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FDA Failing to Remove Toxic Chemicals from Cosmetics

Posted 6/1/04
Activists Push for Safer Ingredients in Makeup

By Molly M. Ginty - WeNews correspondent

(WOMENSENEWS)--It's the beauty industry's ugly secret.

For decades, cosmetic companies have made products containing chemical
compounds that have been linked to reproductive birth defects and cancer.
The compounds are phthalates (pronounced THA-laytes) and they help cosmetics
adhere without smudging.

The European Union has banned phthalates from all cosmetics and now a
coalition of advocacy groups has given U.S. companies a deadline of Monday,
May 3 to support a ban.

Three environmentally-conscious manufacturers (Body Shop International,
Urban Decay Cosmetics and Aveda Corporation) have already volunteered to
remove phthalates from all their products. But New York-based Estee Lauder
Companies, Inc. (which has annual revenues of $4.7 billion) and
Cincinnati-based Procter and Gamble Company (which has annual revenues of
$40.2 billion) are the only large, multinational companies to follow
suit--and they have done so by removing phthalates from one product, nail

Representatives of the $29 billion cosmetics industry (which is not subject
to regulatory approval before putting its products on the market and which
does not have to list phthalates on ingredient labels) are balking at the
proposed ban.

Industry insiders say levels of the substance are safe and the outcry is all
based on tests of animal subjects that do not translate into human risks.
They argue that there is no need for them to reformulate their U.S. products
and use substitutes for phthalates, as they will for all products sold in
Europe starting in September 2004.

On April 19, Estee Lauder pledged to eliminate the chemicals from its MAC
and Clinique nail polish lines, while on the same day, Procter and Gamble
promised to remove them from its Max Factor and Cover Girl nail polish

"This is a much bigger issue than nail polish or phthalates," says Barbara
Brenner, the executive director of the San-Francisco-based Breast Cancer
Action, one of the advocacy groups putting pressure on the cosmetics
industry. "It could be the beginning of a revolution in consumer safety.
People need to know that some cosmetics contain toxic chemicals and they
need to demand that safer ingredients be used."

Industry Minimizes Risks

For their part, many cosmetic industry representatives insist that phthalate
levels in makeup do not pose a hazard to human health. "Science clearly
supports the continued safe use of these ingredients," says Gerald McEwan,
vice president for science at the Cosmetic, Toiletry, and Fragrance
Association, a Washington-based trade group. He invokes studies done by
independent researchers and by the cosmetics companies themselves.

Health advocates, however, say a growing body of research indicates that the
ingredient is not worth the risk.

A 2000 study at the University of Puerto Rico in San Juan linked phthalates
(which are also used to soften plastic) to early puberty in girls. Studies
conducted at Harvard University in Cambridge in 2002 and 2003 linked the
chemicals to decreased sperm counts in men. Researchers from several
different environmental groups say that phthalates, which disrupt hormone
function, may contribute to the rising incidence of uterine problems in
women, testicular cancer in men and infertility in both sexes.

In May 2002, the Environmental Working Group, a Washington-based advocacy
organization, tested 72 cosmetics and found measurable levels of phthalates
in three-quarters of them. Though the levels were minimal, scientists warned
that their combined effect could pose health problems. They pointed to a
2000 study by the Atlanta-based Centers for Disease Control and Prevention,
which found that phthalate levels in young women (who represent the bulk of
cosmetics consumers) may be 20 times higher than average. The group's
researchers called on the scientific community to study phthalates in more
depth and to reassess exposure levels that are considered safe.

Intensifying Campaign

The decision to remove phthalates from nail polish comes in the wake of
intense lobbying from health and environmental groups.

In March, Breast Cancer Action and 60 other organizations sent a letter to
Estee Lauder Companies Inc., the Procter and Gamble Company, Avon Products
Inc., Revlon Consumer Products Corporation, Unilever, and the L'Oreal Group
demanding that these companies comply with European regulations banning
"carcinogens, mutagens and reproductive toxins." The chemicals they're
targeting include di-n-butyl phthalate (DBP, commonly found in nail polish)
and di(2-ehtylhexyl) phthalate (DEHP, found in perfumes).

The Cosmetic, Toiletry, and Fragrance Association calls the European
regulation "unnecessary" and dismisses research on phthalates for two
reasons: Phthalate levels in cosmetics are well within U.S. safety standards
and because most studies on the chemicals' ill effects have been conducted
on animals and not humans.

Some Human Effects Reported

While it's true that most phthalate studies have been done on mice and rats,
adverse effects in humans have been reported.

When Olivia James gave birth to her son Darren seven years ago, she learned
he had bright eyes and a dimple on his right cheek. She also learned he had
hypospadias, a birth defect in which the urethra fails to extend the whole
length of the penis.

Repeated surgeries have corrected Darren's problem. But his mother, now 40
and living in Princeton, N.J., still can't shake the horror she felt when
learned about phthalates and realized her son's condition could be linked to
the chemicals in the makeup and hair products she used during her 15 years
as a professional model.

Every day of her career, James slathered on foundation, eye shadow, lipstick
and mascara containing phthalates. In addition to wearing heavy makeup,
James also had her hair straightened once a month. Like many hair products
aimed at African Americans, the straightener she used contained a high
concentration of phthalates.

"American manufacturers argue that no single product has been proven to have
a detrimental effect," says James, 40, of Princeton, N. J. "But when you're
using 10 or 20 of these products each day, the cumulative exposure does add

The cosmetic industry's defense--that it follows safety standards--is coming
under fire.

Federal authorities have set the safety level for phthalate exposure at
2,800 milligrams of phthalates per kilogram of body weight per day--a
threshold the critics say is too high.

"This standard is based on old studies," says Stacy Malkan, a spokesperson
for Health Care Without Harm, an environmental advocacy group based in
Washington, D.C. "Information is not only incomplete, but conflicting. The
National Toxicology Program lists some phthalates as carcinogens, but other
government agencies do not."

Putting Risks on Labels

Health advocates are urging authorities to reform labeling practices and
study cosmetic ingredients in more depth.

The federal Food and Drug Administration takes a hands-off approach to
cosmetics. Instead of testing products before they hit the market, the FDA
regulates these products only after they are sold, investigating health
complaints when and if complaints are filed.

"The FDA says there is no harm until harm is proven," says Malkan. "U.S.
cosmetic companies are not required by law to mention phthalates or many
other chemical compounds on their labels. Nail polish is actually one of the
few products for which phthalates must be listed."

With the nail polish victory behind them, health advocates are demanding
that U.S. cosmetics manufacturers starting using the same formulations they
use in Europe, where cosmetics are made in factories separate those sold in
the United States. In addition, they're calling for further study of other
suspect ingredients: parabens (which are in face creams and lotions and have
been found in human breast tumors) and formaldehyde (which is found in nail
polish and blush and has been linked to cancer).

Health advocates have made some headway in California, where regulators have
added the phthalate DEHP to the list of chemicals known to cause birth
defects. Later this year, California legislators plan to vote on a bill
requiring more detailed labeling of cosmetics and banning all ingredients
that fail to meet standards for "safe use."

"Chemicals linked to birth defects and infertility don't belong in
cosmetics," says Bryony Schwan, a spokesperson for the Montana-based
advocacy group Women's Voices for the Earth. "We demand that manufacturers
act responsibly and immediately remove them from the products that we use
every day."

Molly M. Ginty is a freelance writer based in New York City.