Since the national organic standards have been put into place, the government now "literally owns" the word "organic". This means that it cannot be used in a discriptive way on labels, marketing or advertisment, etc. It cannot be used in any strange spellings or even illustrations that would indicate that someone is growing or producing something using organic methods. Doesn't this sound like DSHEA. So, unless you want to play by corporate rules and pay the extreme fees involved, you cannot let your customer know that you are doing things organically any other way. This means that in order for Chris and I to let people know that we are organic growers we have to pay those fees and do all the big business requirements and as the big buisness interests get more and more involved, the standards get twiked...but it doesn't matter, because in order for us to live in the world as an organic producer we have to be compared to the Krafts and M& M Mars and General Mills of the world and as they weaken standards, the consumer may or may not know that there is any difference in what they do and what we do. Jane Goodall calls it shallow industrial organics and deep earth organics. She's right... and this is what the difference will be for herbs and herbalists if these types of regulations come into place. We will have shallow industrial herbs and herbal services in the lime light. Underground and nearly invisisble is where the deep earth herbs and herbalists will be forced to exist.

Why do I care about that...? Here is only one example. Before the organic laws were laws, people were growing organically, using very strict methods, self imposed, and your reputation depended on you doing it right and that's what kept you in buisness...not laws! Another requirement with the USDA organic regulations is that we can no longer make any of our own imputs like natural pesticides. You know in my book, I have all these recipes for making your own soap spray, ant bait, fungicide with baking soda, etc. Well, we used to make our own remedies like these and that was easier and saved us money as farmers. We also didn't have to worry about "inert ingredients and whether they were ok or not, because we only had the ingredients that we put into the remedy and we knew exactly what they were. Now we are required by the regulations to use only products that are "labeled for the specific purpose" and nothing can be homemade. This means that we now spend hundreds of dollars a year buying insecticidal soap spray, boric acid ant bait gels and natural oil fungicides to name a few things. This is one of the things that worries me about the TM proposal...will it become impossible to make your own teas, tinctures, salves, etc.! Will the law require that only manufacturered preparations be used, especially by practitioners. Not only is that unnecessary and unappropriate perhaps for the person planning to use the herbs, it is expensive! Herbs are supposed to be the people's medicine, not profits in a company's coffers! They are supposed to be available to all people, not just people who can afford the product or the service! Are herbalists only be considered legidimate if they are"regulated" by laws that are highly influenced by business standards of industry organizations, insurance companies and product manufacturers? These laws are not inclusive, because they cannot be when they are based only on a western scientific protocol. We are no better or worse as organic growers just because we are licensed. We are good organic growers because of our practices and the resulting product that comes from those and that would be the same whether or not we were licensed. However, when we are required to be "licensed or registered or certified" by law (It's all the same thing really isn't it) it is only available to those who have the resources to comply. Otherwise you can "do business".

Hmm... These types of regulations take the service of herbalists and the plants out of the hands of the people and put them into the control of the government. The rules are made by the companies that can afford to lobby that government, not by the people...it's as simple as that. History repeats itself and our society don't seem to get any wiser sometimes as a result of past lessons.

----- Original Message -----

From: CYNPILEGGI

To: rclover

Sent: Friday, April 14, 2006 10:33 AM

Subject: (no subject)

Tammi,

If you have any documentation you can share about the changes that the USDA imposed when they took over Organic certification, and any other such info we can use to create the case for the aspects of the TMC proposal that will be damaging to Herbalists, I appreciate the assistance.

Peace & Love,

Cyn

From: CYNPILEGGI
Sent: Monday, April 17, 2006 8:27 PM

Subject: Comments on the TMC Proposal - Cynthia Pileggi & Doug Whan

Greetings Everyone,

We have been reviewing the TMC proposal for several days.Text directly from the Traditional Medicines Congress Proposal is in black. My comments are in purple.Comments made by Doug Whan are in green.

The TMC has spent what is obviously a great deal of time, consideration and energy to create the Proposed TMC Regulatory model with good intentions. In reviewing this carefully, some of us see that this proposal has potential to significantly impact us in ways that may not serve the greater community. Traditional Medicines are often referred to as the peoples medicines. Many of us using Traditional Medicines considered using herbs and Traditional Medicines an innate right.

There are those like me, who make at least a part of our living creating formulas and products, recommending, dispensing or writing about herbs and traditional medicines.

This could be a fantastic opportunity if all went perfectly.

A new classification ~ Traditional Medicines. Labels and product brochures with complete, truthful information on health benefits, disease claims, detailed instructions for use and safety. In a perfect world, this would be great.

