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FDA to Re-examine Anti-Bacterial Chemical in Soaps, Cleansers

Triclosan linked to hormonal changes, antibiotic resistance in recent studies

THURSDAY, April 8 (HealthDay News) -- The U.S. Food and Drug Administration Thursday acknowledged that there could be safety concerns regarding triclosan, an ingredient found widely in consumer products, such as antibacterial soaps, toothpaste and cosmetics, clothing and toys.

In an update to its Web site, the agency stated that "triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review."

The FDA did not recommend that consumers change their behavior with respect to these products.

At issue is whether or not triclosan alters hormone regulation in humans, as it has been shown to do in animals. Such disruptions can cause developmental or other problems.

There is also concern that triclosan may contribute to resistance to antibiotics, whereby bacteria develop ways around the potentially lifesaving drugs.

One public health advocacy group applauded the FDA announcement.

"It's about time FDA has finally stated its concerns about antibacterial chemicals like triclosan," Dr. Sarah Janssen, a medical doctor and staff scientist at the Natural Resources Defense Council, said in a news release issued Thursday. "The public deserves to know that these so-called antibacterial products are no more effective in preventing infections than regular soap and water and may, in fact, be dangerous to their health in the long run."

However, a representative of the cleaning-products industry defended triclosan's safety profile.

"With all due respect to the statement made by FDA, the agency has in its hands a wealth of scientific data showing a distinct germ-killing benefit of antibacterial soaps containing triclosan," said Brian Sansoni, spokesman for the Soap and Detergent Association (SDA). "We believe these products play a very important role in everyday hygiene routines for millions of Americans."

The FDA update may have come in response to a report in the Washington Post that said the agency had sent a letter to Rep. Edward J. Markey (D-Mass.), chairman of the House Energy and Commerce Subcommittee on Energy and the Environment. That letter acknowledged that research had recently raised "valid concerns" about the safety of triclosan, the Post reported.

That letter was a response to a letter Markey had sent to the FDA in January, asking for an update of the FDA's scientific review of the chemical.

According to the Post, Markey has called for a ban on triclosan in products geared toward children and any products that could contaminate food, such as cutting boards. Some countries have already banned or put restrictions on triclosan, the newspaper stated.

"We're certainly going to continue providing an informed perspective to FDA, to EPA [the Environmental Protection Agency] and Congressman Markey and others who might be challenging its safety and effectiveness," the SDA's Sansoni said.

While reiterating that triclosan is not known to pose any danger to humans, the FDA did state that it is "reviewing all of the available evidence on this ingredient's safety in consumer products. FDA will communicate the findings of its review to the public in spring 2011."

The agency also pointed out that it has no evidence that triclosan is any better than soap and water for cleaning purposes.

A University of Michigan review of data, published in 2007 in the journal Clinical Infectious Diseases, found that antibacterial soaps that contain triclosan as the main active ingredient are no better at preventing infections than plain soaps.

More information

There's more on triclosan at the FDA's Web site.

SOURCES: April 8, 2010, news release and Web site posting, U.S. Food and Drug Administration; Brian Sansoni, spokesman, Soap and Detergent Association, Washington, D.C.; April 8, 2010, news release, Natural Resources Defense Council, Washington, D.C.

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