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 Traditional Medicines Congress Calls for Comments on “Ideal Regulatory Model”

The Traditional Medicinals Congress is comprised of the American Herbal Products Association along with 8 other national organizations who have drafted “A Proposed Regulatory Model for Traditional Medicinals”.   In 2004 the TM Congress came together with the intended goal “to benefit public health by ensuring access to traditional medicinals in a manner that provides a reasonable expectation of public safety”. 

The document details the Congress’ agreed upon stipulations for creating an “optional new category” for classifying and labeling herbal products apart from the Dietary Supplement Health and Education Act, under which herbs may not be marketed as medicines. 

 

The guiding assumptions and key components of the document are posted online at www.ahpa.org  as well as on the other sponsoring organizations’ websites. 

 

Public comments may be sent to TMCongressFeedback@pobox.com .  The deadline for comments is June 30th, although this date may be extended. 

 

 

Regulated: Public Safety or Restricted access?  By Kara Sigler, Clinical Herbalist Intern

 

We have all been hearing about the Traditional Medicinals Congress recently, the proposed legislation by nine national organizations to regulate how herbs are labeled and what herbs may or may not be available to the public in the future.  But why just now?  The TM Congress originally met in 2004 to draft “A Proposed Regulatory Model for Traditional Medicinals”.  Yet it has only come to the attention of the lay Western Herbalist community within the last few months.  Even the American Herbalists Guild, the only voice of western herbalists on the board of the TM Congress, was not forthcoming in announcing to the public, or even its own members that the document was being drafted.  The AHG website has one small press release on the TM Congress dated November 29th, 2005, which directs readers to the AHPA official site where the document can be downloaded.  The only comment by the president of the AHG read “We are pleased to be part of this group of national organizations working cooperatively…”.  Apart from that the AHG made no stance on the drafted document.  A few AHG members that I spoke with had not seen any mention of the TM Congress in any newsletter they had received.  This lack of informing western herbalists, who will definitely be affected by the legislation, does not bode well for this community unless we take it upon ourselves to make our opinions heard and incorporated into the proposal.   Responding to a question already fielded publicly, the AHPA webpage states that Yes, others may join the Traditional Medicinals Congress as long as they meet the stated criteria.  Western Herbalists need to be more represented on a national level since this kind of legislation affects not only the way we practice our craft, but also the way we dispense and make our medicines, and the way our educational facilities may be accredited in the future. 

 

While carefully reading over the Guilding Assumptions and Key Components of the proposed document, I found that the language used was not difficult or full of jargon, yet I did have to read between the lines.  The supposed “goal of the Traditional Medicinals Congress is to benefit public health by ensuring access to traditional medicinals in a manner that provides a reasonable expectation of public safety”.  This alleged purpose of regulating the sale of herbal medicines for the public’s own safety worries me.  Questions arise for me such as what is considered “reasonably” safe for public consumption, what constitutes a “traditional use” that must be proven to use herbs, and who in the future will be a “qualified” practitioner to dispense said “safe” herbs.  The document claims to be acting in the interest of the public, “to ensure access”, but they are just creating more regulations and removing herbal medicine further from the hands of the people to heal themselves.

To their credit, the TM Congress is creating a framework for instituting regulations by a group of practitioners and manufacturers, who truly have traditional medicinals quality as their focus, as opposed to being regulated by an outside government agency.  As it stands there are few regulating bodies over the use of herbal products, namely the FDA under the Dietary Supplement Health and Education Act and the Food Drug and Cosmetic Act, which the TM Congress deems not to be effected by this “optional new category” they are creating.  So why institute regulations and laws where they previously did not exist and seem not to leave a lack there of?  A closer look at the home page of the sponsoring herbal organizations brings the answer into sharp relief.  By changing the way herbs can be labeled as medicinals, the AHPA and other large scale herbal manufacturers have financially to gain by filling a market niche that if regulated, could exclude smaller companies from the fees imposed by accreditation and restricted public access to certain herbs deamed unsafe by the Traditional Medicinals Congress board. 

Although the authors of the draft state that their document does not affect herbalists, it does lay a groundwork for future regulations and accrediting standards for designating who is a qualified practitioner to dispense said herbs.  This especially affects western herbalists and traditional healers who are not accredited or licensed, and who practice outside an allopathic model of regulation. This subject is at the forefront of political and economic legislation as the herbal industry boasts $4 million in sales and continued rapid growth.  Hopefully the country’s blossoming awareness of traditional medicinals and alternative models of healing means that these will continue to be accessible to the public and the practitioners of non-western forms of medicine.  We shall see in the future whether this type of legislation actually passes, and whether it will help or harm those it is intended to protect.  

ers:

 

Traditional Medicines Congress ~  By Lainie Baker, Clinical Herbalist

 

The Traditional Medicines Congress asserts that a primary purpose for instituting guidelines is to ensure safety to the public by removing direct consumer access to plant medicine viewed as a threat to public health. They go on to profess that distribution of restricted traditional medicines by “qualified” professionals will improve public safety.

 

Plant related deaths are extremely rare. In the 2000 Annual Report of the American Association of Poison Control Centers (AAPCC), only nine deaths occurred when using botanical medicines. Seven of these deaths included the intentional abuse of Ma Huang. Compare this with a clinical study report in 1998 that conservatively estimated 107,000 hospitalizations annually for Non-steroidal Anti-inflammatory Drug (NSAID)-related gastrointestinal complications and at least 16,500 NSAID-related deaths that occur each year among arthritis patients alone. With so many over-the-counter, non-herbal toxins available to consumers, it seems the focus of herbalists would be better placed on beginning a movement toward removing these toxins, rather than plant medicine, from consumer reach.

 

I’m fascinated at the notion of the Congress that it can effectively remove these “harmful plant substances” from the public. Plants abound and where there is need, there is resourcefulness. In this case, to presume control over community access is to presume control over nature.

 

Additionally, if there were truly a need for consumer safety from plant medicine, this kind of prohibition of public access would stem from the public itself, from those who are directly affected. However, the request for public safety comes from those who may financially benefit and ultimately gain control over the trade.

 

On a different note, who would be considered a “qualified” practitioner as stated throughout the document? While the Congress announced that they currently take no position on license requirements for practitioners, it seems the model they are proposing serves as a prelude to it.  For example, because the American Herbalist Guild has an exam focusing on a science-based approach to botanical medicine, and is one of the only organizations in the country to hold an exam, it is likely that the government will accept this existing standard as the model for herbal training and qualification. The result would be the exclusion of other equally valuable traditional methods of healing. Methods such as Curanderic, Shamanic and Energetic healing would be relegated to second-rate status and possibly even restricted from legal practice. To limit the scope of what herbalism means by certifying only in a science-based approach is to endanger the practice in alternative paradigms and strip the livelihood of many practitioners who have dedicated their lives to healing those in the community. Additionally, with the current medical system in place, can the public really afford to have a reduction in their choices of health care? It’s certainly something to think about.


 

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