the aromaconnection blog

NPA moves ahead with its "Natural" Product Seal

The Natural Products Association (NPA) has announced that applications for its "Natural Standard" certification are available. The certification process will be based on the NPA Standard published on May 1 [PDF] and discussed here previously (which is not quite ready for prime time, in this reviewer's opinion). Certification will cost $500 per product for members of the NPA, and $1,250 for non-members. The standard requires that labeled products must be made with at least 95% all natural ingredients.

Since the NPA's membership fees for suppliers are not posted on their website, it's difficult to determine what impact this will have on small suppliers who would like to use the seal.  Since the public seems to be more aware of the "Organic" designation, and there are two competing seal programs (OASIS and NSF/ANSI) out there, it may turn out that there isn't even a place for a natural products standard and certification program.  There have been other attempts to define "natural" products, notably the Natural Ingredients Resource Center (NIRC) and the Campaign for Safe Cosmetics (CFSC). The problem with all of these is that they tend to define "Natural" (a positive) by stating what isn't natural (a negative definition).

The NPA definition of "Natural" from their May 1 version of the standard is:

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

The NPA goes on in their draft standard to specifically list allowed and prohibited ingredients (although the natural ingredients are on an attached list that doesn't seem to be attached) and then has an "Illustrative List of Allowed Ecological Processes".

This contrasts with the NIRC definition (partially quoted):

Natural Ingredients include  plant, animal, mineral or microbial ingredients...

• present in or produced by nature.

• produced using minimal physical processing.*

• directly extracted using simple methods, simple chemical reactions or resulting from naturally occurring biological processes.*

Neither of these definitions really have much "meat" compared to the definitions included in the "real" standards that have been proposed (OASIS & ANSI/NSF Organic Standards), both of which have over 60 definitions of terms that need to be precise so people know what the standard really means.

The "Natural" standard process has not been transparent and subject to the scrutiny that it needs to be subjected to. Moving ahead with it before it has been vetted by the industry and consumers is definitely not in the best interest of either. There has been some discussion of these issues in closed mailing lists, but that does little to force the NCA to open up the process and produce a real standard that has some meaning and can work effectively.

For more information, an article in the June Perfumer&Flavorist discusses "The Case for Natural Personal Care Standards." (Sorry, they make you pay for it.) Although the article contains some misinformation, it is a generally good overview of the state of standards issues as it stood before the Natural Beauty Summit.

Technorati Tags: natural products,definition of natural,NCA,NIRC,natural standards

Natural Beauty Summit tackles certification fragmentation

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

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

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

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

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

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

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

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

Is This The End of The Indie Beauty Products Boom as We Know It?

The past decade has seen an explosion of small, independent aromatics products companies emerge from the kitchens and basements of America.  From aromatherapy wellness products creators, indie natural perfumers,  sultry incense  formulators,  handmade soap makers and makers of bath products galore - creative entrepreneurs have conjured up myriad offerings from bath fizzies to sugar scrubs to pampering spa products. 

Then, along came the Food and Drug Administration Globalization Act of 2008, announced last month, proposing to give the FDA authority to affect new regulations that could stop the growth of this creative movement dead in its tracks.  For some, it could be the end.  Under the new rules proposed, The FDA could mandate an annual registration fee of no less than $2,000 (possibly more) per manufacturing facility.  This could put some out of business.    

The Personal Care Products Council (formerly the Cosmetic, Toiletry and Fragrance Association), has already testified before the House Committee on Energy and Commerce, outlining the self-regulatory efforts of the major cosmetic industry over the past several decades.  From the written testimony of Pamela G. Bailey, CFO and President of the PCPC,   "The result of manufacturer safety practices and voluntary initiatives under a existing framework of Federal law has been an outstanding safety record that has been commended by previous FDA Commissioners.  Cosmetics and personal care products are the safest category of products regulated by the FDA."  Stephen F. Sundlof, D.V.M., Ph.D., Center for Food Safety and Applied Nutrition, also submitted testimony which included the following:  "We believe the proposed legislation should be more closely targeted and prioritized according to risk. Several of the legislative sections appear not to be sufficiently focused on high-risk products. Some of these requirements would divert resources, which could detract from important product safety and security priorities."   While these larger entities are not arguing for or against the proposed legislation, these seem to be cautionary statements that would lead us to believe the larger industry has faith in existing industry efforts to self-regulate cosmetic safety via the CIR (Cosmetic Ingredient Review) established by CFTA in 1976 and funded entirely by the industry, evaluating more than 1,300 ingredients and publishing peer-reviewed scientific literature, available to the public. 

