August 11, 2008

EFFA’s Citral, Farnesol & Phenylacetaldehyde submission is thrown out by the SCCP

(Being an excerpt from forthcoming Cropwatch Newsletter August 2008)

by Tony Burfield August 2008.

Curiously ignored by the cosmetics trade press, whose hacks probably failed to understand its significance, the Scientific Committee on Cosmetic Products (SCCP) Opinion SCCP/1153/08 on Dermal Sensitisation: Quantitative Risk Assessment (QRA) for Citral, Farnesol and Phenylacetaldehyde (adopted 24th June 2008) threw out the ‘industry-proposed’ QRA approach for setting safe levels of exposure to citral, farnesol and phenylacetaldehyde in cosmetic products. The Opinion is extensively argued & fairly damning - the SCCP noted that the QRA approach is based on data from experimental sensitisation tests on humans e.g. the Human Repeated Insult Patch Tests (HRIPT) and that model suffers a lack of detailed method description, application experience, is not (yet) validated, and has no strategy to make it so. Epidemiological & experimental data are not integrated into the QRA model; & whereas the model allows for various product categories of exposure, the risks from aggregated exposure (including occupational exposures) are not considered. The SCCP further remark that there is no scientific consensus on the safety factors used. Perhaps most tellingly, the committee consider that safe levels of exposure to existing substances known to cause allergic contact dermatitis in the consumer should be based on clinical data and/or elicitation low-effect levels (Cropwatch comments: as has proven successful for nickel & chromium allergic contact dermatitis). In this light, the required data for citral, farnesol & phenylacetaldehyde was not forthcoming, in spite of a specific request made by Brussels for EFFA to provide it.(all that was provided were a series of model-generated numbers, the relevance of which, in terms of consumer safety, being unknown).

Cropwatch had previously put forward an objection to SCCP ‘expert’ committee over the EFFA submission (of IFRA QRA-based data) on citral, farnesol & phenylacetaldehyde, a copy of which can be seen at http://www.cropwatch.org/objectcitral.pdf. Cropwatch had maintained that this particular submission passed on by EFFA was uniquely important, because it represented first use of the QRA methodology in submissions to the SCCP ‘expert’ committee, to further restrict newly alleged allergens (a process we described as ‘sneaking allergens in by the back-door’). Since the existing classification of allergens under 2003/15/EC has proven so scientifically controversial, it seemed both inappropriate and extremely unwise to legislate to include further allergens in the Cosmetics Directive until the underlying science is better sorted out.

Background

To recap, a considerable head of pressure is building up over the apparent misclassification of a number of fragrance chemicals as allergens under Council Directive 2003/15/EC (the ‘26 allergens’ debacle) which is becoming impossible to ignore. Amongst the highlights of relevance here, you will remember that Storrs (2007) pointed out that the basis for inclusion of fragrance ingredients as allergens has never been defined by the SCCP committee, that Schnuch et al. (2004) have presented evidence showing that an number of fragrance chemicals listed in the ‘26 allergens’ debacle (including citral & farnesol), are rarely found as allergens, and that Sanchez-Politta et al. (2007) had indicated that there was little independent peer-reviewed evidence to support the case showing phenylacetaldehyde as a sensitiser. It is not immediately apparent therefore why EFFA chose to make this QRA-based submission in such an incomplete form, as they must have expected rejection. .

Perhaps at this point we should pause briefly, to explain some procedural theory. The QRA is basically an exposure-based methodology for dermal sensitisation risk assessment, a key component of which is consideration of the dose (of sensitiser) per unit area to determine sensitiser potency. IFRA has expressed its intention to employ this particular methodology "as the core strategy for primary prevention of dermal sensitisation to these materials in consumer products.” Allergic contact dermatitis itself is a skin disease which is classically considered to arise from a series of immunological events, the first being an induction process from a low-molecular weight chemical (for example, a component of an essential oil). Continued exposure to this chemical at a sufficient concentration gives rise to an elicitation process which results in the physical manifestation of the disease. Risk assessment models to predict the potential skin sensitisation potential of fragrance ingredients incorporate three factors: predicted no-effect levels of sensitisation under experimental conditions, an appropriately deemed safety factor, and an exposure assessment. No-effect levels can be derived from predictive tests to determine the sensitisation potency of fragrance ingredients using animal based methodology (as in the Murine Local Lymph Node Assay or LLNA), or by using humans volunteers via the Human Repeated Insult Patch Test (HRIPT). In the HRIPT, fragrance ingredients are tested at ten times the use level on healthy human volunteers – if sensitization occurs, the maximum permitted level is taken as a tenth of the no effect level - but the HRIPT test is now considered an unethical procedure. Results obtained in the LLNA test can be mathematically treated to give an EC3 value (the concentration causing a threefold increase in the lymph node stimulation index) which is obtained by linear interpolation of the LLNA response data; these values being used to give an estimate of sensitiser potency, or to rank contact allergens.

