Lozen Posted April 17, 2006 Dear plant, supplement, tincture, salve and tea lovers, I recently attended the Southwest Conference on Botanical Medicine, and heard about the Traditional Medicines Congress Proposal and Regulatory model. I will admit that I haven't read through the entire document as thoroughly as I should have yet because I have been out of town and swamped with fifty different projects, but I think it is very important to pass it on because it looks like it could seriously affect the face of plant medicine in this country and impact herbalists, herbal product manufacturers (including me making purslane pesto or calendula salve in my backyard), herbal store owners, curanderos, etc. etc. the list goes on and on. Please read the proposal carefully and make your voice be heard. The proposal is available here: http://www.ahpa.org/05_1129_TMCongress_ProposedModel.pdf Send your feedback to [email protected] In addition, you can send your comments the American Herbalists Guild (for the record, it's our understanding that the Guild did not help in writing this proposal, but got involved after the fact so that herbalists could have their voice heard)and to the American Herbal Products Association. It is my understanding that the AHPA did not mention this proposal to board members at the last board meeting. Websites for AHG and AHPA are www.americanherbalistsguild.com and www.ahpa.org. AHPA claims that the TM Congress has no interest in regulating herbalists or preparations that herbalists use, but the document implies otherwise, imo. Please read it carefully and send comments, questions, prayers, etc. Yael Share this post Link to post Share on other sites
hajii Posted April 17, 2006 (edited) Lozen, welcome back! I'm sorry to hear about that proposal. The work you and other herbalists do is very valuable. Have you considered creating a petition people could sign? Edited April 18, 2006 by hajii Share this post Link to post Share on other sites
VCraigP Posted April 18, 2006 Dear plant, supplement, tincture, salve and tea lovers, I recently attended the Southwest Conference on Botanical Medicine, and heard about the Traditional Medicines Congress Proposal and Regulatory model. I will admit that I haven't read through the entire document as thoroughly as I should have yet because I have been out of town and swamped with fifty different projects, but I think it is very important to pass it on because it looks like it could seriously affect the face of plant medicine in this country and impact herbalists, herbal product manufacturers (including me making purslane pesto or calendula salve in my backyard), herbal store owners, curanderos, etc. etc. the list goes on and on. Please read the proposal carefully and make your voice be heard. The proposal is available here: http://www.ahpa.org/05_1129_TMCongress_ProposedModel.pdf Send your feedback to [email protected] In addition, you can send your comments the American Herbalists Guild (for the record, it's our understanding that the Guild did not help in writing this proposal, but got involved after the fact so that herbalists could have their voice heard)and to the American Herbal Products Association. It is my understanding that the AHPA did not mention this proposal to board members at the last board meeting. Websites for AHG and AHPA are www.americanherbalistsguild.com and www.ahpa.org. AHPA claims that the TM Congress has no interest in regulating herbalists or preparations that herbalists use, but the document implies otherwise, imo. Please read it carefully and send comments, questions, prayers, etc. Yael Who is behind this proposal? This is the first most important question. A cursory reading of the document leads me to believe that this represents a power grab by the FDA. Language which looks innocuous enough but which seems to proceed from the assumption that there is NO assurance of safety in traditional medicines. wouldn't we be better served focusing on some better assurance of safety in Pharmaceuticals? This smells rotten to me, very rotten. Craig Share this post Link to post Share on other sites
Lozen Posted April 18, 2006 The proposal was actually written by herbalists, is the scary part. Groups that signed up (and that you should contact!!!) include: Acupuncture and Oriental Medicine Alliance (AOMA); American Association of Naturopathic Physicians (AANP); American Association of Oriental Medicine (AAOM); American Herbalist Guild (AHG); American Herbal Products Association (AHPA); Council of Colleges of Acupuncture and Oriental Medicine (CCAOM); Medicinal Herb Consortium (MHC); National Ayurvedic Medical Association (NAMA); and National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). I spoke with Michael McGuffin from AHPA at length this morning about my concerns with this proposal and how it would affect me personally, esp. as a user of chaparral, which I'm sure a lot of people would love to outlaw. I definitely don't agree with the proposal and find some wording extremely problematic, but I think the intent behind this is a good one--Michael is concerned that it's basically illegal to write medicinal uses on products being sold right now, and that herbs are already regulated either under the label of vitamins and supplements or under the FDA. I don't have copies of the acts he mentioned yet, but I will get ahold of it. He was unsatisfied with the Dietary Supplement Health and Education Act; this proposal is a response to that act. Another reason for this act is that the FDA keeps taking away herbs we use, and he thought this would make it possible, at l east for "qualified practitioners" or manufacturers, to use plants that are otherwise illegal, so that they would still be available. In any case, it sounds like