May/ June 2013 Beauty Tips for the FDA

Did my wife’s cosmetics give her breast cancer?

By John F. Wasik

(Studio 504)

When Kathleen felt a lump in her right breast she began a journey that millions have experienced—or, sadly, will experience. After a painful biopsy and other tests confirmed it was cancer, my wife was thrown into a cauldron of tears, doubt, and fear for herself and her loved ones. Our two daughters were then just eight and twelve.

Like many cancer patients, Kathleen also experienced a stranglehold of guilt. Was it something she did or didn’t do that fed the tumor? Was it the meat in our diet? Our water? The air? Her genes? I assured her that we couldn’t be at fault. We had banned soda pop and anything with high-fructose corn syrup from our house more than a decade before. We tried to eat organic food, we were transitioning to more vegetarian fare, and she did yoga and took regular walks. We didn’t even have cable.

After a test showed that Kathleen didn’t have the BRCA breast cancer gene, her surgeon, Dr. Sonya Sharpless, suggested that environmental factors might be implicated. But what could they be? Kathleen had already thrown out a bevy of household cleaning products and plastic containers.

Then she discovered the work of the Breast Cancer Fund, a San Francisco-based advocacy group that for the last ten years has been focusing on cancer-causing agents in personal care products. Through a coalition of health and environmental groups called the Campaign for Safe Cosmetics (of which the Breast Cancer Fund is the principal sponsor), the organization has been drawing attention to the fact that known carcinogens—substances like formaldehyde—are used as preservatives in everything from suntan oil to makeup. Kathleen frantically threw out her all her expensive Clinique and Shiseido cosmetics.

Did a lifetime of using cosmetics cause or contribute to Kathleen’s breast cancer? We don’t know. But here are some facts that every American woman and her loved ones should absorb. The European Union bans nearly 1,400 chemicals from personal care products because they are carcinogenic, mutagenic, or toxic to reproduction. But in the United States, the Food and Drug Administration entrusts safety regulation of cosmetics to a private entity that is housed and funded by the industry’s trade association. To date, this entity has found only eleven chemicals to be “unsafe for use in cosmetics.” The FDA has no oversight of cosmetics products before they come on the market and, unlike the EU, leaves it to the cosmetics industry to determine which ingredients should be banned.

Because the American cosmetics industry is largely self-regulated, American women have to worry that they may be exposed to all sorts of cosmetics ingredients that may be dangerous to their health. Without greater powers for the FDA to regulate cosmetics, there is just no way that people like Kathleen who have cancer, or those who fear getting it, can know for sure. Indeed, even while in the hospital cancer patients are exposed to cosmetic products that the FDA has never evaluated and that activist groups like the Campaign for Safe Cosmetics say contain known or suspected carcinogens.

This happened to Kathleen. During her first round of chemo in 2009, some volunteers at the hospital came calling with a little red bag that contained products from Clinique, Estée Lauder, and Del Laboratories. Everything from eyeliner pencils to blush was in the bag, accompanied by a brochure that provided helpful advice on skin care and wig purchases.

Her well-meaning visitors were part of the Look Good Feel Better program (LGFB), which involves 16,000 volunteers who hand out $10 million worth of personal care products every year to women being treated for cancer. Behind this effort is a Who’s Who of the personal care industry: Alberto Culver, Avon, Chanel, Coty, Aveda, Johnson & Johnson, Neutrogena, L’Oreal, LVMH, Mary Kay, Procter & Gamble, and Unilever, among others. The sponsors, as Kathleen learned from the brochure, are the American Cancer Society and the Personal Care Products Council (PCPC), the leading national trade association representing the global cosmetic and personal care products industry, which, through its tax-exempt foundation, kicked in $8.6 million to LGFB in 2011.

No doubt many women who are feeling awful about the loss of their hair, breasts, and dignity are grateful for these gifts from the cosmetics industry. But Kathleen, even though the chemotherapy by this point had caused her hair to fall out and turned her skin ghostly white, was not one of them. Upon reviewing the contents of her LGFB bag, she realized that several of the products in it contained parabens—chemicals that mimic estrogen and that according to the Campaign for Safe Cosmetics are linked to cancer. You can image how that made her feel.