Overall Cropwatch has major concerns over the interpretation of data obtained from these procedures - amongst them are worries that these predictive tests do not sufficiently distinguish between (weak) sensitisers and irritants; that outcomes for single ingredients are highly dependent on test substance purity (which is causing on-going controversy e.g. in the cases of linalool & coumarin), and that, anyway, different animal-based tests (such as rat popliteal lymph node assay or PLNA) yield conflicting results to the LLNA. For example, the LLNA results categorise citral as a low to medium potency sensitiser, whereas Friedrich et al. (2007) found that citral was an irritant & not an immuno- sensitising substance at all, in primary positive PLNA responses.

Regarding the occurrence of the individual fragrance ingredients in question, we explained in our submitted objection detailed above, citral is a mixture of two acyclic monoterpenoids, neral & geranial, which can be regarded as branched chain aliphatic unsaturated aldehydes (cis- and trans-3,7-dimethyl-2,6-octadien-1-al). Citral occurs widely in varying component isomer ratios in many natural products including citrus oils, & concentrated and terpeneless citrus oils such as lemon oil & orange oils, in lemongrass oils, Litsea cubeba oil, black pepper oil, verbena oil, melissa oil, ginger oil, etc. etc. In layman’s terms, most people are regularly exposed to citral in their daily lives e.g. hand exposure occurs when peeling & cutting citrus fruits, and citral is regularly imbibed in the diet as a natural or synthetic flavouring component of some spices and in fruit-based or fruit-flavoured soft drinks.

Farnesol a common sesquiterpene alcohol component of many essential oils, the isomers of which may be typically be found to 4.5% in neroli oil, and to 1% in rose oil. E,E-farnesol also occurs in Santalum spicatum (Australian sandalwood) oils and extracts to 5% (subject to confirmation, IFRA quote to 8%), which distinguishes it from the lower concentrations found in the oil of Santalum album (E.I. Sandalwood). Farnesol is also an impurity in many commercial grades of bisabolol; Cropwatch has recently described [http://www.cropwatch.org/newslet8.pdf] the demise of the Candeia Plant (Eremanthus erythropappus) which was harvested to the point of extinction in the Atlantic Brazilian rainforest to furnish demand from the German pharmaceutical trade for its natural (-)-a-bisabolol content.

Phenylacetaldehyde has a piercing green odor, which on dilution is reminiscent of hyacinths, and is a minor component of many essential oils and fruits – for example it occurs at up to 5% in the headspace of the sweet-pea blossom, Lathyrus odoratus.

Concluding Remarks

To sum up, it remains to be seen whether the SCCP committee will be able to stick to the principles enshrined in their Opinion SCCP/1153/08, in the face of inevitable pressure from industry, and are able to insist that clinical evidence be provided which shows that allergic contact dermatitis is unequivocally linked to exposure effects from specific fragrance chemicals. If they are able to maintain this, and the required forensic examinations of the available clinical & experimental evidence are independently carried out, the list of allergens fulfilling the required allergenic listing criteria could be very short, and the committee will need to reverse their own previous Opinion on allergens & make changes to Directive 2003/15/EC. Meanwhile IFRA plunges even deeper into its predictive QRA-based sensitiser policy, with the announcement of the 43rd IFRA Amendment (a summary of which will be put out by Cropwatch shortly). Remember, in spite of the pretence of a state of voluntary regulation, IFRA & EFFA members are required to fulfill the requirements of the IFRA CoP to the letter, right or wrong. Overall therefore, the casual observer could be forgiven for thinking that the gulf between toxicological theory/conjecture about sensitisation issues, and the link to robust clinical evidence, is becoming an ever-wider chasm, and we are merely observers in a power-struggle between toxicologists & regulators. Cropwatch pessimistically believes the outcome is inevitable - the regulators salaries depend on the continual passing of new legislation (whether it is appropriate or not) and the data-providing toxicology machine is now the most powerful force in the aroma/cosmetics world. One way or another therefore, aroma ingredients will continue to be restricted & prohibited unnecessarily. The status quo is maintained by the attitude of the fragrance customers, who seem to worry little about whether legislation is either scientifically sound or fair, they just want to know that the fragrance providers are following the current rule-book.

Friedrich K., Delgado I.F., Santos L.M.F., Paumgartten (2007) "Assessment of sensitisation potential of monoterpenes using the rat popliteal lymph node assay." Food & Chemical Toxicology 45 (2007), 1576-1322.

Sanchez-Politta S, Campanelli A, Pashe-Koo F, Saurat JH, Piletta P. (2007) "Allergic contact dermatitis to phenylacetaldehyde: a forgotten allergen?" Contact Dermatitis 56(3),171-2.

