By SABRINA TAVERNISE
Published: December 16, 2013
After years of mounting concerns that the antibacterial chemicals that
go into everyday items like soap and toothpaste are doing more harm than
good, the Food and Drug Administration said on Monday that it was
requiring soap manufacturers to demonstrate that the substances were
safe or to take them out of the products altogether.
The proposal was applauded by public health experts, who for years have
urged the agency to regulate antimicrobial chemicals, warning that they
risk scrambling hormones in children and promoting drug-resistant infections, among other things. Producers argue that the substances have long been proved to be safe.
“It’s a big deal that they are taking this on,” said Rolf Halden, the director of the Center for Environmental Security
at Arizona State University, who has been tracking the issue for years.
“These antimicrobials have taken on a life all of their own,” Dr.
Halden said. “Their use has really proliferated.”
Studies in animals have shown that the chemicals, triclosan in liquid
soaps and triclocarban in bar soaps, can disrupt the normal development
of the reproductive system and metabolism, and health experts warn that
their effects could be the same in humans. The chemicals were originally
used by surgeons to wash their hands before operations, and their use
exploded in recent years as manufacturers added them to a variety of
products, including mouthwash, laundry detergent, fabrics and baby
pacifiers. The Centers for Disease Control and Prevention found the
chemicals in the urine of three-quarters of Americans.
The F.D.A. said that accumulated scientific information has prompted it
to re-evaluate whether these chemicals are safe when used over long
periods of time. The agency also said there was no evidence that the
substances were any more effective in preventing infection than plain
soap and water.
The proposed rule does not require producers of the soaps to take them
off the market immediately. The F.D.A. has given companies a year to
produce data showing that the chemicals are both safe and effective. If
they cannot prove, the chemicals will need to be removed from the
products, the agency said. The rule is open for public comment for 180 days. It does not apply to hand sanitizers, which will be considered separately.
The move seemed to rattle the industry, which said in a statement that it was “perplexed that the agency
would suggest there is no evidence that antibacterial soaps are
beneficial,” because it has long provided data to the agency showing the
soaps’ safety and efficacy, including at a public meeting in 2008.
Changing the products could have a major financial impact. An estimate
by the market research firm Kline & Company found that antimicrobial
and antibacterial hand soaps represented about half of the $900 million
market for liquid hand soaps in the United States in 2012. However, the
use of triclosan in the $2.2 billion toothpaste market has been
decreasing because of growing public concern over the ingredient, said
Carrie Mellage, a vice president of consumer products at Kline.
Federal regulators started to look more closely at the chemicals in the
1970s, with the F.D.A. first creating regulations to control them in
1978. But very little has been done since, public health advocates
complain, partly because of agency slowness, but also because of
industry lobbying. The Natural Resources Defense Council,
frustrated by the inaction, filed a lawsuit in 2010 to force the agency
to issue a final rule. Mae Wu, a lawyer with the council, said that
under a settlement signed with the F.D.A. last month, the agency
committed to taking final action by 2016.
The F.D.A.’s move followed one last week that would phase out
the use of antibiotics in animals raised for meat, and another in November that all but banned the use of trans fats in prepared foods.
Taken together, the moves seemed to indicate that the F.D.A. is back in
action after a long silence during months of bitter political battles
that dragged on for months, even after the 2012 election, public health
advocates said.
“I think they’re ready to take on hard issues that they
did not before,” said Dr. Stuart Levy, a professor of medicine and
microbiology at Tufts University and the president of the Alliance for the Prudent Use of Antibiotics.
Dr. Halden compared triclosan and triclocarban with static on a
telephone call, interfering in the final message that is delivered to
the body. He said awareness of the risks rarely made it beyond a narrow
circle of public health experts, but he hoped that the F.D.A.’s move on
Monday would change that.
“These chemicals interfere with the regulation of the human body,” he
said, citing studies in animals. The chemicals accumulate in ground
water and soil, and one study of human breast milk found the chemicals
in the milk of 97 percent of the women tested, he said. “The fascinating
thing is the public has not taken note of this issue.”
The gathering science that helped prompt the F.D.A.’s move includes
studies on laboratory rats that showed decreases in thyroid hormone
levels, said Dr. Colleen Rogers, a microbiologist at the F.D.A. Another
agency official cited studies showing changes in animal cells’ ability
to respond to estrogen and testosterone.
Senator Edward J. Markey, Democrat of Massachusetts, who has pressed
federal regulators to more closely control antimicrobials, welcomed the
move, saying the chemicals had long “existed in a regulatory black hole,
despite serious concerns about its impact on public health.” He said
studies have linked triclosan to the disruption of other hormone
functions important for fertility and puberty. He added that proper
thyroid function is important for brain development, particularly in
children.
The industry argued that the active ingredients in antimicrobial soaps
are over-the-counter drugs that go through rigorous reviews by the
F.D.A., including of data. Two trade groups, the American Cleaning
Institute and the Personal Care Products Council, cited a review of two
dozen studies they said showed washing hands with antimicrobial soaps
produces “statistically greater reductions in bacteria on the skin” than
with plain soap.
“In some instances, these products have been found to be critical in the
reduction of infection and disease,” the groups said. They said they
intended to file comments to the F.D.A. “reaffirming” that the use of
antibacterial wash products does not contribute to antibiotic
resistance.
The Henkel Corporation, which makes Dial soaps, some of which include
the antimicrobials, said it “takes the proposal seriously,” and that it
always makes sure “every ingredient in our products meets all applicable
legal and regulatory requirements.”
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