibacterial soaps and body washes that are used with water. It does not apply to hand wipes, hand sanitizers, or antibacterial soaps that are used in healthcare settings such as hospitals.

Colleen Rogers, PhD, a lead microbiologist at FDA, notes that the laboratory tests that have historically been used to evaluate the effectiveness of antibacterial soaps do not directly test the effect of a product on infection rates. She explained that if the FDA proposal is mandated, it would require clinical e studies that specifically test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap.

Many antibacterial soaps contain triclosan, which is a chemical that has raised concern among many environmental and industry groups. Animal studies have found that triclosan may alter the way hormones function in the body. Data from animal studies does not always predict a similar effect in humans; however, these studies have attracted the attention of the FDA; thus, the agency is of the opinion that further studies be conducted to evaluate possible harmful effects on humans. The FDA notes that in addition to causing hormonal problems, laboratory studies have found that triclosan might contribute bacterial resistance to antibiotics. In addition, the FDA notes, recent studies have suggested that exposure to these active ingredients is higher than previously thought; thus, raising concerns about the potential risks associated with their use regularly and over time.

The FDA has established a 180 day comment period, during which consumers, healthcare professionals, environmental groups, scientists, industry representatives and others can discuss and evaluate the proposed rule and the data it reviews.

Take home message:
Although the FDA proposal is subject to debate for half a year, the odds are that the proposal will become a ruling. Inasmuch as there is no prudent benefits to the use of antibacterial soaps over plain soap and water, it would be prudent to avoid their use.



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