The paraben parable

Most of the consumers I have spoken to, usually visitors to natural product trade shows, know that they don’t want to see parabens in the natural products they use. Most of the same people, when I pressed them for an explanation, had no idea why. But they know with great certainty that parabens are now persona non grata.

In referring to parabens, the Campaign for Safe Cosmetics cites the Environmental Working Group’s Skin Deep database. Here you can see that parabens have been linked to, among others, developmental/reproductive toxicity, endocrine disruption and neurotoxicity. Now, I’m not going to present an extensive, drawn-out academic argument here, but I would like to suggest a comparison with tea tree oil, which has also been linked to endocrine disruption and neurotoxicity. And, both parabens and tea tree oil have been “linked to” skin allergies too. The natural products industry, with which I am intimately associated, has decided that tea tree oil is OK – after all, it’s natural – and parabens are not. They are “chemicals”.

The paraben “scare” was based on the fact that parabens were found in the breast tissue of women with breast cancer, even though no causal association was established. Presumably milk might be found in cancerous breast tissue too, but does that mean that milk causes breast cancer? No, the fundamental reason for banishing parabens was that the popular press decided that parabens very likely caused breast cancer. Like a starving rottweiler with a bone, journalists, especially in the UK, decided that parabens should be banned, and they have got their way. Bravo.

Why am I defending parabens? Because I abhor bad science. I do think there are potential concerns about parabens and hormone disruption, and I am NOT saying that I believe them to be completely devoid of risk. But then, nothing in this universe in completely devoid of risk. I’m just saying…what can we learn from this devastatingly effective media-driven campaign and its apparent ignorance of what is, and isn’t, sound science.

17 comments to The paraben parable

  • Robert,

    Thank you for shining some much-needed light on this issue of parabens, product preservation, and risk management.

    My response to a client whose product has enjoyed over ten years of safe and efficacious use, yet is still questioned in regard to the preservation system: “What some critics want for a cleansing product is turbocharged water. It still requires packaging and preservation.”

    It seems to me that you’re just saying that the answer to your final question above, which you have been practicing for many years, is: education, discussion, debate, and facilitation of scientific validation for essential oils and nature-based products.

    More power to you. You have my continuing support.

    Bill McGilvray
    The Australian Essential Oil Co.
    NSW Australia
    and
    Plant Extracts International Inc.
    Hopkins MN

  • Thank you Robert for sharing this content, I prefer not to use any product containing parabens, however I agree that we need more education, discussion, debate and facilitation in regards to essential oils, parabens & in fact any natural or synthetic ingredients.

  • Robert – first of all let me stay, I love your style of writing. Secondly, I appreciate your scientific view of the “bad science” behind lambasting parabens. My comments come from someone who has followed the course of parabens for about 8 years now. I am among many small and large personal care manufacturers who have no faith in and would like to kindly (or maybe not so) tell Skin Deep they don’t have a clue, they use no knowledge of an ingredient – essential oils for a good example, to grade an ingredient as a “bad” ingredient.

    That being said, while working on a project with a medical doctor who was asking me to formulate a cream as a carrier for his cancer preventative product, one of the partners, a research scientist at a well-known cancer research center (sorry, I signed a paper saying I can’t tell) who is very much involved in cancer research, advised us to leave out the parabens. He’s not going to get a grant to do such a study and, therefore, you won’t find a lot of science behind the fact. The incidence, as per Skin Deep’s site, of “developmental/reproductive toxicity, endocrine disruption and neurotoxicity”, is very small. However, you must consider that EVERYTHING you put on your body and/or clean with have in the past contained parabens. The effects are cumulative and over a course of many years of using these products, may very well cause problems. Can this really be proved with what most would consider “good science”? Would anyone pay to prove this? Well, I don’t think so.

    The other issue with parabens is I know personally and in dealing with other of my customers – they cause acne, pure and simple. Maybe not for everyone, but I’m thinking for a very large portion of the population they do. These people have been spending lots of dollars at the dermatologist for years, finding no answer or relief, when, in fact, just using natural, organic, paraben-free products is all that was needed – all along. I can personally attest to that and it is, in fact, why I started making my own products. Do I have funding to do research about this? Well..no..not yet.

