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The FDA May Seek Labeled Warnings On Untested Cosmetics

Apr 9, 2005 | St. Paul Pioneer Press

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 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 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 all of 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 they are safe for use and for our employees to make. For us, this should not be an issue."

Kraus said he believed 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 "the safety of this product has not been determined." Until now, the FDA has relied on the cosmetics industry to police its products.

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.

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.


Here are some products identified as possibly troublesome for health reasons in a study called "Skin Deep" by the Environmental Working Group, a nonprofit group that watchdogs the cosmetics industry:

Lipstick: 28 percent of 711 products examined contained ingredients researchers say could be linked to cancer, such as butylated hydroxytoluene, Nylon 6, ferric oxide, polyethylene, titanium dioxide.

Nail polish: 71 percent of 123 products examined contained ingredients known to be, suspected of being or possibly linked to birth defects, including toluene, dibutyl phthalate and ethoxyethanol acetate.

Shaving products: 51 percent of 167 products examined contained penetration enhancers — such as glyceryl lanolate, myristoyl sarcosine, PEG-7 glyceryl cocoate and propylene glycol — which could increase exposure to possible carcinogens or other ingredients of concern. A penetration enhancer helps ingredients soak into skin.

Shampoo: All 413 products examined contained ingredients whose potential adverse health effects have not been fully studied by the industry, according to the study. They include coal tar, ethanol, silica and zinc chloride.

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