By Elizabeth Grossman

While the US Supreme Court was debating the Affordable Care Act, the US House of Representatives Energy and Commerce Committee Health Subcommittee held a hearing to examine the current federal oversight of cosmetics and personal care product safety. The hearing revealed that the US Food and Drug Administration (FDA), the federal agency that oversees the more than eight billion such products now sold annually in the US, knows astonishingly little about these products’ ingredients. This data gap – perhaps better described as a data chasm – is compounded by the inadequacy of current Material Safety Data Sheets, and leaves US workers and consumers without sufficient information about how these products may affect their health.

It might be assumed that the FDA knows exactly what’s going into cosmetics products (which as a category includes things like shampoo, soap, children’s bubble bath, hand lotion, and deodorants as well as make-up and hair-styling products) and strictly regulates their safety before products go on the market. It does not. It might also be assumed that federal regulation specifically bars the use in cosmetics of substances identified as carcinogens or as developmental or reproductive toxicants. It does not. And it might be assumed that the FDA has the authority to require the recall of products found to contain hazardous ingredients – including known carcinogens. It does not.


As testimony from Michael Landa, director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) at the March 27 hearing made clear, the FDA has information on but a small fraction of cosmetics products ingredients. Landa explained that only about one-third of the approximately 1,600 cosmetics manufacturers that have registered with the FDA’s Voluntary Cosmetic Registration Program have filed any voluntary product ingredient statements. Only about 39,000 such statements are now on file with the FDA. Landa also noted that between 2004 and 2010 the number of cosmetics imports to the US nearly doubled, growing from less than one million product lines in 2004 to more than 1.9 million 2010, adding to oversight challenges. Asked how many cosmetics companies do business or manufacture cosmetics in the US, Landa replied, “We don’t have a complete list.”

Regarding specific ingredient oversight, Landa explained that except for color additives cosmetic ingredients are not subject to FDA pre-market approval. Apart from eight substances currently prohibited as cosmetic ingredients and three whose use is restricted (a list last updated in 2000), manufacturers can use any ingredients as long as the products are accurately labeled as specified by the Fair Packaging and Labeling Act. Manufacturers do test ingredients, of course, but there is no FDA pre-market oversight of this testing or of product labels. Manufacturers oversee their own labeling and product safety.

Cosmetics in the Workplace
A lack of information about cosmetics’ ingredients and their health impacts isn’t just a problem for consumers. It’s also of concern to the million-plus workers who use cosmetics on the job. However, workers may lack even the protections afforded to consumers. Products sold only to salon professionals may not have ingredient labels, because the law regulating consumer cosmetic product labels doesn’t apply to those sold specifically to salons. Material Safety Data Sheets (MSDSs) supplied and compiled by chemical product manufacturers are designed to list a substance’s chemical components and characteristics, including toxicity and health hazards, and can help fill this gap. However, the sheets are produced without regulatory oversight, and many of those in use lack key information. They can also be very technical, a disadvantage for the many salon workers for whom English is not a first language. One 2011 industry report put the number of US hair and nail salons at more than 1 million and employees at nearly 1.5 million. California alone has close to one-half million beauty and nail salon workers. Many are recent immigrants, and work long hours and extended work weeks.

The case of the hair-straightening/smoothing product called “Brazilian Blowout” vividly illustrates the flaws in the current system and how they can affect workers’ health. Brazilian Blowout’s health hazards came to public attention in 2010, when a Portland, Oregon hair stylist using the product reported difficulty breathing, nose bleeds, and eye irritation. The product’s MSDS listed no hazardous – or other chemical – ingredients and no health precautions. But an Oregon OSHA lab found formaldehyde in all samples tested well above permissible levels. The samples included several from a product labeled “formaldehyde free,” which was found to contain over 8% formaldehyde.

Oregon and federal OSHA (which also conducted its own tests) decided the product was incorrectly labeled and that numerous salons using product were violating OSHA’s formaldehyde hazard communication standard. California, Connecticut, and Oregon state authorities sent manufacturer GIB warning letters, as did OSHA and FDA. OSHA also issued citations to salons using these products for failing to protect workers from formaldehyde exposure. Complicating the situation for salon workers is that many are actually self-employed but hired as contractors by the salons, thus limiting their recourse to rights protections that cover traditional employees.

