FDA says Studies on Triclosan, Used in Sanitizers and Soaps, Raise Concerns
The Food and Drug Administration said recent research raises "valid
concerns" about the possible health effects of triclosan, an
antibacterial chemical found in a growing number of liquid soaps, hand
sanitizers, dishwashing liquids, shaving gels and even socks, workout
clothes and toys.
The FDA and the Environmental Protection Agency say they are taking
a fresh look at triclosan, which is so ubiquitous that is found in the
urine of 75 percent of the population, according to the Centers for
Disease Control and Prevention. The reassessment is the latest signal
that the Obama administration is willing to reevaluate the possible
health impacts of chemicals that have been in widespread use.
In a letter to a congressman that was obtained by The Washington
Post, the FDA said that recent scientific studies raise questions about
whether triclosan disrupts the body's endocrine system and whether it
helps to create bacteria that are resistant to antibiotics. An advisory
panel to the FDA said in 2005 that there was no evidence the
antibacterial soaps work better than regular soap and water.
The FDA was responding to inquiries from Rep. Edward J. Markey
(D-Mass.), who has been pushing federal regulators to take stronger
action to restrict the use of triclosan and other chemicals that have
been shown in laboratory tests to interfere with the delicate endocrine
system, which regulates growth and development.
"The proliferation of triclosan in everyday consumer products is so
enormous, it is literally in almost every type of product -- most
soaps, toothpaste, cosmetics, clothes and toys," Markey said. "It's in
our drinking water, it's in our rivers and as a result, it's in our
bodies. . . . I don't think a lot of additional data has to be
collected in order to make the simple decisions about children's toys
and soaps that people use. It clearly is something that creates a
Markey wants triclosan banned from all products designed for
children and any product that comes into contact with food, such as
cutting boards. Other countries, including the members of European
Union, have banned or restricted use of the chemical.
Brian Sansoni of the Soap and Detergent Association, which
represents the $30 billion U.S. cleaning products industry, said
concerns about triclosan are unfounded.
"These products and ingredients have been reviewed, regulated and
researched for decades," he said. "We believe the science strongly
supports the safety and efficacy of these products. It's more important
than ever that consumers continue to have access to these products.
It's a time of increased threats from disease and germs."
Triclosan was developed as a surgical scrub for medical
professionals. It is also used in pesticides. In recent years, it has
been added to a host of consumer products to kill bacteria and fungus
and prevent odors. It can be found in everything from kitchen cutting
boards to shoes, often packaged with labels that tout "antibacterial"
Most hand sanitizers, such as Purell, use alcohol and do not contain triclosan.
Sarah Janssen, staff scientist at the Natural Resources Defense
Council, which joined with several other environmental groups last year
to petition the FDA to restrict the use of triclosan, said the soap
industry was taking advantage of consumer fears. "Especially with the
H1N1 outbreak, people get really scared and think they need to take
extra precautions without thinking that soap and water works just as
well," Janssen said.
Because it is found in so many different types of products,
triclosan is regulated by three different federal agencies: the FDA,
the EPA and the Consumer Product Safety Commission. But the FDA, which
oversees its use in personal-care products, medical devices and
products that come into contact with food, has been working for 38
years to establish the rules for the use of triclosan but has not
completed that task.
The FDA is committed to issuing the rules quickly and is working
with EPA to review the most recent data on triclosan, said Doug
Throckmorton, deputy director of the agency's Center for Drug
Evaluation and Research. He said the FDA is also revisiting the 1997
approval it gave for the use of triclosan in Colgate Total toothpaste
because at the time, scientists had not yet raised concerns that
triclosan can disrupt the endocrine system.
"For triclosan, the science is changing," Throckmorton said. "Based
on what we know, we don't have evidence to suggest this chemical is a
threat to human health. However, we have to understand better the
health effects and we have to work with other agencies to collect that
information and then decide whether or not we need to change how it's