An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series.

This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the series to forewarn consumers, clinicians, corporations, and governments of possible serious adverse events. They may also quicken the response rate during Phase IV post-marketing surveillance, in which governments could then exercise their regulatory powers.

The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine

The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine

Traditional knowledge for promotion of socioeconomic inclusion of local communities / Uso do conhecimento tradicional para promover a inclusão socioeconômica de comunidades locais

This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.

O artigo mostra o papel desempenhado por institutos públicos de pesquisa no Brasil na promoção da inclusão socioeconômica de comunidades locais por meio do uso do conhecimento tradicional e da medicina popular. Organizações não-governamentais e cooperativas são importantes para angariar recursos, defender os interesses das comunidades locais e influenciar mudanças no ordenamento jurídico. Entretanto, exigências de cunho legal relacionadas às Boas Práticas de Fabricação e à necessidade de comprovação da eficácia de medicamentos, impostas pela Agência Nacional de Vigilância Sanitária, tendem a demandar a intervenção de um instituto público de pesquisa capaz de auxiliar tais comunidades na aprovação e comercialização de medicamentos produzidos a partir de plantas medicinais. Assim, institutos públicos de pesquisa são essenciais para realizar estudos científicos que comprovem a eficácia das plantas medicinais e para auxiliar as comunidades locais a criarem a infraestrutura necessária para atender às exigências da Agência quanto a Boas Práticas de Fabricação.

Traditional knowledge for promotion of socioeconomic inclusion of local communities.

This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.

[Recent progress of international harmonization of crude drugs and medicinal plants--activity of FHH (The Western Pacific Regional Forum for the Harmonization of Herbal Medicines)].

The Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH) was established in 2002. The general proposed objective of the FHH is to promote public health by recognizing and developing standards and technical guidelines that aim to improve the quality, safety and efficacy of herbal medicines. At a sub-committee meeting of FHH nomenclature and standardization held in Tokyo, all the participants recognized the importance of comparing the descriptions of herbal medicines contained in member countries' pharmacopoeias or monograph standards as the first step in the harmonization of nomenclature and standardization. It was agreed to set up five expert working groups (EWG) to carry out the following specific tasks: 1) Nomenclature, 2) Testing Methods in Monographs, 3) List of Chemical Reference Standards (CRS) and Reference of Medicinal Plant Materials (RMPM), 4) List of Analytically Validated Methods, and 5) Information on General Tests. In this review, we report four topics of FHH activities from 2002-2009 as follows: 1) Comparative study on testing methods and specification values for crude drugs used in monographs among four Western Pacific regional countries (Japan, China, Korea and Vietnam), 2) Comparative study on TLC conditions for identification, chemical assay conditions for component quantification used in monographs among the four countries, 3) Comparative study on general testing methods for crude drugs among the four countries, 4) Comparative study on TLC identification for crude drugs used in monographs among the four countries considering harmonization and clean analysis.

[Dissection of differences and similarities of botanical drugs in European Union, US and Canada].

Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.

Practitioners of Western herbal medicine and their practice in the UK: beginning to sketch the profession.

OBJECTIVE: To profile the profession of Western herbal medicine (WHM) in the UK. DESIGN: A self-completion postal questionnaire sent to a sample of practitioners of WHM in England. RESULTS: A typical practitioner of WHM in the UK is female, aged 41-50, white, and practises part-time from a shared clinic or from home. Motivations to embark on a career in WHM are grounded in an interest in natural healing and the desire to help others. The practice of WHM in the UK responds extensively to women's health needs. Tensions in the practice of WHM are identified between a framework of healthcare that is described as 'traditional' and the influences of evidence-based developments in healthcare. CONCLUSION: Women, both as practitioners and as patients, and women's health needs play a central role in the contemporary practice of WHM in the UK.

Regulation of herbal medicines.

Complementary and alternative medicine is an increasingly popular form of health intervention used by millions of people in the UK each year. The demand for such therapies has seen their use grow and many have been adopted by district nurses as a supplement to the treatment and care they provide their patients. The use of complementary and alternative medicine is largely unregulated and this has led to increasing call for more effective regulation to ensure patient safety. Of particular concern recently has been the need to regulate the use of herbal medicines. This article considers the proposals for the reform of herbal medicines and professional and legal implications for district nurses who use complementary and alternative medicine in their practice.

An examination of the clinical practices and perceptions of professional herbalists providing patient care concurrently with conventional medical practice in Australia.

OBJECTIVE: To examine the clinical practices and perceptions of herbalists providing patient care concurrently with conventional medical practice. METHOD: A postal survey was sent to all full members of the National Herbalists' Association of Australia (NHAA). There were 649 members in practice at the time of the survey and the total response rate was 58.2%. RESULTS: Most of the patients who visit professional herbalists seek care for chronic conditions have been medically diagnosed and continue to consult a general practitioner (GP). Study findings indicate that many patients who visit herbalists are taking herbal and pharmaceutical medicines concurrently. Therapists reported a high rate of referral to GPs for medical diagnosis, treatment and/or prescription. The majority of herbalists also routinely include a pharmaceutical case history as part of their consultation and patients are encouraged to inform their GPs if they are taking any herbal therapies. The majority of herbalists reported a need for closer collaboration and cooperation with the medical community in the future. CONCLUSION: Herbalists in Australia are fully aware of the value of medical diagnosis and inter-referrals, are well informed about patient medications and require a closer working relationship with the medical community. Further research is needed to investigate potential interactions between herbal and pharmaceutical medicines to maintain high safety standards for the public.