the aromaconnection blog

Natural Beauty Summit tackles certification fragmentation

Cosmetics Design-Europe reported on the natural Beauty Summit held last month in New York with the headline Natural Beauty Summit tackles certification fragmentation.  We reported in this blog on the Summit before it happened, and although we were unable to attend, have been gathering information that goes beyond the sketchy report in CD-E, and we'll be reporting more in depth about the various standards and the process of their development in the near future.

Apparently the discussion got rather heated as the panel made presentations focusing on six different approaches to standardization for certification of natural and organic personal care products in North America: the USDA NOP, a Retailer's standard proposed by Whole Foods markets, Organic standards proposed by NSF and OASIS. CD-E referred to the NSF standard as being for consumer goods, but it appears to us to be equivalent to the OASIS standard and they seem to be two wheels on the same unicycle.

However, when it came to the panel discussion, Horst Rechelbacher, founder of Weleda and Intelligent Nutrients, and chair for the conference's first session on Sustainability, chose to challenge the panel on the fact that they were contributing to the fragmentation of the certification process and consumer confusion.

The panel discussion became heated, with Rechelbacher accusing the panel representatives of being self-serving and panel members defending themselves by explaining that the development of the market in the US had made private certification necessary.

Rechelbacher apologized for his comments, but stressed that he wanted to see greater regulatory harmonization.

The Natural Products standard proposed by the NPA apparently wasn't included in the discussion. As we pointed out in our discussion of that standard (see link) the orderly Standards development process mandated by ANSI isn't being followed by most of the standards developers. The one exception is the standard being proposed by NSF, which is going through the ANSI standards development process and has gone through it's first round of review, although the public has apparently not been brought in on the process yet. And neither have the independent small producers.

Coming soon: a comparison of the NSF and OASIS organic standards.

Technorati Tags: OASIS Standard,Body Care Standard,Organic Standards,Natural Product Standards

New Study Confirms psychoactive effect of [Frank]incense

A new study published in the The FASEB Journal, a journal of experimental biology

"found that incensole acetate, a Boswellia resin constituent, when tested in mice lowers anxiety and causes antidepressive-like behavior.” 

The press release goes on to cite this study as an explanation of how burning incense may have had a spiritual effect--a fact that is obvious to holistic aromatherapists. The significance of this study is that the study the mechanism that causes the effect was discovered.

There is an earlier study (2) on the anti-inflammatory effects of  Boswellia by the same authors that isolated the compound from Boswellia carterii, the common frankincense. The study authors suggest that the exact mechanism of the effect may be by activating TRPV3 that is found in neurons throughout the brain. TRPV3 is an ion channel implicated in the perception of warmth in the skin, as well as in the brain.

For this study, the incensole acetate was injected intraperitoneally into the mice, and then the mice were subjected to behavioral tests. A control group of mice that were known to be insensitive to TRPV3 stimulation was also used.

The psychoactive effects of frankincense are well known to aromatherapists, who are also aware that the the burnt resin has entirely different chemical composition than the essential oil components(3). Since the administration in this case was by injection and because incensole acetate is a (relatively minor - 2.3%) constituent of the essential oil there may be a different effect through inhalation of the essential oil; in any case this study did not address that. Reference (4) studied the Pyrolysates (burnt products) and found that insensole rises to 22% and incensyl acetate to 15.5%, so the effect may be greater when incense is used.

The study has been widely reported on in the scientific media, but as usual the press release was used as the major source and no one appears to have asked any interesting questions, which are answered in the full paper.

It would be interesting to see this study repeated using the essential oil.

References:

(1) Arieh Moussaieff et al. Incensole acetate, an incense component, elicits psychoactivity by activating TRPV3 channels in the brain, Published online before print May 20, 2008 as doi: 10.1096/fj.07-101865. Abstract at http://www.fasebj.org/cgi/content/abstract/fj.07-101865v1

(2) Arieh Moussaieff et al. Incensole acetate: a novel neuroprotective agent isolated from Boswellia carterii, Journal of Cerebral Blood Flow & Metabolism advance online publication 16 April 2008; doi: 10.1038/jcbfm.2008.28. Abstract at http://www.nature.com/jcbfm/journal/vaop/ncurrent/abs/jcbfm200828a.html

(3) Lis-Balchin, Maria.  Aromatherapy Science: A guide for healthcare professionals. Pharmaceutical Press: 2006. p. 193.

(4)  Basar, Simla. Phytochemical Investigations on Boswellia Species. Dr. dissertation. University of Hamberg 2005. Online at http://deposit.ddb.de/cgi-bin/dokserv?idn=975255932&dok_var=d1&dok_ext=pdf&filename=975255932.pdf

Technorati Tags: frankincense,aromatherapy,incense,how aromatherapy works

Furanocoumarins in Cosmetics: What’s all the Fuss About?

Copyright © Tony Burfield April 2008 

Preamble 

The EU Cosmetics Commission, well known for setting the pace worldwide for
(over-)-precautionary cosmetics legislation, is seemingly determined to limit furanocoumarins (FC’s) in retailed fragranced products to minutely low levels. This is because they consider that these materials present a potential photomutagenic & photocarcinogenic risk to users, when products containing these items are applied to the skin and subsequently exposed to sunlight. The IFRA proposals to limit FC’s in such products are being opposed by Cropwatch amongst others. Cropwatch favour no furanocoumarin restrictions for aroma ingredients, but propose reliance on an alternative warning label solution (‘only wear under heavy clothing’ or ‘if applied to the skin, do not expose to sunlight for 12-24h’). Major sources of FC’s in fragrances are citrus oils, especially cold-pressed citrus oils, and FC’s are especially prevalent in lemon, grapefruit, lime & bergamot qualities. We are also exposed to furanocoumarins from vegetables & fruit in the diet, which may also slightly increase our chances of developing adverse outcomes such as melanoma after sunlight exposure, or which may interfere with the metabolism of prescribed drugs (e.g. from consumption of grapefruit juice etc.). However, as we have learned, because of the way that the EU legislature is set-up & advised, more stringent precautionary legislation applies to cosmetics within the EU than it ever does for foodstuffs. 

Cropwatch FC Data-Base 

Because of the lack of accurate information on FC’s in aromatic raw material ingredients, Cropwatch has extensively updated its Furanocoumarins A-Z listing in Natural Aromatics (the latest update can be seen at http://www.cropwatch.org/FC A-Z.pdf). Cropwatch took on the task of constructing this data-base because of the relative unavailability of accurate information on citrus oil furanocoumarin distribution to essential oil users and to perfume formulators. As can be checked from the data-base, the information on furanocoumarins which IFRA/RIFM has previously published,  is often insufficiently detailed (in terms of botanical species, variety, geographical region, processing methodology and time of season) to be particularly useful. Cropwatch has also included its previous notes on the importance of citrus ingredients to the perfumery art, and also presents notes & references on photo-toxicological topics, as well as notes on individual FC’s and their occurrence in natural products.

The information on furanocoumarin concentrations within citrus & other aroma ingredients is needed in the light of IFRA's proposals, currently set before the EU Commission, whereby six major marker furanocoumarins have been identified by IFRA, and it is proposed that their concentration (in any combination) within retailed fragranced cosmetics should not exceed 5ppm for products left on the skin, and 50ppm in wash-off products. Although IFRA's proposals are slightly less severe than the previous blanket proposal by the SCCP to limit all furanocoumarins (whether phototoxic or not) & furanocoumarin-like substances (nobody knows what this definition means!) to 1ppm in cosmetic products across the board, they are still unworkable. In particular the FC proposals spell the end of the line for natural perfumery, as exemplified in traditional citrus colognes, chypres, fougeres etc. Eighty to ninety percent of male fragrances (and a smaller percentage of female fragrances) also contain citrus oils, and so will be severely affected also. But, since DG-Ent/SCCP has a history of rubber-stamping IFRA policy, it can only be assumed that EU legislation will eventually reflect IFRA’s proposals. However, Cropwatch has learned that many cosmetic companies are sufficiently brave and independent-thoughted enough to plan to simply ignore any rulings on future furanocoumarin limitation. 