  • You are no doubt aware that many natural products and aromatherapy companies have resigned as signers on the Compact for Safe Cosmetics because they don’t seem to be concerned about the opinions of their signers if they happen to challenge the position CFSC takes on any ingredient. Many of us see CFSC as overzealous and perhaps more concerned with their political positioning than actual consumer safety. None of us want to see unsafe products, but felt that their influence on Washington (especially the FDA Globalization Act) was not in the best interests of their small company signers. Not weighing in on the subject of parabens themselves; still wading through the scientific evidence, and agree that we see bad science, even in some of the more prestigious journals. Like to see your further thoughts on parabens with more detail if you find the time.

    Marcia Elston
    Samara Botane
    http://www.wingedseed.com

  • Robert,

    Thanks for adding your sane voice to the paraben debate. Parabens have been and continue to be used in food and medicine. Who is to say that the parabens got into the breast tissue from a cosmetic and not from an ingested food or medicine, or shots injected directly into the blood system…or even from the chemotherapy drugs themselves. Just because the parabens are in the breast tissue that doesn’t mean they caused the cancer.

    The EWG, a.k.a. Skin Deep, a.k.a.Campaign for Safe Cosmetics organization is on a mission to cause panic in consumers using bad science in order to push for more regulations. My guess is that they already have already volunteered their organization to be that extra layer of regulation.

    I’m just saying…

  • robert

    What we do know about parabens is that they have a weak hormone disrupting action in vitro and in rodents, that they are (still) found in a great many personal care products, and that they, or metabolites, are found in human urine and various body tissues. As far as I know, it has not been conclusively shown that the amounts to which humans are exposed cause hormone disruption that leads to, for example, low sperm count in men. The evidence seems to be accumulating in an unfavorable direction for parabens, but I am still of the opinion that the “cancer scare” tactics of the media were premature, ill-considered and unwarranted. I believe incremental legislation is preferable to sweeping, knee-jerk reactions as we saw with “allergens” in the EC.

  • robert

    I agree the CFSC, the EWG & Skin Deep tend are often overzealous in exposing the hidden toxins in consumer goods. Guilt by association seems to be viral. For example, “has been known to cause skin allergies” could mean that one person in 10 million reacted. It’s rather like the plethora of advertisements that claim “clinical testing has shown that up to 80%…” add your own ending. But, “up to 80%” of course means any number you care to pick that is lower than 80. And, if not guilt by association, then guilt by legislation, whether or not the legislation makes any sense. “Risk assessment” is what is supposed to happen, and it often does, though even there, sometimes the parameters seem to be pretty arbitrary.

  • I read the study that was done which caused all this hooplah. For one, no one mentioned that the drugs the cancer patients were taking contained parabens, and also, no other parts of the body were tested.

    As for parabens causing acne, I’d like to see that study and how much parabens were in the products these people were given. Diet, stress and a number of factors cause acne. I could see where parabens could be an irritant for some people and cause a reaction or rash, but to cause clogged pores, blackheads and whiteheads is interesting. There are a number of ingredients in lotions which can cause a reaction, so to isolate it to primarily parabens is quite hard to do.

    I do markets and I travel in a variety of different temperature zones so I use parabens in my water-based lotions. I only use 1% per batch of lotion. I get five 8 oz. bottles per batch which equates to 0.20% of parabens. The FDA okays up to 25% as being safe. Also, the studies done on the rats were given a huge dose of parabens beyond the acceptable human use. While there are so-called natural preservatives on the market, I’ve yet to see any that hinders the control of mold and bacteria like parabens. The one that does adversely affects the consistency of my lotion, so I don’t use it. The others only create a hostile environment for mold and bacteria. However, if you are in a very hot and humid enviroment with your products, that isn’t to say your products won’t get mold or bacteria.

    I have literature on parabens and I flat out tell people I use them, so far, I haven’t had a problem. If I find customers don’t want them, I have people I can refer them to. So far I haven’t seen enough evidence for me to jump on the “harmful” bandwagon.

  • I just saw this on NAHA’s blog: In vivo and in vitro studies have confirmed the ability of parabens to penetrate human skin intact and to be absorbed. The health risks from aggregate use of body care products containing parabens have been shown to include increased incidence of female breast cancer, interference with male reproductive functions, and increased development of malignant melanoma. Therefore, where possible, it is recommended to eliminate use of paraben-containing products. Darbre PD & Harvey PW. Paraben esters: review of recent studies of endocrine toxicity, absorption, esterase and human exposure, and discussion of potential human health risks. J Appl Toxicol. 2008 Jul;28(5):561-78.