In October 2011, the company questioned federal OSHA’s testing results. OSHA defended its testing and asked the company to take corrective action. In November 2011, the National Institute for Occupational Safety & Health (NIOSH) released a health hazard evaluation report on “Brazilian Blowout” that found11% formaldehyde in a formulation labeled “formaldehyde free.” Meanwhile, the California Attorney General’s office had filed a class action lawsuit against GIB for failing to warn consumers about Brazilian Blowout’s formaldehyde contents, and – because formaldehyde is a carcinogen – for violating California’s Proposition 65 and California’s Safe Cosmetics Act.

The settlement reached with California in February 2012 requires GIB to put formaldehyde warning labels on two Brazilian Blowout products and make substantive to changes to its website and the products’ material safety data sheets. The company was fined $600,000: $300,00 for violating Proposition 65 and $300,000 to reimburse the California Attorney General’s office. The settlement also includes product and medical cost reimbursements to hair stylists with valid claims, with medical payments capped at $2000. Individual suits against the company are ongoing.

Brazilian Blowout Original” continues to be sold. Its MSDS, accessed on April 5, 2012, says the product is a hazardous substance and that it “releases formaldehyde (gas), a suspected carcinogen.” The US Centers for Disease Control and Prevention, however, considers formaldehyde a known human carcinogen, as does the International Agency for Research on Cancer (IARC).

The company has posted private lab test results showing its “Brazilian Blowout Zero+” – advertised as formaldehyde free – contains no formaldehyde. The MSDS, available on request from GIB, lists the second ingredient as dimethyl urea. Without lab analysis, it’s not possible to tell how much, or precisely which formulation of dimethyl urea the product contains. But safety data sheets for dimethyl urea describe it as a skin contact, inhalation, and eye irritant and as also toxic to kidneys, the nervous system, liver, and mucous membranes, particularly with repeated or prolonged exposure.

Trying to bridge the data chasm
Material Safety Data Sheets, however, can omit key information. As Women’s Voices for the Earth science director Alexandra Scranton points out, MSDSs will not list by-products. This means that the MSDS for chemicals known to release formaldehyde (OSHA lists at least five dozen different names for such substances) do not have to spell this out, even they are regulated by OSHA’s formaldehyde standard. If this sounds confusing, it’s because it is.

Two bills to increase FDA’s authority to regulate cosmetic product ingredients are now being considered by Congress. Both would establish mandatory registration with fees for all cosmetics manufacturers over a certain size. These funds would support an expansion of FDA’s capacity to inspect manufacturing facilities and to test and otherwise oversee cosmetics products. The Obama Administration’s FY2013 FDA budget makes a similar proposal. Both proposed bills would give FDA authority to recall unsafe cosmetics products, require manufacturers to substantiate ingredient safety information, and require manufacturers to report products’ adverse health effects.

The Safe Cosmetics Act (H.R. 2359), sponsored by Representative Jan Schakowsky (D-IL), would specifically bar carcinogens and reproductive and developmental toxicants from cosmetics and allow individual states to set more stringent cosmetic safety standards. The Cosmetics Safety Enhancement Act (H.R. 4252), sponsored by Representative Frank Pallone (D-NJ) would do neither. At this point, neither bill includes what could be called a “plain language” provision to make ingredient labels understandable without a chemicals database, not to mention scientific interpretive skills, patience – and often a magnifying glass.

Tackling problems posed by the current MSDS system are beyond the capacity of either proposed bill. The new globally harmonized safety data sheet system will in due course improve visibility of hazard notations, but not institute information oversight. For now, cosmetics products continue to contain formaldehyde, formaldehyde-releasing chemicals, and many other substances with well-documented health hazards, along with thousands of other chemicals of unknown toxicity. And the FDA remains without the capacity to verify the safety – and safety claims – of the millions of products used daily by millions of American workers and consumers.

Elizabeth Grossman is the author of Chasing Molecules: Poisonous Products, Human Health, and the Promise of Green Chemistry, High Tech Trash: Digital Devices, Hidden Toxics, and Human Health, and other books. Her work has appeared in a variety of publications including Scientific American, Salon, The Washington Post, The Nation, Mother Jones, Grist, and the Huffington Post. Chasing Molecules was chosen by Booklist as one of the Top 10 Science & Technology Books of 2009 and won a 2010 Gold Nautilus Award for investigative journalism.

