Antibacterial Chemical Raises Safety Issues

The maker of Dial Complete hand soap says that it kills more germs than any other brand. But is it safe?

That question has federal regulators, consumer advocates and soap manufacturers locked in a battle over the active ingredient in Dial Complete and many other antibacterial soaps, a chemical known as triclosan.

The Food and Drug Administration is reviewing the safety of the chemical, which was created more than 40 years ago as a surgical scrub for hospitals. Triclosan is now in a range of consumer products, including soaps, kitchen cutting boards and even a best-selling toothpaste, Colgate Total. It is so prevalent that a survey by the Centers for Disease Control and Prevention found the chemical present in the urine of 75 percent of Americans over the age of 5.

Several studies have shown that triclosan may alter hormone regulation in laboratory animals or cause antibiotic resistance, and some consumer groups and members of Congress want it banned in antiseptic products like hand soap. The F.D.A. has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute.

The F.D.A. was to announce the results of its review several months ago, but now says the timing is uncertain and unlikely until next year. The Environmental Protection Agency is also looking into the safety of triclosan.

The outcome of the federal inquiries poses a significant risk to the makers of antimicrobial and antibacterial hand soaps, which represent about half of the $750 million market for liquid hand soaps in the United States, according to the market research firm Kline & Company.

Many of those soaps use triclosan as the active ingredient and say so on the label. Dial Complete is the fifth-best-selling liquid hand soap in the nation, according to data collected from most major stores (except for Wal-Mart) by SymphonyIRI Group, a Chicago-based market research firm.

Richard Theiler, senior vice president for research and development at Henkel, the German-based manufacturer of Dial Complete, said there was no real evidence showing that triclosan was dangerous for humans. He also said that several recent studies had proved the effectiveness of triclosan in killing germs, and that those studies had been submitted to the federal regulators.

“It has been used now in products safely for decades,” Mr. Theiler said.

But as consumer groups have campaigned against triclosan, some consumer product manufacturers have removed it and substituted less controversial ingredients. Reckitt Benckiser removed triclosan from three face washes, for instance. And citing “changing consumer preferences,” Colgate-Palmolive replaced triclosan with lactic acid in Palmolive Antibacterial Dish Liquid, and its Softsoap liquid hand soap has been reformulated without the chemical.

Colgate, however, continues to use triclosan in its Colgate Total toothpaste because it has been proved to fight gingivitis, a claim approved by the F.D.A.

“The safety and efficacy of Colgate Total toothpaste is fully supported by over 70 clinical studies in over 10,000 patients,” the company said in a statement.

Scientists have raised concerns about triclosan for decades. Last year, Representative Edward J. Markey, Democrat from Massachusetts, pressured the F.D.A. to write regulations for antiseptic products like hand soap, including the use of triclosan. The process of creating regulations was started more than three decades ago, but has been repeatedly delayed. In the meantime, Mr. Markey has called for a ban on triclosan in hand soaps, in products that come in contact with food and in products marketed to children.

The concern is based on recent studies about the possible health impacts of triclosan, which the F.D.A. said, in a Feb. 23, 2010, letter to Mr. Markey, “raise valid concerns about the effect of repetitive daily human exposure to these antiseptic ingredients.”

Several have shown that triclosan disrupts the thyroid hormone in frogs and rats, while others have shown that triclosan alters the sex hormones of laboratory animals. Others studies have shown that triclosan can cause some bacteria to become resistant to antibiotics.

Brian Sansoni, spokesman for the American Cleaning Institute, said the evidence against triclosan was hardly convincing and that the chemical had been used safely in consumer products and in hospitals for decades. He said there was no evidence that triclosan caused antibiotic resistance.

“You would think after heavy use in hospital settings over several decades it would have shown up by now,” Mr. Sansoni said. “This is one of those big urban myths that opponents of these products try to spread.”

Concerning studies that showed triclosan to be an endocrine disrupter, he said that the animals used in the studies were subjected to “levels that the rat, let alone us, would never come in contact with in everyday use.”

According to a lawsuit filed last year by the Natural Resources Defense Council, the F.D.A. first proposed regulating over-the-counter topical antiseptic drug products like triclosan in 1972, but the review has never been completed. In 1978, the F.D.A. proposed eliminating triclosan as an active ingredient in hospital scrubs and in hand soaps within a couple of years.

The agency issued a similar order in 1994, but again, nothing final was authorized, the lawsuit says.

The environmental group’s lawsuit sought to pressure the F.D.A. to complete its regulations of antiseptic soaps.

Triclosan is often the active ingredient in soaps that are marketed as antibacterial or antimicrobial, even though, in 2005, an F.D.A. advisory panel said triclosan-laced soap was no better at preventing illness than other soap and water.

“A lot of people mistakenly believe that if they buy something with a chemical in it that is antibacterial that it’s a plus,” said Dr. Sarah Janssen, a senior scientist at the Natural Resources Defense Council. “I think the marketing of these far outweighs the statements on F.D.A.’s Web site, which most people don’t even go to.”

Dr. Douglas Throckmorton, the F.D.A.’s deputy director for regulatory programs, said its review was primarily focused on hand soaps but could extend to other consumer products if the agency determined that triclosan raised health concerns. He said that the F.D.A. had determined that triclosan provided a benefit in Colgate Total, by fighting gingivitis, where triclosan in soap did not.

“That is an important difference to us,” he said.

Indeed, several lawsuits have been filed saying that Henkel is making false claims in its marketing of Dial Complete. But Mr. Theiler, at Henkel, said he was confident that recent studies would vindicate triclosan.

“We note that the F.D.A. stated in their announcement on April 8, 2010, that the agency ‘does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time,’ ” he said. “We concur with this position.”