Schnuch A., Uter W., Geier J., Lessmann H. & Frosch PJ. (2004) "Contact allergy to farnesol in 2021 consecutively patch tested patients. Results of the IVDK." Contact Dermatitis. 50(3), 117-21. Schnuch A. (2005) Öko-Test, No. 7 (July) 2004, 55

Schnuch A., Uter W., Geier J., Lessmann H., Frosch P.J. (2007) “Sensitization to 26 fragrances to be labelled according to current European regulation. Results of the IVDK and review of the literature.” Contact Dermatitis. 57(1), 1-10.

Storrs F.J. (2007) “Allergen of the year: fragrance.” Dermatitis 18(1), 3-7.

Posted by Tony Burfield on August 11, 2008 in Essential Oils/Plant Extractions, Regulatory Issues, Safety/Toxicity | Permalink | Comments (0) | TrackBack

UN Numbers for Essential Oils

United Nations (UN) Numbers are four-digit numbers used world-wide in international commerce and transportation to identify hazardous chemicals or classes of hazardous materials.

A friend asked me how to determine what these numbers are for essential oils, since the number is requested on the shipping forms from most shippers. After spending an afternoon researching the question, and realizing that it is rather obscure, I decided to share what I learned with the world.

The prefix UN is followed by 4 numbers ranging from 0000 to 3500,  There are also NA numbers usually starting with 8 or 9 that identify items that haven't been assigned an actual UN number. You may see the 4 digit number on a diamond shaped sign on a tank truck on the highway. Sometimes they are referred to as UN/NA numbers.

The problem with identifying the numbers for essential oils is there isn't a one to one correspondence between a UN number and an essential oil. A number of essential oils may fit into one UN Number. The UN Number is associated with the MSDS sheet for an oil, but there is no requirement to put that number on the MSDS sheet.

In researching this, I determined that there are at least six different numbers that can be assigned to a an essential oil: CAS. IUPAC, EINECS, FEMA, UN, and FDA. There is an effort to develop a Globally Harmonized System (GHS) for all chemicals. But that's another story.

I discovered an Excel spreadsheet on the website of the (US) Office of Hazardous Materials Safety. I downloaded it and analyzed it, but it didn't seem too useful for our purposes, since I could only find about 50 items out of over 3000 that might include an essential oil or an essential oil component. These are the classifications that essential oils fall into. But which ones?

I finally discovered a Word document prepared by EFFA (the European Flavor and Fragrance Association) as an introduction to its 2008 Code of Practice. When I went to the EFFA Home page, lo and behold--a link to this introduction and its 3 Annexes: Attachment 1 for chemicals, Attachment 2 for complex natural substances, and Attachment 3 for potential hazards from complex natural substances. The Attachments are Excel spreadsheets that can be downloaded. 

Right now I leave it to the reader to decipher what all the abbreviations mean.  If you are shipping essential oils, you can use the table in Attachment 2 to look up the UN Number, the Hazard Class, and the Packaging Group.  Then you'll have to follow the instructions of your shipper. Most shippers have training classes available for a nominal fee.

If you want to figure it out for yourself, the packaging rules for the US are included in the Code of Federal Regulations Title 49 Part 173. The HMT spreadsheet from the Office of Hazardous Materials Safety mentioned above tells you which Sections apply. For example, from the EFFA table you can determine that frankincense (called olibanum there) is UN1169, Class 3, Packaging Group III. If you go to the HMT table you will see that UN1169 is Extracts, Aromatic, liquid and for non-bulk shipping you need to go to section 203. The link to that is here. When you get there you can look up other sections by going to the top level and then finding the other section in the contents.

Note that all these regulations (in the US at least) only apply when you are shipping regulated hazardous materials in containers over 1 ounce. There are packaging rules here that you will have to meet for smaller quantities. There may be some other exceptions but I haven't figured them out.

The regulations are complex and figuring them out is difficult.  I hope this information helps you find your way through the jungle.  However, I take no responsibility if you don't get it right.

Posted by Rob on August 11, 2008 in Essential Oils/Plant Extractions, Regulatory Issues, Safety/Toxicity | Permalink | Comments (0) | TrackBack

August 02, 2008

Saturday Night Lavender Blogging

I found this while Googling bees and lavender to respond to a comment recently added to an old post from dave, who inquired about why bees become docile while on his lavender. He notes that some have died.

Has anyone else observed this phenomenon?

While I was Googling also found this link to Sleepy Bee Lavender Farm in Connecticut. Check out their link page for some good links for lavender growers.