Comments

  1. #1 Chemjobber
    April 11, 2012

    “Without lab analysis, it’s not possible to tell how much, or precisely which formulation of dimethyl urea the product contains.”

    I think it’s interesting that the company decided to switch to this product — it’s not immediately clear what the reason might be. It’s certainly not going to cross-link like formaldehyde. Also, what is meant by “formulation of dimethyl urea”?

  2. #2 Elizabeth Grossman
    April 11, 2012

    Perhaps “formulation” is not the technically correct word but dimethyl urea exists in different versions registered under different CAS numbers, two being 1,3-DIMETHYLUREA; UREA and N,N’-DIMETHYL- UREA. There is also 1,1-dimethyl urea, and perhaps there are others. The ingredient list on this product only said “dimethyl urea” and did not provide a CAS number.

    The Environmental Working Group’s Skin Deep database lists a number of synonyms for dimethyl urea. The Cosmetic Ingredient Review, the cosmetics industry’s organization that assesses product ingredients does not list dimethyl urea on its website database.

    I selected this product simply as an example of the challenges involved in understanding exactly what’s in a cosmetic product even with labeling etc.

  3. #3 Michael Wood
    April 12, 2012

    In re the limitations of an MSDS, it’s worth mentioning that at the time we began our original investigation (along with the folks at OHSU’s CROET), the MSDS for both Brazilian Blowout products available at the time (which did not include Brazilian Blowout Zero) did not acknowledge the presence of either formaldehyde or methylene glycol (hydrated formaldehyde, which undergoes a reversible change in chemical composition, causing the company to argue that a liquid could not contain formaldehyde). In fact, the MSDS said there were no hazardous chemicals, and the Acai Professonal Smoothing Solution was advertised as “formaldehyde free” and containing no formaldehyde in spite of formaldehyde levels that we identified (using standard analytical methods and protocols) at levels considerably higher than one would find in embalming fluid.

    Unfortunately, the entire structure of hazard communication breaks down if manufacturers omit — or even actively misrepresent — the hazardous contents of their products.

    Michael Wood, CSP
    Administrator, Oregon OSHA

  4. #4 Perry Romanowski
    April 12, 2012

    As a cosmetic chemist I find this article poorly informed. Using the non-science based EWG Skin Deep database is just lazy journalism. Did you ever think to consult a cosmetic chemist before writing?

    The case of the Brazilian Blow out vividly shows that regulations are working. Someone reported a problem, the government investigated and the company had to change their formula (after paying substantial fines). Now their products contain a warning statement and people avoid them. How would should the regulatory system to work?

    It is not possible to guarantee that a harmful product is never marketed. Even with the stringent regulatory requirements of launching a new drug results in unsafe products on the market occasionally.

    Note the Cosmetic Ingredient Review board is made up of scientists. These are not shills for the cosmetic industry. They are independent scientists who publish their results. The cosmetic industry has no interest in creating products that harm their consumers. That makes no sense.

    Cosmetics are not a danger to people. Just look at the safety history of the industry. While the government doesn’t force specific tests there is a law that says it is illegal to sell unsafe products. And the cosmetic industry takes it seriously (at least the companies with scruples).

    And if you are afraid of cosmetics…don’t use them. They are not necessary to live a healthy life.

  5. #5 Barbara J Nelson
    April 12, 2012

    Where can I find information to read that a lay-person could better understand. I get the idea, but I am not a scientist, and am disturbed about the toxins in make-up, baby products and such. I would really like to talk and have a better understanding as to discuss this with my friends.
    Thanks \Barb

  6. #6 Jennifer Arce
    April 12, 2012

    @Perry Romanowski you are wrong about Brazilian Blowout having to change their formula. In fact the CEO of the company bragged:
    “We get to sell the product forever without reformulation,” he said. “In my eyes, that’s the acquittal we’ve been waiting for.”

    Brazilian Blowout is the perfect case study showing how BROKEN our regulatory system is!

    This product has been proven to be UNSAFE by many government agencies, was sued by the state of California and yet is still being sold everyday (without reformulation)
    because our government DOES NOT give the FDA the authority to take this product off the market!