As can be verified from the data-base, the degree of risk associated with the phototoxicity/photocarcinogenicity of furanocoumarin-containing essential oils, such as cold-pressed bergamot oil, has never been universally agreed amongst toxicologists & dermatologists, over the past several decades. Slightly modifying a passage from the data-base might be illuminating here. In 1988, Young et al. found that a bergapten induced tan is protective against the DNA-damaging effects of solar radiation (bergapten is a major FC in bitter orange, grapefruit, bergamot & other citrus peel oils). Following the finding that the use of bergapten applied in sunscreen enhanced the body’s natural protection for several weeks, even when the sunscreen plus bergapten use was discontinued, funds were provided by the Cancer Research Campaign & Laboratoires Bergaderm to develop a lotion to improve the body’s natural defences (Anon 1992). This product, believed to contain some 30ppm bergapten, was eventually trialed as reported in the media (Hunt 1992). However worries about the furanocoumarin photocarcinogenicity led the EC to order Laboratoires Bergaderm not to release their bergapten-containing Bergasol product onto the market past July 1996 (Goldemberg 1996), eventually forcing Laboratoires Bergaderm into liquidation. It is very difficult for Cropwatch to predict whether, on balance, this EC action subsequently caused deaths or saved lives. What it does illustrate is the rising power of non-technical, non-elected bureaucrats, who are even prepared to act in areas where there is not a 100% consensus of scientific opinion, against the policies of bodies like the Cancer Research Campaign (for references see the A-Z listing). [Thanks to Martin Watt for supplying articles verifying this story]. 

To recap the inadequate state of knowledge that we have on FC’s, the full range of identities of FC’s within many individual citrus & other essential oils (e.g. angelica & cumin) is still incomplete. The properties & phototoxic effects of individual furanocoumarins too are largely unknown, as very pure samples of the materials have been difficult or impossible for toxicologists to obtain. The mutual interactions of substituted coumarins & furanocoumarins within essential oils, their actions when applied to biological systems (the skin) remain virtually unexplored. Risk/benefit considerations of complex biological substances containing furanocoumarins are hardly touched on, and are unlikely to be since RIFM is only geared to evaluate risk, and the Cosmetics Commission still lives in the Dark Ages as it will not accept risk/benefit evaluations (although it will have to eventually). Further, three recent papers on the (pseudo)photo-plastogenicity of cosmetic ingredients (titanium dioxide, zinc oxide) highlight the fact that the methodology of these in vitro studies are seriously flawed – so much so that one group of researchers (Lynch et al. 2008 – see the data-base!) has called for an urgent review of phototoxicity testing techniques as applied to cosmetic materials. Yet, despite these fundamental detractions, some unseen hand appears to be cracking the whip over the EU Commissioners heads, who in turn appear to be exerting pressure on industry for answers & progress. But the science simply isn't there to justify any hasty and ill-conceived legislation on these matters. We don't even know how therapies involving furanocoumarins, such as PUVA, actually work. 

End Thoughts 

In summary, proposals to severely limit furanocoumarins in cosmetic products to such proposed minute levels mentioned above will prohibit the effective use of many citrus oil ingredients within fragrances. Many of us will see this eventuality as an act of cultural vandalism, and we known that many MEP's at Brussels, too, are concerned at the way the Cosmetics Commissioners are systematically wrecking our cultural heritage of high-art perfumery. Enough is enough. It is not the brief of the EU Cosmetics Commission to permanently damage the art of perfumery by denying perfumers the use of 'un-messed about' citrus ingredients, 

Cropwatch wishes to thank those who have contributed, and are continuing to contribute, information to the furanocoumarins data-base. Updates to the data-base will continue to be issued.

Tony Burfield for Cropwatch

Technorati Tags: furanocoumarins,fragrance,furanocoumarin,Cropwatch,citrus oils,EU Cosmetics Commission,IFRA

New Book "examines" Alternative Medicine

A new book due to published in England later his month (Trick or Treatment? Alternative Medicine on Trial by Simon Singh and Edzard Ernse, published by Bantam on April 21 at £16.99) is excerpted in the [London] Daily Mail with the title Are we being hoodwinked by alternative medicine? Two leading scientists examine the evidence.

Illustrated with a provocative photo showing oil being poured from a vessel containing a rose onto the back of a nude woman (suggesting Rainbow Therapy? or aromatic massage? or?) the authors claim to be evaluating the claims of alternative medicine "by using the principles of evidence-based medicine."

The article includes information on Alexander Technique, Aromatherapy, Bach Flower Remedies, Chiropractic Therapy, Hypnotherapy, Magnet Therapy, and Osteopathy and includes a sidebar on "Best and Worst Herbal Remedies."

It's hard to evaluate the information presented in the excerpt from the book prepublished in a newspaper, since there are no references given and the information presented is sketchy at best.  For example, the section on aromatherapy is:

• AROMATHERAPY

WHAT IS IT? Plant essences (known as "essential oils") are used to treat or prevent illnesses or enhance wellbeing. There are several ways of doing this. Most commonly, the diluted oil is applied to the skin via a gentle massage, but it can also be added to a bath or diffused in the air.

Aromatherapists believe that different essential oils have different specific effects. Aromatherapy is advocated for chronic conditions such as anxiety, tension headache and musculoskeletal pain.

DOES IT WORK? Some clinical trials confirm the relaxing effects of aromatherapy massage. However, this is usually short-lived and therefore of debatable therapeutic value. Some essential oils do seem to have specific effects. For instance, tea tree has anti-microbial properties. However, these efects [sic] are far less reliable those of conventional antibiotics. There is no evidence that aromatherapy can treat specific diseases.

I've had personal experience with several of the therapies covered in this article, and I'm sure that they work. In the case of Aromatherapy, Herbalism, and Magnet Therapy, I'm familiar with enough evidence to suggest that, when used appropriately, they do work.  I've experienced Chiropractic therapy, Massage, and Osteopathy and I can report varying success. I've also experienced our conventional allopathic medicine system with varying success. My personal opinion, as a user of these systems, is that an educated integrative approach is best. In theory, the sort of information included in this book is what is needed for the consumer to evaluate therapies so that they work with their medical providers to get the best possible care. Based on the summary of Aromatherapy above, it would appear to be nothing of the kind. I guess we'll have to wait for the book.

This book appears to be part of a well orchestrated campaign in the UK to discredit alternative medicine.  The same campaign is going on, to a slightly lesser degree, in the US. We've seen that in the media recently, as previously discussed in this blog.

 

Technorati Tags: aromatherapy regulation,alternative medicine,CAM

Aromatherapy Thymes Notable Launch

MrMagazine.com, a website/blog for the magazine industry, has declared Aromatherapy Thymes magazine as one of the "30 Most Notable Launches of 2007."

There are many health and medicine magazines jockeying for a position on today’s newsstands, but few give readers the type of information that Aroma Therapy provides which is why it has made it on the list of top launches for 2007.

Mr. Magazine has interviewed Patricia Carol Brooks, the Editorial Director, about the process of creating the magazine. She found her two biggest challenges to be "maintaining the integrity of the essential oil trade through informative articles and staying in contact with essential oil distillers in the U.S and abroad and coordinating the distribution channels for our market." By 2011 she expects the magazine to be "recognized worldwide as a reliable reference for aromatherapy and a publication that brought the distilling, trade, sell and distribution of essential oils to forefront."

There were a total of 715 new magazines launched in 2007, so this actually a fairly significant honor.

The blog link for the interviews is here. (The link above is to their web page, which is slightly abridged.)

The Definition of Natural

UPDATED

At a webinar presented by Perfumer&Flavorist Magazine last month, there was a discussion of the definition of "natural" when used in the natural products industry, which of course includes the natural aromatic products that are the focus of this blog. The webinar grew out of a similar discussion by natural products retail brand owners and suppliers that was featured in a Special Naturals & Organics issue of "GCI (Global Cosmetics Industry): The Business magazine for the Global Beauty Industry," a sister publication of P&F.

It turns out that the "Natural" Products Industry has not yet agreed upon a definition of what "natural" products are. There is reference in both the Webinar and the article referenced above to an effort to develop a "Natural Personal Care Products Standard" being put together by the Natural Products Association (NPA)and to be discussed at their National Lobbying Day to be held in Washington, DC on April 8.  Unfortunately the NPA didn't get their draft up on their website, so we can't link to the specifics. However, there are other definitions of "Natural" in use.

