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Under court order, the FDA will review controversial antibacterial Triclosan in 2014

Green Right Now Reports US regulators have taken a first step toward placing limits on the controversial ingredient triclosan, which is used in most antibacterial soaps despite studies suggesting it...

Green Right Now Reports

Triclosan warningUS regulators have taken a first step toward placing limits on the controversial ingredient triclosan, which is used in most antibacterial soaps despite studies suggesting it has an array of negative effects on human health and the environment.

Antimicrobial chemicals, conceived to serve as powerful germ killers that could enhance hygiene, have come under increasing criticism for potential causing antibiotic resistant strains of bacteria or superbugs and also for acting as hormone disruptors.

Pointing to research that triclosan and other synthetic antibacterials interfere with human hormones, possibly depressing fertility and causing fetal development anomalies, the Natural Resources Defense Council petitioned the US Food and Drug Administration to examine the safety of the chemical, and similar antimicrobials. (Recent research even suggests that triclosan exposure may even impair muscle activity.)

When the FDA failed to take action, the NRDC sued, accusing the agency of delaying controls for triclosan for 35 years.

“FDA first proposed in 1978 to remove triclosan from certain consumer products. But because it took no further action, the chemical has been widely used in antimicrobial soaps sold in the United States,” the NRDC said in a statement. Triclosan also turns up in hand sanitizers, dishwashing liquid and personal body products.

In November, a US District Judge in New York ruled in favor of the NRDC and demanded that the FDA take action.

FDA officials unveiled their plan right before the Christmas break, announcing that the agency would ask the companies that produce triclosan and similar agents to verify their purported benefits.

Under the FDA proposal, if the companies cannot show the effectiveness of the antibacterial ingredients, they would have to reformulate or potentially relabel their products.

Triclosan in Runoff -- BoulderCreekGraph USGS

Triclosan has been found in water runoff, as this sample graph from US Geological Survey samples in Colorado demonstrate.

“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 said in a news release about its decision.

The agency quoted an in-house expert explaining that antibacterials simply may not be needed in household settings, and therefore are not worth the risks they pose to the broader environment and human development.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The US Centers for Disease Control advises people to wash their hands frequently with plain soap and water to lower their risk of catching colds and the flu. The CDC also endorses alcohol-based sanitizers are effective germ-fighting tools.

The public can comment on the FDA proposal over the next six months. The companies that produce triclosan and the second most-used antimicrobial, triclocarban, will have a year to submit their safety and effectiveness evidence to the FDA.

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