    In the meantime there are salon workers SEVERLY SICK and are suffering from major health problems!
    If ONE PERSON chooses to do this treatment…THE ENTIRE SALON IS EXPOSED!
    Unsuspecting clients are being exposed to high levels of toxic formaldehyde without their knowledge or consent and workers have to breathe this in all day!

    Up until January 2012 certified stylists were getting email after email and letters saying how safe this product is and that the government test results were proven faulty! Thanks to the California Safe Cosmetics Act the emails have stopped.

    BUT- those little warning labels on the bottle? The clients don’t see those!! The GMA hidden camera investigation shows EXACTLY what is going on in salons and how the clients are being lied to. Please read my blog for more information:

    http://notjustaprettyface.org/blog/hairsylist-speaks-out-its-time-to-ban-toxic-brazilian-blowout#comments

  7. #7 Perry Romanowski
    April 13, 2012

    @Barb – There are a number of places to find information. Some sites I recommend include Cosmeticsinfo.org, FDA.gov/cosmetics, TheBeautyBrains.com, and Personalcaretruth.com. Note these sites are written by people who have scientific backgrounds. There are lots of bloggers and chemophobes like (notjustaprettyface.org) who hold lots of opinions about chemicals but have never been trained in the subject. Why these people believe their opinions are superior to people who actually have degrees and have done research in the field is baffling to me. Ask a toxicologist about chemical safety, not an English major.

    @Jennifer – This example of a rouge company does not mean the entire industry is corrupt. I personally worked on a project that looked at using formaldehyde donors to straighten hair (before Brazilian Blowout came out) and while the technology worked, we didn’t launch the product specifically because we couldn’t make it work at acceptably safe levels. The regulatory system is not broken.

    If you are afraid of cosmetics, don’t use them. Getting a hair straightening process is not necessary! If you are afraid, stay away. But don’t let your fear govern the actions of people who are not afraid.

  8. #8 Elizabeth Grossman
    April 13, 2012

    To clarify: I did not use the Environmental Working Group SkinDeep to research this story. I only offered it and the Cosmetic Ingredient Review database as examples of difficulties non-professionals seeking information about ingredients listed on cosmetics/personal care products labels may encounter when attempting to understand exactly what is in a product, for whatever reason they may seek that information.

    I obtained the MSDS for the “Brazilian Blowout” products directly from the company and simply researched “dimethyl urea” as best I could without a specific CAS number, which is not included on the MSDS ingredient list. The “Brazilian Blowout” case is clearly an unusual one.

  9. #9 Poppie
    April 13, 2012

    California just tested 37 salon fingernail polish samples typical of the selections available in professional salons here, and the result was that more than HALF had hazardous chemicals in them (formaldehyde, tuolene, and phthalates) that were not listed on the labels, or specifically noted on the labels that these were free of these chemicals.

    Tests showed that many were absolutely misslabeled.

    Google California nail polish news and you will get the lowdown. Obviously the industry is unable to police itself.

  10. #10 Perry Romanowski
    April 14, 2012

    @Elizabeth – That’s a reasonable enough mode of action but in the future when writing about cosmetics, I would encourage you to contact scientists (cosmetic chemists) who actually know something about the area. You can find unbiased experts via the Society of Cosmetic Chemists (scconline.org).

    @Poppie – While some of the products were mislabeled it is not a safety issue. The products are legal to sell. Believe it or not there are safe levels of these compounds. It is the dose that makes the poison. Water can be toxic in high enough concentrations.

    The labeling should be addressed and companies that mislabel their products should be fined.

    For more on the subject see this report done by NPR.
    http://www.npr.org/2012/04/12/150474920/calif-study-nail-products-contain-toxic-chemicals

  11. #11 deborah hoadley
    May 11, 2012

    Elizabeth..THANKYOU…I work in the health industry…customers ask me on a daily basis for healthy beauty care products , creams and lotions, makeup ,vitamins.I am very happy to steer them away from the unhealthy items we carry to the few products that are safe…I have been reading labels for years….the cosmetic industry is full of chemicals that evan in small amounts accumalate in the liver and cause irreparable damage.
    In response to the above comment..” water can be toxic in high enough concentration” YOU BETCHA…ESPECIALLY after all the excess harmful chemicals are deposited their from their carcinogenic products!!!!!!