RE: American Botanical Council Comments on Traditional Medicine Congress Proposal for A Proposed Regulatory Model for Traditional Medicines [issued November 1, 2005]
June 30, 2006
Dear Members of the Traditional Medicine Congress:
The American Botanical Council (ABC) commends the Traditional Medicine Congress (TMC) and its constituent member organizations for their initiative in proposing a new regulatory framework for “Traditional Medicines” marketed and sold in the United States.
American Botanical Council. ABC is a nonprofit research and education organization, tax exempt of the Internal Revenue service code section 501(c)(3). ABC was founded in 1988 with the mission to promote accurate, responsible scientific and traditional-based information on the responsible use of herbs, phytomedicines, and other plant-based ingredients and preparations.
Goal of Traditional Medicines Congress (TMC). First, ABC wants to affirm that it supports the intended goal of the TMC, as stated in its November 2005 proposal: "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."
ABC would also hasten to add that the benefit to public health should also be conducted in a manner that not only provides a reasonable expectation of safety, but also quality and reliability, i.e., that the public can have confidence in such products' overall quality and that the public can have a reasonable expectation that the products can reliably deliver some type of purported health benefit that is consistent with the products' labeling, marketing, and intended use.
Composition of the Traditional Medicines Congress. ABC is aware that the initial basis of the TMC has been comprised of professional organizations representing various practitioners of traditionally-oriented healthcare systems that employ herbal preparations as part of the traditional modality of healthcare, as well as involving a leading trade association representing the herbal industry in the United States. To ABC’s knowledge, all, or at least most, of these organizations are subject to section 501(c)(6) of the IRS tax code, and, as such, ABC is aware that the primary purpose for all of these organizations is to promote and protect the interests of their members, be they traditional health professionals or herb-producing companies. Thus, the initial TMC proposal of November 2005 was drafted by organizations whose primary purpose is predicated on the interests of its members. To ABC’s knowledge, the initial draft of the TMC did not include consultation with or input from nonprofit organizations whose mission is more aligned with promoting and fostering the general public good, i.e., organizations such as academic institutions, education and research organizations, or organizations dedicated to promoting and fostering the interests of healthcare and health product consumers. Nevertheless, TMC has made its initial proposal public and has invited comments from all segments of the public, for which ABC is most grateful for such opportunity.
Recent Historical Background in U.S. ABC has been interested in the development of a rational framework to govern the production, marketing and sale of traditional herbal medicine products for over 15 years. In the early 1990s, recognizing the lack of a rational and effective regulatory system for herbal medicinal products in the United States at that time, I presented numerous lectures on the subject of the need for some regulatory reform in this area. As evidence of this, in October 1990, I authored an article in a leading consumer health magazine on the subject for the need for the development of a traditional medicines framework for medicinal plant products. (Blumenthal, 1990) However, given the exigencies of the regulatory and legislative period of that time, ABC set aside this topic.
As some long-time observers will recall, in 1992 and the following year, legislation was introduced into the U.S. Congress that eventually resulted in the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the law that created a regulatory framework for herbs and other dietary supplement ingredients to be regulated as dietary supplements, i.e., as a category of foods, not food additives nor drugs. During the public discussion that surrounded the development and eventual passage of DSHEA, there was considerable confusion among members of Congress, the media, and others about whether herbs specifically were safe, whether there was any reliable data to support their safety and efficacy for a variety of uses, and whether this particular class of ingredients, unlike conventional vitamins, minerals and other conventional nutritional components, should be regulated as foods or as drugs. Consequently, ABC realized that to propose a regulatory category for herbs as so-called traditional medicines, which would be widely viewed as a type of medicine or drug, would be antithetical to the efforts to create some baseline rationality in the regulation of herbs as dietary supplements, i.e., foods, as already proposed by the sponsors of DSHEA. Accordingly, in order to minimize confusion, ABC ceased its efforts to promote traditional medicines as a potential new category of drugs or another yet-to-be determined regulatory category.
