April 24, 2007
Update on CAM Guidelines
Almost before the ink was dry on the previous two posts, I received an update e-mail from the Natural Solutions Foundation. Apparently over 100,000 people have used the link here to send a message to the FDA, but the link is either overloaded or has been sabotaged. If you try to use the link and it doesn't work, you might try this alternative address here.
A request was made to the FDA to clarify the comment period, but the FDA has promptly responded refusing to do so. Thus you need to get your response in by April 30. UPDATE: Deadline has been exteded to May 29! See AAHF site for more details.
The update also includes information about the American Association for Health Freedom, and a link on their front page includes a lot more information and talking points about this issue that you may be able to use in your comments. Some of the points they make include:
The AAHF (American Association for Health Freedom) is concerned that "
1. [there be] A public hearing by the FDA before the finalization of the guidance.
2. Changing the title of the guidance to use the phrase "Complementary and Alternative Modalities" and not the prejudicial "Complementary and Alternative Medicine" as in the draft.
3. FDA recognize that "therapies that may benefit" are not the same as "treatment of disease" and do not have to be regulated as "medicine."
The page also includes a link to The Integrator Blog which I strongly suggest that you read before commenting. This article, entitled "The FDA's Guidance on CAM: What is the Appropriate Response?" puts the whole issue in perspective, suggests that perhaps the Internet has over-reacted to what the FDA claims is simply a clarification of the existing state of things, and warns of the danger of "crying wolf".
Both the AAHF and the editor of the Integrator Blog seem to feel that Congressional action may be more appropriate and necessary in the long run.
After reading all this stuff, my tendency is to comment and request an extension of the commenting date until at least July 1 so that more detailed comments can be prepared. And ultimately to follow on and work with the Health Freedom groups to get the federal and state laws changed to make things clearer and more acceptable of health freedom, and in particular aromatherapy.
Let CAM Continue to Develop Freely
This is the legal brief from the Natural Solutions Foundation mentioned in the previous post.
Let CAM Continue to Develop Freely
To: Food and Drug Administration
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard” allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard” model. The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds.
The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. That distinction is between “treatment of disease” and “therapies that may benefit.” In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.” CAM is not “medicine”, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.” In fact, CAM seeks to shed the appearance of “medicine” which is not in keeping with CAM traditions and activities.
We request the FDA take the following steps: (1) hold public hearings on the proposed Guidance; (2) formally revise the Guidance title to replace the word “Medicine” with “Modality” and (3) use of the terms “therapy” and “therapeutic” with reference to Complementary and Alternative Modality health practices, instead of the words “treat” and “treatment of disease” which are used exclusively in the draft Guidance. The terms “treat” and “treatment of disease” are, in fact, antithetical to CAM therapies.
CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve and maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard approaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and "Dr. Mom" home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at "more efficient physiological integration and function of the human organism, leading to optimal wellness." This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness.
The terms “therapy” and “therapeutic” do not occur, for example, in the context of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not “diagnose, treat, cure or prevent” any disease. It does not specifically forbid the use of the word “therapy” (or “therapeutic”). Under the Supreme Court’s rule in the Thompson v Western Medical case, we should expect that these words would not be forbidden by the Courts and should not therefore be overtaken by the regulators.
Further, the Code of Medical Ethics of the American Medical Association also acknowledges an independent use of the term “therapy.” The original Hippocratic Oath, with its injunction to "Do no harm." has been replaced by a complex Code detailing the relationship between physician and patient and alternative practitioner. Changes made during the early 1990's were inspired by anti-trust lawsuits brought (and won) during the 1980's by chiropractors and other non medical practitioners. These changes are just now becoming recognized by regulators and courts.
While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to "refer" a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard. While physicians "prescribe" treatments for disease, therapies that may benefit may be subject to "referral" thereby further indicating the distinction. Thus, for example, Dietary Supplements that support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician. Purveyors may restrict sale of therapeutic products to physicians, complementary practitioners, exercise and health care professionals, although they should not be required to do so.
We have analyzed the word “therapy” and the similar word “therapeutic” because these words are not forbidden by DSHEA and are referenced by the AMA Ethics Code. We recommend “Therapeutic Nutritionals” for alternative practices centered on Nutrition. We recommend the use of the qualifying word, “Nutritional” in this context to make it completely clear that the practitioner is not offering “treatment of disease.”
