Are Herbs and Traditional Medicines Threatened?

The USA has broad access to herbs, but this freedom could be lost.

The Traditional Medicines Congress (TMC) is proposing federal regulation that will affect everyone involved with herbs by:

• Restricting access to herbal products
• Creating regulatory challenges for practioners
• Increasing costs
• Limiting health care options
• Standardizing herbal formulas, texts and education
• Restricting innovation in herbalism
• Creating a new category called Traditional Medicines

Help Protect Diversity & Herbalism:
Stop the TMC!

What is the Traditional Medicines Congress?

The Traditional Medicines Congress (TMC), formed in 2004, is comprised of two officers from eight organizations. The TMC drafted the document, A Proposed Regulatory Model for Traditional Medicines.

TMC Members

• Acupuncture and Oriental Medicine Alliance (AOMA)
• American Association of Naturopathic Physicians (AANP)
• American Association of Oriental Medicine (AAOM)
• American Herbalist Guild (AHG) — (The AHG withdrew in Oct. 2006 after controversy in the herbal community concerning the TMC proposal)
• American Herbal Products Association (AHPA)
• Council of Colleges of Acupuncture and Oriental Medicine (CCAOM)
• Medicinal Herb Consortium (MHC)
• National Ayurvedic Medical Association (NAMA)
• National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM)

The TMC Regulatory Model Proposes to:

• Establish herbs as medicines instead of as dietary supplements — the pharmaceuticalization of herbal products.
• Set manufacturing and labeling standards for traditional medicines that would be financially prohibitive to all but large companies.
• Standardize and restrict criteria for ingredients and formulas classified as traditional medicine.
• Create legal qualifications as to who can dispense traditional medicine products, restricting access to herbs and other traditional medicines.
• Establish an industry advisory body working within the federal government.
• Create a federal regulatory model that is similarly structured to international directives that has damaged practitioners, consumers and especially herbalism.
• Undermine DSHEA (The Dietary Supplement Heath and Education Act of 1994)

Intellectual Property Rights

Traditional Medicine and herbal medicine serve as a public health safety net. Inhibiting this safety net under the ruse of consumer protection, to further corporate profits, is an act of biopiracy. The TMC proposal would violate the intellectual property rights of both cultures and culturally empowered individuals who hold cultural knowledge of medicinal plant use. This violates UNESCO (United Nations Educational, Scientific and Cultural Organization) and WIPO (World Intellectual Property Organization) guidelines.

What is the Potential Effect of the TMC Regulatory Model?

Americans enjoy freedom of access to a diversity of herbs and herbal products no longer found in many countries. The TMC model proposes the creation of a new category of federally regulated substances called traditional medicines (TM). This includes: herbs, plant derived products, minerals and animal health products. This proposed TM category has the potential to restrict access to herbs in the USA.

The document appears as an attempt towards harmonization with the restrictive regulations of the EU. The language is similar to the EU's Traditional Herbal Medicinal Products Directive (THMPD) (See these articles for more about the THMPD: The Legal Framework for Herbal Medicinal Products in Europe and The European Commission's Herbal Directive.) THMPD is being enacted worldwide, despite public outcry. THMPD has reduced access to traditional herbal preparations and the number of viable small- to medium-sized herbal companies. Innovation, new raw materials and new uses for established herbal products would be limited in their development and legality by the TMC regulations.

The vast majority of herbs in the marketplace are safe.

The guiding assumption behind the TMC's proposed regulation is that herbs are a threat to public safety. The TMC needlessly assumes the role of 'protector'.

What is Most Contoversial About the TMC?

The Dietary Supplement Heath and Education Act of 1994 (DSHEA) protects our freedom of access to herbs and addresses public safety. The proposed TMC regulation will undermine DSHEA. It creates costly changes in the way herbs and other traditional medicines are classified. These regulations change herbs from classification as 'dietary supplements' to 'medicines'. This is significant as it switches the burden of proof from the FDA to the individual manufacturer. The manufacturer must bear the expense which will in turn increase cost to the consumer. The TMC's proposal is an attempt at standardization and conformity that will rob herbalism of its traditional roots.

This federal regulation creates an industry backed advisory panel within the Department of Health and Human Services (HHS), the overseer of the Food and Drug Administration (FDA). It inserts corporate interests, in the form of an advisory panel, inside the federal agency of Health and Human Services.

