WASHINGTON — It’s a chemical that’s been in U.S. households for more than 40 years, from the body wash in your bathroom shower to the knives on your kitchen counter to the bedding in your baby’s 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 from toothpaste to toys.
The agency’s 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 Michigan’s School of Public Health. “At this point, it’s 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. That’s 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. It’s 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.
Now, four decades after it was charged with reviewing triclosan, the FDA is planning to complete its review. FDA spokeswoman Stephanie Yao said evaluating triclosan and other antibacterial agents is “one of the highest priorities” for the agency, but did not offer an explanation for the delay.
The FDA’s website currently states that “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 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.
While it can take years for the government to make rules, members of Congress say there is little precedent for the FDA’s four-decade review of triclosan.