We are fortunate to have Donnamaria Coles Johnson who because of her passion for cosmetics and beauty products has tirelessly championed for small beauty products companies.  If you are a small cosmetic manufacturer and are not a member of the Indie Beauty Network, you are missing a plethora of ideas, education and networking to assist your business development.  Donnamaria has put up a public page to address this latest FDA issue, open to the public for comments and suggestions.   She will be preparing a position paper, using members' comments that will carry our voice to be heard by the Committees in charge of vetting public comments.  You can find Donnamaria's message and governmental links here:  http://www.indiebusinessforum.com/forumdisplay.php?f=41 

We urge all small natural cosmetic manufacturers to keep abreast of this issue and join efforts as needed to make sure that indie business doesn't get left behind.     

Organic/Natural Standards to be Discussed at Upcoming Meeting

The big players in the Beauty Products World are gathering together in New York later this week at "The Natural Beauty Summit" to "create a forum to learn and discuss the key challenges the cosmetics industry faces in the areas of natural and organic products as well as sustainability" . . . or so says the program for the conference, to be held at the Hilton Hotel in New York City May 15-17. This is a followon to a similar summit in Paris last November, to be followed by a sequel, again in Paris, in October 2008.

Sponsored by Organic Monitor and Beyond Beauty Paris, the main focus of this conference will be Natural Cosmetics with a major session on Standard & Regulatory Issues followed by a panel discussion, and the next day a Natural Cosmetics Workshop focusing on "an assessment of the growing number of standards and certifications for natural and organic cosmetics . . . [with] a critical review of the major standards, comparing and contrasting the similarities and differences between them."

The list of standards and proposed standards that will be covered at the session is:

• A Retail products standard proposed by Whole Foods
• the USDA National Organic Program Standard applied to Cosmetics
• the American NSF Standard
• the OASIS Standard
• A review of European natural and organic standards harmonization
• ECOCERT and BDIH

The aromaconnection blog will be following these issues closely as they develop.  Notably missing from the above list is the NPA (Natural Products Association) standard we blogged about yesterday and last month. We are working on a table showing details of the standards and comparing their features.  In fact, we are probably duplicating what may show up in the proceedings of the NBS (if there are any), but we hope to get it into print sooner.

Organic Monitor, one of the co-sponsors of the NBS, predicts that 2008 will be the beginning of "an industry shake-up" as various standards are unveiled in Europe and North America. In this linked article, they reference several standards that are not included on the list above. They also express concern about fragmentation that could lead to a reduction of trade, but express also the "more optimistic view" that Cosmetics might follow the lead of the textile industry and develop a harmonized global standard.

In the meantime the infighting has already begun. OCA and Dr. Bronner's have challenged what they call "weak" ECOCERT and OASIS standards, according to this OCA Press Release widely reported in the media mid-March. And as we reported yesterday, the C.A.M. Report is somewhat skeptical of the whole idea.

We can probably look forward to an exciting year!

Technorati Tags: organic standards,natural standards,cosmetic standards,NSF,OASIS Standard,ECOCERT Standard,BDIH Standard

Perfume Politics: The Oppressive Perfumer's Guild

Guilds are perhaps the precursors of modern trade unions, and also, paradoxically, of some aspects of the modern corporation.  Guilds are actually small business associations and have little in common with trade unions.  They are more like cartels in that they assume exclusive privilege to produce certain goods or services or dictate standards of a profession.  Guilds can establish restrictive guidelines or a rigid system and can exclude those who do not abide.  Guilds emerged with a similar spirit and character to the original patent systems and are not generally conducive to a democratic free flow of development and interaction.   

In the modern democracy, we have created nonprofit organizations or NGO's intended to benefit a group by collective efforts and by providing public education or  services that benefit society.  Legal nonprofit corporations receive tax relief, but are required to provide public reporting and transparency.  Such nonprofit endeavors are usually governed democratically and operated by officials periodically elected from within the membership.  This creates a structure that will evolve the endeavor into the future separate from and not dependent on or owned by any one member. 