Posted by Rob on August 2, 2008 in Essential Oils/Plant Extractions, Oil Crops | Permalink | Comments (0) | TrackBack

July 24, 2008

Cropwatch Five Years on

Part 1. Threatened Natural Aromatic Species

Cropwatch came into being around 2003-2004 in order to directly address concerns about the over-exploitation of natural aromatic ingredients, and their over-regulation by officials prone to the excessive influences of lobbyists from the pharmaceutical & chemical industries, from toxicologists & dermatologists, and, as we have learned to our considerable dismay, from various environmental groups. At present Cropwatch remains independent & non-financed, but with a level of popular support which we believe is (conservatively) over twenty times that of any industry-financed organisation. In order to summarise progress over the past 5 years or so of Cropwatch’s activities, we have divided the reporting into two parts: this part reporting on threatened natural aromatic species, and the second (in preparation) looking at the non-transparent world surrounding the over-regulation of our natural aromatic materials.

Threatened species

Since the essential oils industry/aroma trade has generally been either too shy to come clean about its use of commodities from threatened species, or is actually in denial about it, Cropwatch decided to write an article on the subject for the Endangered Species Update magazine in 2003 (see http://www.cropwatch.org/unethical.htm). This was well-received at the time, and article reviews were featured in leading trade magazines such as Soap, Perfumery & Cosmetics. Further work challenging individual companies who sell or use commodities from rare or threatened species has been on-going since 2003, with some limited measure of success, but when challenged these companies invariably fake surprise, become hostile or defensive, or plead ignorance.

Our major work in this area is the “Update on threatened aromatic plants used in the aroma & cosmetic industries” now in its corrected, expanded and updated 5th revision (93pp), and Cropwatch has the IUCN’s express permission to quote the Red List Status of the individual aromatic species identified. This 5th version includes an extended section on natural product status, & a revision of the alphabetical data-base of threatened species, including rosewood oil (see below for URL). Most of the points we need to make at this juncture are contained within this document. In the introductory lead-in, we quote Bobbi Low (2004) from the periodical Threatened Species: “Many problems in managing and protecting endangered species arise not from our ignorance of the species’ ecology, but from human conflicts of interest”.

Nevertheless, to counter any claims of ignorance, and also attempting to cover “human conflicts of interest”, Cropwatch decided to make collected information about threatened species available on its website in the wider public interest. To this end we have constructed an on-going series of periodically updated articles and data-bases, which either provide information on the subject, or point to where it can be found. Topics cover so far can be listed out as follows:

Extensive bibliography on agarwood (1st revision 2008: 35pp): http://www.cropwatch.org/agarbib2008.pdf

Agarwood files – chemistry, botany, microbiology etc. (2004) at: http://www.cropwatch.org/agarwood.htm

Extensive sandalwood bibliography (4th revision 2008: 67pp): http://www.cropwatch.org/santalum.pdf

Ambergris article (2005) at: http://www.cropwatch.org/ambergris.htm and (2006): http://www.cropwatch.org/ambergrisupdate.htm

A short note on the ecological status of Cedarwood Atlas (2004): http://www.cropwatch.org/cedarwood.htm

Update on threatened aromatic plants used in the aroma & cosmetic industries (5th revision 2008: 93pp): http://www.cropwatch.org/v105.pdf

Exploited trees: some brief sketches (2006): http://www.cropwatch.org/cropwatch13.htm

Chinese medicine consumes threatened species (2005): http://www.cropwatch.org/tigers.htm

Rosewood sustainability (2004): http://www.cropwatch.org/cropwatch6.htm

Australian sandalwood oil: a tale of spin & hype? (2004): http://www.cropwatch.org/cropwatch2.htm

Documents in preparation include ‘Rosewood oil – the real story’ and ‘Misguided attacks on alternative medicine’ which is intended to include the still unfolding gynecomastia - lavender oil - tea tree oil situation. We are also in the process of preparing a ‘Threatened species in the natural drug trade’ data-base, although this will be a long task. We are always grateful for contributions, corrections or suggestions for any of these items, most of which are-, or intended as-, continuously upgraded living documents.

Sections on sandalwood & agarwood in the “Update on threatened aromatic plants….” particularly, go hand-in-hand with the extensive sandalwood & agarwood bibliographies listed above. You should be able to make your own minds up from some of this data about the claimed sustainability of commodities from certain species, and to learn the identities of some of the companies who are using these commodities.

Adulteration

Another topic that the aroma industry really doesn’t want to talk about is the widespread practice of the adulteration of essential oils and aromatic materials. Cropwatch presented (a subsequently much-plagiarised) account of this practice slightly updated at http://www.cropwatch.org/adulterationupdate08.pdf. Whenever natural aromatic commodities go short – as lemon oil is at present, due to widespread global crop failures – the natural ingredient buyer can particularly expect an increased risk of buying substandard, adulterated or blended material. The failure of the IFRA-RIFM-REXPAN hierarchy to have ever investigated the health & safety aspects of adulterated fragrance ingredients is shameful, and clearly illustrates the limitations & no-go areas for trade-funded, non-independent safety organisations. Unfortunately, the hapless regulators of the profession are almost totally dependent on organisations such as these for direction & technical information. But you would all know that already…….

