FDA bans antibacterial soaps containing triclosan

WASHINGTON — In a major victory for environmentalists and public health advocates, the US Food and Drug Administration today banned the use of triclosan as an ingredient in antibacterial soaps, saying that such cleaners were no better than regular soap, and could be harmful.

Despite a long and expensive lobbying campaign, the $30 billion personal care products industry was unable to prove that the widely used antibacterial cleansers were safe and effective.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term.”

However the rule does not apply to other products that use triclosan, including hand sanitizers, cosmetics, and some brands of toothpaste.

The scientific debate over triclosan dates back to 1978, when the FDA first proposed a safety review of the chemical. Over the years, FDA reviewed triclosan, used in liquid soap, and triclocarban, used in bar soaps, but did not take action. In 2010, the Natural Resources Defense Council sued FDA to force them to do so. Today’s announcement is the outcome.

“This is a big deal,” said Mae Wu, senior attorney with the Natural Resources Defense Council. “It’s a great step for getting triclosan and triclocarban out of these products.”

“I am pleased that the FDA has taken the action to ban triclosan from antibacterial hand soaps, and now we must ban it from all products intended for use by children and products intended to come into contact with food,” Senator Edward J. Markey, who has advocated for a ban on triclosan, said in a statement. “From toothpaste to toys, we should restrict the use of this ineffective and potentially dangerous chemical that continues to pollute our bodies.”

The Personal Care Products Council, which represents the industry, was not immediately reachable for comment. But in earlier notes on the group’s website, John Bailey, then the group’s chief scientist, said, “triclosan has been safely and effectively used for decades.”

“It is critical that antibacterial hand wash products continue to be available to consumers in high-risk settings,” Bailey said. Among the high-risk settings he noted were public restrooms and toilets, and also activities such as shaking hands, traveling, preparing family meals, and changing diapers.

FDA disagreed. Its rule today gives companies one year to reformulate their products without triclosan, triclocarban, and 17 other compounds included in the new rule. The agency agreed to give manufacturers more time to prove three other substances are safe and effective.

“They kicked that can down the road,” Wu said.

Some animal studies have shown that triclosan can disrupt the way that hormones work, setting the stage for long-term problems such as poor sperm quality, infertility, and damages to the developing brain, leading to learning disabilities.

Other studies, most notably by Dr. Isaac Pessah of University of California, Davis, and his colleagues, have found evidence that triclosan can impair heart function in animals.

In light of those kinds of findings, some manufacturers have already removed triclosan from their products, including Procter & Gamble, Johnson & Johnson, and Avon.

In its place, the FDA touted a simple replacement: Soap and water.

“Following simple hand-washing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” said Dr. Theresa M. Michele of the FDA’s Division of Nonprescription Drug Products. “We can’t advise this enough.”