May/ June 2013 Beauty Tips for the FDA

Did my wife’s cosmetics give her breast cancer?

By John F. Wasik

“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.)

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.