Cosmetics Ingredients ScrutinizedApr 18, 2005 | The Kansas City Star The Food and Drug Administration is investigating whether the chemicals that make shampoos fragrant and nail polish chip-resistant are hazardous to your health.
Since last year, the agency has been studying phthalates (pronounced tha-laytes), a group of chemicals used for decades in an array of personal-care products. Studies on animals have shown the chemicals could harm reproductive organs or cause other health concerns.
Of the 48 cosmetics it surveyed, the FDA found most contained at least one phthalate. The chemicals do everything from making plastic more flexible to slowing evaporation to allow a perfume's fragrance to linger. They show up in shampoo, hair spray, deodorant, skin cream, body wash and other products.
The European Union already has banned two phthalates from cosmetics sold on the continent. With pressure mounting for more regulatory action in this country, several large manufacturers, such as Revlon and Procter & Gamble Co., have removed those phthalates from their products sold in the United States.
The FDA has released few details about its investigation into phthalates. It said in a statement to The Kansas City Star, "At the present time, FDA does not have compelling evidence that phthalates, as used in cosmetics, pose a safety risk."
The agency said if evidence that phthalates are harmful is found, it "will advise the industry and the public, and will consider its legal options … in protecting the health and welfare of consumers."
Stacy Malkan, a spokeswoman for the Campaign for Safe Cosmetics, a coalition of health and environmental groups, said of the effort by manufacturers to remove phthalates: "That's really a great first step, but there's still a long way to go to work toward really safe cosmetics. That's just the tip of the iceberg."
The coalition began lobbying the industry a year ago to remove phthalates. It also has received pledges from more than 80 smaller cosmetic companies to not use chemicals suspected of causing birth defects, cancer and other health problems.
The cosmetics industry, which generates $32 billion a year, recently found itself on the defensive over the chemicals it uses. Marian Stanley, manager of the American Chemistry Council's phthalates panel, said "scare tactics" were behind some of the opposition. She said the use of phthalates was very low and it primarily was in nail polish.
Even then, Stanley said, "you'd have to be using massive amounts of this stuff."
The council's phthalates Web site stated that in the 50 years the chemicals have been used, "there is no reliable evidence that any phthalate has ever caused a health problem for a human from its intended use."
The FDA regulates cosmetics, but unlike its oversight of the pharmaceutical industry, does not do premarket safety testing. The agency investigates complaints only after a product is in use.
In recent years various studies have raised red flags. The federal National Toxicology Program found that rats exposed to phthalates developed a higher risk of birth defects related to male reproductive systems. But it said the exposure level of most people was too low for serious concern.
The federal Centers for Disease Control and Prevention found in 2000 that the levels of phthalates in young women were much higher than average. Other academic studies have shown possible links to early puberty in girls and decreased sperm counts in men.
On the other hand, a panel of experts funded by the cosmetics industry surveyed more than 500 cosmetics for risks from three phthalates in 2003.
"The conclusion was that these (three phthalates) were all safe to be used in cosmetics," said Gerald McEwen, vice president for science for the Cosmetic, Toiletry and Fragrance Association, the industry trade association.
The panel, which regularly reviews cosmetic ingredients, was set up with the help of the FDA and the Consumer Federation of America and includes representatives from both.
Reflecting the recent concern over chemicals in cosmetics, a state legislator in California introduced a bill last month that would mirror the ban the EU imposed on two phthalates.
The chemicals affected were dibutyl phthalate (DBP) and Di(2-ethylhexyl) phthalate (DEHP). On a list of ingredients, phthalates can either appear by name or be identified simply as a fragrance.
California also wants to include several phthalates on a state list of products whose labels must warn consumers if their contents contain reproductive toxins or known carcinogens.
Meanwhile, the EU also has banned several phthalates that make toys supple enough for young children to suck on or chew.
While noting that scientific data on some of the phthalates were "either lacking or conflictual," the EU's order, still awaiting final approval, said "it cannot be excluded that they pose a potential risk if used in toys and child-care articles."
Last month, the National Toxicology Program said that it would reconvene its panel to study health risks to children from phthalates.
Concerns also extend to the use of phthalates in medical products made from PVC, such as intravenous bags and tubing. In 2003, the American Academy of Pediatrics said that hospitals should explore alternatives.
Health and consumer groups have pressed the FDA to take a more activist approach.
"The FDA has been pretty unresponsive to consumer concerns around safety in cosmetics," said Kevin Donegan, a spokesman for the San Francisco-based Breast Cancer Fund. "Recent consumer concerns has driven it to look more closely at this issue."
The fund is one of several groups involved in the Campaign for Safe Cosmetics' lobbying of the industry.
"Our products are in compliance, including in the U.S.," said Timothy Long, a Procter & Gamble spokesman.
Stanley of the chemistry council said that it is costly for companies to reformulate products for different parts of the world. And some agreed to follow the EU guidelines in the United States, she said, "to put peoples' minds at ease."