The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law as interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – but can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes or affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of "truthful and not misleading" and must be based on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.”
As the High Court said in Thompson, "We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning..."
What is the proper level of substantiation for CAM nutrient or health claims? It is not the "significant scientific agreement" required of drug claims, but rather, the general "competent scientific evidence" standard that applies to all commercial claims. That does not imply that purveyors need to have multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of Dietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that "the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe. There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard” medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by a policy of Laissez-Faire: allow CAM to develop freely in the public interest.
Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, un-manageable and unreasonable costs and other invasive technologies of modern medicine. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed. This has been settled law for over a hundred years.
"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed, -- nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to our system as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment” and “therapy” if the US Constitution and public are to be served.
Dated: April 6, 2007
Maj. Gen. Albert N. Stubblebine III,
(US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
Ref: Federal Register: February 27, 2007 (Volume 72, Number 38
[Notices - [Page 8756-8757]
[wais.access.gpo.gov - DOCID:fr27fe07-95]
FDA vs CAM (Urgent Action Required)
The Food and Drug Administration (FDA) has posted its intention to put out a document on guidance on how they intend to regulate Complementary and Alternative Medicine Products (CAM) under the existing laws on the books. (The Food and Drug Act (Act) and the Public Health Service Act (PHS Act). One could presume that a clarification of this issue might be a good idea, but it appears that this is just another attempt by the forces supporting Big Pharma and allopathic medicine to regulate everyone else by declaring things are not medicine as "Medicine" and thus regulating them.
2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability
FR Type: Notice
Action: Availability.Guidance.Level 1
SUMMARY: The Food and Drug Administration (FDA, we) is announcing the availability of a draft guidance for industry entitled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." In recent years, the use of complementary and alternative medicine (CAM) products has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("the Act") or Public Health Service Act ("PHS Act"). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the Act or the PHS Act.
The Docket Notice is posted here. The actual document is posted here. I recommend that you download it and read it before preparing your comments. You can post your comments here. COMMENTS ARE DUE BY April 30 (actually they are legally required to allow more time because the clock doesn't start until they actually Publish the notice in the Federal Register, not on the date they approve it for publication--but this is the Bush administration, so it's not even worth mentioning that point--just get your comments in by APRIL 30!)
Response to this document from others
There has generally been a concerned response to this document among the blogosphere and alternative health sites. A cross section of the response is capsulized in the comments section to this Daily Kos Diary. There is more information available at the Democracy in Action Health Freedom Solutions site here, and they have a petition form that you can sign there to become a co-signer of their extensive legal brief that is in the little box at the bottom of the page. I urge you to sign this if you agree with it. However, it is generally more effective, in responding to documents such as this, to write and post your own comments in your own words. [Nothing prevents you from doing both].
So what does this document do?
The purported purpose of this document is to give "guidance" to citizens regarding the application of existing laws and regulations to the "groups of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine." It uses the classifications defined by NCCAM (biologically-based practices, energy therapies, manipulative and body-based methods, and mind-body medicine), defines a fifth domain of "whole medical systems", and discusses how these may be regulated as cosmetics, devices, dietary supplements, drugs, food, and food additives. They also state that CAM products are not exempted from regulation. In footnote (3) they state emphatically that mention of a CAM product of method in this document "should not be construed as expressing FDA [approval] of that particular [practice] or [that it] is safe or effective for its intended uses of safe for use."
The document goes to some length to define in detail how their regulations might apply to the various modalities (called Medicine by them) and what authority they have under existing law or regulations to regulate the modalities or their components. I'm not going to go into these in detail here (you can download the document and read it yourself here --a duplicate of the link above) but I will try to explain how it might apply to you and me in the following section.
How does this apply to aromatherapy and perfumery?
To the extent that perfume is a cosmetic (applied to the human body in any way, several of which are defined, for "cleansing, beautifying, promoting attractiveness, or altering the appearance") is definitely can be regulated as a "Cosmetic" so I won't talk much about perfume (for if perfume is used for treating something it is probably more accurately defined as aromatherapeutic).
Holistic aromatherapy can be defined as a "whole medical system" and contains or utilizes aspects of the other four domains. Use of essential oils is a biologically based practice; when elements of Chinese medicine or homeopathy are considered we are using an "energy therapy"; massage therapy is certainly a "body based or manipulative" therapy; and because aromatherapy can have spiritual or psychological influences it is a "mind-body" therapy. Although neither aromatherapy nor homeopathy are mentioned in the guidelines, we can rest assured that they intend that we are covered. And if aromatherapy doesn't fit into any of domains we can be sure that it is included as a "cosmetic" if it touches the body.
