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Table 3 Summary of participants or document type/level of policy-making, methods, types of evidence, facilitators and barriers

From: Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

First author and year

Participants or document type/level of policy-making

Types of evidence

Summary of description of methods

Facilitators to the implementation of DHS regulations

Barriers to the implementation of DHS regulations

Alostad et al. 2019 [18]

The main participants that were identified and interviewed included senior and middle managers employed in the registration of HMs in Bahrain and Kuwait drug regulatory authority. Moreover, scientific reviewers who were also involved in the registration process were selected and took part in observations (in regard to how HMs are currently registered and classified in the National Health Regulatory Agency after the implementation of policy and interviews. The managers identified were primary decision-makers of policies impacting HM registration. On the contrary, the scientific reviewers were employees who were responsible for applying policies concerning HM categorization and conducting detailed analysis on quality control.

Comprehensive field notes were written down during the three major segments of HM registration procedure which include the regulatory review and requirements as well as approximate schedules for important breakthroughs in the review methodology. Furthermore, legislative documents relating to HM registration requirements and its guidelines, along with ministerial decrees were also analyzed.

Data were collected in Bahrain, employing a sequential study format. The preparedness was consecutively measured in Kuwait for implementation purposes. Using the policy triangle model proposed by Walt and Gilson was employed. Then, actors, study background and process elements were identified. Data sources were examined for information regarding legislative policies and any direct information about HM registration procedures. Semi-structured interviews were conducted with twenty three officials (8 officials from the Bahraini drug regulatory authority; 5 reviewers and 3 managers, 15 officials from the Kuwaiti drug regulatory authority; 9 reviewers and 6 managers). These actors were all involved in the HM registration processes. Lastly, this data was analyzed using thematic analyses and findings positioned employing the aforementioned model.

Main facilitators included the increased teamwork between varying parties such as the National Health Regulatory Agency officials and external experts. There existed very open lines of communications, sort of the open-door-policy, allowing both groups to expand their knowledge base in regard to policy development. Furthermore, there was also support received from the government, especially the Supreme Council of Health which allowed the regulations to come in a smooth and quick manner. In addition, there was not a need for supplemental training as all reviewers responsible for policy implementation were experts and had experience in the production process. The old reviewers taught the new reviewers everything such as how to use the guideline and why it is important that they use it.

One major barrier includes the variability of how a HM is defined across the world. For instance, the United States categorized it as a food supplement, whereas the United Kingdom licenses it as something altogether. Kuwait imports HM from these two countries, thereby, making the challenge to classify HMs appropriately that much more enormous. There has also been increased resistance from agents to comply with new frameworks being developed from a social and political perspective. It has taken a long time for them to adapt as sometimes these groups are not even aware of the current and updated regulations. Continuous change in HMs regulations: this is very problematic because every country has its own method of assessment and their own classification system, with the same herb you find it banned in one country, but in another country it is classified as a health product.

Carvalho et al. 2018 [32]

Policy-making was conducted on a country/national level. Governmental documents like drug registration documents and license papers of HMs were analyzed. Additional documents included evidence from different pharmaceutical laboratories as well as physician's prescriptions. These prescriptions were obtained in order to differentiate HMs sold under prescription from those categorized as nonprescription.

The research was carried out with ANVISA database.

Information from ANVISA was placed in an Excel spreadsheet. It was categorized under the following columns: commercial name, botanical name, single or combined herbal medicine, over-the-counter or prescription, licensing holding company, business location, licensing validity and therapeutic category. Then, a survey was performed on the notification platform of ANVISA to ensure viable notifications are presented for HM products.

Financial endorsement systems were provided continually for research, development and production purposes in the field of HM. These included funds from the Ministry of Health and other governmental agencies for research and production of herbal medicinal products. A unique notification system was also established for herbal medicinal products permitting quick product release and an expanded repository of drug data on the Brazilian Herbal Formulary. Newer regulations (e.g., on Brazilian biodiversity) have prompted the elevation of access to genetic heritage. Previously, there were multiple steps involved to obtain permission for HM studies, however, the new law only allows new applications for new products after sufficient and reliable market research, making the process more efficient. Brazil also contains a large population that is “all-ears” to HM and natural products being used for therapeutic purposes.