The French Perfumer's Guild of antiquity was perhaps the worst example of the power a Guild over its members.  Established by an edict of King Philippe-Auguste in 1190 (reconfirmed by patent letters by King Jean in 1357, again by King Henri III in 1582, and again by Louis XIV in 1658, the "confrerie des Maitres Gantiers et Parfumeurs") that primarily gave glovemakers of the extended medieval period the exclusive right (i.e., monopoly) to manufacture and sell cosmetics of all types.  Why glovemakers, you ask?  Gloves were made from leather tanned using urine and other toxic and putrid substances and needed to be scented before they could be respectably worn.  The glovemakers were wealthy manufacturing businesses and they were quite adept at organized efforts to lobby each respective monarchy, reminding of the importance of their role in medieval society and thereby acquiring the sanction necessary to maintain their monopoly.  And, one can also suspect that favors were extended.  Today, we might call them bribes.  As you can see, this monopoly continued for a long time and was grounded in the necessity for perfuming what would otherwise be unusable products - leather gloves.   The corporation or guild, headed up primarily by master glovemakers,  established the sole credentials of those who could sell gloves as well as perfumed goods and dictated the kinds of products they could manufacture . . . a long list including sachets with perfumed powders, compositions used in burners for environmental scent, pomades for the hair, soap, cosmetic creams, scented gloves and even tobacco.  A quaint novelty to us today, but in common use then, was the "oyselets de Chypre."  These were cloth birds in bright colors, decorated with feathers and stuffed with aromatic powders, then placed in ornate cages and hung from ceilings or walls to add fragrance to a room.

By 1750, there were 250 master perfumers, members of the corporation who had served 4 years as an apprentice and an additional 3 years as "compagnons" before reaching the status of master.  For all intents and purposes, they were slaves, not free (until the Revolution that is) to work outside the confines of the guild or to develop their own trade and commerce.  Only rarely were there exceptions, a notable one being René Le Florentin, Catherine de Medicis's personal and favorite perfumer.  Le Florentin had a reputation for talent in creating scents and fabricating poisons!  And, obviously Catherine was well positioned to demand for him premature status.

Everything changes.  Along  came the French Revolution, rendering perfume and other objects considered frivolous luxury symbols of excesses of the aristocracy out of favor.  With the exception of popular scents like, "parfum á la Guillotine".  Under the Terror, choice of scent indicated political affiliation, a kind of odorous password.  Politically correct scents could literally save one from execution.  Napoleon's return from conquering (so he claimed) Egypt, along with his renowned heroic status gave him the power to re-establish the importance of French manufacturing to the glory of the nation.  His fondness for cologne bode well for the lagging perfume industry, establishing imperial commissions as well as scientific and technological research in organic chemistry . . . a science that would revolutionize the perfume industry in the latter half of the 1700's.   Thus, the adjective "French" is aligned with the noun "civilization" and under a new empire, cosmetic luxury products had a more general and populist allure.

One would hope that we are beyond the oppressive restrictions imposed on the medieval creative perfume artists of the day and that individuality and inventiveness are the modern dictates for his or her endeavors and acceptance.  And, that perfume guilds are fashioned after the democratic principles of modern non-profits and NGO's. 

References

Stamelman, Richard, "Perfume: A Cultural History of Fragrance from 1750 to the Present", 2006, Rizzoli International Publications, Inc.

Classen, Constance, Howes, David, Synnott, Anthony, "Aroma: The Cultural History of Smell", 1994, Routledge Press

Newman, Cathy, "Perfume: The Art and Science of Scent",  1998 National Geographic Press

http://www.wikipedia.org/

Cropwatch at the Cross-Roads

Cropwatch Statement

After 4 or 5 years of continuous activity, Cropwatch has some choices to make. Do we go on the way that we have been, snapping at the ankles of those who run & regulate the aroma industry so badly, or should we 'old dogs' learn some new tricks? Cropwatch supporters, and organisations sympathetic to our aims, regularly offer us donations and advise us of potential sources of grants, to which we have always said 'no thanks, we're non-financed'. Our current thinking is that this might be a mistake, since we are limiting our potential effectiveness. .

We are certainly not asking everyone for money, but we are asking you to help us with some feedback on how a financial input could potentially help the aroma world to become a better & fairer place, so please mail us if you have any thoughts or ideas.

Our initial list of ideas to use donated funding would be:

1. To finance risk/benefit studies on natural aromatic products. This research is needed because the existing major players such as IFRA/RIFM, are set up only to investigate the risks/hazards of fragrance ingredients (but not the benefits), & EFFA can only present the safety risks of essential oils, absolutes, resinoids etc in terms of the imagined hazards of the individual contained chemicals, rather than adopting a holistic approach for the aromatic ingredient as a whole. Therefore both organisations are badly positioned to defend natural aromatic ingredients against the current avalanche of restrictive legislation. The EU Commissioners have previously declined to accept safety-data based on risk/benefit considerations, although we believe this policy to be untenable in the long-term - it is the norm in virtually every other regulatory area (biocides, agricultural chemicals, pharmaceuticals etc).

