WASHINGTON — It’s a chemical that’s been in U.S. households for more than 40 years, from the body wash in your shower to the knives on your kitchen counter to the bedding in your baby’s basinet.
But federal regulators are now deciding whether triclosan — the germ-killing ingredient found in an estimated 75 percent of antibacterial liquid soaps and body washes sold in the U.S. — is ineffective, or worse, harmful.
The U.S. Food and Drug Administration (FDA) plans to deliver a review this year of whether triclosan is safe.
The ruling, which will determine whether triclosan continues to be used in household cleaners, likely will have implications for a $1 billion industry that includes hundreds of antibacterial products, from toothpaste to toys.
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Recent studies of triclosan in animals have led scientists to worry t it could increase the risk of infertility, early puberty and other hormone-related problems in humans.
“To me, it looks like the risks outweigh any benefit associated with these products right now,” said Allison Aiello, professor at the University of Michigan’s School of Public Health.
The concerns over triclosan offer a glimpse at a little-known fact: Many chemicals used in everyday household products have never been formally approved by U.S. health regulators.
That’s because many germ-killing chemicals were developed before there were laws requiring scientific review of cleaning ingredients.
The controversy also highlights how long it can take the government to review the safety of such chemicals.
In the case of triclosan, Congress passed a law in 1972 requiring that the FDA set guidelines for dozens of common antibacterial chemicals found in over-the-counter soaps and scrubs. The guidelines function like a cookbook, detailing which chemicals can be used in what products, and in what amounts.
In 1978, the FDA published its first tentative guidelines for chemicals used in liquid hand soaps and washes. The draft stated triclosan was “not generally recognized as safe and effective.”
The FDA published several drafts of the guidelines over the years, but the agency never finalized the results. So companies have not had to remove triclosan from products.
Meanwhile, the agency did approve triclosan for use in Colgate’s Total toothpaste in 1997, after Colgate-Palmolive submitted data showing the ingredient helped fight gingivitis.
Last summer, the FDA said its review of triclosan would be complete by late 2012. That target date slipped to February, which has also come and gone.
In March, a federal appeals court said a lawsuit by the nonprofit Natural Resources Defense Council aimed at forcing the FDA to complete its review could move forward.
Four decades after it was charged with reviewing triclosan, the FDA is planning to complete its review.
The FDA’s website states: “The agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”
The American Cleaning Institute, a cleaning-products trade organization, says it has provided reams of data to the agency showing triclosan is safe and effective.
“Triclosan is one of the most reviewed and researched ingredients used in consumer and health-care products,” says Brian Sansoni, a spokesman for the group, whose members include Colgate-Palmolive and Henkel Consumer Goods, maker of Dial soap.
U.S. scientists agree the FDA review is overdue.
The Endocrine Society — doctors and scientists who specialize in the hormone system — flagged triclosan four years ago as an ingredient that alters levels of thyroid hormones and reproductive hormones such as testosterone and estrogen.
Triclosan was initially used in hospitals in the 1970s as a scrub for surgeons before an operation.
It was also used to coat the surfaces of catheters, stitches and other surgical instruments.
Beginning in the 1990s, triclosan began making its way into hundreds of antibacterial consumer goods, ranging from soap to socks to lunchboxes.
The growth has in part been fueled by Americans who believe antibacterial ingredients provide an added level of protection against germs.
In 2007, researchers at the University of Michigan and other universities compiled data from 30 studies looking at the use of antibacterial soaps. The results showed soaps with triclosan were no more effective at preventing illness or reducing bacteria on the hands than plain soap.
Other studies have shown that longer hand-washing improves results far more than adding antibacterial ingredients.
The Centers for Disease Control and Prevention (CDC) recommends washing hands at least 20 seconds. The CDC also recommends using hand sanitizer — most of which use alcohol or ethanol to kill germs, not chemicals like triclosan — if soap and water are not available.
To date, nearly all of the research on triclosan’s health impact comes from animal studies — which are not necessarily applicable to humans — but the findings still worry researchers.
A 2009 study by scientists at the Environmental Protection Agency showed that triclosan decreases levels of testosterone and sperm production in male rats.
Female rats exposed to triclosan showed signs of early puberty and altered levels of estrogen and thyroid hormones.
Some experts also argue that routine use of antibacterial chemicals is contributing to a surge in drug-resistant germs, or superbugs, that are immune to antibiotics.
Few studies have attempted to track antibiotic resistance tied to triclosan in the real world. But laboratory studies have shown antibiotic-resistant strains of E. coli and other bacteria can grow in cultures with high levels of triclosan.
As a result of the growing concerns, some leading medical societies, hospitals and companies have abandoned the chemical.
Johnson & Johnson has pledged to remove triclosan from all its adult products by the end of 2015. The company says none of its baby products contain the ingredient.