FDA to Investigate Safety of Cosmetics

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FDA to investigate safety of cosmetics
By By Judy Foreman
Special To The Sun
Originally published April 8, 2005

For decades now, the cosmetics industry - a whopping $35 billion-a-year business - has been humming along happily with relatively little oversight from the Food and Drug Administration, which by law is supposed to regulate food, drugs and cosmetics.

But in February, the FDA sent a strongly worded letter to the Cosmetic, Toiletry and Fragrance Association, a trade group that represents 600 manufacturers, putting the industry on notice that the FDA has made cosmetic safety a top priority for 2005.

It's about time, because, startling as it may be, nobody really knows how safe - or dangerous - most cosmetics may be.

Given the paucity of reports of harm from cosmetics, consumers can reasonably assume that cosmetics are safe, said Dr. Barbara Gilchrest, professor and chair of the dermatology department at the Boston University School of Medicine. When cosmetics are put on the skin, she said, "Very little gets into the systemic circulation."

But that's not reassuring enough for a growing coalition of environmentalists, who have banded together as the Campaign for Safe Cosmetics, or for Europe, which more tightly regulates cosmetics. In September, the European Union banned the use in cosmetics of any substance that may, at least in animals, cause cancer, mutations in DNA or reproductive problems. Several major companies - Revlon, Unilever and L'Oreal - said their products already conform to the European standards.

In the United States, there are examples of potentially worrisome ingredients in many cosmetic and personal care products, including nail polish, moisturizers and lotions, according to the Environmental Working Group, a watchdog group in Washington.

The group, which includes specialists in toxicology, biology, public health and environmental engineering, is leading the charge against the industry. It recently compared ingredients in 7,500 personal care products against lists of known and suspected chemical health hazards.

It found that one in every 120 cosmetic items, including shampoos, lotions, makeup foundations and lip balms, contains known or probable carcinogens, said spokeswoman Lauren Sucher.

The cosmetics association vehemently denies this charge. "We wouldn't use ingredients like that," said spokeswoman Irene Malbin.

It's unclear whether the concentrations of those ingredients are high enough to cause health problems, or even whether these chemicals can cross the skin barrier. But a citizens' petition that the Campaign for Safe Cosmetics filed last summer has clearly raised enough questions to prompt the FDA's crackdown.

Take hair dyes. Historically, they have been made with ingredients derived from coal tar, a known human carcinogen, according to the National Toxicology Program, part of the National Institutes of Health. Dark dyes made decades ago may have increased the risk of non-Hodgkins lymphoma, particularly when used long-term.

Even so, "Over the years, there have been enough studies of hair dyes to conclude it is unlikely they raise the risk of most cancers," said Eugenia E. Calle, director of analytic epidemiology for the American Cancer Society.

Another concern, according to the environmental group, is phthalates, softeners that are often not listed on product labels because they may be subsumed under the term "fragrance." Some phthalates are banned in Europe but not in the United States.

"The FDA does not have compelling evidence that phthalates, as used in cosmetics, pose a safety risk," said Dr. Linda Katz, director of the FDA office of cosmetics and colors.

But Scott Masten, a toxicologist at the National Institute of Environmental Health Sciences, said that for one phthalate, called DBP, "There is clear evidence of adverse effects on reproductive development in laboratory animals."

Many of the products consumers think of as cosmetics, such as sunscreen and anti-dandruff shampoos, are actually classified as over-the-counter drugs, and therefore must get FDA approval before they are allowed on the market.

Sodium borate, listed as an inactive ingredient in many diaper rash creams, "should not be used on infant skin or on injured skin," according to a panel of experts funded by the cosmetics industry itself. That panel, the Cosmetic Ingredient Review board, which includes an FDA representative, reviews the safety of ingredients in cosmetics. So far, it has reviewed only a small fraction of the thousands on the market.

If the FDA follows through on its tougher scrutiny of personal care products, it's likely that issues like this will increasingly come to light. At the very least, more products will probably carry warning labels saying, "The safety of this product has not been determined."