Burt's Bees has a definition posted on their website that is probably the draft, since the Chair of the NPA committee working on the Standard is from Burt's Bees. The draft requires that products labeled "Natural" must "be made with 95% truly natural ingredients, contain no ingredients with potential suspected human health risks, and use no products that significantly or adversely alter the purity/effect of the natural ingredients." "Natural" is defined as "Ingredients that come from a purposeful, renewable/plentiful source found in nature (flora, fauna, mineral) and using "Processes that are minimal and don't use synthetic/harsh chemicals, or otherwise dilute purity."

The standard goes on to define when non-natural ingredients can be used, and then provides a list of ingredients that should never be used, including (of interest to us because of their use in solvent extraction) Petro Chemicals, and finally to list Processes that should never be used: "Ethoxylation, sulfonation, polymerization and unfavorable varieties of quaternization — Industrial processes using caustic solvents that leave residual compounds and impurities that may end up concealed in the final consumer product."

The draft NCA definition is not the only one out there. The International Association of Natural Product Producers (IANPP) has produced two definitions, one for Natural Ingestible Ingredients and another for Natural Topical Ingredients. They are careful to set these definitions in a context that excludes "considerations such as safety, allergies, toxicity, animal testing, socially responsible packaging and business practices (fair trade, third world projects, responsible use and ingredient disposal, cooperative work environment), respect for endangered species, biodegradability/environmental friendliness, environmentally protective methods of production, etc." These, of course, are important, but in their opinion need to be considered separately from the definition of "natural."

The IANPP definition contains similar elements, but differs from the NCA definition in some significant ways:

• It doesn't deal with the issue of allowing a percentage of ingredients to not be natural. 
• It contains a more precise processing limitation: "Any changes to the original natural ingredient must not undergo changes in one or more covalent bonds during manufacturing and/or processing." 
• It requires that "solvents must be found in nature (originate from plant, animal or inorganic mineral sources) and the processing method must not introduce anything that is not of natural derivation" 
• It defines synthetic "as a substance not derived from natural sources with biological and/or accepted food processing/handling techniques 
• It lists acceptable and unacceptable processing methods (of interest to use, the acceptable list includes "cold pressing, ... natural water/alcohol extraction, ... extraction with natural solvents, expeller pressing (oils), steam distillation, [and] supercritical CO2 Extraction...." (ultrasonic extraction is missing from the list). 
• The unacceptable processing method list contains only two items: Gamma Ray Irradiation and Synthetic solvent extraction. 
• [I think they've made an error in their web page--under Gamma Ray Irradiation they list two bullets that seem to refer to preservatives], allowing Preservation by thermal, sound, or photochemical methods including microwave, ultrasound, UV, or infrared) but listing nuclear or thermo-nuclear preservative methods as Not Acceptable. 
• They don't list specific banned chemicals, but instead ban artificial/synthetic "additives, colorings, coloring agents, preservatives, antibiotics, hormones, processing aids, carriers, synthetically derived and/or processed contaminants from packaging, GMO’s or other non-natural ingredients" 
• Require that ingredients be "Be fully disclosed and documented regarding ingredient derivation and method of processing" 
• Include the words “preserved with” on the label regarding preservative ingredients.

As mentioned in the GCI article, there are some other definitions of natural that are being used by some companies. These all need to be integrated together with a public discussion of the issues.  The NPA intends to have a discussion, I'm sure, but so far it hasn't been out on the web where the small companies who may not be members of the NPA can access it.

I don't think either of the definitions discussed here are adequate to become the exact definition used by the industry. They use somewhat different approaches, and both contain elements that ought to be included. More discussion is definitely needed.

UPDATE: An attempt to contact the IANPP resulted in a response indicating that the IANPP has turned its project over to the NAP and that there should be some results by the end of this year.

Notes and News

• P&F has gleaned statistics from Datamonitor on the growth of  the Fair Trade market, stating that "ethical consumerism will increasingly come to the fore as people shop for products they feel akin to politically, ethically and aesthetically."  Aromatic extracts such as essential oils, CO2's and absolutes are not even on the radar screen with the  regulators such as Transfair  and flo-cert.  My report on Cote d'Ivoire cacao production revealed that determining abuses will not be an easy job. The P&F article predicts a 15.7% growth through 2012 for the countries covered, concluding that "transparency and trust will become increasingly important currency in the emerging  'green'  marketplace." 
• Insect repellent products made with  Nepeta cataria should carry a warning to caution people not to use when hiking in areas where Cougars, Lynx, Bobcats or other large cats are present.  All cats (even those big guys) are attracted to catnip, and forest rangers have begun using it to attract Cougars for tagging and research.  All cats will have a physiological reaction to the chemical compound nepetalactone in catnip which has been found to induce a psychosexual response in both male and female cats. One might say that catnip has an aphrodisiac effect, however some cats can be very possessive of their catnip, and some cats have been aggressive after use.  We highly recommend that product manufacturers alert their customers of this potential danger. 
• As reported by Jennifer Minigh, PhD, in ABC's (American Botanical Society) Herbclip, a recent double-blind, randomized and placebo-controlled trial published in BJOG (British Journal of Obstetrics and Gynecology 2008) shows that saffron Crocus sativus L. looks promising for treating PMS (premenstrual syndrome).   Using the dried stigma encapsulated, saffron was effective in treating mild to moderate depression via serotonergic mechanisms.  This is likely the first study of saffron's effects on PMS, with 50 women participating ages 24-50 and comparisons to other studies are therefore probably not possible. 
• An upcoming Sandalwood Conference to be held in Kununurra, WA  promises to  "Revolutionize the Global Indian Sandalwood Supply."  Rob blogged about this briefly when news of the crop development and establishment of a production plant in Kununurra came out in December.  This news is creating new excitement, as expressed by Georges Ferrando, from Albert Vieille, who says with a processing plant due to be built in Kununurra next year, the region will become a world leader within five years.  "India is number one in supplying sandalwood oil, but I think very, very quickly, Kununurra will become the supplier number one in the world".  The growers are expecting the first harvest in 2014.  The conference will  present comparisons of plantation-grown Santalum album to that grown in the wild, an overview of the international fragrance market, the uses of naturals in fragrance, setting standards for a reliable supply, as well as cover issues of indigenous participation and environmental responsibilities.  In addition to featured presentations, there will be round table discussions and plantation tours.

The kind of aromatherapy article we don't need

An article about aromatherapy and essential oils has been published on Mike Adams Natural News web site.  Entitled Raise Your Immunity Frequency With Essential Oils to Beat the Common Cold, the article appears to have been cobbled together from old Young Living web sites and brochures--a mixture of science and pseudoscience that could tarnish the reputation of the Natural News web site, which has risen quickly to an Alexa rank of under 50,000 since its inception in late January.

The electrical engineer in me (BSEE 1965) has struggled for years with the concept of frequency as applied to essential oils. I've read what Young Living web sites say (mostly derived from Gary Young's book Aromatherapy: The Essential Beginning), looked at Bruce Tainio's web site, and read a bunch of stuff about Royal Rife. Since most of these materials are written in general terms (using technical terms that may or may not be understood by the person quoting them), it's hard to figure out exactly what they mean. Tainio, on his web site, is obviously amused by what he sees as misuse of the concepts he developed

If you find information about the frequency meter or about Bruce's research that did not originate from us, or that is not included in this web site, it may or may not be entirely accurate. Please remember to take it with a grain of salt. We do!

At any rate, I am both amused and chagrined by the attempt to use the frequency theory to justify and explain essential oil use. Even if the theory is valid (there seems be a dearth of published research) the author doesn't do a very good job of proving her case.

From an introduction explaining about frequency, she cites some research showing that stress or negative attitudes increase the likelihood of getting a cold (probably true), detours into avoiding antibiotics because they don't control viruses (also true) and throws in a pastiche of facts about colds, and eventually arrives at a conclusion: Lo, essential oils have a high frequency and can be used to raise the body's frequency, thus making it healthy!

Citing in vitro studies done by Young Living staff that showed that essential oils have anti-bacterial and anti-viral properties, and French practices of internal use, she admits that "While this is an over-simplification of the serious medicinal aspects of aromatherapy, it is helpful, nevertheless, in demonstrating the effectiveness of therapeutic essential oils in the medical arena."

The article list several essential oils claimed to be effective against cold viruses, including oregano, thyme, fennel, juniper cinnamon, rosemary and clove. It isn't clear how the oils are to be taken, but internal use is implied by the wording. There are no safety warnings or even suggestions that the oils should be diluted or might be best dispensed by qualified practitioners. There is no direct link to Young Living as a supplier, but there is a link to the author's web site and from there a broken link to a YL site.