Tony Burfield

Co-founder Cropwatch

Posted by Tony Burfield on July 24, 2008 in Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Oil Crops, Regulatory Issues | Permalink | Comments (0) | TrackBack

Essential Oils and Poison Center Reports

A note in the previous post referenced data about poison center reports for essential oils.  This piqued my curiosity, so I read the article in the New York Times and then looked up the original data to gain some perspective.

The NYT article turns out to be an opinion piece based on a book that appears to be part of Big Pharma's attack on natural supplements and natural products. The linked version is rife with corrections that had to be made after publication. The original article was trying to make the case that there were all sorts of "poisonings" that took place from vitamins, supplements, and natural products, and that this was a very bad thing. The corrections begrudgingly pointed out that the data were based on calls to poison centers, and were really about "exposures" and not about actual "poisonings." And they still didn't do a good job of putting it all in a real perspective, failing to mention that half of all poison reports are about pharmaceuticals.

I'm going to focus here on essential oils, which after all are the subject of this blog. Table 22 from the report lists the essential oils (I've omitted details on age, reason, and minor outcomes--look at the full report for that):

Essential oils No. of Exposures Adverse
Reaction
Treated in Health Care Facility Outcome Major/Death
Clove oil 446 22 101 0/0
Cinnamon oil 599 29 48 0/0
Eucalyptus oil 522 5 99 3/0
Pennyroyal oil 36 5 14 0/0
Tea tree oil 951 35 151 2/0
Other/unknown 4728 53 406 1/0
Category total 7282 149 819 6/0

Let's put that in perspective--this is out of 2,765,665 total exposures. There were only 6 cases with major outcome and no deaths. In the overall, approximately half of exposures (51%) were for pharmaceuticals, and 49% were non-pharmaceuticals. Essential oil exposures were about .0000263% of all the exposures.  Or for more perspective, there were 17,725 exposures to Soap, with 329 adverse reactions, 5 major outcomes, and no deaths. Perfume got 16,495 exposures, and there was actually 1 death.

The vast majority of EO exposures were to children under the age of six (5422 or 75%) with a smaller number (537) to older children and 1239 to adults. There is a good reason why we put a warning on the bottles about keeping out of reach of children, but I guess some people don't heed it.

The EO's broken out in the listing are probably the most common ones available and are sold in most pharmacies for a variety of uses. It would be unfair to assume that they are the most dangerous.

Just for drill, I looked at the 2006 annual report and it had similar data, with the total number of EO exposures rising slightly to 7377.

The problem with these data is that they are only the exposures actually reported, and in order to calculate the true risk we need to know the number of users. Ideally it would be good to be able to refer to the risk per 1000 users and compare it to other substances similarly. However, since we can only estimate the number of users, and there are no data here, we are just guessing.

The comparison to soap may be useful.  Everyone (well, almost) uses soap and has it available where it can probably be reached by children. If essential oils are just as safe as soap, then the roughly double exposure would suggest that half of people have essential oils in their home.  Since that probably isn't true, then we can assume that essential oils are less safe than soap.

The main thing we can conclude from these data is that we should keep essential oils out of the reach of children, and that they haven't caused any deaths.

Posted by Rob on July 24, 2008 in Essential Oils/Plant Extractions, Safety/Toxicity | Permalink | Comments (5) | TrackBack

July 22, 2008

Notes and News

  • Organic Monitor reports that there is an increase in the acreage of organic citrus groves in Florida. They focus on juice, but this should lead to better availability of organic citrus oils. 
  • The C.A.M. Report has resurrected the Lavender/Tea Tree Gynecomastia issue again, by reposting an old post from 2007 without updating it to include information about challenges to the original research. 
  • In the same post the C.A.M. report mentioned (without citation) a report that in 2005 essential oils were linked to 7,282 reports to poison control centers. UPDATE: JR forwarded the citation in a comment. He reported on this in the C.A.M. Report here. The article cited was here. The original source (PDF) of the data was the 2005 report of the American Association of Poison Control Centers.
  • A new blog on food and local agriculture has been added to our Agriculture Horticulture link roll: La Vida Locavore.  Worth checking out if you like food.

Posted by Rob on July 22, 2008 in Essential Oils/Plant Extractions, Lavender/Tea Tree/Gynecomastia, Notes and News, Weblogs | Permalink | Comments (1) | TrackBack

June 29, 2008

Pine Oil Tick and Mosquito Repellent

In one of those strange serendipitous moments that can happen with Google Alerts, I visited an article entitled "Tick and Mosquito Repellent Can Be Made Commercially from Pine Oil" which describes "a naturally-occurring compound prepared from pine oil" that deters mosquito biting and repels ticks.