Does the TMC really think they will get enough members of Congress believing in the TMC proposal?

Do they have any members of Congress interested in sponsoring this legislation? Getting support over the arguments provided by the AMA, pharmaceutical companies and other interested parties who will be doing their best to sway Congress will be a challenge.

Once in their hands, members of Congress could see this Proposed Model as a way to control access to what many still believe is an un-regulated industry- (herbs and dietary supplements)......Has the TMC considered this?

Those who have worked with local, federal or state government, in trying to pass legislation, are aware that legislators are influenced by many factors. They are influenced by their constituents, special interest groups, lobbyists and other agendas that are often unrelated to the actual piece of legislation. Amendments could be added to the TMC model with no recourse on the part of the TMC to stop the momentum once it has started.

Herbs and traditional medicines have been scrutinized, disrespected, and eradicated by various administrations and the media.

It would be easy for a member of state or federal government, involved once this goes public, to specify that all Traditional Medicine Practioners must be licensed practitioners or licensed professionals. They merely have to add licensed in front of professional or practioner. The TMC would need strong support to maintain their goal.

Who are the 'professionals' who are given protected access via this proposal and how is professional status determined? In this document sometimes 'professionals' is the term used, other times, practitioners, Traditional Medicine Practitioners or qualified practitioners. Consistent terminology with clear definitions are needed.

This proposal appears to have the potential of creating even less direct access, putting Traditional Medicines in their own category, regulated for use only by those determined to be qualified by the FDA, HHS, with input by the TMC. It appears that only those recognized as the 'qualified health professionals' will truly have unfettered access, not the public, the community of herbalists, the health food stores and other resale venues who have helped promote Herbalism and the use of safe Traditional Medicines.

I also see potential challenges with the adverse reaction section.

November 2005 the bill HR 4282 was introduced to Congress, the Health Freedom Protection Act. It has 15 co-sponsors, and is sponsored by Rep. Ron Paul (R-TX) in a grassroots campaign to end FDA and FTC censorship. There is an article in Vitamin Retailer Feb. 2006 issue on this bill and should be information on the internet about it. This bill may cover some of the needs expressed by the TMC?

Thank you to everyone who has been voicing their thoughts, opinions and suggestions.

Best Regards,

Cynthia Pileggi & Doug Whan

Guffey CO

(Page 1)

A Proposed Regulatory Model for Traditional Medicines:

Guiding Assumptions and Key Components

Introduction

"In the spring of 2004 a diverse group of organizations decided to initiate a cooperative process to exchange ideas about the future of traditional medicines in the United States. The result was the creation of a Traditional Medicines Congress, now sponsored by eight national organizations."

The list of organizations whose efforts have resulted in the Proposed Regulatory Model for Traditional Medicines, the Traditional Medicines Congress (TMC):

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);

Under what auspices is the TMC organized? Is it a non-profit agency?

Are there bylaws governing the TMC and if so, is it possible to obtain a copy of the bylaws?

Has the TMC kept minutes and agendas for all meetings?

Would the TMC please provide all minutes, agendas, and a roster of those organizations attending the meetings and those individuals (who act as spokes persons, decision makers) representing each organization with membership in the TMC? Is there a Chair person for the TMC?

"Each of these either represents or is engaged in standards setting, certification or accreditation for health care practitioners who include traditional medicines in their scope of practice; educational institutions that provide training in traditional medicine; manufacturers of traditional medicines; or growers and producers of traditional medicine ingredients."

As stated in this paragraph, each of the organizations proposing this regulatory action is actively involved in setting standards, certification and accreditation for the group they represent. Please note that some of these organizations (Acupuncturists and Naturopathic Physicians) have actively pursued licensing for their members in many states. Please understand that I am not in any way making a judgement on their decisions for licensure. I strongly believe in both of these healing modalities and honor their expertise, wisdom and their decision for licensure.

Is it a goal of at some of the members of the Traditional Medicines Congress to require all Traditional Medicine Practioners to be licensed?

Could the state or federal governing bodies require licensure stemming from the TMC Model?

Is there a way to protect the rights of all Traditional Medicine Practioners and Traditional Medicines without licensure?

(Page 1)

"Representatives of each of the sponsors of the Traditional Medicines Congress have created a specific proposal for a better way to regulate traditional medicines. At the very beginning of this process a clearly specified goal was agreed upon to emphasize both the value of traditional medicines and the responsibilities that are associated with their use:

The goal of the Traditional Medicines Congress is to benefit public health by ensuring access to traditional medicines in a manner that provides a reasonable expectation of public safety."