Certainly the world of aromatherapy would be better served by an article that is more in accord with confirmed scientific theories of aromatherapy and which provides precautions for use. I remember meeting a woman several years ago who had had a liver transplant because in her naive state she overdosed on herbs that destroyed her liver. The same thing can happen from high doses of conventional drugs or essential oils.

Technorati Tags: aromatherapy,essential oils

Pacific Institute of Aromatherapy Response to OSU Aromatherapy Study

Dr. Kurt Schnaubelt responds in detail to the OSU Aromatherapy Study at the Pacific Institute of Aromatherapy site (scroll down the page to find the article entitled "Aromatherapy Won't Make You Well, Study Shows or creating sensations by omission"). He distinguishes three aspects of the paper: The factual paper itself; the popular rendition in the press release as reprinted "ad nauseam"; and thirdly the issues

that can be raised about the purpose and meaning of a recent trend, in which studies like the one discussed here aggressively prove the lack of efficacy of natural remedies. In recent times a number of well financed and immaculately organized studies have reported that the efficacy of various important phyto pharmacons does not exceed that of placebo. Plant medicines demoted in this fashion include St Johnswort, Echinacea, Saw Palmetto and Black Cohosh and soon probably also Gingko. Publication of the negative results generally appear in high level medical journals and spawn endless repetitions in scientific journals as well as the mainstream press generating the impression that somehow all the inherited wisdom about plant medicine is a figment of the imagination, unfit to perform under scientific scrutiny. The aspect entirely omitted from this discussion is that the methodology of the studies is entirely unsuitable to demonstrate the efficacy of neither the whole therapeutic approach of phytotherapy (or for that matter aromatherapy) nor that of a selected plant extract.

Dr. Schnaubelt points out some of the shortcomings of the study and that the parameters studied "do . . . not truly relate to suggestions the aromatherapy literature makes about these two oils."

He takes on the Science Daily rewrite (which, as we have pointed out here, is actually an almost verbatim copy of the OSU Press Release) with pithy analysis closing with "If cultural critics were to look for a perfect example of rampant scientism, here is one!"

He then goes into a detailed discussion of the definition of Aromatherapy, the rejection of plant medicine by the pharmacological industry, and goes on to suggest that liver detoxification enzymes evolved as a response to the need for mammals to process out the essential oils in new plants they are eating.

It is ironic that plants are the native substrates having triggered the evolution of this enzyme system, which also removes the vast majority of all synthetic drugs. In todays medical literature this very enzyme system is generally referred to as drug metabolizing (!) enzymes creating the impression that somehow the removal of the synthetic drug is a feature that comes with its purchase.

This article is well worth reading and deserves a large audience.  It's too bad we can't get it as widely exposed as the OSU press release that stimulated it.

Technorati Tags: aromatherapy,lavender oil,lemon oil,essential oils

The OSU Aromatherapy Study-- the real story

Two recent posts (here and here) have documented the publication of a study entitled "Olfactory influences on mood and autonomic, endocrine, and immune function"  and an accompanying press release about it entitled "AROMATHERAPY MAY MAKE YOU FEEL GOOD, BUT IT WON’T MAKE YOU WELL". There have been a number of comments from Aromatherapists on some blogs and mailing lists about the study--mainly based on the press release. Although we are not necessarily defending the study here we feel that the study should be judged on its own merits (or deficiencies) and not on what the OSU Public Relations department has released to the public.

What the study is about

In the introduction the the paper, the authors cite two main references (Price and Price, 1999) and (Hirsch, 2001) with a few others, to define what aromatherapy is, and effectively limit the scope to inhalation aromatherapy, although that is not specifically stated. They cite three mechanisms for how aromatherapy works: Systematic effect theory that "posits that essential oils act like a drug or enzyme", immune function enhancement, and relaxation. They state that "efficacy data are scant, and potential mechanisms of action are controversial." After briefly reviewing some of the literature for lavender, lemon, and placebo (the three oils of choice for the study) they then set forth the exact parameters that they felt defined the study:

To compare and contrast the diverse perspectives about whether and how odors affect health, we examined the autonomic, endocrine, and immune consequences of one purported sedating or relaxant odor, lavender, one activating or stimulant odor, lemon, and distilled water as a no-odor control during both resting and “challenge” or stress conditions in a mixed or between-within repeated measures design; each subject served as his or her own control during three separate 6 h[our] visits. Depending on their random assignment, participants were either given no information about what odors they would be smelling or what to expect (the “blind” group), or they were told what odors they would smell and what changes to expect from the relaxant, stimulant, or no odor exposures (the “primed” group).

Our protocol for each session included a cold pressor, a laboratory stressor that elevates stress-related hormones, heart rate, and blood pressure (Blandini et al., 1995; Hirsch and Liebert, 1998). Both before and after the cold pressor we performed tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, a process mediated by both endocrine and immune systems (Choi et al., 2005). Our design thus provided a way to examine the ability of lemon and lavender odors to modulate stress and pain responses to the cold pressor, as well as wound healing via the speed of skin barrier repair.

In summary, they evaluated two essential oils and a water placebo via inhalation and measured some physiological parameters to determine if there were actual effects. The final paragraph of their introduction summarizes the predictions of results that they expected to obtain from the study and defines the parameters to be measured:

Specific predictions can be derived from the various theories posited to explain the effects of essential oils. For example, if the systemic effect theory is correct, even relatively short-term exposure to lavender would be expected to produce larger declines in the production of cortisol and catecholamines, faster skin barrier repair, lower pain ratings in response to the cold pressor, and smaller stress-related immunological changes compared to lemon and the no-odor control; short-term exposure to lemon oil should produce greater transient increases in positive affect, heart rate, blood pressure, and catecholamines than either lavender oil or the no-odor control. If expectancies determine the pattern of responses (Jellinek, 1997), then the primed group's mood and physiological responses to lemon and lavender odors would be greater than the blind group; similarly, those with positive expectancies about aromatherapy in advance of participation would be expected to show greater changes. By assessing olfactory influences on mood and autonomic, endocrine, and immune function, our design allowed us to contrast these diverse conceptual perspectives, clarify mechanisms, and assess possible clinical efficacy.

I'm probably push the boundaries of fair use in my quoting, but I want to be fair to the authors and it's really hard to summarize this stuff very well.  See what happened when they tried at the OSU Public Relations department, or even in the summary to the paper.

Methodology

I've reviewed the methodology and won't go into detail here, other than to summarize.  They had 56 participants in the study; they excluded people who might have adversely affected the study (such as those with no or a reduced sense of smell); they attempted to control any variations in methodology by standardizing the application of the oils and the measurements. One thing that I initially questioned was that they froze the essential oils (at -80C) and thawed only enough to use at the time of a session, but they did perform MSGC's on the oils at the beginning and periodically throughout the study to verify that there were no changes.  Dr. Robert Tisserand assured us that freezing should not be a problem causing variability. They obtained their essential oils from a Chemical Supplier, but they provided no specific lot or country of origin data. The vendor has online data available for other lavenders (a 40/42 that came from Russia, for example), but not for this one. The vendor has two lemon oils, but neither has the correctly spelled botanical name and it's not clear which one was used. There is no evidence in the paper that the oils used were appropriately of aromatherapy quality.

The paper describes in detail exactly how they measured each of the parameters; how the experimenters were blinded so they couldn't tell which odor was being used, and how the data were gathered. I'm not going to go into detail here; the methods appear to be adequate to the non-expert.  They've stated their methods of statistical analysis in general terms.  Since the study was peer-reviewed, we should probably assume that they got the data analysis right.

The method of application of the odors has been questioned. Since they applied the odor to the participants for a period of several hours, and during that time the participants were being tested, they needed a standardized way to apply it. So they applied 100 microLiter of the EO to a cotton ball and taped it between the nose and the upper lip on top of a piece of surgical tape barrier to avoid absorption through the skin. What wasn't made clear in the press release was that they replaced the cotton 4 times [at irregular intervals] during the study period to maintain odor strength and they removed the cotton ball for a lunch break, then applied a new cotton ball to complete the testing.

Another potential issue was the mention in the paper of placement of a "heparin well" in the arm of each participant at the beginning of the session and its removal at the end. Since heparin is a chemical anticoagulant (that has been in the news lately because of bad material imported from China), we were concerned that its presence might bias the results.  However, a Google search revealed that the well is merely an IV tube that is placed to allow easy access for taking blood samples during the study.  Apparently it's a common practice during research at OSU. There was no heparin introduced into the body during the testing.

