Safety of cosmetics is a gray area
By Robert Cohen
Star-Ledger (New Jersey)
May 27, 2007
Washington — OPI Products, a leading professional nail-
care company, reformulated its nail polishes, treatments and
hardeners in the past year to remove chemicals that some
have warned could pose potential health threats.
The California company insisted its products were
completely safe and met all Food and Drug Administration
requirements, but said it altered the formulas to comply
with new safety standards recently imposed by the European
Union and to eliminate concerns raised by a number of public
"Rather than getting mired in the question of whether the
old formulas were safe, I'm sure you will agree it's more
important to focus on the future," Eric Schwartz, chief
operating officer of OPI, said in a March letter to a member
group of the Campaign for Safe Cosmetics.
The Campaign for Safe Cosmetics, a coalition of health
and environmental organizations, for several years has been
pressuring personal-care product and cosmetic companies to
phase out chemicals they say have been linked to cancer,
birth defects and other health problems.
The organization has targeted hair dyes, shampoos,
mascara, antiperspirants, deodorants, perfumes, creams, nail
polish and other products. While chemicals in any one
consumer item alone are unlikely to cause harm, the
coalition argues, repeated exposure to industrial chemicals
from many different sources on a daily basis could have
negative long-term health consequences.
In the case of OPI, the company eliminated dibutyl
phthalate, toluene and formaldehyde, three potential
The cosmetic campaign has met with some success, fueled
in part by the EU's 2004 ban on use in cosmetics of more
than 1,000 of chemicals known or strongly suspected of
causing cancer, mutation or birth defects.
The effort also has aided a newly enacted California
chemical ingredient disclosure law for cosmetics, and a 2007
EU policy requiring all companies, including cosmetic firms
that produce or use chemicals, to collect extensive data on
possible human health risks of the substances.
Now many of the industry's big players are fighting back
against the public campaign, refuting claims there are any
health or safety problems.
John Bailey, executive vice president for science at the
Cosmetic, Toiletry and Fragrance Association, said the
industry has a long record of safety, and spends
considerable time and money in scientific research and
product formulation to ensure the public health is
The claims by the health and environmental groups about
carcinogens and dangerous ingredients in cosmetics, he said,
represent "scare tactics" rather than rigorous science.
Their information, he said, is "incomplete," and "they are
not telling the full story."
Bailey, a former head of the FDA's office of cosmetics,
acknowledged some manufacturers such as OPI that market in
Europe and want to avoid public relations problems have
decided to make changes in their products.
"Companies are in business and they have to make
decisions for marketing reasons," Bailey said. "They have to
be responsive to consumer perceptions."
So far, the consumer coalition has convinced about 550
companies to sign a compact agreeing to remove all toxic
chemicals and replace them with safer alternatives. Many of
the companies are part of the "natural products" industry,
including the Body Shop, Burt's Bees, Avalon Natural
Products and Aubrey Organics.
But the coalition has met resistance from the big names
in cosmetics and personal care products, including Estée
Lauder, Revlon, Chanel, Clinique, L'Oreal, Unilever and
Procter & Gamble.
"By signing the compact, cosmetic companies are giving
the activist groups -- who often do not rely on sound,
peer-reviewed science in their reports -- the authority to
define 'safe,'" said an Estée Lauder statement. "Since our
company's standards are often higher than most regulatory
boards, we would never relinquish the responsibility of
determining the safety of our ingredients."
Estée Lauder, however, recently removed dibutyl phthalate
from its nail polishes to meet EU marketing requirements,
while Revlon and other companies have taken similar steps
with some of their product lines.
Under U.S. law, the FDA neither tests, reviews nor
approves cosmetics and personal-care products before they go
on the market, and only bans certain color additives and a
handful of substances from use.
Under the law, companies are required to list ingredients
on product labels or package inserts and prepare the
products under sanitary conditions. They are prohibited from
making false or misleading claims.
"Cosmetic firms are responsible for substantiating the
safety of their products and ingredients be fore marketing,"
the FDA says in its Web site.
But the agency has never de fined what constitutes a safe
product. The industry says the standard for a safe product
is one that does not irritate the skin when used as
"Under U.S. federal law, companies can put virtually
anything they wish into personal-care products, and many of
them do," said Jane Houlihan, vice president of research for
the Environmental Working Group, one of the members of the
Campaign for Safe Cosmetics.
While the industry says the number of adverse reactions
from cosmetics is small and confined mostly to skin
irritations, Houlihan said, "There is no requirement that
cosmetic injuries be reported and no tracking system in
"Consumers also have no way to know how exposure over a
lifetime might be affecting their health," she added.
Houlihan's organization and others in the coalition,
including the Breast Cancer Fund, Commonweal, Friends of the
Earth and the National Environmental Trust, say they will
press Congress to strengthen the FDA law to set firm
standards for testing and safety, arguing the time is long
overdue and the list of suspect ingredients is quite
The coalition points to mercury, found in some eye drops,
ointment and deodorants; formaldehyde and toluene, found in
nail products; petroleum distillates, found in some mascara,
perfume, foundation, lipstick and lip balm; ethylacrylate,
found in some mascara; coal tar, found in dandruff shampoos
and hair dyes; dibutyl phthalate, found in some nail polish,
perfume and hair spray; and lead acetate, found in some hair
dyes and cleansers.
One company on the Environmental Working Group's "Skin
Deep" Web site database that lists potentially troublesome
products is Combe of White Plains, N.Y., the maker of
Grecian Formula hair dyes, which contain lead acetate.
"We know enough about lead that it should not be in
personal- care products," Houlihan said. "We have taken lead
out of house paint and gasoline. Why are we still using it
in men's hair dye?"
Combe spokeswoman Joy Robinson said the company
reformulated some Grecian hair dye products in Canada, where
lead acetate was recently banned, but continues to use the
ingredient in the United States, where the FDA has approved
its use as a color additive.
"Lead acetate has been used in the United States and
throughout the world as a color additive for gradual acting
dyes to color gray hair for more than 40 years," Robinson
said. "These dyes have been extensively tested for safety by
products without harmful ingredients