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FDA may require warnings on untested cosmetics

WASHINGTON—Imagine reaching for a tube of lipstick or a can of shaving cream and finding this label: "Warning—The safety of this product has not been determined."

Many popular cosmetics and personal care products could bear such warnings if the Food and Drug Administration decides they need them. The agency would act if it determines that their ingredients haven't been adequately tested to assure their safety. It's now working to decide that.

Last month the FDA informed the Cosmetic, Toiletry and Fragrance Association, a Washington-based trade group, that manufacturers of untested products may have to add the warning.

There's no hard evidence of any health impact from long-term, low-dose exposure to the kinds of chemicals in cosmetics, said Lauren Sucher, a spokeswoman for the Environmental Working group, a private nonprofit research center.

Some ingredients in cosmetics, such as methylpentan-2-one, found in nail polish, haven't been tested. Others, including triethanolamine, used in skin scrubs, are among the chemicals that researchers fear might cause cancer.

Products that could be in line for FDA warnings, based on the Environmental Working Group's study, include:

_ Mascara, which can contain ingredients linked or potentially linked to cancer.

_ Liquid hand soap, which may contain ingredients suspected of raising the risk of breast and skin cancer.

_ Hair dye, which can contain coal tar, which has been linked to bladder cancer and non-Hodgkin's lymphoma.

"The bottom line is people don't know what the health effects are of the many chemicals we're putting on our bodies every day," she said. "But consumers do have the right to know who's looking to see whether they're safe."

A study last year by the Environmental Working Group found that only 18 of 7,500 common cosmetics and toiletries had had all their ingredients fully tested for safety.

"So we're talking about over 99 percent that have never been fully assessed for safety," Sucher said.

"Companies often do tests of short-term acute exposure to see whether their products make eyes water or skin itch," she said. "Often, however, they're not looking at whether they might cause cancer or birth defects that are long-term and don't affect the profitability of their products."

Eric Kraus, the vice president for corporate communications at The Gillette Co., in Boston, which makes shaving creams and other personal care products, said: "Gillette products undergo rigorous testing, based on the best available scientific information, to assure that they are safe for use and for our employees to make. For us, this should not be an issue."

Kraus said he believed that Gillette's product-safety tests included determinations of whether they could cause birth defects or cancer.

There's no federal requirement that the ingredients in such products be tested for safety. But federal law requires that cosmetics with unassessed ingredients include an FDA warning label informing consumers that "the safety of this product has not been determined." Until now, the FDA has relied on the cosmetics industry to police its products.

Dr. Samuel Epstein, professor emeritus of environmental and occupational health at the Chicago School of Public Health at the University of Illinois and the chairman of the Cancer Prevention Coalition, called the FDA's recent letter to the cosmetics trade group "the first glimmer of responsibility in several decades."

Janet Bartucci, the vice president for global communications at New York-based Estee Lauder, the cosmetics and personal care products company, said in an interview that she saw no need for FDA intervention. "Because there is so much testing done by individual companies, they haven't had any need to step in."

The FDA declined to comment for this article because it's still reviewing a petition by the Environmental Working Group seeking recalls or warning labels on a wide variety of personal-care products.

The FDA doesn't assess the safety of cosmetics and toiletries before they hit the market, as it does with drugs. The cosmetics industry does its own evaluations through an independent panel of experts whom it appoints. Representatives of the FDA and the Consumer Federation of America, an alliance of public interest groups, attend those sessions.

Since 1976, the panel, known as the Cosmetic Ingredient Review, has found 694 ingredients to be safe and nine to be unsafe. In a statement this week, the Environmental Working Group said the panel had reviewed only 11 percent of the 10,500 cosmetic ingredients recorded by the FDA.

"The 89 percent of ingredients that remain unassessed are used in more than 99 percent of all products on the market," the group's statement said.

The Cosmetic, Toiletry and Fragrance Association, which created the review panel, responded positively to the FDA's letter suggesting stronger federal oversight of its products.

"Even an industry with an exemplary safety record such as ours functions best with a tough cop on the beat and we welcome FDA's action," Ed Kavanaugh, the association president, said in a prepared statement.

In an interview, however, Irene Malbin, the association's vice president for public affairs, called the Environmental Working Group's "Skin Deep" study "completely wrong."

"Cosmetics are safe and consumers can have complete confidence in their products," Malbin said.

The use of cosmetics dates to ancient Egypt, when people used eye makeup and scented themselves with unguents. Now it's a $35 billion U.S. industry, and the stakes for consumer confidence are high.

Concern over the use of possibly dangerous chemicals in personal-care products "marks a trend of increased regulatory and consumer interest," said Heather Langsner, a senior chemical analyst with Innovest, a New York-based investment research firm. "Many companies are already conducting voluntary phase-outs of certain chemicals. They see the writing on the wall."

_The "Skin Deep" report and a searchable product guide are available online on the Environmental Working Group's Web page, at www.ewg.org/reports/skindeep

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(Goldstein covers Washington for The Kansas City Star. Kimberly Morrison contributed to this story.)

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(c) 2005, Knight Ridder/Tribune Information Services.

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