WASHINGTON – Its a chemical thats been in U.S. households for more than 40 years, in the body wash in your bathroom shower, on the knives on your kitchen counter and in the bedding in your babys basinet.
But federal health regulators are just 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 is planning 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, could have implications for a $1 billion industry that includes hundreds of antibacterial products including toothpaste and toys.
The agencys review comes amid growing pressure from lawmakers, consumer advocates and others who are concerned about the safety of triclosan. Recent studies of triclosan in animals have led scientists to worry that 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 Michigans School of Public Health. At this point, its just looking like a superfluous chemical.
The concerns over triclosan offer a sobering glimpse at a little-known fact: Many chemicals used in everyday household products have never been formally approved by U.S. health regulators. Thats because many germ-killing chemicals were developed decades ago before there were laws requiring scientific review of cleaning ingredients.
The controversy also highlights how long it can take the federal government to review the safety of such chemicals. Its not uncommon for the process to drag on for years, since regulators must review volumes of research and take comments from the public on each draft.
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 for manufacturers, detailing which chemicals can be used in what products, and in what amounts.
The American Cleaning Institute, a soap and detergent trade organization, says it has provided reams of data to FDA showing that triclosan is both 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 Inc., maker of Dial soap.
Triclosan was initially used in hospitals in the 1970s as a scrub for surgeons preparing to perform 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 that 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.
Troclosans safety also has become a growing concern in recent years. To date, nearly all of the research on triclosans health impact comes from animal studies –which are not necessarily applicable to humans – but the findings still have researchers concerned.
A 2009 study by scientists at the Environmental Protection Agency showed that triclosan decreases levels of testosterone and sperm production in male rats. And 2010 study by University of Florida researchers found that triclosan interfered with the transfer of estrogen to growing fetuses in pregnant sheep.
Some experts argue that routine use of antibacterial chemicals like triclosan 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 that 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 of its adult products by the end of 2015. The company says none of its baby products currently contain the ingredient.