Is this proposal about Public Safety? Aren't the Public Safety issues already addressed by the FDA and DSHEA? Is this proposal being written to Protect those 'few' who abuse Herbs such as Ephedra from themselves, while at the same time it opens a Pandora's Box for the total control of Traditional Medicines by the government? Control that the government does not have now, and longs for?

Are there that many adverse reactions to Traditional medicines that we need to Protect the Public from them?

If this is a public safety issue this is already covered by existing laws.

• A traditional medicine category will preserve access by professionals to

traditional medicines that state or federal regulatory agencies have withdrawn, or may withdraw, from the market under current regulatory frameworks.

This paragraph states 'will preserve access by professionals' once again.

Keeping any potentially unsafe, highly medicinal herbs in the hands of qualified practitioners has merit, of course.

However, what criteria does the TMC propose for determination of who will be recognized as 'professionals' with access to ALL Traditional Medicines?

Please list the withdrawn and/or threatened herbs and traditional medicines that the TMC, is considering for limited access.(Eventually this list would have to include input from the FDA and HHS if this becomes law).

• A traditional medicine category will support the use of traditional medicines,

by both health professionals and consumers.

The language used here clearly states... "will support the use by health professionals and consumers."

Does this language exclude those who may currently be purveyors of safe Traditional Medicines such as Health Food Stores, mail order catalogs, Food Co-Op's, Fresh Herb and Mushroom Growers, internet sites, herb schools, etc.

Will all resale outlets have to hire Traditional Medicine Practioners to dispense herbs an other traditional Medicines?

It appears that many herbs and other traditional medicines could be taken off the shelves of our neighborhood health food stores and made available ONLY through a group that the TMC, FDA, HHS and the US Congress determine as qualified health professionals.

• "A traditional medicine category will ensure the public’s access to traditional

medicines and to truthful information about them."

The potential to expand the truthful information that we will be able to provide with Traditional Medicines is an important benefit of this proposal.

• A traditional medicine category will ensure practitioner access to traditional

medicines that, for safety reasons, should not be directly accessible to the

public.

Please provide a detailed list of the traditional medicines being referred to that are unsafe except in the hands of a qualified practioner?

How will it be determined if a practitioner (including an Herbalist or other non-licensed Traditional practioner) has the education and qualifications to dispense, recommend, prescribe, and maintain unrestricted access to all Traditional Medicines?

Page 13 of the proposal mentions the National Commission for Certifying Agencies (NCCA).

Would the NCCA be involved in setting up certification or other methods of determination for qualifications for access to use, and dispense Traditional Medicines (TM)?

• Accurate information about traditional uses and indications for traditional

Medicines will improve public safety.

This is an important benefit of the Traditional Medicines category. We all strive for accuracy and public safety.

Does the TMC feel that only 'qualified health practitioners' can create and dispense accurate information?

• "A traditional medicine category will support the use of traditional medicines,

by both health professionals and consumers." (from page 1)

• Distribution of restricted traditional medicines by qualified professionals will

improve public safety.

Are 'qualified professionals' the only venue of distribution of these restricted ingredients?

Terms need clear definitions.

• A traditional medicine category will provide a contribution to repair the U.S.

health care crisis.

It could benefit the US health care system if insurance companies recognize the category of Traditional Medicines and educational information is available to the public. Will pharmaceutical lobbyists and other special interest groups influence US Congress to limit access of Traditional Medicines? Will these high power, highly financed groups influence US Congress to create their own determination of what is considered safe, who is qualified to dispense and generally create their own rules that will become law?

• Creation of a traditional medicine category in the U.S. will be harmonious with

international models. Is this an attempt to conform to and /or adopt the CODEX model?

• Most traditional medicine ingredients and products will remain directly accessible to the public.

What products and ingredients will remain directly available, has a list been created? Which products and ingredients will be limited and / or prohibited? What does directly available mean and available though what venues- Health Food Stores, Practioners offices, Food CO-OP's, mass market stores, internet, direct mail, etc?

• Some traditional medicine ingredients and products will be accessible to

practitioners only (and so not accessible to the public without practitioner

supervision). Which Traditional Medicines are referred to here? What criteria and which governing body will determine who will be the practitioners with unrestricted access, and those with limited access? Will there be 2 classifications of Traditional Medicines, restricted and unrestricted?

• Many ingredients and products that fall into a new traditional medicine

regulatory category will also be able to be marketed as dietary supplements

under DSHEA.