If you want to understand in detail how they intend to apply the existing laws to regulate CAM and thus aromatherapy, you need to read the draft guidelines. I'm going to rip through an interpretation of how tangled a mess it is, with or without the guidelines, as the FDA is currently proceeding:
If an aromatherapist makes any claims or diagnosis that an essential oil might be used to treat or affect a "disease", then the oil is a drug and can be regulated. If it is a "New drug" then it has to go through a costly approval process. If you use it in a "device" such as a diffuser, and make claims about it affecting a "disease" or of affecting "any function" of the body, then the device is subject to FDA approval. If you take an essential oil internally, then it is either a "food," a "food additive," or a "dietary supplement" and if you make any claims, then it can be treated as a drug. If the oil is on the GRAS (generally recognized as safe) list, then you can get by, but might still have to get premarketing approval. If you can meet the definition of a "dietary supplement" then you can get by if you add the notice about it not being intended to have anything with disease, and if you word your marketing materials "just so" you can probably sneak by. But it is a tangled web, particularly if we are trying not to deceive.
So what can we do about all this?
First of all, it is important to note that the laws that are referenced in the Guidelines are already on the books, and given the current political and social climate, it's unlikely that they will get repealed or even substantially changed. So what we need to do is attempt to influence the document via a massive public outcry. The Health Freedom movement is trying to get the word out to as many people as they can. Unfortunately a lot of people haven't understood the subtleties of how this is being put forward by the FDA. As Rima E. Laibow, MD and others point out, what the FDA is attempting to do is shift the definition of CAM from being therapy or a treatment modality to being Medicine. This is covered in detail in the legal brief they've posted here, but which is hard to read at that location. Since I haven't found it online in a readable location, I will post it below the fold in a new post here. I suggest that you read it, and sign and send it at their message sender here. But then go to the FDA Docket site here, and make your own comments in your own words.
Remember, the deadline is April 30!
April 21, 2007
Rapeseed (syn. Canola) Revisited.
For a few weeks at about this time of year, parts of England’s ‘green and pleasant land’ turns into a nauseous Day-Glo yellow vista, as farmers submit us hapless country-lovers not only to hideous horizon-wide visual onslaught, but also to our annual toxic gassing of unpleasant volatiles from rapeseed flowers (Brassica napus spp. oleifera) coupled with a seasonal overload of rapeseed pollen.
Uses - bio-diesel & cosmetics.
When the UK crop matures, some of the fixed oil produced is sold for bio-diesel, mainly to Germany, according to an illustrated article in a recent Guardian supplement (Blythman 2007). Elsewhere, it is quoted that some 40-60% of European rapeseed production goes to bio-diesel production (Mudeva 2006); Apart from France, Poland is also among top rapeseed-oil producing countries, its’ output being quoted as 1.49 million tons in 2004 (Krukowska 2004), although UK production is expected to top 2 million tons in 2008 (Blythman 2007). DEFRA have previously pointed out that 1 ton of rapeseed gives 0.38 tons of rape methyl ester (one possible bio-fuel, besides rape ethyl ester etc.). In other parts of the world, opposition to bio-fuels, especially bio-ethanol, has been vigorous (see Larouchepac 2006), but it hasn’t stopped the Canadian Agriculture minister in 2006 announcing $11 million in funding initiatives for Canadian farmers in biofuels opportunities (N.B. already 40% of the rapeseed grown in Canada is GM, according to Teitel 2001).
Supplementing diesel is apparently in line with the EU commitment to increasing the share of bio-fuelled transport to 10% (Kroeger, 2007), although this has bought criticism from many environmental NGO’s who say the policy will do more harm than good (Anon 2007). Some of these criticisms have been aired in the UK national press, such as the fact that land, which should be primarily set aside for food production, is being raffled off to appease the modern great God: the motor car. In a slightly different area, George Monbiot has criticized the UK government for not disqualifying palm-oil (which he maintains will actually worsen greenhouse gas discharges) from EU-driven bio-fuel targets (Monbiot 2006). True, a public consultation exercise on the bio-fuels policy topic was conducted by the EC (EC 2006), but as usual, the EC was more concerned with policy than practicality, and failed to ask views on the pertinent issues.