[Neither is this just a European problem. The U.S. House Committee on Energy and Commerce have just announced draft legislation (Global Harmonisation Act 2008) intended to stimulate discussion on how to provide adequate funding and authority for the FDA to ensure the safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalised marketplace. The draft legislation already highlights several areas which will affect the fragrance industry]. 

2. To develop statistical data on the adverse effects of restricted & prohibited aromatic materials. This data would be a potential bombshell to blow apart the over-precautionary approaches of the cosmetic regulators and career toxicologists, who are in such a powerful position in global regulatory circles. Where this data exists (e.g. the Schnuch data on alleged allergens) it is already causing red faces. The EU Commissioner has previously indicated to Cropwatch (Brussels 2007) that this type of adverse reaction data is inadmissible as safety evidence. But if you are familiar with English history, you might recall that King Canute failed to hold back the waves and so his followers realised he was not all-powerful. So too, the regulators will not be able to ignore the fact that many restrictions on natural products are based on corporate toxicological constructs which don't manifest in the great numbers of negative health effects predicted.

3. To assist with the growing & production of useful commodities from threatened aromatic plants, for cosmetic, aromatherapeutic, flavour & medicinal outlets, in a way that benefits the poor.

4. To set up or help set up a natural aromatics products professional body, with the help of other interested parties. Already we can identify several sub-divided areas which badly need assistance: natural perfumery, the use of naturals within conventional perfumery, natural biocides, herbal drugs & medicines, aromatherapy, natural cosmetics etc. 

5. The lobbying of officials & regulators. As we have seen, the more the establishment closes ranks (and its mind) to contrary & dissenting views, the more popular support we have been able to attract. In terms of numbers we are potentially a powerful force. However we have to ask ourselves whether there is any point in continuing the lobbying game. Many of the points we make go unanswered because the officials involved are not sufficiently technically adept or experienced to even understand the arguments put forward. So is it better to plough ahead with a voluntary regulatory system of our own making - at least we might have the experience, familiarity & resources to do a better job. The enormity of the task is detracting, but this is put more into perspective if sufficient funding were to be available.  

6. To keep the flame of our traditional perfumery heritage alight. When we read that several major aroma corporations are training fledgling perfumers in pure synthetic perfumery, it makes us wonder if the world has gone quite mad. Once perfumers used to be creative artists with forthright temperaments, views and opinions, passionate about their art. Now, are we all to be reduced to company drones? I was related a story recently concerning a certain essential oils salesman who offered unmarked samples of  real good quality Bulgarian lavender oil, and a synthetic lavender construct to a group of young perfumers at a certain megacorporation. The group preferred the artificial lavender construct because "it smelled like linalyl acetate, like its supposed to."  Heaven help us! But maybe some of us 'old-timers' should organise courses & lectures to pass on the 'ancient knowledge of the art of perfumery' before it is lost forever.   

OK, after 5 or so years of trying, we pretty much know what the problems facing us are - what we don't have is a consensus on the best way to solve them. Maybe you can help?

