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© Oxford University Press 2006.
NEWS |
Safe Cosmetics Act Aims To Lessen Cancer Risk
The state that is home to Extreme Makeover and the Miss Universe pageant seems like an unlikely locale for the country's first state cosmetics regulatory act. But not to State Sen. Carole Migden and her constituents in San Francisco and adjacent Marin County. They see cosmetics as likely contributors to the area's unusually high rate of breast cancer.
There is little direct evidence linking cancer and cosmetics, but Migden's safe-cosmetics bill passed easily through the state legislature with the support of the Breast Cancer Fund and other California-based advocacy groups. Although the landmark bill applies only to cosmetics sold in California, it's expected to shape the formulas of products sold from Pacific Grove to Atlantic City. It is unclear whether carcinogen-free cosmetics would affect the cancer rate. Too little is known about what cosmetics are absorbed through the skin and whether the dose is high enough to cause any harm.
"Because cosmetics are not very regulated, manufacturers are permitted to put an unlimited amount of toxic products in cosmetics," said Kevin Donegan of the Breast Cancer Fund, a San Francisco–based nonprofit that lobbied for the California Safe Cosmetics Act. "Ingredients suspected of causing cancer shouldn't be used in cosmetics."
Public's Right To Know
When it takes effect in January 2007, the act will require cosmetics manufacturers to report potentially harmful ingredients to the state Department of Health Services (DHS), which will alert consumers. DHS officials in September had not determined how they would notify the public but expected to use both electronic and print media. Manufacturers must report ingredients listed as carcinogens or reproductive toxins in any of several registries, including lists from the National Toxicology Program, the International Agency for Research on Cancer, and the state's Office of Environmental Health Hazard Assessment. Several listed carcinogens are found in cosmetics, including formaldehyde in several nail polish formulas and coal tar in dandruff shampoos.
Under current labeling requirements set by the U.S. Food and Drug Administration, manufacturers don't have to list many ingredients in the products we rub, dust, and brush on our skin. The FDA requires ingredient listings, but it exempts fragrances, flavorings, and ingredients that are trade secrets. California will demand an accounting of all reportable ingredients.
"The basis of the law is the public's right to know," said Kevin Reilly, D.V.M., the DHS deputy director of prevention services.
The California act also authorizes the DHS to test the health effects of suspect cosmetics, a duty advocates believe the FDA should carry out but rarely does. The FDA leaves testing to the cosmetics industry. The agency tests toiletries only when it receives reports of problems. Such reports are rare, and they are usually about acute allergic reactions.
"The [Food, Drug, and Cosmetic Act] places the burden of safety on the manufacturer and distributor," said FDA spokesman Arthur Whitmore.
Since 1976, the industry has funded the Cosmetic Ingredient Review panel to assess cosmetics' safety. The seven voting panelists are hospital and university researchers from dermatology, pharmacology, veterinary medicine, and environmental medicine. Representatives from the Cosmetic, Toiletry, and Fragrance Association; the Consumer Federation of America; and the FDA serve as "liaison" panel members, but they do not vote on product safety. The panelists review about 100 cosmetics ingredients a year. Of the 1,286 chemicals they've studied, nine were declared unsafe. At least one of the nine, hydroxyanisole, is still in use; the neurotoxin and skin irritant is used as a skin lightener in Porcelana and Scarguard.
Advocates for safe cosmetics complain that nearly all chemicals in toiletries escape review.
"Consumers believe these products face greater scrutiny than they do," said Michael Thun, M.D., the American Cancer Society's vice president of epidemiology and surveillance. "It's not possible for consumers to make an informed choice."
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Cosmetic Ingredient Review Panel Director F. Alan Andersen, Ph.D., explained that the panel can handle only about 100 ingredients a year. The panel chooses which ingredients to review based on their frequency of use and likelihood of causing harm. Because it only reviews studies and does not conduct research, the panel is also limited to chemicals that have been studied recently. Many new and uncommon ingredients are not examined by the panel simply because nobody has researched them.
"We've [reviewed] 60%–70% of ingredients used today," Anderson said. "The problem is formulas keep changing."
The Cosmetic Ingredient Review Panel's limited reviews are good enough for the FDA. "We defer to the CIR," Whitmore said. "The CIR has a good track record."
Europe Leads the Way
Although the California act breaks new regulatory ground in the United States, the movement that inspired it has been brewing for several years, both here and abroad. Concerns over the long-term effects of cosmetics use arose in the mid-1970s, when Bruce Ames, Ph.D., of the University of California–Berkeley, reported that a carcinogenic coal tar derivative was found in 89% of permanent hair dyes. The FDA in 1979 asked manufacturers to put a warning label on dye kits. Instead, companies removed the ingredient, and consumer fears waned.
