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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 interest groups.

"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 carcinogens.

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 protected.

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 directed.

"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 place."

"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 extensive.

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 renowned scientists." 


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