Cropwatch Team

Technorati Tags: Cropwatch,natural aromatic products,perfumery,natural perfumery

Earth Day 2008

"The President in Washington sends word that he wishes to buy our land. But how can you buy and sell the sky? The land? The idea is strange to us. If we do not own the freshness of the air and the sparkle of the water, how can you buy them? Every part of this earth is sacred to my people. Every shining pine needle, every sandy shore, every mist in the dark woods, every meadow, every humming insect. All are holy in the memory and experience of my people. We know the sap which courses through the trees as we know the blood that courses through our veins. We are part of the earth and it is part of us. The perfumed flowers are our sisters. The bear, the deer, the great eagle, these are our brothers. the rocky crests, the juices in the meadow, the body heat of the pony, and man, all belong to the same family. The shining water that moves in the streams and rivers is not just water, but the blood of our ancestors. If we sell you our land, you must remember that it is sacred. Each ghostly reflection in the clear waters of the lakes tells of events and memories in the life of my people. The waters murmur is the voice of my fathers' father. The rivers are our brothers. They quench our thirst. They carry our canoes and feed our children. So you must give to the rivers the kindness you would give any brother. If we sell you our land, remember that the air is precious to us, that the air shares its spirit with all the life it supports. The wind that gave our grandfather his first breath also receives his last sigh. The wind also gives our children the spirit of life. So, if we sell you our land, you must keep it apart and sacred, as a place where man can go to taste the wind that is sweetened by the meadow flowers. Will you teach your children what we have taught our children? That the earth is our mother? What befalls the earth befalls all the sons of the earth. This we know: the earth does not belong to man, man belongs to the earth. All things are connected like the blood that unites us all. Man did not weave the web of life, his is merely a strand in it. Whatever he does to the web he does to himself. One thing we know: our god is also your god. The earth is precious to him and to harm the earth is to heap contempt on its creator. Your destiny is a mystery to us. What will happen when the buffalo are all slaughtered? The wild horses tamed? What will happen when the secret corners of the forest are heavy with the scent of many men and the view of the ripe hills is blotted by talking wires? Where will the thicket be? Gone? Where will the Eagle be? Gone! And what is it to say goodbye to the swift pony and the hunt? The end of living and the beginning of survival. When the last red man has vanished with his wilderness and his memory is only the shadow of a cloud moving across the prairie, will these shores and forests still be here? Will there be any of the spirit of my people left? We love this earth as a newborn loves its mothers heartbeat. So, if we sell you our land, love it as we have loved it. Care for it as we have cared for it. Hold in your mind the memory of the land as it is when you receive it. Preserve the land for all children and love it, as God loves us all. As we are part of the land, you too are part of the land. This earth is precious to us. It is also precious to you. One thing we know: there is only one God. No man, be he red man or white man, can be apart. We ARE all brothers after all."

      -Chief Seattle

The nature Conservancy Earth Day Ideas
Take action for climate crisis solutions at we
Recycle old computers, cell phones and other electronics
Earth Day official events and activities
Professional advice for business sustainability initiative
Earth Day Facts from Rochester, NY plus more links
Make every day Earth Day from Madison, Wisconsin
Adverse effects of palm oil by Dove from Greenpeace
We can do it! from Sierra Club
The Rainforest Initiative
Whitefeather Forest Initiative
The African Conservation Foundaton
Long list of intragovernmental, governmental and private (NGO) environmental orgs

That ought to keep us busy.

Happy Earth Day! from all of us at the aromaconnection group blog.  

The Sky Fell In

Part of the sky fell in over the weekend. The UK's Times newspaper ran a 2-page story (see Times OnLine ) describing how the new Natural Healthcare Council modelled along the lines of the General Medical Council, (GMC) will regulate aromatherapy, reflexology, massage, nutrition, shiaztzu, reiki, naturopathy, yoga, homeopathy, cranial osteopathy & the Alexander & Bowen techniques in the UK. Nigel Hawles, the health editor for the Times, described the move as a success for the Prince of Wales. I believe, on the other hand, that it will be an unmitigated disaster for CAM.

What is the real motivation behind this? Its all about money & control. The pharmaceutical trade has for a long time looked with envy at the £130 million per year turnover generated by Complementary Alternative Medicine (CAM), which is expected to rise to £200 million within four years (Hawkes 2007) and its storm troopers have sought to kick complementary alternative medicine in the head, via adverse media coverage, at every possible opportunity. The threat posed is that the rise of complementary therapies and the popular use of natural products such as tea tree oil, ginseng, valerian etc., diverts attention from convention medicine & the potential income from conventional synthetic drug sales. Therefore any negative utterance by some academic 'expert' (who those of us within CAM have generally never heard of) knocking aromatherapy, herbal medicine, homeopathy etc. is faithfully reported by various lightweight science reporters who work for the supposedly independent quality UK newspapers such as the Guardian, the Independent or the Observer. Cropwatch has been puzzled as to why our rebuttals of the shallow, non-investigative & biased reporting has never been featured in the letters pages of these organs. We don't have to look far for an answer. Its down to sinister lobbying organisations and their many sympathisers, such as Sense About Science (hilariously described as ‘a charity’ by obedient newspaper hacks) who are thought to be indirectly financed by the pharmaceutical & chemical organisations & trades, and who exert their considerable influence in distorting media science reporting, defending GM products and. promoting an anti-environmentalist stance - for example dismissing industrial pollution effects in terms of false illness beliefs, arguing against organic food & vitamin supplements, alternative medicine and so on.. For the real low-down on Sense About Science (SAS), see the LobbyWatch website at http://www.lobbywatch.org/profile1.asp?PrId=151, or Martin Walker's free downloadable E-book: Cultural Dwarfs & Junk Journalism. One of SAS's more chilling beliefs is that public discussion of scientific matters & their ethics should be discouraged and legitimate arguments trivialised or dismissed as fantasy, since the SAS view is the only valid one. The Corporate Science supporter Ben Goldacre, who runs a 'Bad Science' column in the Guardian which exercises a vendetta against various CAM professions such as homeopathy & nutrition, is under the Guardian's editorship protection, such that counterattacks to some of his nonsensical ramblings never see the light of day. Goldacre, who professes to be a mere hospital medic, whilst being quick to criticise CAM, refuses to comment on his own profession's lamentable failings (such as the abysmal statistics surrounding the failure of MD's to correctly diagnose & prescribe the appropriate treatment for a given patient's ills, the hundreds of thousands of patients who die or who's health is severely adversely affected by the unwanted side-effects of prescribed pharmaceuticals, or the hilarious but thorough reporting of an extensive study by the Union of Concerned Scientists that following a course of conventional drug treatment appears to statistically increase the chances of shortening your life, not to mention the serious chances of dying or losing limbs from hospital acquired infections!).