There are not that many professionals who specialize in the field of HM, especially those which require advanced education and knowledge on biopharmaceutical techniques. There has also been a reduced amount of herbal medicinal products available which can be attributed to National Active Pharmaceutical Ingredients suppliers who are unable to comply with the standard production practices, causing Brazil to import the majority of its HMs. Even with ANVISA organizing several workshops and technical meetings, these were not enough to improve the number of licensed herbal medicinal products. Many pharmaceutical companies do not attend them or use these resources and, as an example, there exists medicinal plants that do not have any licensed herbal medicinal products.

Molin et al. 2019 [18]

Dietary supplement samples were previously placed into different categories based on the efficacy ratings given by governmental websites. However, researchers evaluated this information and created a new categorization criteria for them. The allowed claims are constituted in ANVISA RDC No. 242 and 243/2018. Following, the claims submitted for the key ingredients were collated with recommendations made by international bodies and consortiums such as the Academy of Nutrition and Dietetics, Dietitians of Canada as well as scientific articles.

The study analyzed various dietary supplement selections using the appropriate legislative procedures for this group of products [(I) Food for athletes; (II) Vitamin and/or mineral supplements; (III) New foods and/or new ingredients; (IV) Food of functional and/or health property; (V) Specific medications; and (VI) Herbal medicines]. The e-commerce stores examined in this study (n = 7) were all Brazilian. Sample prices within these stores ranged from R$ 19.50 to R$ 244.45

With current budget limitations, along with specifications to portray the sample as a sample of interest, only 44 samples could be obtained. These samples were acquired through mail.

A qualitative, observational and descriptive study was conducted using Google as the primary tool of dietary supplements sold in Brazilian online stores. Product ingredients, side-effects, outlying commercial claims were all assessed. This was to promote and shed light on how existing regulations can be further improved. Effects and outcomes related to specific ingredients as described by manufacturers were compared with theoretical information presented in scientific literature.

It has been noted how a great deal of the population have an increased distrust in modern medicine and are relying more on natural (especially HMs) and alternative therapies for medical illnesses. This is because many associate the word “natural” with a healthy human being that uses safe practices derived from medicinal plants to better his lifestyle and cure diseases. Moreover, more and more individuals are attracted towards the idea of using such natural products as “self-medication” in order to have better control over their own health.

There exist commercial appeals used by business professionals to attract buyers in purchasing their products. Not only that, but the sellers promote a fake image that the products being sold are highly effective, without backing them up with any sort of research. Advertising rules are not being followed by suppliers to the same extent as a result of inconsistency in the inspections carried out by regulatory agencies. The rise of digital transformation and e-commerce platforms have allowed for a growth in the number of dietary supplements available on the market, as well which indirectly contributes to the inefficiency of the inspection of these products.

Ndeinoma et al. 2018 [9]

Creation of Indigenous Plant Task Team, chief governing body for resource mobilization and knowledge exchange. The purpose of its formulation was to have a supervisory group for INPs in Namibia that aspires to contribute a properly enunciated, multi-stakeholder medium for resource mobilization and information sharing.

In the study, two modes were used for information acquisition: open-ended interviews and a questionnaire. These helped to create a governance model from the information provided by the subjects. Then, official documents were analyzed precisely which included workshop proceedings, and policy documents. In order to identify the varying networks and types of activities during interviews, legislative proceedings for multiple governance bodies were also assessed.

Residents that originated from communal areas were used. They resided in areas where varying INPs are grown. A questionnaire was also employed which contained a list of INP stakeholders, and the participants had to choose with whom they had previously collaborated with. Ties between potential actors and firms could be established through this. The data were also going to be used to formulate a governance model which illustrates trends of actor relations within the INP field in Namibia. This was carried out to get a better picture on possible effects of such interminglings on INP policy-making.

Creation of Indigenous Plant Task Team, chief governing body for resource mobilization and knowledge exchange. The purpose of its formulation was to have a supervisory group for INPs in Namibia that aspires to contribute a properly enunciated, multi-stakeholder medium for resource mobilization and information sharing.

The roles and functions of the Indigenous Plant Task Team were not understood well enough by the general public and even some of its own members. There has been a lack of participation and engagement by representatives of traders or harvesters in meetings and multi-stakeholder forums for INP. Furthermore, the representatives of representatives from the formal state bureaucracies, non-governmental organizations and academic institutes outnumber the representatives of locally based primary producers. The policy network may limit the number of members that can attend certain meetings leading to this issue.