A small amount of rapeseed oil is used in cosmetics, especially in soap-making, as a carrier for fragrances in 100% ‘natural’ perfumes, and as a diluent for candle fragrances, in lamp oils etc. However considering rapeseed oil’s negative eco-associations above (nitrate leaching, crop spraying requirements etc.) this fragrance diluent usage stops at ‘natural’ perfumes and for obvious reasons does not extend to claims for ‘organic’ perfumes.
Rapeseed oil production – the negative aspects.
Committing a large area of agricultural land to growing rapeseed has a downside. Some of the issues here include:
1. The increased use of harmful crop sprays. Rapeseed is prone to widespread attack from a variety of insect & microbiological predators. An average crop might receive the following sprayings: 3 of herbicides, 2 of fungicides & 2 of insecticides per growing season (Office of National Statistics through Blythman 2007). Insecticides commonly used include glufosinate ammonium & the hormone disruptor vinclozolin.
2. Possible eco-damage. Rapeseed crop production is associated with higher demands for nitrogen & sulphur-based fertiliser application, and excessive nitrate leaching into water sources is associated with rapeseed cultivation, causing localised environmental problems. In addition, decaying rapeseed vegetation (in common with other Brassica spp.) is known to put thiocyanate into the soil (Brown & Morra 1993), & soils treated with defatted rapeseed meal were determined to yield 6µg/g of thiocyanate (Brown et al 1991), although please note that a determined chemical value for thiocyanate, & and its total bioavailability, may differ. Microbiological degradation over several days will offer the principle detoxification route for thiocyanate (Brown & Morra 1993).
However the Canadian Canola Board indicate that breeders of Canola varieties have reduced the glucosinolate contents in rapeseed meal (where the bitter taste of glucosinolates acts as a feeding deterrent). Already they claim Canadian Canola meal has only an average 16µg/mol total glucosinolates (and some years it has been lower than this), compared with traditional meal which contains 120-160µg/mol. Judging by the nitrile & isothiocyanate volatiles coming from flowering rapeseed fields in the UK, this sort of technology hasn’t yet spared UK citizens from their annual gassing.
3. The GM issue. Monsanto has been amongst those companies producing transgenic rapeseed varieties, modified to be resistant to RoundUp (known in Australia as RoundUp Ready canola). You may remember Monsanto previously hit the headlines when it prosecuted a Canadian farmer, who, it was claimed had allegedly infringed their property rights (wind-blown (?) GM rapeseed plants had appeared on his land). The judge, to the outrage of GM protesters, found for Monsanto (Teitel 2001), and although the case was later reviewed, the court still found for Monsanto (BBC 2004). The EC halted new approvals for GMO’s in 1998 due to intense consumer opposition, but the US filed a complaint at the WTO in 2003, supported by Argentina & Canada. The US action has been widely seen by EU consumers as bullying, and since the FDA has been involved in international GMO promotion, Cropwatch now sees this organization not as a reliable independent health authority, but as an authority hopelessly tainted by political influence.
In 2004 the EU introduced labeling & traceability procedures for GMO’s, but meanwhile the US has proved to be the leading source of global GM contamination. For example between 2001 & 2004 hundreds of tons of maize contaminated with Sygenta’s unapproved transgenic variety Bt10 were distributed world-wide and entered the global food chain, without the US authorities noticing for these four years…
The EC, in a totally undemocratic move, authorised Monsanto in August 2005 to be allowed to grow the GM rapeseed variety GT73 in Europe for 10 years, going against the wishes of the EU member states, 13 out of 25 of whom had voted against the proposal. The EU Commissioners seem, for unknown reasons, keen to promote GM technology throughout Europe, and are out of touch with the opinions of the majority of EU citizens who maintain a strong anti-GM stance. A more recent evaluation of the safety of GM canola, including the explaining away of increase in liver weights of rats fed GT73 canola, is to be found at FD Govt Au (2007).
The European Commission just recently authorized the Bayer Chemical Company to be allowed grow three GM rapeseed varieties in Europe for the next 10 years, modified to resist glufosinate ammonium.
And so it goes on….