they are going to go through with it in one way or another, and in my opinion, I think the best way we could spend our energy would be to come up with specific examples of things that need to be rewritten. For example, I asked Michael if they would consider changing the list of books to "including, but not limited to" and of course add about two hundred books that I'm going to send him the list of. I also mentioned that some traditional uses are proprietary information and are passed down from generation to generation and that trade secrets and tribal lore should not need to be either written or shared publically. Secondly, I recommended that they remove the word "qualified" because it implies a qualifying agency or board. Michael recommended the word "knowledgeable" but I'm not sure I agree with that either, as I'd rather have unknowledgeable people be able to use herbs as well, and who determines who is knowledgeable? Michael recommended saying "considered knowledgeable by their client" but I don't know if that would fly either. I told Michael I ate a lot of ice cream the other day, and am not a nutritionist, and got a stomachache, and even gave ice cream to others in the past who also got stomachaches, but I don't need a regulatory body to consider me a qualified and/or knowledgeable nutritionist in order for me to serve food to others... He is considering removing the "knowledgeable practitioner" clause altogether and making the proposal solely about products being sold. I told him that he had better closely define a lot of the language used, including "knowledgeable practitioner" for instance. I also told him I'd like to see public minutes of Board meetings (which are in the works), as well as specific names of the people involved in making the proposal. They are working on getting the minutes posted. I expressed concern with the way they asked for feedback, basically asking for help in fundraising and contacting Congress to implement the proposal. I expressed concern with the timing. Michael said the AHG did not do a good job of getting this information out to herbalists. He also said that the reason this proposal is moving so fast is because of acupuncturists he is working with who are feeling impatient. I told him to tell them to do the healing sound for liver, and he laughed and said I need to tell the herbal community to do the healing sound for liver as well. I told him if the deadline was extended, it would probably take care of things. I mean we have until June 30th to comment on it... I asked for a change in the paragraph that says "Facilities that prepare traditional medicines that are available only through the agency of a qualified practitioner, including, for example, a practitioner clinic; a compounding pharmacy; or a school, utilize production practices that are appropriate to the individual setting to assure that manufactured products are not adulterated. Such facilities, however, are exempt from any specifically mandated good manufacturing practice regulations." I asked him if he would add "Yael's kitchen" and "Yael's backyard." I plan on going over this entire document with a fine-toothed comb and sending specific section rewrites and constructive criticsm, making sure that all of the clauses (etc.) that would affect herbalists and medicine-makers would not be limitting by. They *say* this is their intent but it would be nice if their intent was written into the document. Some follow-ups on kitchens and on "proprietary information" or tribal lore.... I am a huge fan of sharing knowledge freely! I write all the ingredients on anything I make and teach others how to make them. However, there are certain plants and certain ceremonies that I won't talk about with just anybody. This is true everywhere. Does that mean those should be regulated? On the reservations if an anthropologist or manufacturer was to ask the elders and the medicine men and medicine women for their hard-won wisdom, I don't think they would give it just for the asking.Heck, even one of my teachers won't give me all of his formulas; he saves it for his apprentices who he hand-picks, there is no application process and I'm not one of them. I am thankful for the knowledge I receive from people, books and plants and ttry not to be greedy about it... As far as licensed kitchens, well this affects me personally. I make salves and liniments in my kitchen. I give most of them away but I do sell some of them off my website, to martial artists I know, and I will even be selling some of them in local stores. In fact, I see salves in most of the stores I shop in, not just Wild Oats but also the co-op, Aqua Vita, Native Seeds/Search, etc. I see lots of liniments and salves and oil (Thai oil and dit da jow) sold at Fong's Wing Chun school and various martial art shops that are not primarily making products in their kitchen. Like most herbalists, I don't make money off of my products. I do it for love and I lose money. I can barely afford the business licenses I'm supposed to get once I make my $600/year (or whatever it is) and I certainly can't afford the extra $125/year plus hundreds of dollars on certified licensed kitchen ingredients to have someone regulate my kitchen. I'm sure that some of the martial art shops making liniments and dit da, recipes handed down by their families for generations (which they may or may not want to share), would not want to get inspected kitchens. So these products will basically disappear, or at least would have to be bought under the table. This would be a sad, sad day. And think of all the workshops you've given or attended to teach people how to make salves whatnot. You are charging for the class and the materials, I presume. Does that mean that this kitchen would need to be inspected as well? I would like for it to not be illegal for me to buy medicine from my friend who has cats in her kitchen. I'm really okay with that. I mean I take a formula that has wu ling zhi in it, also known as feces trogopterori, or stir-fried squirrel shit. If I can deal with that, I can deal with a cat hair in my salve... Share this post Link to post Share on other sites
