After more than 40 years of study, the US government says it has no evidence
that the anti-bacterial chemicals used in countless common soaps and washes
help prevent the spread of germs, and it is reviewing research suggesting they
may pose health risks.
Regulators at the Food and Drug Administration said they are revisiting the
safety of chemicals such as triclosan in light of recent studies that suggest
the substances can interfere with hormone levels and spur the growth of
The government's preliminary ruling lends new support to outside researchers
who have long argued that the chemicals are, at best, ineffective and at worst,
a threat to public health.
"The FDA is finally making a judgment call here and asking industry to
show us that these products are better than soap and water, and the data don't
substantiate that," said Stuart Levy of Tufts University School of
Under a proposed rule released, the agency, which monitors product safety,
will require manufacturers to prove that anti-bacterial soaps and body washes
are safe and more effective than plain soap and water. Products that are not
shown to be safe and effective by late 2016 would have to be reformulated, relabelled
or removed from the market.
"I suspect there are a lot of consumers who assume that by using an
anti-bacterial soap product they are protecting themselves from illness,
protecting their families," said Sandra Kweder, deputy director in the
FDA's drug centre. "But we don't have any evidence that that is really the
case over simple soap and water."
A spokesman for the cleaning product industry said the FDA already has
"a wealth of data" showing the benefits of its products.
According to the FDA it will cost companies millions to comply with the new regulations, including reformulating some
products and removing marketing claims from others.
The rule does not apply to hand sanitisers, most of which use alcohol rather
than anti-bacterial chemicals.
The agency will accept data from companies and researchers for one year
before beginning to finalise the rule.
The proposal comes more than 40 years after the FDA began evaluating
triclosan, triclocarban and similar ingredients. Ultimately, the government
only agreed to publish its findings after a three-year legal battle with the
Natural Resources Defense Council, an environmental group that accused the FDA
of delaying action on potentially dangerous chemicals.
Triclosan is found in an estimated
75% of anti-bacterial liquid soaps and body washes sold in the US, including
some brands of Dial from Henkel AG & Co, one of the nation's largest soap
More than 93% of bar soaps also contain triclocarban or triclosan, according
to the FDA.
While the rule only applies to personal hygiene products, it has
implications for a broader $1 billion industry that includes thousands of
anti-bacterial products, including kitchen knives, toys, pacifiers and
toothpaste. Over the last 20 years, companies have added triclosan and other
cleaners to thousands of household products, touting their germ-killing
The FDA was tasked with confirming those benefits in 1972, as part of a law designed
to set guidelines for dozens of common anti-bacterial cleaners. But the
guidelines got bogged down in years of regulatory delays and missed deadlines.
The agency published a preliminary draft of its findings in 1978, but did not
finalise the results until recently.
Most of the research surrounding triclosan's safety involves laboratory
animals, including studies in rats that showed changes in testosterone, oestrogen
and thyroid hormones. Some scientists worry that such changes in humans could
raise the risk of infertility, early puberty and even cancer.
FDA scientists stressed that such studies are not necessarily applicable to
humans, but the agency is reviewing their implications.
Routine use concerns
On a conference call with journalists, Kweder noted that the government's
National Toxicology Program is already studying whether daily skin exposure to
hormone-altering chemicals could lead to cancer.
Other experts are concerned that routine use of anti-bacterial chemicals
such as triclosan contributes to a surge in drug-resistant germs, or superbugs,
that render antibiotics ineffective.
In March 2010, the European Union banned the chemical from all products that
come into contact with food, such as containers and silverware.
A spokesman for the American Cleaning Institute, a soap and cleaning product
trade organisation, said the group will submit new data to regulators,
including studies showing that company products do not lead to antibiotic
"We are perplexed that the agency would suggest there is no evidence
that anti-bacterial soaps are beneficial," said Brian Sansoni. "Our
industry sent the FDA in-depth data in 2008 showing that anti-bacterial soaps
are more effective in killing germs when compared with non-anti-bacterial soaps."
The group represents manufacturers including Henkel, Unilever,
Colgate-Palmolive Co. and Dow Chemical Co.