So why is Cropwatch opposed to the Natural Healthcare Council regulating CAM? The Nigel Hawkes article suggests regulation is needed partly because of high-profile cases where therapists have reportedly attacked clients. This argument is clearly absolute nonsense – the National Health Service has always represented much more of a risk. For example here in the UK, an inquiry started in 2000 decided that the medical practitioner Dr Harold Shipman allegedly killed up to 250 of his patients, some 218 of whom have been subsequently identified. Health care authorities subsequently carried out heavy modifications to medical practice to increase patient protection, but this move was merely 'shutting the stable door after the horse has bolted'.

As it is, regulation has all but destroyed the perfumery trade, & Cropwatch spends most of its spare time fighting the absurdities of the EU regulation outfall, and UK/Canadian/US National legislation that concerns natural aromatic & medicinal products. Within the EU in the cosmetics/essential oils sector, a bunch of Brussels lawyers with no scientific knowledge are advised by so-called 'expert' committees (themselves a bunch of academics with no trade experience) who rely on big industry to provide scientific evidence on ingredient safety & other regulatory matters. Of course big industry biases furnished safety evidence to 'expert' committees towards to their Corporate interests, and they employ and finance toxicologists to support their hyperbureaucratic policies, which are themselves so complex, that they profoundly disadvantage all of the less powerful competition with less available technical manpower resources. A similar state of affairs exists in Biocides regulation, where EU Directives are completely written around the interests of the chemical industry, making it virtually impossible cost-wise for small natural biocides with their small financial resources producers to sell their relatively safer products in Europe. It is a running open sore.

If the Natural Healthcare Council were to fully regulate all the CAM areas mentioned in the first paragraph, it would require a complete college-full of multi-disciplinary experts to administer the eleven or so areas mentioned. It will be very interesting to see who they put up to do this - we are promised eight of these regulators, who we learn elsewhere will be probably lay people under the chairmanship of Dame Joan Higgins.. What it probably would mean, is that those who passionate about CAM are going to have to spend much of their time, unpaid & unrewarded, teaching the regulators (and no doubt their “expert” advisers) how to do their job properly. If previous patterns are repeated, the regulators will make inappropriate decisions based on biased evidence proffered by those with hidden agendas, which the rest of us will have to spend years undoing. Although Cropwatch has made some unacknowledged headway in doing exactly this in other areas (cosmetics, biocides), it is extremely dispiriting the think that there is potentially much more to take on here as well.

First indications are that joining the proposed scheme will be voluntary, eventually to be obligatory. The Council will (initially) only have powers to strike off errant or incompetent therapists, or to set minimum standards for practitioners. This latter prospect is, in itself, most intriguing. Within aromatherapy, the low educational entry requirements & abysmal course standards set in UK colleges are a national joke, so setting minimum standards for practitioners will presumably be a great source of material for satirical magazines such as Private Eye. The profession is starved of finance, so no substantial evidence-based aromatherapy data-base exists as such - anything that does exist is likely to consist of published (so-called) aromatherapy studies by non-practising academics, rather than tapping the massive collective experience of everyday practitioners. Aromatherapy trade & academic magazines are owned by aromatherapists, their chums, & aromatherapy supply sellers - who profit from promoting their own businesses within the magazines.