Smile Posted April 18, 2006 I mean I take a formula that has wu ling zhi in it, also known as feces trogopterori, or stir-fried squirrel shit. Yummy! Share this post Link to post Share on other sites
Lozen Posted April 18, 2006 by Cascade Anderson Geller RE: "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components," which you will find by clicking on this link: http://www.ahpa.org/trad_med_congress.htm Dear friends and colleagues: When my husband got me wired and hooked to computers and then the Internet over the past two decades, I vowed to tithe10% of my computer time to issues I deemed important to the public good. As I've advanced fully into the far-side of middle age, I find that a majority of my time, computer and otherwise, could be spent on advocacy and activist issues. It is increasingly more difficult to decide whether or not to forward yet another item to our friends and colleagues who are facing their own barrage of information. If I didn't feel that the regulatory model proposed by the Traditional Medicines Congress was potentially extremely problematic for all of us, I wouldn't bother with it and I certainly would not fill up your inbox with yet another item to ponder or simply junk. Although whatever comes down the pipe if some form of the proposed regulation were to get enacted, I would do my best to keep it from affecting me much personally. None-the-less, I still feel compelled to speak up because of not only the potential ramifications of it for the future of herbalism, but because of the way it came about. After interviewing many well-connected and well-known people in our field, as well as others who are members of the endorsing groups, none of which admitted having any knowledge about this proposal nor the creation of the congress, I have to believe that the self-appointed congress did not want to have a public dialog. Of course if any regulatory action were to be begun, a public dialog would break out and this would tap a whole bunch of energy (remember DSHEA.) Federal regulation is the highest and roughest sea to navigate. We cannot allow a small self-selected group to craft and guide herbalism into these treacherous waters. Though I don't know all of the ins and outs about the American Herbal Products Association (AHPA) <www.ahpa.org> it seems that they have done some sound work in the past. However, by becoming the administering agent, as it appears they have, of the Traditional Medicines Congress and their regulatory proposal, they appear to be overstepping as well as treading on thin ice. They admit, for example, that running a public dialog is too much for their administrative staff. This alone should raise not only hackles, but an absolute flood of questions by all sectors within the herb industry, especially AHPA members, as well as those members of organizations who apparently paid hundreds, or more dollars, for membership into the Traditional Medicines Congress. (There have been requests made to the email address of the congress for information about the financial arrangements of this organization.) If the administrator of the congress cannot manage a public process within the small herb community, how will they manage the cumbersome, tricky and highly murky federal process once it has begun? Once the large warship of the federal legislation and regulatory process gets a head of steam, whoever is paddling the small boat of the herb world will be begging and pleading for bailers from every aspect of the profession. The herbal world will be plunged into a tidal wave of convolutions and seemingly illogical antics of government. Absolutely all hands will be needed on deck to make sure that any semblance of the diverse herb network we know will be left afloat. Alas, there will be casualties and most likely these will be things that we all take for granted right now, but that vastly enrich our lives. Perhaps more disconcerting, the congress seems to be spinning a tale that regulation is needed. Better minds than mine have said that this is absolutely untrue. I know for a fact that in our nation we have better access to herbal products, including bulk herbs, from a myriad of small and larger companies, as well as access to a huge variety of health care consultants, some licensed and others not. I can walk into a sterile pharmacy and buy tinctures and capsules from the slick-packaging, larger companies, go to the national health food store chains and find a bioregional-crafted salve, or support the local food co-op and find herbalists I've never met, but am sure I would enjoy taking a walk with, just by reading the labels on their favorite herbal tonic available on the shelf. We can find each other and our interesting products at farmer's markets, craft fairs and other venues. Thankfully, these herbalists are not afraid of being arrested or fined for selling their wares. In fact, after three decades of herb-shopping around the entire globe, I think access to supplements and herbs and alternative health care is one of our greatest remaining freedoms; maybe one of the best testaments to free enterprise left. My European friends and colleagues are shocked to find that we can formulate as we like, actually combine red clover, yellow dock and nettles into one bottle if that's what appears to be called for. At an "herbal festival" in the mountains of Provence last summer, our