  • robert

    Thank you Ann. The NAHA blog you quoted from is at http://tinyurl.com/yjc7er9 and the article it cites is here: http://tiny.cc/YD1LQ (then click on PDF). The article is a 2008 review of the risks of paraben exposure authored by Philippa Darbre and Philip Harvey. Darbre was widely vilified in the scientific and cosmetics communities for initially suggesting that parabens might cause breast cancer, with no compelling evidence to support that assertion. So presumably she has a vested interest in proving herself to be right.

    As the NAHA blog states, in their review they say that in vivo and in vitro studies have confirmed the ability of parabens to penetrate human skin intact and to be absorbed. But, Darbre and Harvey do NOT say that “The health risks from aggregate use of body care products containing parabens have been shown to include increased incidence of female breast cancer, interference with male reproductive functions, and increased development of malignant melanoma.” Nor do they recommend the elimination of paraben-containing products anywhere in their article.

    On breast cancer they write: “It has been suggested previously that chemicals with oestrogenic and/or genotoxic properties applied in bodycare cosmetics around the breast area could be a contributory factor in the rising incidence of breast cancer (Darbre, 2001; Darbre, 2003; Harvey and Darbre, 2004). Compelling evidence of a link comes from the disproportionately high numbers of female breast cancers which originate in the upper outer quadrant of the breast and which is the area to which underarm and bodycare cosmetics are targeted (Darbre, 2001, 2003).” So, the authors repeat their previous hypothesis, which may turn out to be correct, but is unproven.

    On male reproduction, they say that in utero exposure of male rat fetuses to butylparaben caused reproductive disorders, and that post-natal exposure of male rodents to butylparaben also caused reproductive disorders. The NAHA blog implies that a connection has been established in humans, and that a causal connection has been established with the use of body care products containing parabens. However, neither assertion is made in the article.

    On malignant melanoma they state: “…a potential involvement of parabens (alone or together with other oestrogenic chemicals in cosmetics including UV filters) should now be considered in studies of the development of malignant melanoma.” So, they are speculating that parabens might be a causative factor in skin cancer, and suggest that this should be investigated. Their speculation is based on reasonable, but so far circumstantial evidence.

    To repeat my previously stated position, I am not saying that parabens are devoid of risk. My own products are paraben-free, because I am concerned about probable hormone disrupting activity. But, I do not like the way the press jumped on the unproven connection with breast cancer. The NAHA blog may be based on evidence that has come to light since 2008, but it reads as if the cited paper supports the assertions made in the blog, which it does not. It is misleading, and only adds to the pool of misinformation and confusion circulating about parabens.

  • Suzanne

    My view has always been that we don’t yet know – so we cannot say for sure one way or the other at the moment. In my opinion, what is equally as bad as touting the proposition that parabens are “bad” is declaring as an absolute truth that they are not (and many therapists do this which I feel is just as irresponsible). We just don’t know yet.

  • Thanks Robert – for your usual detailed and well thought-out response. I think your last paragraph pretty much sums it up for all of us who manufacture personal care products. Of course it would be easier and cheaper to manufacture WITH parabens, but most of us are turning away from it for the reasons you state. Besides which, the public’s perception has already been drawn to the point there won’t be any turning back to parabens – my own personal opinion of course. Which, is the reason you initiated the conversation to begin with. I think we all agree on the media’s ability to persuade the public simply to get attention and for that reason only, with no real interest in whether what they write is true and accurate. Which brings us full circle back to the Skin Deep Database. In every magazine I pick up and look under the cosmetic review sections, the public is being told 100% of the time to go to Skin Deep for any and all information they need concerning ingredients and/or products to buy. When, in fact, I think we all agree it is, using your term, bad science and even to the point of no science. I don’t think we’ll be able to educate the public otherwise, though I try. Thanks again for taking the time to respond.

    Marcia – just one question – when you said “resigned as signers” – did you mean they re-signed as in signed up again, or resigned as in resignation type resigned? I think from the rest of your statement, you meant as in resignation, but just wanted to clarify that for myself. We resigned (as in resignation), but they still put our name up there just with no products. I’ve written them several times telling them we weren’t re-signing the compact. Now, with all the public thinking that’s the only place to go, I’m wondering if even though I don’t agree with them or their politics, it might be prudent to re-sign. Thoughts anyone? Our products don’t have any “bad” ingredients except their dislike for essential oils and not understanding their use. At least that’s how it was when I last checked, but that’s been at least a year ago.