4. Allergic Reactions
According to my unscientifically-based observations (i.e. talking to some UK GP’s), rapeseed pollen causes untold seasonal respiratory misery for a proportion of the (rural?) UK population, but this fact is apparently disputed by oilseed organizations. The scientific press shows little clear direction on the issue either – just a handful of articles, both for (e.g. Focke et al. 1998; Hemmer et al. 1997) and against (e.g. Guylling 2006) an allergic association. Previously Parrat et al. (1995) had shown in a Scottish study that allergic reactions were not directly related to airborne pollen levels, although Welch et al. (2000) ruled out cross-reactivity with grass pollen. Soutar et al. (1994) investigating 1000 people from the Aberdeen area had suggested the prevalence of symptoms was small and could be caused by chemicals from the crop chemicals. Similarly Murphy (1999) had concluded that rapeseed allergenicity only had a minimal impact on health. An article by Butcher et al. (1994) looked for possible aeroallergens/irritants & identified 22 volatiles from rapeseed flowers.
More recent studies paint a more illuminating picture, however. Children with IgE-mediated allergy to foods often show reactions to rape seeds in skin prick tests (pathways unknown). Puumalaein et al. (2005) have shown that 2S albumins (seed storage proteins) may be responsible for the rapeseed food allergy, and investigations characterising these proteins being investigated by Palomeres et. al. (2002). More recently, Fiorina et al. (2003) employed an in situ aerobiologic test to detect the presence of a rapeseed allergen, where routine tests had failed, and Hermanides et al. (2006) describe cases of occupational allergy to Brassica pollens.
It seems that science has yet to catch up with UK people’s anecdotal experiences of eye & upper respiratory irritation from rapeseed volatiles or pollen and offer some explanations. Or is there a conspiracy of silence? An excellent thread from 1996 on the Gentech archive (Gentech 1996) shows examples of academic unawareness (failing to find what published studies there are), UK ministerial indifference (no evidence, but revealed to be simply because of a lack of authoritative studies) and a surprising dearth of North American & Canadian anecdotal symptom reporting, in contrast to the UK experience. The Gentech article also provides 14 references related to allergenicity of rapeseed/rapeseed products – which had proved so hard for some authorities to find (err, no change there then!).
The persistence of public belief that rapeseed cultivation causes widespread seasonal respiratory distress has been remarked upon by Blythman (2007), who maintains (paraphrasing his words) that in the absence of a clear case of causation, maybe we should own up to the fact that in the UK, we simply don’t like the stuff.
I, for one, am quite willing to own up to that fact.
Anon (2007) “Brussels biofuels push met with skepticism.” – see http://www.euractiv.com/en/environment/brussels-biofuels-push-met-scepticism/article-160789
BBC (2004) see http://news.bbc.co.uk/1/hi/business/3736591.stm
Blythman J. (2007) “Seeds of Discontent.” The Guardian G2 19.04.07 pp4-8. See also http://environment.guardian.co.uk/energy/story/0,,2060538,00.html?gusrc=rss&feed=1
Brown P.D., Morra M.J., McCaffrey J.R., Auld D.L. & Williams III L. (1991) "Allelochemicals produced during glucosinolate degradation in soil." J. Chem. Ecology 17(10), 2021-2034.
Brown P.D. & Morra M.J. (1993) "Fate of Ionic thiocyanate (SCN-) in Soil" J. Agric. Food Chem. 1003, 41, 978-982.
Butcher R.D., MacFarlane-Smith W., Robertson G.W., Griffiths D.W. (1994) "The identification of potential aeroallergen/irritant(s) from oilseed rape (Brassica napus spp. oleifera): volatile organic compounds emitted during flowering progression." Clin Exp Allergy. 24(12), 1105-14.
EC (2006) http://ec.europa.eu/energy/res/legislation/biofuels_consultation_en.htm
FD Govt Au - see “GM Canola safety assessment” at http://www.foodstandards.gov.au/newsroom/factsheets/factsheets2004/gmcanolasafetyassess2498.cfm
Fiorina A., Scordamaglia A., Guerra L. & Passalacqua G.(2003) "Aerobiologic diagnosis of brassicaceae-induced asthma" Allergy 58 (8), 829–830.
Focke M., Hemmer W., Hayek B., Gotz M. & Jarisch R. (1998) "Identification of allergens in oilseed rape (Brassica napus) pollen." Int Arch Allergy Immunol. 117(2), 105-12
Gentech (1996): see archive at http://www.gene.ch/gentech/1999/May-Jun/msg00001.html
Gylling H. (2006) "Rapeseed oil does not cause allergic reactions." Allergy 61(7), 895.
