National Geographic News
Dawn Ultra antibacterial soap in a kitchen Tuesday in Chicago.

The FDA has asked for evidence of the effectiveness of antibacterial products.


Brian Clark Howard

National Geographic

Published December 17, 2013

Federal officials' questions about antibacterial soaps have raised a lather among environmental and consumer advocates concerned about the safety of controversial ingredients in these cleansers.

Reviving a long-running controversy over antibacterial soaps and body wash, the U.S. Food and Drug Administration (FDA) announced on Monday that the makers of such products will have to prove that they are more effective than plain soap and water in preventing illness and curtailing infection.

According to the agency announcement, manufacturers will also need to prove that their products are safe for long-term use.

"Our goal is, if a company is making a claim that something is antibacterial and in this case promoting the concept that consumers who use these products can prevent the spread of germs, then there ought to be data behind that," said Sandra Kweder of the FDA's Center for Drug Evaluation and Research, in a statement. (See "Washing Hands in Hot Water Wastes Energy, Study Says.")

Alluding to the controversy around the most common active ingredients in thousands of antibacterial soap products—triclosan (liquid soaps) and triclocarban (bar soaps)—the FDA said, "Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects."

The move comes more than a decade after antibacterial soaps were established on store shelves; one 2001 survey found 45 percent of soaps contained these antibacterial agents, which act to inhibit or kill off bacteria.

Such soaps have been in at least some use to kill off odor-causing bacteria since the 1920s, according to the American Cleaning Institute, an industry group. In 2005, an FDA antibacterial soap panel had called for more research on the safety of antibacterial products.

Now, with the call for data from manufacturers, disagreement over the safety of antimicrobial soaps has bubbled up into wide public view.

Safety Concerns

The FDA's recent announcement doesn't go far enough for some critics of triclosan, including Beyond Pesticides, a Washington, D.C.-based environmental and public health advocacy group. Nichelle Harriott, a staff scientist at Beyond Pesticides, told National Geographic that the FDA's announcement is "a good step forward" but that it lacks enough teeth.

For years, Beyond Pesticides has asked the FDA and the EPA to ban triclosan and the closely related triclocarban from consumer products, out of concern over their safety. In addition to soaps, triclosan and triclocarban also appear in a wide range of "antibacterial" items, from cosmetics to toothpaste, kitchen utensils, clothing, toys, and furniture.

Responding to such advocacy group pressure, one of the largest manufacturers of antibacterial products, Johnson & Johnson, recently announced that it was voluntarily phasing triclosan out of many products by 2015.

Problematic Chemicals?

Harriott said that, in her view, there are three main problems with triclosan and triclocarban: Studies suggest that they may be directly harmful, may lead to antibiotic resistance, and don't really work on the most important pathogens.

To the first point, Harriott said, "Triclosan is an endocrine disruptor, meaning it interferes with our hormone system, and in particular thyroid hormone." Since research to that effect is based on animal studies, she said the jury is still out on how seriously the chemicals might impact a human being over the course of their life, but she said there is enough data for concern.

She said animal studies have specifically linked triclosan to interfering with estrogen and pregnancy hormones, and noted that the scientists who conducted at least one of those studies warned that it could affect fetal development. In a study on sheep published in the November issue of the journal Environment International, researchers concluded that the "high potency of triclosan as an inhibitor of estrogen sulfotransferase activity raises concern about its possible effects on the ability of the placenta to supply estrogen to the fetus, and in turn on fetal growth and development."

"We don't want chemicals we use in cosmetics and soaps impacting the unborn," said Harriott.

FDA Response

The FDA wrote on an agency webpage that was updated last on December 16 that "triclosan is not currently known to be hazardous to humans." The agency acknowledged recent studies that call into question its safety, but noted that "effects in animals don't always predict effects in humans."

Still, the FDA wrote, "several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review."

Harriott said that a study by the U.S. Centers for Disease Control and Prevention and published in Environmental Health Perspectives found traces of triclosan in urine in 75 percent of samples taken from 2,517 U.S. adults. Swedish and Australian studies also found it in umbilical cord blood and human breast milk, Harriott said, noting that the chemical is known for accumulating in fatty tissue.

What all that actually means in terms of people's health is still unclear, Harriott admitted, although she said it concerns her enough to want to see triclosan and triclocarban banned.

The Environment International study also noted that triclosan is increasingly found in the environment as a contaminant of sewage sludge and wastewater. That's one of the reasons why the agency Health Canada asked companies to voluntarily phase the chemical out of use above the border in 2012.

In support of that request, Environment Defense Canada told Health Canada, "Canadians should not be brushing their teeth and washing their dishes with a cancer-causing chemical."

In defense of the agent, the American Cleaning Institute says on its website that "triclosan has been used safely in personal care products for more than 30 years."

Leading to Superbugs?

Harriott said there have also been studies showing that bacteria have become resistant to triclosan in the lab. "Those strains that became resistant to triclosan are also resistant to antibiotics, and it's a major concern when you talk about the efficacy of antibiotics in a medical setting," she said.

Harriott said it's unclear if such triclosan-resistant bacteria are currently living in the real world, outside laboratories, but she said she thinks it is likely.

Striking a blow at their effectiveness in the first place, Harriott also said of triclosan and triclocarban that "they get rid of germs, but they don't get rid of the organisms of public health interest, like E. coli and staph. They have no effect on those."

Washing Alternatives

For all those reasons, Harriott says she tells people to stick with what they know is safe: plain old soap and water. "I understand people are concerned about germs, but regular soap and water works just as fine as antibacterial soaps," she said.

If people don't have access to those, the next-best thing would be alcohol-based sanitizers, she said.

"Anything beyond regular soap and water and sanitizers is just not necessary," she said.

craig hill
craig hill

So antibacterial soaps attack the ability of the thyroid to keep our immune systems working and ward off illness? Just when Fukushima radiation pulses are flying around Earth's atmosphere and the radiation from it settles most stridently in the thyroid to give thryroid cancer? Which of course completely destroys one's immune system as if a much more intense, global plague of AIDS.

What a coincidence. 

Stephen Jones
Stephen Jones

I remember the warnings about antimicrobial soaps a decade ago, but marketing forces in the USA are powerful in many respects.

roy eldon
roy eldon

When I used antibacterial soap over a period of time before preparing meals it caused me all kinds of nasty problems with my hands especially around the nails and the cuticles. It just dried up the skin on my hands until they were unhealthy.

Roger Bird
Roger Bird

Just what is happening down at the FDA?  I don't understand how such a racketeer influenced, corrupt organization can come up with such a good call.  I am confused.  Perhaps they are turn themselves around.  I doubt it.

Gabby Bunch
Gabby Bunch

This is very interesting... I wonder what they will do if they ban triclosan

Roger Bird
Roger Bird

@khoo kok   Try not being germ-phobic.  90% of the DNA in/on your body is germs.  Almost all germs are helpful.

Marc T.
Marc T.

@Roger Bird :  Maybe the soap industry refused to increase the FDA's Christmas bonus from them.

craig hill
craig hill

@Gabby Bunch They will never ban it. It's patented and profitable. To ban it would interfere with global commerce. Greater priorities take precedence over lesser priorities.


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