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The comment period for a draft concept paper on a proposed new model for the regulation of traditional medicines in the United States has been extended to June 30, 2006.
The draft document, A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components, was released last November by the Traditional Medicines (TM) Congress, a coalition comprised of a trade association and 8 national professional organizations of traditional practitioners.*
At least 70 comments have been submitted to date, but the TM Congress has recently received requests to extend the comment period from a number of practicing herbalists.
Three key areas of confusion that were apparent in the initial review process are now being clarified, according to a press release issued on March 29:
1. The TM Congress is not suggesting that herbs that are now marketed as dietary supplements under the Dietary Supplement Health & Education Act (DSHEA) be required to be sold as traditional medicines. Instead, the vision of the TM Congress is to create an optional new category. As envisioned, products in this new category could be labeled with their traditional uses (including medicinal uses) so long as such products conform with traditional criteria such as dose and preparation.
2. The TM Congress is not attempting to influence the practice of medicine or the scope of practice of any therapeutic discipline. The TM Congress drafted its proposed regulatory model to differentiate between products that are offered for retail sale and traditional medicines that are provided directly to a patient, for example, by an acupuncturist or an herbalist. The primary focus of the model is on the first of these, and attention has been given to the need to ensure that practitioners maintain direct control over traditional medicines that they produce for their patients.
3. The TM Congress takes no position for or against license requirements for practitioners. Licensing for healthcare practitioners of every discipline is regulated on a state-by-state basis. The TM Congress has expressed neither support for nor opposition to expanding licensure requirements for any of the practitioners that use herbs in their practices, as this issue is outside of the scope of the Congress’ purpose.
The complete text of the document, A Proposed Regulatory Model for Traditional Medicines, is posted online at http://www.ahpa.org/05_1129_TMCongress_ProposedModel.pdf. Comments should be emailed to TMCongressFeedback@pobox.com by June 30, 2006.
* Acupuncture and Oriental Medicine Alliance (AOMA); American Association of Naturopathic Physicians (AANP); American Association of Oriental Medicine (AAOM); American Herbalists 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).
Source: Traditional Medicines Congress. Comment period for Traditional Medicine model extended. [press release]. Silver Spring, MD: American Herbal Products Assn., Mar. 29, 2006.
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