Is it proposed that there will be at least two categories within the Traditional Medicines Classification? One category of traditional Medicines that are sold as such in current retail outlets, and through practitioners. The second category is those Traditional medicines with use restricted to practitioners (qualification to be determined).

Does the TMC proposal provide that Traditional Medicines in the first category (safe for direct use by consumers) be available through a variety of resale outlets including but not limited to: Health Food Stores, Internet Outlets, Mail order and Mass market stores, Herbalists, Acupuncturists, Naturopathic Physicians and other Traditional Medicine Practioners?

In the TMC proposal, would people in a retail setting for example, who do not necessarily have professional training in Traditional Medicines, be allowed to relay the information on the label and in the educational materials pertaining to the Traditional Medical use of the single ingredient or combination?

If some of the products under Traditional Medicines classification will fall under DSHEA, why did the TMC chose to not address this act?

Wouldn't support for DSHEA, which is currently under attack by Congress, be a better starting point for protecting our rights and continuing efforts for public awareness and safety?

page 3

• Additional losses to traditional medicine materia medica may be incurred in

the time that it takes to create a traditional medicine category.

Please explain what the TMC means here? What losses are feared? Is there an eminent threat some of us may be unaware of?

• Recognizing that professional practice of medicine is regulated at the state level, this TM Congress intends to maintain awareness of the potential impact on all stakeholders at state levels.

Who does TMC consider to be stakeholders at the state level?

Note the terminology- Professional Practice of Medicine is regulated at the state level. What role, what position do non-regulated Herbalists hold in this proposal?

Is this proposal one that TMC intends for adoption State by State or is the intention to create a federal law?

In discussing state regulation - Isn't it true that states require licenses for those who are regulated such as MD's, DC's ND's and Acupuncturists?

• Some current trends in national politics create a window of opportunity favorable to creation of a traditional medicine category.

Please elaborate here.

What is this 'window of opportunity' that the TMC sees that many of us do not? The climate in this current administration~

They lowered the standards for Organics until it almost means as much, or as little as the word natural, and put many ethical, organic small family farms out of business.

An administration that has the FBI compiling lists of Vegan's, reducing standards protecting our air, water and earth, and calls environmentalists 'terrorists'.

This is a Congress that the TMC feels provides a window of opportunity?

Please enlighten those of us who are looking into a different window.

Traditional Medicines Congress

DRAFT Key Components (page 4)

November 2005

d. The forms in which traditional medicines are used include:

i. Powders.

ii. Essential oils.

iii. Decoctions, distillations, infusions, solutions, and waters

iv. Fluid extracts, glycerites, honeys, mucilages, oils, oxymels,

spirits, tinctures, vinegars, medicated wines, and other extracts

in liquid form.

v. Aperitifs, cordials, elixirs, and syrups.

vi. Juices of herbal ingredients.

vii. Solid and semi-solid extracts.

viii. Powdered extracts and granulations.

ix. Capsules (hard shell or softgel), perles, pills, and tablets.

x. Lozenges, pastilles, and troches.

xi. Snuffs.

xii. Creams, gels, lotions, ointments, and salves.

xiii. Compresses, fomentations, liniments, plasters, poultices.

xiv. Moxabustion.

xv. Baths and washes.

xvi. Steam inhalations.

xvii. Douches and enemas.

xviii. Suppositories and pessaries.

The list of potential preparation and ingredients is included as Traditional Medicines is extensive.

What about Homeopathic preparations- pellets, gels, creams, etc? Will Homeopathic products be considered Traditional Medicines? Should an association of Homeopaths be made aware of the TMC Proposal?

Would the same formula provided in different forms, be classified differently? If traditionally a formula was in a tea or beverage form (an herb such as Kava for example), but a company decides to put in a tablet. Would it still be considered a Traditional medicine when in a non-traditional form?

(page 6)

f. Traditional medicines

i. That are offered for sale to any person for resale

1. Must either:

A. Consist of or be prepared from a single traditional

medicine ingredient; or

B. Conform to a traditional formula; or

C. Be a modified form of a traditional formula, such

modification to be in conformity with traditional

indications;

How is this to be determined? Does this preclude innovation? Would any new technology or new information on a use of a traditional medicine have to be approved first? What about patented formulas and processes? Will they be excluded from being classified as a TM?

If one ingredient were changed in a Traditional Formula would it no longer come under these rules and with access therefore available to everyone regardless of professional certification?

2. And must:

A. Be lab