The current movement to determine the safety of toiletries grew from the discovery about 6 years ago that people absorb the endocrine disruptor dibutyl phthalate (DBP) through their skin. DBP is one of a class of phthalates that are widely used in cologne, aftershave, nail polish, hair spray, and moisturizer. It acts against male sex hormones, called androgens. Studies suggest that DBP has the most impact on males and that the effects are strongest during fetal development. Young mothers were particularly frightened by the finding that phthalate levels are highest in women of reproductive age.
Research on DBP's effects is still in its infancy, but the evidence was strong enough to convince the European Union to banish it from cosmetics. DBP is among many cosmetics ingredients that Europe banned in 2004 because of their association with endocrine disruption, cancer, or birth defects.
Europe's new regulations helped convince American consumer activists that not all cosmetics sold in the United States are safe. The nonprofit Environmental Working Group led the way with its Skin Deep Web site, which rates the safety of 14,000 personal-care products.
Many activists were pleased when several cosmetics manufacturers, including industry giants L'Oréal and Revlon, agreed even before California's ban to sell only products meeting the European standard. Late in August, three leading nail-polish companies bowed to pressure from consumer groups and announced plans to remove toxic chemicals. Sally Hansen, Orly International, and OPI Products promised to reformulate their products without DBP. Sally Hansen, the top-selling drugstore brand, also agreed to remove formaldehyde and toluene. Other companies still using toxic ingredients are likely to eliminate them before January, when the California law goes into effect.
"I think some players may reformulate their ingredients," said John Hurson, vice president of government affairs for the Cosmetic, Toiletry, and Fragrance Association.
Hurson and his colleagues emphasized that companies removing ingredients that must be reported in California are responding to public pressure and not genuine health threats.
"It's a business decision companies make if they perceive adverse public opinion," said John Bailey, Ph.D., the association's executive vice president for science. "These ingredients are safe under the conditions in which they're used."
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Cancer Link Tough To Prove
Nobody has been able to tie breast cancer or any other cancer to cosmetics. Too little is known about whether potential carcinogens in nail polish, shampoo, or hair spray are absorbed. And if they are, is the dose enough to cause cancer?
"Evidence doesn't support a connection between cosmetics and breast cancer," Bailey said.
Leaders of the country's biggest nonprofit cancer organization agree. Although the much smaller Breast Cancer Action and Breast Cancer Fund lobbied for the California act, the American Cancer Society remained silent.
"There isn't sufficient evidence to say cosmetics cause cancer," said Christy Schmidt, the American Cancer Society's senior director of policy.
Both proponents and opponents of the new California act agree that some ingredients in personal-care products are carcinogenic, at least under some circumstances. Their differences arise from their views on studies of those ingredients. Opponents say the studies fail to show that the quantities in cosmetics are enough to cause any harm. Proponents say they have enough evidence of harm, even though they admit that proving that anyone's cancer was caused by deodorant or nail polish or hair dye is all but impossible.
One of the biggest targets of safe-cosmetics activists in recent years has been DBP, which is used as a fragrance and plasticizer in dozens of toiletries, particularly nail polish and hair sprays, and other household items. DBP caught the attention of public-health officials in October 2000, when researchers from the Centers for Disease Control and Prevention reported in Environmental Health Perspectives that a study of 289 adults showed DBP exposure was higher than expected and particularly high in women of childbearing age. Now California's Safe Drinking Water and Toxic Enforcement Act lists DBP as a toxin that may cause developmental defects.
However, evidence that DBP causes cancer is scarce and comes mostly from animal studies. Rats fed high doses of DBP develop benign testicular adenomas, which suggests that humans could develop testicular cancer. There is more evidence that it causes developmental abnormalities in people, especially a shortened distance between the anus and the base of the penis, but that evidence is also weak.
Paul Foster, Ph.D., who's studying the effects of phthalates at the National Institute of Environmental Health Sciences, admits that even if phthalates do cause measurable abnormalities, the source of exposure it tough to pin down.
"Phthalates are in the air," he said. "They're in food. They're in drinking water. Even some drugs use them for enteric coatings. Women of childbearing age are exposed to multiple phthalates."
However, when asked if women or their offspring could be harmed by phthalates in nail polish, Foster replied, "I can't imagine you'd get sufficient exposure from that."
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