WHO Guidelines. In the early 1990s ABC participated in the World Health Organization’s development and ratification of the WHO Guidelines for the Assessment of Herbal Medicines (Akerele, 1993). ABC was instrumental in ensuring that the language of the WHO Guidelines included recognition of complex herbal formulations that are listed in traditional materia medica from such traditional medicine systems as Ayurveda, Traditional Chinese Medicine, etc. In addition, the WHO Guidelines recognize historical use as part or all of the basis for evaluating safety and presumed efficacy, especially if no modern scientific or clinical data contradicts the historical traditional record. ABC believes that the development of a new regulatory framework for herbs as traditional medicines should be consistent with the philosophy and policies of WHO.
German Commission E Monographs. During the time that DSHEA was being debated in Congress in the summer of 1993 ABC launched a project to help provide the herb and medicinal plant community, as well as scientists, clinicians, legislators, regulators, journalists and others some information on the safety and efficacy of many herbs commonly employed in Europe by translating, editing and publishing in English the entire body of work produced by the German Commission E (Blumenthal et al., 1998). Much of the Commission’s work covered all the available literature on over 300 herbs sold as nonprescription medicines in German pharmacies. Many of the therapeutic uses approved the Commission E and authorized by the German government were based, at least in part, by recognition of the traditional uses of many of these herbs, many of which contained a growing amount of scientific and clinical research supporting such clinical use. As pointed out by the late Professor Varro E. Tyler, the Commission E’s criteria for efficacy employed a “doctrine of reasonable certainty” with respect to the totality of traditional/historical use data, scientific and clinical information when available.
Based on ABC’s experience with the WHO Guidelines and the German Commission E Monographs, as well as other activities and projects, ABC has had a long-standing policy that the safety and efficacy of herbal preparations and phytomedicinal products sold in the U.S. market should be evaluated rationally, which presupposes inclusion of data based on traditional use as well as more modern scientific and clinical data, when available.
International Models. ABC believes that any rational regulatory framework for TMs in the U.S. should be made in recognition of existing regulatory frameworks in other regions that already accommodate traditional herbal medicinal products (THMPs). Although modern scientific and clinical data are usually preferred by regulatory authorities, there appear to be a framework for recognition of traditional use data in the regulatory systems that are in place in Australia since about 1991 and that has been recently established in Canada as part of the Natural Health Products Directorate’s mandate. Evaluations and approvals based on traditional use data are also currently being implemented in the European Union. ABC believes that there are specific provisions in these regulatory systems that warrant attention and possible adoption. ABC suggests caution with respect to any attempts to establish a new regulatory system that is not complementary to the international systems that are already in place. In fact, considering the relative costs being borne by companies to have their products evaluated and accepted in these other regulatory regimes, it might be appropriate to consider some type of complementarity whereby the proposed U.S. system may recognize the safety and presumed efficacy for a traditional claim of a product that has already received a license in such other countries, provided, of course, that GMP and other baseline requirements can be documented. Given the time and costs to produce a product license dossier for one of these regulatory systems, it might be reasonable and appropriate to consider the official recognition of such as adequate for an application under a Traditional Herbal Medicine Category here in the U.S.
Definition of Traditional Medicine. Re Section I(a), p.4: ABC appreciates the rather detailed and wide definition of the components of traditional medicine preparations. ABC believes that the definition of a traditional herbal medicinal product (THMP) should be made in such a manner as to allow for the maximum fluidity and accommodation with existing definitions in other international regulatory systems, i.e., to the extent that this is deemed reasonable and feasible. These would include the Australian Therapeutic Goods Administration, the Canadian Natural Health Products Directorate, the European Medicines Evaluation Agency (EMEA)’s EU Directive for Traditional Herbal Medicinal Products (THMPD), etc.