  • Thank you for your feedback, Robert. I always appreciate the opportunity to take another look at the research and, like yourself, do not intentionally support the dissemination of misinformation and/or out-of-date research.

    Regarding my comments in the NAHA blog, my objective was to introduce the idea of potential toxicity and the ability of parabens to penetrate the skin, as some authors support. It was not my objective to make a direct claim that the Darbre and Harvey study, which asserts that parabens can cause breast cancer, is correct. Though you felt “The NAHA blog implies a connection has been established in humans,” to further clarify, in my article I was only confirming the ability of parabens to penetrate human skin intact and to be absorbed.

    Therefore, the assertion that “parabens are best avoided in our skin care products” is more an issue of common sense because we encounter parabens in a large variety of places (some we can control, some we cannot), such as in personal care products, plastics, our food, and the air. Therefore, I simply wanted to make people aware of the potential dangers of the aggregate accumulation of parabens (the combination of absorption of parabens into the body whether through primary or secondary absorption or from the environment). I also wanted to voice that one solution to help minimize potential health risks is to limit the absorption of parabens that we can control, such as those found in personal care products.

    As such, in our college store, the Apothecary Shoppe (www.apothecary-shoppe.com), we have chosen to support only paraben-free products. We do not endorse or carry any paraben-containing products, nor do I personally manufacture any line of products paraben-free or otherwise.

  • Denise - MCS Patient

    Chaeya – Comment made on February 11th, 2010 at 10:35 am

    The argument that parabens are an effective means for deterring the growth of mold and mildew, and that so little is needed to promote efficacy, is misleading. The real message being shared is that parabens are cheap to use which is a primary reason parabens are found in the majority of personal care products today.

    Using a safer, if any preservative and clearly informing the consumer of the product’s safe shelf life as indicated through a “use by date” may be a more healthy solution than the continued use of parabens.

    The defense of parabens offered by Chaeya seems reasonable in the context of one container of a single product. However, when extrapolated across the market to all of the products which contain parabens, the risk of harm becomes very real. Parabens are frequently included in shampoos, conditioners, hairsprays, deodorants, lotions, tanning products, cosmetics – both inexpensive drugstore types as well as high-end products touted as being dermatologist tested and pure. These are just a few of the products used by adults and children, the list could go on for pages.

    A 2004 article in the Journal of Applied Toxicology indicated parabens are believed to act like the female hormone estrogen. In high levels estrogen can cause women to develop breast cancer. The article also stated the only ingredient used more frequently than parabens in personal care products is water.

    Given the above, the average person is bombarded daily with parabens, and at net consumption levels far beyond even the US Government’s most optimistic safety guidelines. Keep in mind that the US Government’s guidelines are developed with an accepted incidence of illness. If the guideline of safety is 25%, the Government concluded that the population of Americans which will be afflicted with toxin related illness at levels below 25% is acceptable. Who in there right mind would want to be classified as such?

    The variable in this discussion is whether the Government’s guideline is based on good science. That is an argument for another day.

  • Dene Godfrey

    Although I have only discovered this blog rather late in the day, I would like to make a contribution, having studied the toxicity studies on parabens in some considerable depth. But first, I would like to make a general comment on the standard of this discussion – it is a refreshing change to see reasoned debate on a blog, rather than the hysterical nonsense that seems to prevail in many (most?) cases.

    Firstly, I am not aware of any published studies that prove, or even claim that parabens cause acne. If they were such a potent cause of acne, given the contributors (and others)assertion that they are ubiquitous in cosmetics (and foods and medicines), surely the vast majority of the female population would be suffering from the condition?

    Secondly, the argument that parabens are used because they are cheap is not supportable. They are used because they WORK! Until the publication of the Darbre study, there was no significant cause to even think about the safety of parabens, so the implication that manufacturers are/were disregarding safety in the name of greater profits is simply wrong.

    There is NO evidence of any accumulative effect from parabens – they have been shown to be metabolised (at least, in part) and excreted (in intact and metabolised forms). Darbre claimed bioaccumulation in her study, which was an unsupportable claim, as it was made on the basis of measuring a presence (and this is hotly disputed, but I can address this and the other fatal flaws in that study at another time, or you can check out my article in the March 2010 issue of Cosmetics & Toiletries) at a single time point. All this can possibly be argued to show is that the parabens may have been present. To demonstrate bioaccumulation, one would need to show that the concentration in the tissues increased over time, ie accumulated! This was not done.