group was absolutely shocked to find a lone and lonely couple at their booth hiding their lovely herb products behind the counter since it has become impossible for anyone outside of pharmacists and other licensed professionals to sell herbals. They were willing to sell things, but only to people that knew enough to ask for something specifically. They warned us that we should not let any of the liquor sellers know that we intended to soak herbs in the alcohols, either, since that would constitute making medicine and be firmly against the law. This is France, for Goddess sake, in the midst of hillsides covered with blooming wild lavender and thyme just beckoning to all knowledgeable herbalists. I confess that although I absolutely loved the movie, Thanks for Smoking, I am not a Libertarian and I do believe in government regulation. I don't believe in unnecessary regulation, however. I find that there is excessive misguided, unnecessary regulation promoted by industry so that they can get access to our local, state and federal tax dollars for huge public works contracts that don't serve the public at all. I could go on a lengthy rant about this issue filled with facts and figures. As one lawyer I spoke to said, "No industry goes seeking regulation, unless there are big bucks to be made in meeting the regulation and that industry can get high-paying contracts for projects that are then necessary to fulfill the regulatory guidelines." I am still missing crucial information about the formation of the Traditional Medicines Congress. I hope that the requests for more transparency will be quickly forthcoming. After spending a bunch of time sleuthing and collecting data, I've crafted some thoughts below. This proposed regulation is unnecessary, unwise and would be a total waste of our tax dollars because of the following: Safety: We absolutely don't need federal regulation to protect us from herbs. A case could be made for some kind of protection from adulterated "herbal products", most of which are imported and not crafted by the American herbalist. This proposed legislation doesn't deal directly with this issue and labeling laws should be in place to protect people in the first place. This draft regulation is misleading in that it creates suspicion that the public needs to be protected from herbs, or at least some of them. I don't believe there are any figures to support this, especially relative to the millions of people who enjoy the freedom to buy or consume herbs and supplements in all their various forms. Access to herbs: We already have the best access to herbs, and now some of the best quality due to the burgeoning organic growers network, in the world. The "ban" on ephedra-ish products seems to have been one of the alleged driving forces behind mobilizing the congress and its draft. My prediction is that if a rendition of this legislation ever came to pass, boy would we ever lose access to more than ephedra in the marketplace. (Of course, there is always ephedra available since it is a gift from the Earth and graces many landscapes across our beautiful globe.) That companies can't write everything they would like to share about their products' label is an issue, but if they think that this legislation is going to open that door, they better read it more closely and think a little harder about the ramifications. Larger herbal businesses should be as concerned as anyone about moving forward with this regulation. Formation of a reigning group: There is the issue of a small group of licensed folks, who may or may not even be able to identify ephedra in the field, getting to travel to Washington and sit around with the secretary of health and human services, who I hope has much better things to do with their time than discuss herbs, most of which are on the GRAS list. I am quite certain that the department of health and human services folks will probably definitely not be able to identify ephedra in the field, and will not have any interest in herb identification in the first place. I also would bet a peck of freshly picked, potent stinging nettles tips, that the secretary, and maybe a few of those sitting on the traditional medicines board, will not have seen a strong solution of hand-stripped Oregon grape rhizome bark whip the pants off any and all of the orthodox conjunctivitis remedies from the pharmacy, either OTC or prescription. I doubt that the regulatory agency would have a category for even the compelling argument that this simple herbal solution has gained such local fame that the local M.D.'s, pharmacists and nurses are willing to get it from their local herbalist to try and get their own children back in school, and therefore cut down the cost of sick child care they are shelling out, after a pink-eye outbreak. Administering to this reigning group could prove to be a somewhat lucrative position for the right person/group, that is if a whole lot of funding can be drummed up from the herbal manufacturing sector. Imagine the small herb business needing to send profits from 5 out of every 10 of their calendula salve pot sales to make sure their whisper is heard in Washington. Then there is the necessary lobbying that this legislation will create. Now there IS some potential wining-and-dining fun and profit to be had, albeit somewhat dampened by the shenanigans of Jack Abramhoff and company. And by the way, where are the authentic "traditional people" on the Traditional Medicines Congress and in the reigning group's model? Sanctioning of the herbal "Holy Scriptures": I can only begin to imagine all of the posturing, and perhaps down right groveling, that will take place when the sanctioned texts, from which we all are supposed to take our information, our formulas, our "wisdom", are