For a while, fighting the cancer was all we could do. After her mastectomy, Kathleen’s chemo treatments proved so debilitating that she ended up in the emergency room and in isolation wards twice in December of 2009. The drugs in her body were robbing her of hemoglobin and she became dangerously anemic, a common side effects of blasting the entire bloodstream with
toxic chemicals.

Kathleen could barely walk. Her immune system was also in shambles and needed frontline antibiotics. We had to get rid of our houseplants for fear of infection. Meanwhile, I was trying to hold body and soul together even as I lost my main source of income as a contract columnist for Bloomberg News.

Once Kathleen began to recover from the trauma of the chemo I decided, however, to throw myself into answering a basic question: How is it, I wanted to know, that the FDA, which was created by the Federal Food, Drug, and Cosmetic Act of 1938, leaves the regulation of cosmetics largely up to the cosmetics industry?

Start with a fact that is hardly a secret yet still little known by the public: the FDA does not have the authority to test cosmetics ingredients before they go on the market. This is explained right on its Web site: “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.”

Instead, as the FDA’s site goes on to explain, “Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.” In other words, the industry is largely responsible for regulating itself. How good a job do they do?

There exists an obscure entity called the Cosmetic Ingredient Review. According to the industry, the CIR is responsible for ensuring the safety of cosmetic products. On its board sit nine voting members. The voting members are all academics, and, according to the CIR, they must meet the same conflict-of-interest requirements as individuals serving on FDA advisory committees. However, there is no independent way to verify what conflicts of interest might actually exist. As a private organization, the CIR is not subject to the Freedom of Information Act, as I found out when I tried to make a FOIA request. Nor will the CIR publicly disclose its budget.

John F. Wasik is a columnist, investigative writer, author, speaker, and the award-winning author of thirteen books.


  • Sarah Jancosek Torff on May 07, 2013 10:22 AM:

    Dear John ~

    This is a well researched and,given my fondness for Kathleen and you and the girls, a very moving one. You raise some important questions. But again, whenever the breast cancer issue arises, there is always the need, in an understandable search for an answer to the question, "Why me?" (or a loved one) to look for AN answer. But, with the exception of those with the BRCA1/2 gene mutation, there is no single answer.

    If cosmetics caused breast cancer, particularly pre-menopausal breast cancer, millions of women would develop it. Yet they don't. We know now that some women will develop cancers that will never kill them, while others, despite the organic/vegan/clean living regime, succumb too early to very aggressive forms of the disease.

    The sad truth is, no one is sure what causes breast cancer - there are only correlations. I know. I have lost a mother and a sister to the sister - and I have several significant risk factors for developing the disease. It's something I live with every day. But there comes a point when we have to live with risk, with agony, with "I don't know."

    Under wire bras, power lines, and all sorts of things have been "implicated" in breast cancer - desperate fads - but no clear links. Likewise, even though the eye liner in a cosmetic may have formaldyhide, that does not mean that small amounts absorbed in the eyelid will cause cancer. It may; but to date there is no scientific evidence that it does.

    I am NOT suggesting that cosmetic ingredients shouldn't be regulated. And I am no fan of the FDA. But in the search for answers to complex questions that affect us with such urgency, I think it is important not to light on too-simple answers.

  • gomer on June 07, 2013 7:43 AM:

    If reasoned unreasonableness is the definition of extremism, the reasonable path advocated by the first commenter is the touchstone for being reasonable for the most asinine reasons. Nearly a quarter of a million new cases of invasive breast cancer are diagnosed each year and nearly 40,000 die. I don't think its unreasonable to apply a risk assessment to cosmetics. Too simple answers? That's not a caution against simplistic thinking. That's a call for complacency, denial, and letting business get a way with murder. Use endocrine disrupting substances all you want. But if you want to profit from the manufacture and sale of this stuff to an unsuspecting public, you ought to pay the price. Sadly, that price won't be comparable to the risk and injury done.

  • Lynn on June 09, 2013 10:02 PM:

    The FDA is such a joke. It is worse than no regulation at all, because it creates a false sense of security in our products. I buy European sunscreens that are safer but technically illegal here, no doubt because our manufacturers don't want the competition, but figuring out how to buy European cosmetics is much trickier. Thanks for exposing this, and thanks to my Rep., Jan Schakowsky, for trying to forge ahead with legislation to help remedy another example of the neutering of our government agencies by business interests.