After I read the press release, which contains the curious statement

Some segments of the public perceive efficient synthetic active ingredients as somehow more dangerous than botanical compounds, giving additional importance to the discovery of plant-based isolongifolenone.

my interest was piqued , so I read the patent which has been issued covering the preparation of the compound and "its use in repelling arthropods". Would this product meet the requirements of the NPA Natural Products standard? Would it meet the requirements of the NIRC definition of "Natural"? It's been over 40 years since I had my last chemistry course, but I think I can figure this out.

Reading through the patent, some interesting facts are revealed. Deet has long been considered the standard for mosquito repellency,

However, Deet is a plasticizer and clinical literature reports the association of Deet with neurotoxicity in humans (Robbins, P. J., and M. G. Cherniack. J. Toxicol. Environ. Health, 18: 503-525 (1986)). Thus, there is a great need for effective alternatives to Deet.

Essentially the process of producing takes isolongifolene, which is a naturally occurring component of Pinus longifolia, and converts it to isolongifolenone, which is also naturally occurring in smaller quantities. This is done via oxidation with tert-butyl hydroperoxide in the presence of a catalyst chromium hexacarbonyl. The process has a high yield but may not meet the natural standard because benzene is used to recover the catalyst (which itself is a considered toxic).

According to Wikipedia

In common with many of the other homoleptic metal carbonyls (e.g. nickel carbonyl and iron carbonyl), chromium hexacarbonyl is toxic and thought to be carcinogenic.

Tert-butyl hydroperoxide doesn't have its own entry in Wikipedia, but a search of the ToxSeek database reveals 143 entries.  Without detailed analysis, one can only conclude that it is a toxic hazard.

The NPA Natural Standard

To see what this means, let's look at the definition of natural in the NPA Standard:

Ingredients that come or are made from a renewable resource found in nature (Flora, Fauna, Mineral), with absolutely no petroleum compounds.

OK, that may work, except for the Tert-butyl hydroperoxide, benzene and the chromium hexacarbonyl.  A check of the NPA Standard's list of prohibited ingredients doesn't have any of those on it, except for the prohibition on petroleum.  We can only conclude from this standard that the isolongifolenone would only be natural if all the traces of either the catalyst or the chemical used to remove it are completely removed.

A look at the processes allowed or disallowed in the NPA Standard reveals that this process is not on either list.  Not surprising, considering that it wasn't known when the standard was written.

NIRC Definition of Natural

The NIRC definition of Natural requires a natural material to be "present in or produced by nature, produced using minimal physical processing, and directly extracted using simple methods, simple chemical reactions or resulting from naturally occurring biological processes."  Based on this part of the definition, our product would seem to pass.  However, the NIRC definition goes on to require that "Natural Ingredients are . . . not produced synthetically, free of all petrochemicals, not extracted or processed using petrochemicals, [and] not extracted or processed using anything other than natural ingredients as solvents."

So it looks like it won't meet this requirement either, even worse than the NPA definition, because of the petrochemical ban and the non-natural catalyst and solvent situation. Even if you could get all traces of the chemicals removed from the isolongifolenone, the processing is not natural.

Conclusion

Based on this analysis, the repellent isolongifolenone cannot be considered a "natural" product under the definitions of either the NPA or the NIRC.

Related Information

While researching this subject, I came across a 2005 Indian study on the effectiveness of Pine Oil as an insect repellent. The pine oils used in the study was analyzed, but didn't reveal the presence of either of the two compounds involved in the patent (they were probably included in the 13% unidentified ingredients. The paper states that pine oil is used traditionally as a repellent in India.

Posted by Rob on June 29, 2008 in Essential Oils/Plant Extractions, Research, Safety/Toxicity, Standards | Permalink | Comments (0) | TrackBack

June 05, 2008

Struggles of Honest Aromatic Crops Businessmen in Afghanistan

image Yesterday's 'Morning Edition' on NPR featured an heroic effort in the hills of Afghanistan by Shafiq Azizi and his business partners to grow and extract roses and other aromatics as an alternative for the poppy growers who trade in the world-wide heroin industry.  Hoping to set an example, they have expended frustrated efforts and a considerable sum of invested money.  Sounds idyllic, however, Shafiq  and Barnett Rubin (an Afghanistan expert and owner of the company that supports Azizi's efforts) are finding the prospect of legal business in Afghanistan is not so attractive to those already engaged in growing poppies.  Also, the corrupt Afghanistan government is hindering any progress or growth of the rose production for perfumery by soliciting bribes and unduly hindering their operations.  An initial $29,000 investment funded the first rose fields and the building of a commercial still, but major setbacks have the investors backing out.  Hopefully, local entrepreneur Abdullah Arsallah's determination to break the cycle of the drug business, and the willingness of a farmer in a nearby village, Haji Ibrahim, will revive the effort. You can read this complete report by Ivan Watson and view video.  We will attempt to keep an eye on this situation and report further progress.       