What Can You Do to Stop the TMC?

1. Be informed. Read A Proposed Regulatory Model for Traditional Medicines.
2. Manufacturers & retailers please review Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal Medicinal Products: Implications for Small–to–Medium–Sized Enterprises by Josef Brinckmann and Michael McIntyre, MA. HerbalGram 2006;70:62-66
3. Send a letter to the sponsoring organizations. Contact the TMC directly through the American Herbal Products Association (AHPA), at mmcguffin@ahpa.org, National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), at bclark@nccaom.org & TMCongressFeedback@pobox.com. Voice your concerns about the TMC, further regulation and their proposal increasing financial and regulatory burdens. Let them know you support our current freedom and herbal diversity. Inform them that you don't agree with harmonizing the USA with restrictive international herb directives.
4. Send the same letter to your favorite supplement companies, trade journals, natural food stores and health freedom advocacy groups in the United States.
5. Members of the TMC organizations, please voice your views on the TMC! Let them know that you will not continue to contribute dues to organizations that undermine DSHEA, health freedom and your business.
6. Write to your Congressional Representatives and let them know that DSHEA protects consumers and ask them to support DSHEA.

For in-depth review of another attempt to regulate herbalists, read: The Washington State Department of Health's Herbalists Sunshine Review.

Please forward a copy of your comments to us: TradMedFreedom@aol.com

Thank you for taking action!

A Declaration of Intent from UK Herbalists

British herbalists are currently reacting to restrictive regulations that are similar to the TMC proposal. These regulations impact their access and freedom to practice herbalism. British herbalists have sent us their response to their equivalent of our FDA.

"It is the inalienable right of all people to use plants for their sustenance and healing. In the spirit of the European Charter of Human Rights, so too is it an essential freedom to seek advice from those who have devoted themselves to the knowledge and application of the health-giving properties of plants.

We conjoin with indigenous traditional healers throughout the world in seeking to protect our plant heritage and maintain the practice of all such natural therapies.

It is a maxim that all who care for the sick shall do no harm: our inheritance is that British practitioners of Traditional Western Herbal Medicine have upheld this absolutely and without exception for a century or more, as we determine to continue.

Likewise we reject the current intention to regulate our medicines in that it will compromise without justification the essential freedoms of the public, herbal practitioners and their traditional suppliers in favour of the few who may profit by it."

Signed,

Chris Caton, Nathalie Chidley, Carol Church, Stephen Church, Christopher Hedley, Tim Lane, Kym Murden, Non Shaw, Sally Viney, Emmett Walsh, Jennifer Wharam and Ania Zwozdiak

Voices for Traditional Herbal Medicine

This information has been prepared and endorsed by a grass roots team dedicated to preserving the voices of herbal diversity and to help stop unnecessary regulation.

Cascade Anderson Geller, OR, Ann Armbrecht, PhD, VT, Paul Bergner, CO, Jane Bothwell, CA, Donna Chesner, AZ, Jessa Faith Fisher, AZ, Chuck Garcia, CA, Rosemary Gladstar, VT, Cheryl Hartt, VT, Tammi Hartung, CO, Phyllis Hogan, AZ, Pam Hyde-Nakai, AZ, Feather Jones, AZ, Jan Keyes, NJ, Elise Krohn, WA, Tony (a) Lemos, MA, Helene B. Leonetti, MD, Kathleen Maier, VA, Guido Mase', VT, Richard McDonald, NM, Michael Moore, AZ, Nancy Phillips, NH, Cynthia Pileggi, CO, Julie Sasinka, CO, Nancy Scarzello, VT, Adam Seller, CA, Mona Shad, PA, Denise Tracy, NM, DeeAnn Tracy, AZ, Kripa Watts Robb, CA, Susun Weed, NY, Doug Whan, CO, Katherine Yvinskas, NJ

Compassion Club Wellness Clinic, Vancouver B.C. Canada

Black Cross Heath Collective Portland, OR

Cascadian Health Educators, OR

MASHH Medic Activists Seeking Health and Healing

Now is the time to take action so that diversity and herbalism will be sustained. Thank you for spreading the message and helping to Stop the TMC!

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