FDA: No Proof Antibacterials Work
A new report issued by the United States Food and Drug Administration all but admits that antibacterial soaps don't do what they're supposed to.
When you're buying soaps and body washes, do you reach for the bar or bottle labeled "antibacterial" "... thinking that these products, in addition to keeping you clean, will reduce your risk of getting sick or passing on germs to others?" asks a consumer-focused positing at the regulatory agency's Website.
Thanks to a drawn-out media blitz over the last several; decades by the makers of so-called antibacterial soaps, it's estimated that every day countless consumers use antibacterial soaps and body washes at home, work, school and in other public settings -- thinking their diligent use of the product will help ward off infections .
But, according to Colleen Rogers, Ph.D., one of the leading microbiologists at the agency, there is currently no evidence that over-the-counter antibacterial soap products are any more effective at preventing illness than plain soap and water.
In addition, "new data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," said Rogers, who further explained there are certain ingredients in such soaps that may contribute to bacterial resistance to antibiotics and may have "unanticipated hormonal effects that are of concern to FDA."
In other words, after years of apparent inaction and allowing soap manufacturers to use possibly harmful ingredients such as triclosan and triclocarban unregulated, the FDA has decided to revisit the issue.
A new rule proposed today would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of their antibacterial soaps -- though the stepped-up regulations would only covers consumer-grade antibacterial soaps and body washes used with water.
Hand sanitizers, hand wipes and antibacterial soaps like those used hospitals would not be affected by the rule change.
The laboratory tests historically used to evaluate the effectiveness of antibacterial soaps have actually not directly tested the effect of products on infection rates.
The new FDA's proposal would change that, by requiring studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap, Rogers said..
Antibacterial soaps -- also referred to as antimicrobial or antiseptic soaps -- contain certain chemical ingredients that are supposed to reduce or prevent bacterial contamination.
Triclosan, contained in a large number of liquid soaps labeled "antibacterial," has been a significant safety concern to many environmental and industry groups.
Animal studies suggested triclosan may alter the way hormones work in the body.
Lab studies have also raised the possibility triclosan ends up bolstering the immunity of bacteria, helping them become more resistant to antibiotics.
That said, the FDA and the Environmental Protection Agency, which regulates the use of triclosan as a pesticide, have been more fully examining together the science and regulatory issues surrounding triclosan.
Meanwhile, the FDA has opened a public comment period on triclosan, encouraging people to discuss and weigh in on the proposed rule changes and the data it covers. The comment period last for the next 180 days.
Officials at the FDA emphasize basic hand washing continues to be one of the most important steps people can take to avoid getting sick and prevent spreading germs.
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