Results

The results listed in the study summary were summarized so as to be difficult to understand to the lay reader.   The authors presented the results of each of the tests in either descriptive or graphical form. The results are subject to interpretation and that is done in part 4 of the paper, entitled Discussion. That will be covered in a future post.

Summary of Problems observed by me:

1. The source and characteristics of the Essential Oils used were not adequately stated and tracked. The authors took care to maintain the oil quality during the study, but there is no way to tell whether the oils were any good to start with. MSGC data should have been included in the paper as well. 
2. The odor strength was not uniformly and consistently maintained because the interval between changes was not standardized, and because of the lunch break. Even if it had been, it can be questioned as to whether it should have, since intermittent application is the usual mode in aromatherapy. 
3. The practice of continuous application of the odorant materials during the entire test is not in accord with my understanding of normal aromatherapy practice, although the paper seems confused on the issue, citing one intermittent study (Goel et al., 2005) and one with "short term inhalation," whatever that means. 
4. No trained aromatherapist was apparently consulted about the study. It might also have been useful to have the opinion of a trained aromatherapist as to the quality of the oils used and their suitability for aromatherapy.

References

(only these mentioned in this post are included here--the full paper has 41 references listed).

Blandini et al., 1995 F. Blandini, E. Martignoni, E. Sances, G. Bono and G. Nappi, Combined response of plasma and platelet catecholamines to different types of short-term stress, Life Sci. 56 (1995), pp. 1113–1120. Abstract | Full Text + Links | PDF (595 K) | View Record in Scopus | Cited By in Scopus (11) 

Choi et al., 2005 E.-H. Choi, B.E. Brown, D. Crumrine, S. Chang, M.-Q. Man, P.M. Elias and K.R. Feingold, Mechanisms by which psychologic stress alters cutaneous permeability barrier homeostasis and stratum corneum integrity, J. Invest. Dermatol. 124 (2005), pp. 587–595. View Record in Scopus | Cited By in Scopus (25) 

Hirsch, 2001 A.R. Hirsch, Aromatherapy: art, science, or myth?. In: M.I. Weintraub, Editor, Alternative and Complementary Treatment in Neurologic Illness, Churchill Livingstone, Philadelphia, PA (2001), pp. 128–150. 

Hirsch and Liebert, 1998 M.S. Hirsch and R.M. Liebert, The physical and psychological experience of pain: the effects of labeling and cold pressor temperature on three pain measures in college women, Pain 77 (1998), pp. 41–48. Abstract | Full Text + Links | PDF (60 K) | View Record in Scopus | Cited By in Scopus (13) 

Jellinek, 1997 J.S. Jellinek, Psychodynamic odor effects and their mechanisms, Cosmet. Toilet. 112 (1997), pp. 61–71. 

Price and Price, 1999 S. Price and L. Price, Aromatherapy for Health Professionals, Churchill Livingstone, Edinburgh (1999). Here in Google Books. 

Tisserand, 2008 Robert Tisserand, Personal Communication to blog author.

Technorati Tags: aromatherapy,essential oils,lavender oil,lemon oil

Aromatherapy Study portrayal on the blogs

The Ohio State University aromatherapy study press release referenced in the previous post, in spite of the fact that it actually confirmed that at least one essential oil, lemon, has an actual aromatherapy effect, is being reprinted or referenced in various blogs as proving that aromatherapy doesn't work.

Here are some of the titles of blog posts and Main Stream Media (MSM) articles picked up by a Google alert for the word "aromatherapy" (I'm not doing links, since most of the items are the same article):

• Aromatherapy may make you feel good, but it won't make you well (original Press Release Title currently at 892 hits--Click here to see the list) UPDATE: Wow! 13,100 hits at 5 pm Saturday UPDATE2: The number has dropped as of 3/25. Apparently Google refined the search.
• Study Finds Aromatherapy Doesn't Work 
• Aromatherapy can cheer, not heal 
• No advantages from Aromatherapy? 
• Aromatherapy Doesn't Fix Body, Study Says 
• Aromatherapy Stinks - kind of - and Other News 
• Aromatherapy's Effectiveness Questioned 
• Two Aromatherapies Don't Work 
• Aromatherapy Doesn't Work? 
• Aromatherapy can cheer, but not heal, says study 
• Does Aromatherapy Work? 
• Doubts cast over aromatherapy in new study 
• Does Aromatherapy Really Work? 
• Study Questions Effectiveness of Aromatherapy 
• Aromatherapy has no physical effects 
• Do Aromatherapy Products Work? 
• Aromatherapy Falls Short, Study Finds 
• Experimental Evidence Supports Runner's High; Aromatherapy...Not... 
• Aromatherapy is Woo 
• Aromatherapy, a Bunch of foolery? 
• Aromatherapy is Bullshit Malarkey, Sez Prof. Malarkey! (And He Should Know!) 
• No Advantages from Aromatherapy? 
• A whiff of scent is no cure for what ails you

I could continue for a long time if I go on to related stories that Google doesn't index directly. And I actually found a few benign headlines. Pravda, for example, has a neutral title: "New study evaluates efficacy of aromatherapy." Another article is entitled: "Aromatherapy makes you feel good, study."

These headlines are an indication that the authors of these blogs didn't actually read the article, or if they did read it selectively. It's a problem with blogging--you need to put a unique title (or so you think) and so you scan the article, throw out a title that reflects your first impressions, post the article, and move on. It's our policy on this blog not to directly reprint an article that someone else has already posted, without their permission. Particularly if we can link to it, which is usually the case.  But a lot of aromatherapy bloggers, or anti-aromatherapy bloggers, don't have those scruples.  Writing something original about something is hard work. Copying it and putting your name on something is easy--and it's also plagiarism. The several hundred newspaper reprints of the press release with the same title are probably not plagiarism, since it probably went out over the wire.

Anyway, this is what we have to put up with. . . .

Technorati Tags: Aromatherapy,media bias,lavender oil,lemon oil

Aromatherapy May Make You Feel Good, But It Won't Make You Well

Or so says a study by researchers at the Ohio State University that is spreading rapidly throughout the Main Stream Media and the Internet and is being cited as proof that aromatherapy doesn't work. Although I found it first on a blog about the convergence of Mormon beliefs and science, a little searching revealed that it has been extensively reported on MSM web sites and the OSU Press Release describing the study has been widely reprinted (621 Google hits for the title above), the most significant of which is ScienceDaily.

The study, published online in the journal Psychoneuroendocrinology, looked for evidence that such aromas go beyond increasing pleasure and actually have a positive medical impact on a person’s health.  While a massive commercial industry has embraced this notion in recent decades, little, if any, scientific proof has been offered supporting the products’ health claims.

This could have as wide spread a circulation as the NEJM article on Gynecomastia which has been discussed extensively on this blog a year ago. And unfortunately, as happened in the prior situation, there will probably be very little coverage of any intelligent criticism or further discussion that we might have about the results of the study.

Most of the wider media coverage is based on the press release, and it's likely that very few persons will read the actual study, because of the exorbitant fee charged to download a copy. The aromaconnection blog has sprung for the cost and I have actually read the paper. I'll need a couple of days to digest it but we will definitely be commenting further on it. My initial evaluation is that the methodology is valid, but that a study that is limited to only two essential oils is not the same thing as "Aromatherapy", but of course over-generalizations have never been rare in the media world or the Internet.

The abstract/summary of the paper is:

Despite aromatherapy's popularity, efficacy data are scant, and potential mechanisms are controversial. This randomized controlled trial examined the psychological, autonomic, endocrine, and immune consequences of one purported relaxant odor (lavender), one stimulant odor (lemon), and a no-odor control (water), before and after a stressor (cold pressor); 56 healthy men and women were exposed to each of the odors during three separate visits. To assess the effects of expectancies, participants randomized to the “blind” condition were given no information about the odors they would smell; “primed” individuals were told what odors they would smell during the session, and what changes to expect. Experimenters were blind.

Self-report and unobtrusive mood measures provided robust evidence that lemon oil reliably enhances positive mood compared to water and lavender regardless of expectancies or previous use of aromatherapy. Moreover, norepinephrine levels following the cold pressor remained elevated when subjects smelled lemon, compared to water or lavender. DTH responses to Candida were larger following inhalation of water than lemon or lavender. Odors did not reliably alter IL-6 and IL-10 production, salivary cortisol, heart rate or blood pressure, skin barrier repair following tape stripping, or pain ratings following the cold pressor.