But of course it is perfectly possible to be a fantastic massage therapist, aromatherapist etc., without having the dubious benefit of attending some badly-taught aromatherapy course and getting the duly signed piece of paper at the finish, and/or having to be obligatorily registered with and represented by some professional aromatherapy organisation or another. Perhaps this consideration should be the first lesson for the potential regulators of the National Healthcare Trust. Or perhaps, as in France, where aromatherapy has been legally designated as a 'sect' (in spite of the fact that now according to some with national pride, aromatherapy was invented in France), it may have to go underground for a while to survive. In any case the freer CAM is from regulation the better. Sure, these professions have an element of scientific content, but basically they are a folk-art, sympathetic to concepts of spirituality & energy flow, and they need to be severely left alone, and they are doing just fine from receiving no attention whatsoever, thanks, from a UK government obsessed with control. Finally, if you have any doubts about how a GMC-styled regulatory body might eventually end up in regulating the CAM profession, have a look at Martin Walkers's account (again in Cultural Dwarfs & Junk Journalism) on how the GMC and some of the major players have dealt with Dr Andrew Wakefield. Wakefield, you will remember dared to raise issues about the safety of the MMR vaccine and possible links with autism, and who is currently involved in GMC a fitness to practice hearing.

Tony Burfield.

P.S. Please pray with us that Prof. Edvard Ernst is not promoted to a position of adviser or authority within the National Healthcare Council. Ernst is a Corporate Science sympathiser who is working undercover as Director of Complementary Medicine at Exeter University, & whose sole purpose seems to be to rip the soul out of CAM, armed only with a Corporate Science device called "the meta-analysis". Ernst's stature & reputation is such that it has even over-awed normally sensible Herbalgram staff who worship & reproduce his every utterance, & who apparently haven't noticed that now HE'S WORKING FOR THE OPPOSITION. Wake up!

Technorati Tags: aromatherapy regulation,aromatherapy,Complementary medicine

NTEF Attacks Angel Perfume via FDA

In what could be a major challenge to the American labeling regulations that allow manufacturers to skimp on accurate reporting of cosmetic ingredients, the FDA has accepted a petition from the National Toxic Encephalopathy Foundation (NTEF) to have Angel Perfume declared "Misbranded", and asked that its importation be halted until the issue is resolved. That could take a long time, given a 180 day turnaround process according to the FDA's procedures, and the general slowness of the regulatory process. Or ultimately the FDA could ignore the issue.

NTEF, which is a watchdog organization on perfume toxicity, claims on its website that the Angel perfume contains toxic ingredients that are not listed on the label. The particular ingredient of concern is coumarin, which is similar to a chemical used in rat poison and is definitely considered harmful. NTEF has requested that the FDA declare the perfume a drug, and prohibit its importation.

Angel perfume, which according to Wikipedia is the #1 perfume in France and the #8 seller in the US,  was formulated in France in 1992 by Thierry Mugler and is now distributed by Clarins, mainly through Nordstrom and other department stores.

Angel perfume actual ingredients, as determined by NTEF scientists by chemical analysis, include essential oil chemicals including alpha-pinene, d-limonene, pachouli alcohol, azulene, and many others as well as coumarin [not listed in the MSGC report, however] and diethylphthalate.  Coumarin is a common ingredient of cassia, tonka bean, clary sage, and lavender, and many other aromatic ingredients used in aromatherapy and perfumery, as well as many food items (strawberries, anyone?). Coumarin, according to a French perfumery article has been banned as a food additive in most countries for many years based on animal research that found it can be toxic in doses of 100 mg/kg/day, which are supposedly 100 times the amount that is typically used in perfumery. NTEF claims toxicity at lower level and cites several references. The issue they are most concerned about is harm to the eyes, but they are also listing possible pregnancy problems, and reduced sperm motility as possible problems, among others.

As pointed out in an article in Cosmetics Design Europe, coumarin is used in over 5,000 cosmetic formulations. The article goes on to attack the NTEF in an irresponsible manner.

I've looked over the information on the NTEF web site, and have a number of concerns about the quality of their evidence. They seem to confuse natural and synthetic chemicals, as I mentioned above coumarin didn't seem to be listed on the MSGC, and their claim that an excerpt from the Clarins 2004 Annual Report verifies their claims is questionable (I didn't see much in the way of Financial records there).  The best (highest quality, that is) article linked from their site is this one, which goes into more specific data about stated contents and their changing history, and specifically how these may be toxic. I'm not saying they are wrong; it's probably up to the FDA to determine the truth, but I think the facts may not be completely supported by the evidence they present.