Hemmer W., Focke M., Wantke F., Jager S., Gotz M. & Jarisch R. (1997) "Oilseed rape pollen is a potentially relevant allergen." Clin Exp Allergy 27(2), 156-61.
Hermanides H.K., Lahey-de Boer A.M., Zuidmeer L., Guikers C., van Ree R., & Knulst A.C. (2006) "Brassica oleracea pollen, a new source of occupational allergens." Allergy 61(4), 498-502.
Kroeger A. (2007) “Denmark Seeks bio-fuel solutions.” http://news.bbc.co.uk/2/hi/europe/6539379.stm
Krukowska E. (ed) (2004) “Polish bio-diesel output seen surging on law change.” – see http://www.planetark.org/dailynewsstory.cfm/newsid/35623/newsDate/14-Mar-2006/story.htm
McEwan M., Macfarlane Smith W.H. “Identification of volatile organic compounds emitted in the field by oilseed rape (Brassica napus ssp. oleifera) over the growing season." Clinical Exptl Allergy 28(3), 332.
Monbiot G. (2006) – see http://www.monbiot.com/archives/2005/12/06/worse-than-fossil-fuel
Mudeva A. (2006) “Food Industry calls for bio-diesel alternatives.” – see
Murphy D.J. (1999) "Is rapeseed really an allergenic plant? Popular myths versus scientific realities." Immunology Today 20 (11), 511-514.
Palomares O., Monsalve R.I., Rodríguez R. & Villalba M. (2002) "Recombinant pronapin precursor produced in Pichia pastoris displays structural and immunologic equivalent properties to its mature product isolated from rapeseed." Eur. J. Biochem. 269, 2538-2545.
Parratt D., Macfarlane Smith W.H., Thomson G., Cameron L.A. & Butcher R.D. (1995) "Evidence that oilseed rape (Brassica napus ssp. oleifera) causes respiratory illness in rural dwellers." Scott Med J. 40(3), 74-6.
Puumalainen T.J., Poikonen S., Kotovuori A., Vaali K., Kalkkinen N., Reunala T., Turjanmaa K, Timo Palosuo T. "Napins, 2S albumins, are major allergens in oilseed rape and turnip rape." Journal of Allergy and Clinical Immunology 117(2),426-432.
Teitel M. (2001). “There you go again, Monsanto.” – see http://www.gene-watch.org/genewatch/articles/14-4monsanto.html
Welch J., Jones M.G., Cullinan P., Coates O.A., & Newman Taylor A.J. (2000) "Sensitization to oilseed rape is not due to cross-reactivity with grass pollen." Clin Exp Allergy. 30(3), 370-5.
April 20, 2007
Notes and News
- A German study suggests Cell Phone radiation as a possible cause of Colony Collapse Disorder, which we have blogged about previously. This issue is finally getting the attention it should have on the Internet and in the media. However, the research has not yet been published, apparently, and no conclusive link has been proven. I guess we can just add it to the list of possibilities. UPDATE: This article in Der Spiegel provides more information both on the study and the overall CCD Situation. The article points out that the so-called cell phone study really used household wireless phones and not cell phones. They suggest adding cell phones to the list of possible causes, but also add a number of other potential causes to the list.
- Tony Burfield of Cropwatch, (and this blog) has accepted an invitation to present a keynote lecture on Sept 12th 2007 at the 38th International. Symposium on Essential Oils (ISEO) 2007 at Graz, Austria. Tony will be presenting a hard-hitting lecture in the Regulatory Aspects section, entitled "Over-regulation is destroying natural aromatics".
- Tony will also be joining the editorial board of Saponifier Magazine, where he will be a Feature and Aromatic Materials Editor. Established in 1998, Saponifier has always been, and always will be, dedicated to the success of the handcrafted soapmaker!
- Citrus aurantium subsp. bergamia was featured as the Botany Photo of the Day recently. Great photos of the plant, albeit with some misinformation about almost everything having to do with the essential oil. It's as if they didn't know about Google, or else didn't know how to sift the wheat from the chaff. Saved a little bit by the commenters.
April 18, 2007
Citrus Perfumery Ingredients may be banned
The April Cropwatch Newsletter is now out and Online, and Tony discusses at length the threat to the use of citrus oils in perfumery by EU Cosmetics regulators who plan to restrict furanocoumarins (FCF's) in cosmetics to less than 1 ppm. He lays out the history of citrus use in perfumery and lays out the case that the decision to ban the FCF's has already been taken, and that this will prove to be an unfair burden on the smaller manufacturers. He also lays out the case that there is actually no proof that FCF's are harmful at 1 ppm.