If you'd like to find the paper on the Internet, you can find it on ScienceDirect by entering the keyword Aromatherapy. Right now it is the first entry.

Coumarin: The Real Story (Updated Jan. 2008).

Copyright © Tony Burfield 2006-2008
A PDF copy of this paper is available on the Cropwatch web site.

What is it?

Coumarin (2H-1-benzopyran-2-one) CAS No 91-64-5, is a crystalline white solid when seen pure, with a hay-like, sweet aromatic creamy odour with certain nutty shadings, much used in synthetic form as a fragrance chemical for perfumes and for fragranced soaps and detergents. Coumarin has a widespread occurrence in natural products too (see separate section below), and is a representative of the lactones (where a lactone is an ester group integrated into a carbon ring system).

 

References:

BfR (2007) – see http://www.bfr.bund.de/cd/10569

Born S. L., Rodriguez P. E., Eddy C. L. & Lehman-McKeeman L. D. (1997) “Synthesis and reactivity of coumarin 3,4-epoxide.” Drug Metabolism and Disposition 25, 1318-1323.

Carlton B. D., Aubrun J-C. & Simon G. S. (1996) “Effects of coumarin following perinatal and chronic exposure in Sprague-Dawley rats and CD-1 mice.” Fundamental and Applied Toxicology 30, 145-151.

Cohen A.J. (1979) “Critical Review of the toxicology of coumarin with special reference to interspecies differences in metabolism and hepatoxic response & their significance to man” Food Cosmet. Toxicol. 17, 277-289.

Fentem J. H. & Fry J. R. (1991) “Comparison of the eˇects of inducers of cytochrome P450 on Mongolian gerbil and rat hepatic microsomal monooxygenase activities.” Xenobiotica 21, 895-904.

Floc’h F. (2002) “Coumarin in Plants and Fruits: Implications in Perfumery.” Perf. & Flav. 27 (Mar/Apr 2002), 32-36.

Givel M. (2003) “A comparison of US and Norwegian regulation of coumarin in tobacco products.” Tobacco Control 12, 401-405

Hadidi H., Zalsen K., Idle J.R. & Cholerton S. (1997) "A single amino acid substitution (Leu160His) in Cytochrome P450 CYP2A6

IKW (2008) – see http://www.ikw.org/pages/prodgr_details.php?info_id=304&navi_id=km&subnavi_id=aktuelles&page_title=Körperpflegemittel

Kaighen M. & Williams R.T. (1961) "The metabolism of 3-14C coumarin" Journal of Med. Chem 3, 25-43.

Lake B. G., Gaudin H., Price R. J. and Walters D. G. (1992a) “Metabolism of [3-14C]coumarin to polar and covalently bound products by hepatic microsomes from the rat, Syrian hamster, gerbil and humans.” Food and Chemical Toxicology 30, 105-115.

Lake B. G., Osborne D. J., Walters D. G. and Price R. J. (1992b) “Identification of ohydroxyphenylacetaldehyde as a major metabolite of coumarin in rat hepatic microsomes.” Food and Chemical Toxicology 30, 99-104.

Lake B.G., Gray T.B.G., Evans J.G., Lewis D.F.V., Beamand J.A. & Hue K.L. (1989) "Studies on the mechanism of coumarin-based toxicity in rat hepatocytes: comparison with dihydrocoumarin and other coumarin metabolites.” Toxicology & Applied Pharmacology 97, 311-323.

Lake B.G. (1999) “Coumarin Metabolism, Toxicity & Carcinogenicity: Relevance for Human Risk Assessment.” Food & Chemical Toxicology 37(4), 423-453.

Lake B.G., Gray T.J.B. (1999) "Studies on the mechanism of coumarin-induced toxicity in rat hepatocytes: Comparison with dihydrocoumarin and other coumarin metabolites." Toxicology and Applied Pharmacology 97(2), 311-323.

Norman R. L. & Wood A. W. (1984) “o-Hydroxyphenylethanol, a novel lactone ring-opened metabolite of coumarin.” Drug Metabolism and Disposition 12, 543-549.

Steensma A., Beamand D.G., Walters D.G. et al. (1994) “Metabolism of Coumarin and 7-ethoxycoumatrin by rat, mouse, guinea pig, Cynomolgus monkey & human precusion-cut liver slices” Xenobiotica 24, 893-907.

Vocanson M., Goujon C., Chabeau G., Castelain M., Valeyrie M., Floc’h F., Maliverney C., Gard A. & Nicolas J.F. (2006) “The Skin Allergenic Properties of Chemicals may depend on Contaminants” Int Arch Allergy Immunol 140, 231-238

2. The NTEF’s campaign against the coumarin-containing Angel perfume2.

The Las-Vegas based NTEF (National Toxic Encephalopathy Foundation) has received some media attention over allegations that Clarins Angel perfume (Thierry Mugler) contains toxic ingredients causing (amongst others) ocular damage. It appears that NTEF president Angel de Fazio had filed a lawsuit in the District Court in Clark County Nevada against Clarins in October 2004 claiming that one spray of the company's Angel Parfum had left her permanently disabled (Montague-Jones 2007b). The same report reveals that, again allegedly according to Clarin’s legal spokesperson, de Fazio's claims had been dismissed in January 2007, the court ruling “that the allegations were without merit and brought in bad faith. She was ordered to pay Clarins $77,851 in costs, fees and sanctions”.

Earlier, Montague-Jones (2007a) had reported that the NTEF had stated that Angel Parfum fits the FDA definition of a health hazard because it contains the scent coumarin, which it considers to be a dangerous poison. The Aromaconnection blog (www.aromaconnection.org) also reported the story on 12th Nov 2007, informing that the FDA has accepted a petition from the National Toxic Encephalopathy Foundation (NTEF) to have Angel Perfume declared "Misbranded", and had asked that its importation be halted until the issue is resolved. Nina Immers posted a long comment to this carried item (Immers 2007) reeling off some well-known toxicology studies on the potential hazards associated with the uncontrolled use of perfumery ingredients. Searching for any comments relevant to Angel perfume, there is a statement that coumarin is hepatotoxic in mice because it is metabolised to coumarin 3,4-epoxide, which has been linked to tumour formation in rats, and it is claimed that there is evidence that this metabolic route occurs in humans. Although Cropwatch was initially doubtful about the validity of this point, we do think that this area needs to be clarified by further research, to examine whether there is a quantifiable risk to the small number of people that cannot detoxify coumarin by the 7–hydroxycoumarin route, as mentioned elsewhere in this document.

Cropwatch had some previous correspondence with de Fazio in Jan 2007, where we commented that the analysis of Angel perfume available at http://www.national-toxic-encephalopathy-foundation.org/oculartest0001.pdf. was extremely poor and that perhaps Cropwatch could have provided a more comprehensive analysis3. We also asked if any the components allegedly responsible for ocular damage caused by Angel perfume had been identified (actually stated as damage to the cornea), Angel de Fazio indicated (at the time)that this information was not available.

3 You could take the view that Angel by Thierry Mugler (Clarins) has the elements of a chypre fragrance (patchouli-evernyl accord), but more importantly is perhaps the first ground-breakingly successful "gourmand" fine fragrance. It is very sweet, having chocolate, red berry, praline, vanilla & cassis aspects. In a comprehensive analysis, you might expect to find veltol, patchouli, evernyl, hedione, frambinone, vanillin, canthoxal, a cassis base and certain lactones present.

Cropwatch was uncertain why Angel perfume had been particularly identified for criticism since there are fragrances still currently available arguably with higher coumarin contents - for example the original "Joop Homme" (Joop 1989) or "Le Male" (Jean Paul Gaultier 1995). Further, an NTEF press release on Aug 27th 2007 seemed to confuse the actual ingredients in Angel perfume with allergens required to be disclosed by labeling. A further NTEF news release of 27th Oct 2007 by de Fazio that maintaining that coumarin is a harmful perfumery ingredient is supported by Jack D. Thrasher, Ph.D., who is described as a "Toxicologist/Immunotoxicologist/Fetaltoxicologist". Unfortunately almost all the supplied references supposedly supporting the case do not actually concern coumarin at all - they concern coumarins such as warfarin, so Cropwatch can’t see this feature actually contributes anything to the case. Nevertheless Montague-Jones picked up the NTEF suggestion that coumarin affected prenatal development & reported it in Cosmetic-Design (Montague-Jones 2007c), & subsequently the article was circulated to the membership of several perfumery trade organisations. We believe this story, which has nothing to do with coumarin, originates from two studies by Wesseling et al. (Wesseling et al 2000; Weisling et al. 2001) which refer to pre-natal etc. exposure studies to the oral anti-coagulants acenocoumarol, phenprocoumon & coumadin (WarfarinÔ) (“coumarins”), and acenocumarol & phenprocoumarol respectively, all of which are capable of crossing the placenta and may affect the central nervous system. Coumarin however is not an anti-coagulant (Feuer 1974).