Posted by Marcia on June 5, 2008 in Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Human Rights, Oil Crops, Perfumery, Trade Issues | Permalink | Comments (0) | TrackBack

June 04, 2008

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

Posted by Rob on June 4, 2008 in Aromatherapy, Essential Oils/Plant Extractions, Incense, Research | Permalink | Comments (0) | TrackBack

May 18, 2008

Book Review: Medicinal and Aromatic Crops

Medicinal and Aromatic Crops: Harvesting, Drying and Processing Edited by Serdar Oztekin and Milan Martinov. Haworth Press: New York. 2007. ISBN 978-1-56022-975-9.

This book was published in 2007, but we recently obtained a copy for our library and realized that it should be in the library, or on the work desk, of anyone who is involved in the production or processing of medicinal or aromatic plants (acronymized in the book as MAP), or even those who have a curiosity about where essential oils come from or how they are or can be produced.

The book starts out with an excellent introduction to the issues involved in aromatic plant production and sustainability as the agricultural system changes from the previous norm of wildcrafted MAP to the more complicated processes of cultivation and the problems of assuring quality, purity, and safety with the transition from Good Wildcrafting Practices (GWP) to Good Agricultural Practices (GAP) which are often unknown to the farmers. There is a good discussion of related environmental issues. One shortfall is that there is no discussion of organic production.

The focus of the book is on mechanization, which the editors claim is generally neglected in the literature and in practice for a variety of reasons, but which should be considered not only to improve production quality  but to improve working conditions for workers. Manual and semi-mechanized methods are not neglected, and renewable energy sources are discussed.

The chapter on Extraction gives a good overview of all the processes commonly used for aromatic plants. The discussion of distillation is illustrated by a thorough description of the production of Turkish rose oil.

A chapter on Industrial Utilization of MAP unfortunately relegates Cosmetics, Perfumery, and Aromatherapy to four paragraphs, with Aromatherapy in a single (short) paragraph, hardly doing justice to the usage.

The book closes with a chapter covering the management of MAP agricultural enterprises and an Appendix discussing a software program that has been developed to assist farmers in the decision making process.

The book is well illustrated with photos and drawings, unfortunately in black and white, and is extensively referenced and well indexed.

Posted by Rob on May 18, 2008 in Book/Movie Reviews, Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Oil Crops, Regulatory Issues | Permalink | Comments (2) | TrackBack

April 28, 2008

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

Posted by Tony Burfield on April 28, 2008 in Aromatherapy, Essential Oils/Plant Extractions, Perfumery, Regulatory Issues, Safety/Toxicity | Permalink | Comments (0) | TrackBack

March 31, 2008

Botany Photo of the Day: Laurus nobilis

Laurus nobilis is the featured species at Botany Photo of the Day with information provided by Connor Fitzpatrick from the Global Facilitation Unit for underutilized species.   They are doing a series on underutilized plants.  Another species featured in this series is Sea buckthorn berry.

Posted by Rob on March 31, 2008 in Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Notes and News | Permalink | Comments (0) | TrackBack

March 26, 2008

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.

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Posted by Rob on March 26, 2008 in Aromatherapy, Essential Oils/Plant Extractions, Safety/Toxicity, Weblogs | Permalink | Comments (0) | TrackBack

March 25, 2008

Cropwatch Update on Citrus Oils

Citrus Oils: the Situation 

Cropwatch is directly opposing IFRA's Risk Assessment on furanocoumarins, and its proposals to severely restrict citrus oil usage in cosmetics products. Unfortunately, because of the lack of transparency exercised by RIFM, IFRA and the EU Commission over this matter. it means that unless you, dear reader, belong to a professional association, probably won't get to see IFRA's information letter IL799 on the topic, or the Risk Assessment that the EU Commission was given in late 2007 by IFRA. IFRA have apparently suggested a cosy future chat with the EU Commissioners, some unnamed industry moguls and fragrance consumers (presumably IFRA or RIFM members) to 'explain matters' - presumably code for agreeing their highly restrictive citrus oil proposals (see below) with the EU regulator. Nobody with an independent or contrary opinion is to be invited. 

In a nutshell, the alleged photo-carcinogenic & photo-mutagenic effects of furanocoumarins (mainly from citrus ingredients) contained within cosmetic preparations are causing concerns to the cosmetic regulators. The previous proposal with the SCC(NF)P 00329/00 Opinion to limit all furocoumarins & furocoumarin-like substances to 1 ppm has been dismissed on all sides as unworkable, since  not all fur(an)ocoumarins are phototoxic, and nobody has a clue about the furanocoumarin content of citrus ingredients they use. Nobody knows either, what "furocoumarin-like substances" are. Similar critical remarks apply to the next stab that the SCCP made at the subject (SCCP 0942/05). 

