Features

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.

“Since we are not a part of FDA, there is no obligation to provide information under FOIA,” Dr. F. Alan Andersen, the CIR’s director, explained in an email, adding, “The annual budget is not a matter of public record, so that information is not available.” According to a search of the Internal Revenue System’s database of tax-exempt organizations, the CIR has not filed a Form 990, which would contain at least its budget. It is accordingly not known whether the cosmetics industry pays the “experts” on the CIR, much less how much.

The CIR does admit that its overall funding comes from the industry’s main trade association, the Personal Care Products Council. The PCPC has filed Form 990, and it shows that in 2011, the organization paid Dr. Andersen, the CIR executive director, a total of $372,151 in wages and other compensation, including a performance bonus of $55,675. And the form shows that PCPC paid a total of $292,257 in employee compensation and contracting fees to a Mr. John Bailey, “a key employee who retired from the Council during 2011 because of his former employment with the FDA.” (John Bailey’s wife also received $49,930 for her part-time work with the council.) There is no breakdown, however, of what the PCPC may have paid the CIR’s expert panel.

The two organizations both list their mailing address as 1101 17th Street in Northwest Washington, D.C., though one is in Suite 300 and the other in Suite 412. In Suite 412, the CIR goes about its business, which does not include conducting any clinical studies or trials. “The panel does not conduct its own research,” spokesperson Lisa Powers explained in an email, “but carefully examines all of the currently available scientific data.”

The CIR discusses its findings at four meetings a year that are open to the public, and publishes the proceedings on its Web site. It also publishes reports in the peer-reviewed International Journal of Toxicology.

Does that mean you should rest assured that your blush won’t give you cancer or damage your unborn children? At least on one occasion, the CIR has pronounced cosmetics ingredients to be safe despite protests that there was no scientific basis for doing so. For example, in 2002, the CIR pronounced that it was safe for the industry to continue adding possible endocrine and reproductive disruptors known as phthalates to cosmetics marketed to women of childbearing age. This decision was based on what the Environmental Working Group characterized as the “ad hoc calculations” by one of the trade association’s scientists during the course of its proceedings.

But the more salient reality is that, regardless of the quality of its research, the CIR has no power over the industry that finances it. How often has the industry taken action to reformulate products that contain harmful chemicals? According to the PCPC, the trade organization does not “keep a record of products that have been reformulated or removed from the market as a result of a CIR review.” Of the 12,500 ingredients used in personal care products, only a handful are not used in the U.S.

By law, cosmetics companies are supposed to do some kind of research into the safety of their products before putting them on the market. “If the safety of an ingredient as used in a cosmetic product has not been established by CIR,” a PCPC spokesman stated, “a company must possess other information to substantiate the safety of the ingredient for its intended use and make that information available for inspection by FDA upon request.” But the FDA’s review of industry-sponsored research, if it happens at all, won’t occur until the product is already on the market.

For example, in recent years, a substantial controversy has arisen over the use of lead in lipstick. Lead can be a pretty serious substance. The Consumer Product Safety Commission banned the use of lead in house paint in 1977, due to the brain damage it has been proven to cause in children. Because of its neurotoxicity, leaded gasoline has been entirely banned in the U.S. since 1995. The FDA also bans the presence of lead in candy bars in concentrations greater than 0.1 part per million.

Yet the FDA never got around to even testing lead in lipstick until 2010. When it did, it found concentrations as high as 3.06 parts per million—or more than thirty times the maximum allowed in candy bars. Whether this is an unsafe level for lipstick users I’ll leave to others to dispute, but the point is, under the current regulatory regime, lipstick users were exposed to these concentrations of lead for decades without their knowing it and without the FDA ever conducting so much as one test. For now, at least, the FDA says the lead in lipstick is safe, though if I were a woman, I wouldn’t be licking my lips.

And what if the FDA does determine that a cosmetic product being sold on the market is unsafe? “FDA does not have the legal authority to order a recall of a cosmetic,” a spokesman explained. “However, FDA works with firms to ensure that voluntary recalls are effective.” One exception provided by the FDA’s statutory authority is for cosmetics products with ingredients that are “adulterated and misbranded.”

The FDA’s lack of regulatory authority over perfumes and other fragrances is also troubling. In 2010, the Campaign for Safe Cosmetics and the Environmental Working Group tested popular colognes and body sprays and found fourteen “secret chemicals not listed on the label.” These substances are linked to hormone disruption, skin irritation, and allergic reactions, according to several studies. The FDA did not test, much less ban, the products, which included American Eagle Seventy Seven, Chanel Coco Mademoiselle, and Britney Spears Curious.

It’s the same story with hair products. In August 2011, under pressure from consumer groups such as the Campaign for Safe Cosmetics, the FDA tested hair straighteners produced by a California company called Brazilian Blowout. The agency found high levels of formaldehyde, a known carcinogen, but did not request the manufacturer to pull the product off the market. The state of California is suing the company while the product remains on the market. The company has agreed to disclose the presence of formaldehyde in Brazilian Blowout, which was previously labeled “formaldehyde free.” In the case of hair products used in beauty salons across the country, which often contain formaldehyde and other toxins, the FDA has even more limited authority to regulate.

The only exception to this pattern of lax regulation is telling: the FDA does vigorously regulate imported cosmetics. Just between January 2000 and December 2011, the FDA stopped more than 14,000 shipments from various countries abroad. That information led me back to the FDA. I wanted to know if they at least had any evidence of personal care products harming people in the U.S.