To summarise, Cropwatch believes that the NTEF haven’t (yet) made a convincing case that coumarin is a dangerous perfumery ingredient presenting quantifiable risks to cosmetic users.

2.Adapted from the author’s blog posting on www.aromaconnection.org

Coumarin-containing Natural Products.

Coumarin occurs widely in natural products, generally being liberated from the corresponding glycoside (melilotoside) on drying coumarin-containing herb material. Dicoumarol is a microbiological biotranformation product in spoiled Melilotus Clover and other hay products, and its presence in fodder at >10ppm is cause for concern, as it is responsible for fatalities by hemorrhaging in cattle. This is because dicoumarol interferes with vitamin K reductase in the liver and the liver is unable to reactivate vitamin K, which leads to a decrease in vitamin K-dependent clotting proteins. The study of this compound paved the way to the discovery of anti-coagulant drugs such as warfarin.

Coumarin occurs widely in natural products; the following natural aromatic materials are of note:

Some Natural Coumarin Sources	Notes
Anthoxanthum odoratum L. Flouve oil	Both essential oil and absolute produced.
Carphephorus odoratissmus (J.F. Gemel)syn Liatris odoratissima Mich. syn. Trilisia odoratissima (J.F. Gmel.)Cass. Deer tongue or Liatris	1.6% coumarin. Ratio of coumarin: dihydrocoumarin: 2,3 benzofuran in volatile fraction of extract 1:3:20(Appleton & Enzell 1971).
Cinnamomum cassia J. Presyl. Cassia oil	Coumarin 4-11% (Burfield 1999). Coumarin to 8.73% (TNO 1996) Eu Pharm V (2) allows 1.5 to 4.0% coumarin in cassia oil monograph.
Cinnamomum zeylanicum Cinnamon bark & leaf oils	To 0.3%; rarely to 0.7%.
Dipteryx odorata (Aubl.) Wild. & sometimes D.oppositifolia Tonka bean absolute	1-3%, or up to 10% coumarin in tonka beans (Hagers Handbuch 1973); also dihydrocoumarin, o-coumaric acid, ethyl & methyl meliotate etc (Ehlers et al. 1996). Tonka absolute contains up to 65% coumarin
Galium odoratum L. syn. Asperula odorata Woodruff absolute & concrete	Variable; coumarin content develops on drying herb, although headspace of freshly cut woodruff found to be 80% coumarin (Surburg et al. 1993). Used in alcoholic beverage flavourings (e.g. vodka).
Hierochloe odorata (L.) Beauv Sweet grass	Use to flavour vodka in Russia.
Lavandula spp. Lavender & Lavandin qualities.	Lavender absolute to 8.0% coumarin; lavandin absolute to 5.0% coumarin. Spike lavender oil to 0.3% coumarin.
Lolium perenne L. & other spp. incl. Phleum pratense (Timothy grass), Poa pratensis L. (Meadow grass), Cynosurus cristatus (Crested Dog’s-Tail), Anthoxylum odoratum L. and Melilotus spp. Foin oil.	Essential oil and absolute produced. Foin essential oil contains some 8% coumarin.
Melilotus alba Medik. Bokhara Clover, or White Sweet Clover	Less used than Common Melilot (q.v.)
Melilotus officinalis L. (Pallas) Common Melilot or Yellow Sweet Clover	0.9% coumarin on dry weight basis. Wagner (1996) says 0.25-0.45% coumarin in herb, together with umbelliferone, scopolin etc.
Mentha spp. Peppermint oil	20 ppm (TNO 1996)

Table 1: The occurrence of coumarin in some common herbs & natural products.

Coumarin also occurs in trace amounts in the oils of:

Billy Goat Weed Ageratum conyzoides L.
Sweet wormwood Artemisia annua L.
Mugwort Artemisia vulgaris L..
Carrot Seed oil Daucus carota L. ssp sativus (Hoffm.) Arcang.
Champaca Michelia champaca L.,
Narcissus spp.
Clary sage Salvia sclarea L.

Melilotus leaves from Melilotus officinalis L. have been used to flavour snuff & tobacco. Tonka bean absolute, deertongue absolute & melilotus absolute find some uses in perfumery, but woodruff absolute is no longer much used, apart from flavouring wines. Coumarin derivatives such as the sweetly herbaceous 7-hydroxycoumarin (umbelliferone) also occur in natural products (e.g. in lavender absolute from Lavandula angustifolia) but derivatives like herniaren are banned by IFRA.

Coumarin in Flavourings.

Use of coumarin and coumarin-containing herb extracts was common in earlier times. Walter (1916) relates the use of woodruff extract from the fresh flowering herb in the preparation of lemonade, but remarks that it tends to be weak and prone to cause turbidity, and gives an alternative recipe for woodruff flavouring constructed from synthetic coumarin, alcohol and tonka bean tincture. Use of woodruff extract in cola, caramel, gooseberry and other flavourings is also detailed, and the use of tonka essence containing coumarin, vanillin etc is also outlined for flavouring of fondants.

Earlier reports of the toxicity and carcinogenicity of coumarin are now believed to be due to impurities, but coumarin is banned in foods in USA (21CFR 189.130), Japan, India, & the EC, and was banned in Germany from 1970 to 1991 (the ban is now replaced by a concentration limit) etc. Since many derivatives of coumarin are commercial poisons, e.g. warfarin, the well-known rat poison, it has been difficult to persuade people of coumarin’s safety. However a detailed discussion of the beneficial uses of Melilotus extract & coumarin in phytotherapy (and there are many) & any remaining toxicological issues are given in a Meliltotus monograph by Mills and Bone (2000).

The FDA dubiously identified coumarin as a carcinogen in 1954. Subsequent studies initially upheld this opinion, but then disproved it. The net result is that because of the controversy (see elsewhere in this document), it cannot be added to foods (although it is famously naturally present in many, including spices (cinnamon), cherries, apricots, green tea, licorice & strawberries!).

In the EU, flavourings are regulated according to the Articles of the European Council’s Directive on food flavourings. Coumarin was placed in Annex II of this Directive (88/388/EEC) in 1988, which was subsequently amended by 91/71/EEC and implemented into UK national law in the Flavourings in Food Regulations 1992: You might remember, that coumarin had been restricted with respect to its allowable concentration in foodstuffs because of allegations of (non-linear dose related) rat & dog carcinogenicity which occurred at high levels of coumarin administration. These considerations caused the regulators to limit coumarin concentrations in food & beverages to 2 mg/Kg, except for limits for chewing gum (50 mg/Kg), alcoholic drinks (10mg/Kg) & caramel confectionery (10mg/Kg). However the EU Scientific Committee for Food (1997) recommended the lowering the coumarin limit to the limit of detection in food, (then 0.5 mg/Kg). However, we know that the metabolism of coumarin proceeds through a different major route of 7-hydroxylation in humans compared with the 3-hydroxylation pathway in rats (Cohen 1979, Fentem & Fry 1993, Kaighen & Williams 1961, Lake et al 1989), further species to species differences being investigated for example by Fenton & Fry (1993), who found that a hepatotoxic route involving 3-hydroxylation and involving a 3,4-epoxide occurs in the rat, but not in baboons, gerbils, some strains of mice, and man. This hypothesis had also been muted by Steensma (1994) amongst others, and was further explored in Lake's paper with Gray (1999), who fed dihydrocoumarin to rats (which cannot form the 3,4 epoxide metabolite) and found no hepatocarcinogenic effect. As was discussed in detail earlier in this document, the existence of genetic polymorphism in humans with regard to the existence of different metabolic detoxification routes for coumarin has brought us to a situation where EFSA has recommended at TDI for coumarin of 0-0.1 mg/Kg body weight.