It is quite clear, too, that our supporters believe these measures are totally ‘over the top’. Bergamot oil for example has an almost ubiquitous use in fragrances (see below) so where are all the predicted adverse fragrance end user reactions? We haven’t actually got a citrus oil derived photo-chemical cancer epidemic on our hands - quite the opposite - we have a near zero reporting of adverse reactions from modern citrus/FCF-containing perfumes.
Tony goes on to discuss the IFRA position, and lay out the case for action via The Campaign for Real Perfume, about which I'm sure we'll be hearing more. The newsletter is extensively documented and should be read by everyone who has an interest in the future of natural perfumery or natural cosmetics.
April 16, 2007
Blog Profiles: Vetiver Network
In the Aroma industry we are familiar with the aromatic and essential oils aspects of Vetiver (Vetiveria zizanioides) (and in fact there is an extensive blog post here about that).
But what we may not be aware of is that there is an extensive international network dedicated to other aspects of Vetiver--in particular its economic value in preventing erosion throughout the world. There is a web site dedicated to Vetiver, (with an extensive bibliography that includes a number of reference links to the Medicinal and Insecticidal uses of Vetiver). And there is a Blog.
The latest entry in the The Vetiver Network (International) - TVNI blog is here and talks about the unique roots of Vetiver grass, which tend to grow vertically, developing into a root system that is "massive, deep, penetrating, tough, very fine and producing essential oil as well." The author attributes this to "centuries of selection for essential oil production."
Essential oil: Essential oil extracted from vetiver roots is highly valued for its fragrance in the perfume industry, insecticidal characteristics for termite control and increasingly for its pharmaceutical values. Vetiver oils are so complex that so far they have not been successfully synthesised.
Another post on the Blog suggests that vetiver has a very high carbon sequestration rate. Effectively this means that only FOUR mature vetiver plants would sequester the same amount of carbon as ONE fast growing poplar tree, considered to be one of the most efficient ways of capturing carbon to fight global warming.
A single individuals "carbon foot print" could be negated by planting 50 to 60 vetiver plants in a tropical country (about 8 meters of vetiver hedgerow).
The bottom line is that you won't find a lot of information on this blog about the aromatic features of vetiver, but there is lots of information about the plant and its characteristics and uses. I get the feeling that these "vetivarians" are fanatics--maybe even more fanatical than we are about perfumery or aromatherapy.
April 11, 2007
Notes and News
- Tumbledown provides instructions (with pictures) for building a sanctuary for bees in your backyard. As he/she says, "Let’s lessen the impact of colony collapse disorder by creating a sustainable network of localized and diversified apiculture."
- Natural Cosmetics are featured in a London Guardian article about L'Oréal, the world's largest cosmetic company.
"Once the preserve of a few hippies, the natural cosmetics phenomenon has gradually migrated into the mainstream and is now a booming market. Sales are only 1% of the global beauty market - just €1.5bn (£1bn). But it is growing at 15%-20% a year, and all the big cosmetic firms have started paying attention."
- "What did they smell like in the ancient world?" at ThinkingShift is a nostalgic take on ancient perfumes found on the island of Cyprus written about by John Roach in National Geographic. Natural perfumers can probably add another believer in the superiority of natural fragrance. Marcia has responded to ThinkingShift with some suggestions where to go to find out what's happening today in the world of natural perfumes and other aromatic delights.
- An effort to partner with Madagascar by the French Cosmetics Industry champions the biodiversity of orchids and could save species like Angracum eburneum longicalcar, in danger of becoming extinct prior to collector Marcel Lecoufle's efforts begun in the 1930's. This partnership could not only bring sustainable development for these orchid species, some delicately perfumed, it could encourage eco-commerce that honors natural ingredients for perfumes and cosmetics.
- Are first-amendment rights for proponents of natural health being clandestinely targeted? These health rights extend to unemcumbered use of essential oils and other plant extracts for aromatherapy, environmental fragrancing and perfumery. A look at recent events by Mike Adams of News Target should make us perk our ears and take notice, as opinions there reinforce the efforts of Tony Burfield at Cropwatch who diligently works to keep us informed and active with regard to IFRA's relationship with and mandates from Codex/EU. Tony's latest efforts and concerns will be covered in more detail in a separate blog.