listed. These texts will guide the conversations of the reigning group and government agency telling us who can use which herb, what herbs can be confined together in the same formula, etc., etc. It will most certainly be a hey day for the writers of "pseudo-science", if I may borrow the phrase that I believe pharmacognosist, Varro Tyler, rest his soul, coined to describe the bulk of herbal literature he came across late in the last century. I took offense of his term two decades ago, but I've come to realize that it is a handy and perfect adjective for far too many of the "serious" herb publications being pumped out today, both from Europe and the U.S.A. If I was a budding herbalist these days, and didn't know better from life experience, I would be quite frankly nervous about all of the deleterious side effects and contraindications being presented in "scholarly" herb works of our times. There is also the issue of the written word versus the spoken tradition. Those authentic traditional people are going to find themselves in the same boat that Columbus arrived in afloat with masses of pieces of parchment that say, "Sorry you lose everything." Thwarting diversity by driving a stake into the heart of organizations and others considered to be loose canons, including educational institutions, professional organizations as well as those individuals who have been dubbed "informal elitists" and who have been deemed to be uninformed about the facts of clinical herbal practice in the field of natural healing: Though most of those in the field of natural healing are, most likely, strong advocates for fighting for policy that protects diversity in nature, when it comes to our own professional turf, we seem to believe that diversity needs to be pruned with razor sharp shears. The language in the draft regulation effectively dumps diversity on the compost heap. Without pointing fingers and getting into old and more recent "war zones", I feel compelled to point this out. Moving forward with this regulation will undoubtedly unleash a "holy war" and the supporters of regulation will need to engage more than one strategist and troops to face two fronts in order to maintain momentum. (Perhaps Donald Rumsfeld will be job-searching at the just the right moment in time.) Like all wars, it will be ugly and painful, and in the end the losses will far and away exceed any, and all, gains. On the upside, our lovely Earth will continue to blanket all of our battlefields with her healing herbs, wildflowers and forests. That is as long as she is capable of supporting these types of highly complicated, green life forms. In fact, this is the main point I would like to make. We are faced with sobering, knee-shaking, brain-quaking and heart-breaking news everyday. The news that life-supporting cycles are broken is supported by our best scientists as well as our wisest traditional medicine people from every locale around the world. Heck, any of us can just saunter up to our neighborhood glacier and see that it is a fraction of its former self in less than half of our lifetimes. When global warming makes it onto a huge cover story in the conservative-leaning Oregonian newspaper, someone better start doing something big. Meanwhile, if this regulation proposal keeps on being pumped, instead of spending our precious time on helping to heal the real wounds of our culture and planet, we are going to be spending a whole lot of time bantering back and forth about one thing that isn't broken. Herbalism in the U.S.A. isn't perfect, and it never will be, but we have access to most herbs, we have access to herbalists and a vast variety of herbal education, we have access to licensed practitioners and degreed education, and we have a wonderfully, diverse group of wild and whacky, insightful and truly special people to share the few moments we have on this our beautiful Earth Mother. It is the grass-roots network, in all of its glorious diversity, that has allowed the U.S.A.'s herbal field to blossom into a financially, and more importantly spiritually, supportive environment. Men and women in "herbal" suits may not want to relate to those tranced out, flowery-bedecked herbalists standing in a circle in some breath-takingly beautiful landscape singing "Standing on the ground with our roots growing down, our branches wide and open." But when that circle unfolds and all of those hundreds, indeed thousands, of people get back into their gas-eating vehicles and become consumers again, those same "herbal suits" are only too happy to spend the profits generated by the sales of their latest rhodiola or maca or staid echinacea products to those hand-holding herbal types who have just become further educated at an herbal conference. The same could be said for the authors and publishers of the many herb books and herb related publications, the administrators of schools and organizations, as well as practitioners with or without credentials. We are connected and we do help each other along the herbal path. I do not believe that more government regulation, nor the threat of it coming from within our own profession, will foster prosperity and goodwill on any level. Instead it will thwart and twist it, feeding mistrust and all its associated darkness and suspicions. In the name of the public good, lets rescue diversity and instead let this draft regulation be laid to rest on the compost heap. Yours with spring flowers in my hair and with roots growing down, Cascade Anderson Geller Portland, Oregon U.S.A. People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices. - Adam Smith If they can get you asking the wrong questions, they don't have to worry about the answers - Thomas Pynchon Share this post Link to post Share on other sites