Coumarin in Perfumery.

Coumarin has a history of importance in perfumery, being the first synthetic (synthesised by W.H. Perkin 1868) to be used in a fragrance - Fougère Royale (Houbigant), where coumarin was combined with lavender, citrus and woody notes.- and since that time coumarin has been fundamental to the fougère perfumery accord, together with lavender and bergamot oils. Synthetic coumarin is used in large volumes in fragrances.

Coumarin has been approved for perfumery use, but was identified as a fragrance allergen by the SCCNFP/0017/98, although many perfumery professionals have refused to believe that pure coumarin is an allergen (see below). Coumarin has been regulated within the 7th Amendment of the Cosmetics Directive (76/768/EEC) such that coumarin requires labeling if present at concentrations of >10ppm in fragrances leave on products, or >100 ppm in fragranced products washed off the skin. Floc’h et al. (2002), Vocanson et al. (2006) & Vocanson et al. (2007) have published data supporting their view that pure coumarin is not a sensitiser, but rather it is impurities that elicit any alleged reaction (see below), an opinion which is widely accepted by the technically-minded in industry, but not, apparently, by the SCCP.

Coumarin as a Sensitiser (?).

An article by François Floc’h et al. (2002), of Rhodia Perfumery & Specialities, looked at pure coumarin applied in homogenous form to the skin of animals and humans, and concluded that coumarin is not a dermal allergen. Coumarin was one of the items you will remember cited in the SCCNFP position paper for Fragrance Allergy in Consumers (SCCNFP/0017/98 final Dec 1999) as being a skin sensitiser, this being the conclusion of previous COLIPA and RIFM opinions. Previous work by Malten K.E. et al. (1984), De Groot A.C. et al. (1988), Larsen W. et al. (1996), and Van Joost T et al. (1985) on coumarin was also reviewed by François Floc’h et al. who commented, amongst other things, on the lack of scientific rigor, and found no statements of the purity of the materials previously used, and who questioned the homogeneity and the stability of the coumarin in petrolatum suspension. Floc’h et al. further indicated the above work failed to distinguish allergy to coumarin and cross-reaction to allergens for which coumarin might be an indicator.

The SCCP Opinion on coumarin as a sensitiser SCCP/0935/05 (adopted 20th June 2006) considers whether coumarin of >99.99% purity had any sensitising properties (industry claims that it doesn’t), & if it doesn’t, whether the Opinion on Fragrance Allergy SCCNFP/0017/98 would need to be changed. The committee concluded that coumarin of 99.9% purity when patch tested at 2% would be able to elicit allergic contact reactions in humans.

A further published paper from Vocansen et al. (2007) on the non-allergenicity of pure coumarin, indicates that dihydrocoumarin, an contaminant of impure coumarin, promotes cell proliferation in the LLNA test whereas pure coumarin does not. The authors state that “that pure coumarin is endowed with very weak sensitizing capacities, if any, and suggest that the presence of contaminants in coumarin preparations may account for the previously reported allergenic properties of coumarin.” All we need now is for the SCCP policy on this issue to come in line with the available evidence (don’t hold your breath).

Cropwatch Comments (from July 2006).

Although the SCCP Opinion heavily criticises various published papers/abstracts/posters by Vocanson et al. (2006), Masamoto (2001), CIT (2001) & INSERM (2003/2004) on regarding alleged coumarin sensitisation on various grounds (i.e. is confusing, there is lack of evidence etc.), those very same remarks apply to their own Opinion. The SCCP document is poorly laid out with lack of clear headings, so that it is not immediately apparent what study you are reading about (until the reader has gone over the paper several times). [The key to understanding the Opinion is that new evidence is considered under various headings: Patch testing, Animal data & LLNA (local lymph node assay) studies, with the identity of the study under consideration confusingly set out in normal type face towards the right hand margin at the bottom of the relevant text (instead of as a heading at the top)]. The discussion 3.3.14 needs rewriting with clear references to the work they are criticising.looks half finished – sloppily, the Vocanson et al. paper is not fully referenced (full details below)

The SCCP Opinion that coumarin of 99.9% purity when patch tested at 2% would be able to elicit allergic contact reactions in humans, seem to us to be largely based on the findings of the study by Vocanson et al. (2006), who claim that they found a reaction of only one subject in 512 hospital patients to pure coumarin (although, on a quick read-through, the SCCP Opinion seemingly only accounts for 510). Commercial samples of coumarin with coumarin derivatives as impurities were found to be weak or moderate sensitisers by the Vocanson team. The SCCP seems to have seized on this one reaction and on the reaction of an individual positive from 101 patients positive to the fragrance mix (of which coumarin is not a component) as evidence that coumarin is a sensitiser. Crucially, the discrepancy between the Vocanson team’s finding of one positive and the SCCP’s reading of two positives is not explained, and presumably the SCCP did not bother to contact the authors for an explanation of why they had dismissed one of these positive reactions.

The SCCP wastes our time reporting on the evaluating an abstract by Masamoto (2001) and concludes, unsurprisingly, there is not enough evidence presented. The SCCP do not provide an explanation of why they were unable to obtain the full paper (maybe they are unable to cope with articles written in Japanese ?).

Cropwatch can only conclude the following:

1. That this SCCP Opinion SCCP/0935/05 only further establishes that the evidence for pure coumarin as a sensitiser is extremely weak. The SCCP defended their previous Opinion on coumarin only by nit-picking at the paper by Vocanson et al. (2006).

2. That criticism by the SCCP of the determinations of the purity of coumarin presented in the publications considered is a bit rich, considering Floc’h’s remarks (Floc’h 2002) that previous work up by Malten KE et al. (1984), De Groot AC et al. (1988), Larsen W. et al. (1996), and Van Joost T et al. (1985) had not paid any/sufficient attention to the issue. If the SCCNFP themselves had looked at the coumarin purity issue more closely in the first place, they would not have classified coumarin as a sensitiser in SCCNFP/0017/98 final Dec 1999.

3. We feel that the SCCP are now adopting a different set of evaluative criteria towards new submitted evidence on coumarin, in order to make judgments that support their previous Opinions – clearly they are being defensive rather than objective.

4. If the SCCP had contacted the authors of the papers on coumarin sensitisation that they were reviewing in SCCP/0935/05 for clarification/further information, it is probable that a different outcome would have resulted. The fact that this was not done has to be seen as having a political dimension.

5. The matter of whether it should be required by law that coumarin – a weak sensitiser at best - should need labeling as required under the 7th Amendment to the Cosmetics Directive, now needs investigation by Judicial Review. Further, the assumption that natural botanical products which contain coumarin are sensitising also needs reviewing; deertongue incoloure (which has a high coumarin content) was after all, previously reported non-sensitising by RIFM (Opdyke D.L.J. 1976)

References.

Appleton R.A. & Enzell C.R. (1971) “Triterpenoids & aromatic components of deer tongue leaf” Phytochemistry 10, 447-449.

CIT (2001): CIT/Study No. 21214 TSS/RhodiascentTM Coumarine/Rhodia Services – RSP 13 Dec 2001

Cohen A.J. (1979) “Critical Review of the toxicology of coumarin with special reference to interspecies differences in metabolism and hepatoxic response & their significance to man” Food Cosmet. Toxicol. 17, 277-289.

Clarke G.S. (1995) “Coumarin” Perf & Flav. 20, (Nov/Dec 1995) 23-34.

de Groot, A.C. et al. (1988) “Allergens in Cosmetics” Arch. Dermatol. 124, 1525-1529.

Ehlers D. et al. (1996) “Reducing the coumarin content of tonka bean extracts using supercritical CO2.” Int J. Food Sc & Techn 31, 93-95.

Felter S.P., Vassallo J.D., Carlton B.D. & Daston G.P. (2006). “A safety assessment of coumarin taking into account species-specificity of toxio-kinetics”. Food & Chem. Toxicol. 44, 462-475.

Fentem J. H. and Fry J. R. (1991) “Comparison of the e€ects of inducers of cytochrome P450 on Mongolian gerbil and rat hepatic microsomal monooxygenase activities.” Xenobiotica 21, 895-904.

Feuer G. (1974) “The metabolism & biological actions of coumarins.” Progress in Medicinal Chemistry 10, 85-158.

Floc’h F. (2002) “Coumarin in plants and fruits: implications in perfumery.” Perf.