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FDA says studies on triclosan, used in sanitizers and soaps, raise concerns

by Lyndsey LaytonWashington Post
April 8th, 2010

The Food and Drug Administration said recent research raises "valid concerns" about the possible health effects of triclosan, an antibacterial chemical found in a growing number of liquid soaps, hand sanitizers, dishwashing liquids, shaving gels and even socks, workout clothes and toys.

The FDA and the Environmental Protection Agency say they are taking a fresh look at triclosan, which is so ubiquitous that is found in the urine of 75 percent of the population, according to the Centers for Disease Control and Prevention. The reassessment is the latest signal that the Obama administration is willing to reevaluate the possible health impacts of chemicals that have been in widespread use.

In a letter to a congressman that was obtained by The Washington Post, the FDA said that recent scientific studies raise questions about whether triclosan disrupts the body's endocrine system and whether it helps to create bacteria that are resistant to antibiotics. An advisory panel to the FDA said in 2005 that there was no evidence the antibacterial soaps work better than regular soap and water.

The FDA was responding to inquiries from Rep. Edward J. Markey (D-Mass.), who has been pushing federal regulators to take stronger action to restrict the use of triclosan and other chemicals that have been shown in laboratory tests to interfere with the delicate endocrine system, which regulates growth and development.

"The proliferation of triclosan in everyday consumer products is so enormous, it is literally in almost every type of product -- most soaps, toothpaste, cosmetics, clothes and toys," Markey said. "It's in our drinking water, it's in our rivers and as a result, it's in our bodies. . . . I don't think a lot of additional data has to be collected in order to make the simple decisions about children's toys and soaps that people use. It clearly is something that creates a danger."

Markey wants triclosan banned from all products designed for children and any product that comes into contact with food, such as cutting boards. Other countries, including the members of European Union, have banned or restricted use of the chemical.

Brian Sansoni of the Soap and Detergent Association, which represents the $30 billion U.S. cleaning products industry, said concerns about triclosan are unfounded.

"These products and ingredients have been reviewed, regulated and researched for decades," he said. "We believe the science strongly supports the safety and efficacy of these products. It's more important than ever that consumers continue to have access to these products. It's a time of increased threats from disease and germs."

Triclosan was developed as a surgical scrub for medical professionals. It is also used in pesticides. In recent years, it has been added to a host of consumer products to kill bacteria and fungus and prevent odors. It can be found in everything from kitchen cutting boards to shoes, often packaged with labels that tout "antibacterial" properties.

Most hand sanitizers, such as Purell, use alcohol and do not contain triclosan.

Sarah Janssen, staff scientist at the Natural Resources Defense Council, which joined with several other environmental groups last year to petition the FDA to restrict the use of triclosan, said the soap industry was taking advantage of consumer fears. "Especially with the H1N1 outbreak, people get really scared and think they need to take extra precautions without thinking that soap and water works just as well," Janssen said.

Because it is found in so many different types of products, triclosan is regulated by three different federal agencies: the FDA, the EPA and the Consumer Product Safety Commission. But the FDA, which oversees its use in personal-care products, medical devices and products that come into contact with food, has been working for 38 years to establish the rules for the use of triclosan but has not completed that task.

The FDA is committed to issuing the rules quickly and is working with EPA to review the most recent data on triclosan, said Doug Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research. He said the FDA is also revisiting the 1997 approval it gave for the use of triclosan in Colgate Total toothpaste because at the time, scientists had not yet raised concerns that triclosan can disrupt the endocrine system.

"For triclosan, the science is changing," Throckmorton said. "Based on what we know, we don't have evidence to suggest this chemical is a threat to human health. However, we have to understand better the health effects and we have to work with other agencies to collect that information and then decide whether or not we need to change how it's regulated."