Now IFRA propose to limit any combination of 6 furanocoumarins markers in finished cosmetics, to 5 ppm for leave-on products, and 50 ppm in rinse off products. The 6 furanocoumarin markers are surrogates for the total furanocoumarin content of the cosmetic preparation, and are identified as follows: bergapten, bergamottin, byakangelicol, epoxybergamottin, isopimpinellin & oxypeucedanin.. In other words, the use of citrus oils in alcoholic perfumery is finished. IFRA are proposing to agree an analytical method for furanocoumarin estimation in cosmetic ingredients by Spring 2008. IFRA are also proposing the use of UV-absorbers to counter the phototoxic effects of furanocoumarins, but these are already in use for many categories of cosmetic products.   

Cropwatch Concludes... 

IFRA-RIFM are busy demonstrating to us all that they know as much about terpene chemistry as they have previously shown they do about botany! In the real world, furanocoumarin concentrations vary in citrus products from zero to several thousand ppm depending on processing, botanical origin down to varietal level, geographical location, growing conditions & history etc. Further, furanocoumarins interconvert & degrade during processing and in the finished cosmetic product, making matters even more complex. IFRA-RIFM have also been essentially dishonest in ignoring the fact that much of the citrus product on the market is adulterated, and they have not discussed the implications of this for furanocoumarin occurrence in citrus ingredients & the toxicological consequences thereof. Luckily the subject is extensively covered in the scientific literature by real experts in the field. 

Previous IFRA & RIFM statements (which are often conflicting) on citrus oil photo-toxicity and essential oil composition have been collected in the accompanying data-base document, together with independent findings from workers in the field. This will be progressively updated. 

Cropwatch has further collected items on individual furanocoumarins, and on relevant photo-toxicological topics so that (a) we assess whether IFRA-RIFM have properly represented the total available knowledge on the subject, and (b) so we can all follow the arguments presented. This will be progressively updated as well. 

Our main conclusion thus far, is that IFRA is not presenting a policy for citrus oils which is in the best interests of the fragrance industry. Rather, it is presenting over-precautionary safety proposal which is in the best interests of toxicologists. Much of the available scientific data available on furanocoumarins is slanted towards so-called 'evidence' from repetitive & relatively extreme medical treatments for serious skin diseases, such as PUVA. There is very little explanation of the relatively low incidence of adverse photo-toxicological effects from furanocoumarin-containing essential oils, the role & interplay of protective & anti-carcinogenic effects of the other components within essential oils, an area which is still little investigated & little understood. The essential oil & fragrance industry has thus been badly served by these developments & could have reasonably expected a vigorous defence of citrus ingredients, not their consignment to the dustbin. 

Cropwatch will continue to campaign for a sensible & proportionate policy for citrus ingredients. Cropwatch supporters outnumber the total IFRA, RIFM & EFFA membership combined and from the contacts we had with perfumers, soap-makers, cosmetics manufacturers etc., we believe they will ignore these proposed IFRA restrictions as both unworkable & unnecessary. . 

The Cropwatch Team

There are two attachments to this post:  Citrus Developments Intro 03.08 and FC's - distribution in aromatic plants

Posted by Tony Burfield on March 25, 2008 in Essential Oils/Plant Extractions, Regulatory Issues, Safety/Toxicity | Permalink | Comments (0) | TrackBack

March 24, 2008

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.

Posted by Rob on March 24, 2008 in Aromatherapy, Essential Oils/Plant Extractions, OSU Aromatherapy Study, Research | Permalink | Comments (0) | TrackBack

March 17, 2008

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.

Posted by Rob on March 17, 2008 in Aromatherapy, Essential Oils/Plant Extractions, OSU Aromatherapy Study, Research | Permalink | Comments (5) | TrackBack

March 09, 2008

Sustainable Development of Aromatic Plants in Laos

Environmental Impacts of Trade Liberalization in the Medicinal Plants & Spices Sector of the Lao PDR

While searching for something else, I happened across the above-titled paper (.pdf) posted on the website of the International Institute for Sustainable Development (IISD). A summary of the publication is available here.

The paper discusses medicinal plants and a number of essential oil species, including Agarwood, Vetiver, May Chang, and Cinnamon. An Annex at the end of the paper includes pictures of the manufacturing process (including the still) for Agarwood. One of the key findings is:

key issues facing this sector at present, include a lack of systematic and scientific approaches to harvesting, specific plans for cultivation and strict enforcement of laws and regulations, weak collaboration amongst concerned authorities (between central and local authorities and between public and private sectors), and limited awareness among rural people on the preservation of biodiversity.

Essentially, they are working on ways to increase medicinal plant and essential oil exports in a sustainable way.

Posted by Rob on March 9, 2008 in Ecological/Cultural Sustainability, Essential Oils/Plant Extractions, Oil Crops, Trade Issues | Permalink | Comments (1) | TrackBack