As it turns out, the FDA does collect reports of adverse reactions to personal care products through its Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS). (Should you care to drop them an email, the address is CAERS@cfsan.fda.gov.)

The FDA was kind enough to let me read through 543 pages of complaints from users of different cosmetics products. People reported about products that burned their skin or caused their eyes to water, and that in some cases sent them to the emergency room. The names of the people involved were all redacted. I wondered how or if the agency was following up on these reports. Despite my queries, the FDA didn’t respond directly, instead referring me to their Web site, which doesn’t have the answers either.

Kathleen’s greatest fear when she was diagnosed with cancer was that our daughters, who were just then getting to the age where they would start to use cosmetics, would be at risk. Again, we can’t know for sure. But there is no doubt that the lax regulation of cosmetics exposes American girls and women—and men and boys as well—to an unknown health risk they do not need to be taking, even if definitive, unbiased science is not always available to evaluate each particular ingredient.

We know, for example, that the skin, our largest organ, easily absorbs cosmetic ingredients, safe or toxic. Repeated low-level exposures may accumulate through a person’s lifetime (such as lead in hair dyes and mercury in skin whiteners). Girls often start using cosmetics at a very young age, thereby increasing lifetime exposure. Puberty is a critical development time for both girls and boys, and exposure to reproductive and/or hormonal toxins often starts before.

So why doesn’t the American public demand that we at least take a precautionary approach, and not use ingredients in cosmetics until they are proven safe, instead of waiting to see how many people they harm?

One explanation is the pervasive corporate influence over how most Americans even think about cancer. Have you noticed all the feel-good advertising that hundreds of companies have adopted to make it appear that they are “working for the cure”? Often they do this by releasing merchandise in pink, the color that has been chosen to show support for breast cancer victims and research. Companies have jumped on the bandwagon to promote everything from pink guns to pink vodka to pink fried chicken. Even NFL players wear pink shoes during the breast cancer awareness period. Some critics call this phenomenon “pinkwashing.”

The first such campaign originated with the cosmetics giant Estée Lauder, which gave $1.5 million worth of pink ribbons away in 1992 to show support for breast cancer patients and research. Cosmetics manufacturers have been in the forefront of pinkwashing ever since. Avon, for example, sponsors the Avon Walk for Breast Cancer. And, of course, with those Look Good Feel Better bags, the whole industry associates itself with being behind a cure or palliative for a devastating disease—albeit one it may be exacerbating. Don’t worry about what’s in your rouge; the money you spend on it goes to “cancer research,” and meanwhile, using more cosmetics will make you “Feel Better.”

When I challenged the industry’s trade group to disclose what chemicals might be in those bags, the PCPC responded, “In an abundance of caution, certain types of products and ingredients, which may be used safely in products for the general public, may not accepted for use in the LGFB kits … each product accepted into the LGFB program is subject to FDA oversight and has undergone multiple levels of review including safety, quality and regulatory reviews by the manufacturer, and is re-evaluated by Council staff before being accepted for use in the kits.”

Yet as we’ve seen, FDA “oversight” is, to put it mildly, weak. To make sure it stays that way, the PCPC alone spent $809,000 in direct lobbying in 2011, according to its disclosures to the IRS, plus $933,955 in conferences, conventions, and meetings, and $785,000 in travel. Meanwhile the staff of its putative research arm, the CIR, serves at the pleasure of the industry.

As public awareness has grown of the links between environmental chemicals and cancer, at least some politicians have responded. One is Illinois Democratic Representative Jan Schakowsky, who in 2012 cosponsored the Safe Cosmetics Act. It would have banned the use of ingredients linked to cancer and reproductive disorders while also requiring companies to include complete ingredient labels on fragrances and salon products. Sponsored as well by Wisconsin Democratic Representative Tammy Baldwin, who was recently elected U.S. senator of Wisconsin, the bill received strong support from the Breast Cancer Fund, along with other consumer groups. Nonetheless, it received just one hearing in the Republican-controlled House, and never left committee. Schakowsky has reintroduced her bill again this year.

Meanwhile, the PCPC and other industry groups, after a $3.5 million lobbying campaign, seeded the introduction of a weak, pro-industry bill called the Cosmetic Safety Amendments Act of 2012. Introduced by New Jersey Republican Senator Leonard Lance last year, the legislation called for registering product manufacturing facilities, disclosing product ingredients, and reporting adverse events from product use (which, as noted above, is already done through the FDA’s adverse report-
ing system).

The bill favored the industry, because it didn’t give the FDA any meaningful power to take harmful products off the market, and rubber-stamped research from the industry-funded CIR. The Lance bill (which has since died) would also have preempted tough state laws such as those found in California, while the Schakowsky bill would not.

In voicing the industry’s support for the Lance bill, the PCPC issued a statement in April 2012. It asserted, without apparent irony, that “FDA regulation of cosmetics has protected the public for decades, and this landmark legislation will enhance protections for millions of American consumers.”

When I requested further comment from the PCPC, spokesperson Lisa Powers replied, “We support increased regulation and authority by FDA over cosmetics. This increased regulation should allow and require FDA to set safety levels on ingredients found in cosmetic and personal care products. We look forward this year to working with Members of Congress on both sides of the aisle on discussion of these issues.”

Schakowsky is optimistic she can reach a compromise with Republicans. “We’re hearing that there’s some possibility that something on cosmetics might move,” she told me in a telephone interview in mid-January. As of this writing, the legislation has not been allowed to come to a vote.

Research for this piece was generously supported with grants from the Nation Institute Investigative Fund, the Chicago Headline Club, and the National Press Foundation.

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

Comments

  • 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.