    As I have run out of space, I will hold the rest for the next posting!

    A common mistake when discussing parabens is to refer to them as a single entity. eg “parabens are oestrogenic”. The most often quoted study (Routledge, E. J., Parker, J., Odum, J., Ashby, J. and Sumpter, J. P. Some alkyl hydroxybenzoate preservatives (parabens) are oestrogenic. Toxicol Appl Pharmacol. 153 (1998) 12 – 19) – and note the use of the word “some” in the title – determined that butylparaben (the most “potent” amongst the parabens) was 100,000 times weaker than oestradiol in a in vivo test. That in itself is a very weak effect, and should perhaps raise the question of whether that weak effect is of concern. Indeed, the lowest observed effect dose was the equivalent to a human weighing 60kg (134lbs) absorbing 40kg (90lbs) of a product containing 0.03% butylparaben (the typical use concentration) PER DAY. A typical exposure to butylparaben (based on COLIPA standard exposure of 17g of total cosmetics per day)is 4,000 times less than the the dose used in the study to give an effect 100,000 weaker than oestradiol. It would take over 100 years of daily use of cosmetics containing butylparaben to reach the dose level found by Routledge – and that is assuming that the butylparaben totally accumulates, which is proven not to be the case. These are simple, substantiable figures – I am not using esoteric statistics here. Does this not raise the question “what on earth is all the fuss about?”? Just for the record, the same study found NO oestrogenic activity for methylparaben – hence my point about not treating parabens as a single entity.

    It is all too easy to carry out a toxiclogical study and to find an adverse effect. Very few of the researchers seem to be concerned about the true context of the work – ie, what is the relevance to real life. In the case of the Routledge study, I would argue, given the figures above, that there is very little (if any) relevance to real life.

    Finally (honestly!) – an important point for Denise to note – having oestrogenic activity is NOT the same as being an oestrogen mimic. Oestrogenic activity is measured purely by the ability of a substance to bind to an oestrogen binding site. What it does when it is there is another matter. If it then behaves in the same way as oestrogen, then it is an oestrogen mimic, and there is possiblel cause for concern. If it does not behave in the same way as oestrogen (and there is evidence that the parabens behave diffently both amongst themselves, and from oestradiol), then this is a totally different situation. Even putting this aside, the comment was that “high levels” of oestrogen can cause women to develop breast cancer – Darbre claimed to have found a few nanograms (0.000000001g) – a level that has been dismissed by cancer specialists as insignificant. The weight of evidence in favour of parabens NOT being linked to cancer is extremely high, supported by the fact that every cancer research charity web site that I have visited specifically dismiss any claim of a link.

  • Thank you for this post. It is very important to avoid bad science and try to expose it when it happens. My ‘favorite’ Skin Deep moment was when I spotted that they’ve given Phenonip a safety rating of zero/green (when the parabens it is made up of are all red and orange and in the ‘bad’ camp)! I wrote to them and took a screenshot but received no reply about this inconsistency.

    The discussion in this thread has been useful and illuminating. What a wonderful group of contributors!

  • alice

    I really wish this post would show up as the first site in any internet search for breast cancer and parabens. I stumbled on this because I was trying to find out whether any other studies have reproduced the initial Darbre one that caused this hysteria (so far the answer seems to be no). I recently got into a bizarre online discussion with someone about the safety of parabens and genetically modified foods and after reading a couple of articles that they cited to support their arguments, I was extremely shocked by how poorly the studies were carried out, yet were being used as ‘evidence.’ I am an academic scientist, but in a completely different field, so I was hoping to find solid research on these topics. I am now deeply troubled by the barrier that seems to exist between the scientific community and the rest of the public (media included) – I feel that more trained scientists should have weighed in on this issue to explain the scientific consensus (as done by Dene Godfrey here) in a way accessible to the public instead of leaving it to journalists. And there is something about the cautious language scientists use, such as “there is no evidence to date that parabens cause breast cancer” that makes it sound like it’s only a matter of time before we do find this, or that no one has ever studied it so no one knows. And this is also mis-leading when there is a great deal of research supporting the safe use of parabens, which ought to be considered in any discussion. What people do with that information in the end is up to them, but I hate that the information is so skewed, and based on very shoddy studies.

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