Quality Control and Good Manufacturing Practices (GMPs). ABC is deeply concerned about the quality of herbal products marketed and sold in the U.S. and worldwide. ABC has long been concerned that DSHEA did not stipulate that the specific identity of an herb or multiple herbs in an herbal product must be clearly defined as to proper identity as a minimum quality control requirement or precondition to making a so-called “structure/function claim” under DSHEA. Although ABC is aware that current federal law requires that all food and dietary supplement products must meet certain standards of uniformity for identity in labeling (e.g., the American Herbal Products Associations’ Herbs of Commerce, 2nd edition [McGuffin et al., 2000]) and that a product would be deemed mislabeled and/or adulterated if it does not contain ingredients accurately corresponding to those stated on the label, ABC nevertheless suggests that all HMPs that are sold with a traditional claim should at least meet a minimum requirement to ensure proper identity of the stated ingredients. Given that the publication of final GMP rules for dietary supplements are believed to be imminently forthcoming from the FDA, ABC would like to propose that these GMPs be adopted for the production of traditional herbal medicinal products sold in the US, i.e., so long as some reasonable exceptions are included (e.g., preparation of herbal products by traditional healthcare practitioners for sale directly to patients, etc.). However, until final GMP rules are actually forthcoming from FDA, ABC reserves final judgment on this matter, i.e., until such rules can be evaluated. However, insofar as the FDA’s proposed GMPs for dietary supplements are mandated by DSHEA to be modeled on food GMPs, and insofar as existing foreign regulatory models for THMPs presume that the constituent herbal ingredients must meet some minimum compendial standard for quality as usually defined in a national or regional pharmacopeia, it is at least theoretically possible that traditional herbal medicinal products that might be made in the U.S. under a proposed new traditional medicines regulatory framework might have a lower potential quality with respect to meeting baseline criteria for quality as recognized in other countries. ABC recognizes that this is a difficult and somewhat speculative area, especially since the FDA’s GMPs for dietary supplements have not yet published, but ABC believes that this point merits future consideration.
Length of Time Required to Qualify for Traditional Claim. ABC believes that it may be constructive to stipulate the minimum amount of time that may be required to constitute traditional use of an herb or THMP, particularly to help establish a baseline for safe use. ABC suggests that the EU standard of 30 years of documented use would be useful (i.e, without the stipulation of 30 years sales in a specific geographical region) in helping to determine minimum time for what constitutes traditional use.
Concern of Impact of Additional Regulation on Small Business. ABC recognizes that small business are vital to a robust economy and that small businesses and their entrepreneurial owners are responsible for much of the creativity and diversity in any market, including the herbal products industry. ABC also acknowledges that a diversity of properly manufactured and labeled natural health products, dietary supplements, and traditional medicines is conducive to affording more consumer choice for selfcare and healthcare. Insofar as many companies who make traditionally-oriented herbal medicines are small cottage industries and/or small companies, ABC is concerned about the potentially adverse impact that heightened regulatory requirements may have on the viability of these small businesses. In virtually all cases, ABC would want to ensure an equitable balance between business viability and consumer choice on the one hand, and protecting consumers’ welfare by ensuring that products are properly manufactured according to appropriate standards and processes on the other.
Summary. In summary, ABC appreciates and congratulates the Traditional Medicines Congress for the initiative it has taken to move this issue forward into public discussion. ABC also is grateful for the opportunity afforded it as a member of the public to provide comments for consideration. ABC believes that consumers are best served when they can access a wide variety of herbal medicinal products, that are properly manufactured from high quality botanical ingredients, that are safe when used according to the products intended use, according to label directions and/or direct instructions from a dispensing practitioner, and are reasonably and honestly labeled for uses that are based on either historical traditional experience and/or the results from modern scientific/clinical research.
Respectfully submitted,
Mark Blumenthal
Founder & Executive Director, ABC
Editor, HerbalGram, HerbalEGram, HerbClip
References
Akerele O. Summary of WHO Guidelines for the Assessment of Herbal Medicines. HerbalGram. 1993;28:13ff.
Blumenthal M. The need for a new regulatory category in herbs. Let’s Live, Oct., 1990.
Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS (eds.). Klein S, Rister RS (trans.). The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin: American Botanical Council, 1998.
McGuffin M, Kartesz JT, Leung AY, Tucker AO. American Herbal Products Association's Herbs of Commerce, 2nd ed. Silver Spring, MD: American Herbal Products Association, 2000.