Face it: Cosmetic safety in doubt
For decades now, the cosmetics industry -- a whopping $35 billion-a-year business -- has been humming along happily with relatively little oversight from the US 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 set cosmetic safety as 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 chairwoman 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, or for European nations, which more tightly regulate cosmetics. In September, the European Union banned the use in cosmetics of substances that at least in animals have been linked to cancer, mutations in DNA or reproductive problems.
Several major companies --
The group, which includes specialists in toxicology, biology, public health and environmental engineering, is leading the charge against the cosmetics 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 -- a charge the cosmetics association vehemently denies. ''We wouldn't use ingredients like that," said Irene Malbin, the association spokeswoman.
It's unclear whether the concentrations of potentially worrisome ingredients are high enough to cause any health problems, or even whether these chemicals can cross the skin barrier. But the FDA suggested in its February letter that the group had raised enough troubling questions to prompt increased federal scrutiny.
Take hair dyes. It's hard to figure out how much of a risk -- if any -- current ingredients pose. Historically, they have been made with substances derived from coal tar, a known human carcinogen, which is the only ingredient specifically exempted from FDA oversight.
Dark dyes made decades ago may have increased the risk of non-Hodgkins lymphoma, particularly when used long term. But, ''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, a federal agency, said that for a phthalate called DBP ''there is clear evidence of adverse effects on reproductive development in laboratory animals." Toxicologist Tim Kropp of the environmental group said research in animals is ''overwhelming" that phthalates can raise the risk of hypospadias in boys, birth defects in which the hole that urine passes through is on the underside, not the tip, of the penis.
It's unclear whether this risk translates to humans. Dr. Terry Hensle, director of pediatric urology at Columbia University College of Physicians and Surgeons, pooh-poohed that risk, noting that the biggest risks for hypospadias are the hormones women take during in vitro fertilization, increased maternal age and the consumption of lots of tofu, which contains plant estrogens.
So what are we left with here? A mess.
The industry insists cosmetics are safe. Environmental groups disagree. And the FDA, until now, has, quite legally, looked the other way.
In fact, the agency is not authorized to approve cosmetics before they go on the market, said Katz of the cosmetics office. The only products that the FDA does review before they are marketed are products like sunscreen and antidandruff shampoos that are actually classified as over-the-counter drugs
But even some of those products, including diaper rash creams, are not getting enough scrutiny, according to the environmental group.
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.
Last week, Jerry Rachanow, an FDA pharmacist and regulatory lawyer, said the ''agency is not aware of any problems with this ingredient."
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, the agency may require more and more products to carry warning labels stating: ''The safety of this product has not been determined."
Judy Foreman is a freelance columnist who may be contacted at foreman@globe.com.