I discussed this with Cropwatch via e-mail, and they pointed out that coumarin is a common perfumery ingredient and question why, if it is actually toxic, that Angel perfume should be singled out. Coumarin in a perfume would pose a very low bodily health threat because it would not migrate through the dermis. Ultimately, there is a question about whether the FDA will take the health claim seriously.

This issue will probably be around for awhile and we encourage your comments and opinions.

More EU Allergens regulation by the back-door

Tony Burfield has sent out an emergency supplement to the Cropwatch Newsletter alerting us that IFRA and EFFA appear to have found a back-door way to sneak a number of fragrance substances into the "26 allergens" legislation without following due process and allowing public comment. I'm not as familiar as I should be with the intricacies of the EU regulatory system, and I haven't quite figured out the details of how it will work.  Tony has submitted a formal objection to the process and in his e-mail states:

We go into high gear on the opposition front if this presently-sought SCCP Opinion goes ahead - Cropwatch is not prepared to watch the destruction of what is left of the European fragrance/essential oils industry by moves like this coming from career toxicologists who do not work in the industry, & their seemingly bemused & obedient EU lawmaking counterparts, without a fight.

Unfortunately the Cropwatch website seems to down right now, so I can't effectively link to the objection PDF.  I will do so as soon as it is back up.  And if the site isn't back up by Tuesday I'll post the document here.

UPDATE: Cropwatch is back up but Tony hasn't yet posted the document; he generally lags a few days behind the date he mails to his subscribers.

UPDATE2: Tony now has the pdf document posted here.

Bush Mentions Essential Oils in Major Policy speech

US President George W Bush mentioned essential oils in a major policy speech on foreign aid on Thursday, May 31, "President Bush Discusses United States International Development Agenda":

And now 14 additional nations are eligible to negotiate compacts with the Millennium Challenge Corporation, headed by Ambassador Danilovich.

Let me give you an example of how this program can make a difference. In Madagascar the leaders of this island nation set a goal in their compact to improve agricultural production. In other words, we work with a nation, they have set the goal; we support their goal. They want their farmers to be able to compete in the global marketplace. We agreed to help by investing in agricultural business centers that work with local farmers. In one village, this initiative helped a group of farmers who were surviving by collecting firewood and producing charcoal. That's how these folks were trying to get ahead. They'd find firewood and make charcoal out of it, and hope they could find a market. It's a tough way to make a living in a modern world.

The business center that the compact established helped the farmers work together to identify a new product, a natural oil used in skin care products. I probably could use some of that myself. (Laughter.) The center helped these farmers develop -- helped them to develop a business plan. They acquired financing to set up a distilling plant. They built relationships with buyers in their nation's capital.

Before America and Madagascar signed our compact, a typical farmer in this village could earn about $5 a week selling charcoal. After two months of bringing the new product to the market, the livelihood of these farmers increased. One farmer was able to raise his income enough to save about $500, money he plans to use for a child's education. (emphasis supplied)

I've done some research and it appears that the "natural oil" is geranium. The original source material for Bush's writers was probably the same as this article:

In Madagascar, a programme identified geraniums as a high value-added market, formed a cooperative, doubled production capacity by training farmers, assisted the cooperative in accessing credit and negotiated a contract with a buyer, who is using the geraniums to produce essential oils for sale to the European market. When asked if the farmers enjoyed the smell of geraniums, the head of the cooperative replied, “We like the smell of money better.” The farmers’ income had increased by two-thirds thanks to MCC assistance.

It doesn't mention the distillation plant, but the article is by a Vice President for the Millennium Challenge Corporation. I searched for more information on the  web, but it doesn't appear to be there. [Note: I am leaving my political opinions out of this post, not because I don't have them, but because we are trying to keep focused on aromatics.]

FDA vs CAM Final Deadline

The final deadline for comments on the FDA vs CAM issue discussed here is May 29, which is coming up soon. If you haven't already commented, go to one of the links in the previous post to make your comments.

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.

 

04/06/07

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

Respectfully submitted,

Maj. Gen. Albert N. Stubblebine III,

(US Army, Ret.)

Rima Laibow MD

Ralph Fucetola JD

For: Natural Solutions Foundation

www.HealthFreedomUSA.org

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!

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.