Alostad et al. 2018 [28]

Authorized government law documents signifying HM registrations were used. These papers were obtained from the drug regulatory authority websites of the five countries.

Official documents were analyzed which were acquired from each countries’ governmental and drug regulatory authority database: United Kingdom Medicines and Healthcare Products Regulatory Agency; Federal Institute for Drugs and Medical Devices Germany; United States Food and Drug Administration; Department for Pharmacy and Drug Control United Arab Emirates; and Bahrain National Health Regulatory Authority.

A qualitative study was performed including five countries where HMs were picked: the United Kingdom, Germany and the United States, United Arab Emirates and Kingdom of Bahrain. Documentary analysis followed by carefully evaluating official law documents of the nations’ drug regulatory authority platforms. This data enclosed registration guidelines, and HM definition and classification which were tabulated using Excel. Similarities and differences were compared and assembled.

Improved regulations have been able to increase both the access and variety of HMs being available for customers. Lack of adequate evaluation can affect consumer safety. Since many HMs are imported in Kuwait, a key challenge is the variable definition an HM carries across global drug regulatory authorities. This expedites the inconsistency in Kuwaiti Drug Regulatory Authority where some products such as imported dietary supplements from the United States, are registered under units with insufficient assessment measures. A countermeasure to this would be the adoption of a harmonized system and having a single unified definition of an HM. This would create standardized regulation procedures that will permit these products to be sold in a clear and safe fashion across the globe. Numerous dietary products escape robust review methods since they are classified under dietary supplements instead, raising another concern. Such challenges need to be considered and acted upon by updating and modifying registration systems in countries like Kuwait.

The lack of registration and assessment of herbal products can be a major disadvantage as the assessment of safety has become more challenging in the United States due to the type of regulation used. Moreover, in the process of improving HM legislation, the Kuwait Drug and Food Control Administration has to consider precisely on how to better regulate products that are arriving from countries where such regulations are obscure or very lax.

Appiah et al. 2018 [25]

Individuals performing or having an interest in HM research were interviewed for this study. A grand total of 25 participants were involved. Of these, 18 were from the Faculty of Pharmacy and Pharmaceutical Sciences, two were from the School of Public Health, one was from the College of Science and one was from the College of Arts and Social Sciences. The aforementioned sub schools and faculties all fall under Kwame Nkrumah University of Science and Technology. Lastly, one informant was interviewed from the Centre for Plant Medicine Research and one participant each from two of the piloted hospitals.

Those having a fundamental learning interest in performing meaningful and scientific research in the realm of HM were used as subjects. These individuals were interviewed to garner information about their opinions in relation to integrating herbal medicine with biomedicine in hospitals in Ghana. Detailed notes on the main ideas were taken throughout the interview by researchers, and speeches were made into transcripts.

This is a qualitative and exploratory study design in which 25 participants were interviewed which had experience conducting research in the field of HM. Two informants were medical herbalists implementing the integration pilot in Ghana. Four important sites for study were discovered: Kwame Nkrumah University of Science and Technology, Kumasi Centre for Plant Medicine Research, Mampong-Akuapem and two hospitals with piloted integration of herbal medicine and biomedicine. Interviews ranged from 19 to 49 min, were recorded (audio only) and transcribed by researchers. Framework analysis model was implemented in order to structure the responses which included: identifying a thematic framework; indexing, charting; and mapping and interpretation. Athematic analysis was created based on the notes of the interviews. Indexing involved assigning certain portions of the transcript to themes. Charting helped to visualize this information (using charts) on Excel. Finally, this data was organized to uncover potential obstacles and opportunities of the integration process and HM policy-making within Ghana.

Most participants have demonstrated that the proposed integration is positive in terms of homogenizing and standardizing medical care in Ghana. There are also potential job opportunities that may come up as a result (such as herbalists), who might not have found employment after completing their degree in HM. With increased HM knowledge, perceptions and awareness in Ghana, the potential to conduct integrated medicine research in hospitals is growing. This combination can now permit efficacious service delivery by inhibiting the practice of fake doctors, especially ones who are distributing fake HMs. With increased financial funding from the government, the country can now build more HM hospitals. These places can then serve as research departments for conducting research studies on HM for various types of diseases.

Deficiency of administrative procedures and precise articulation of government policy on the new integration could be a limitation to efficient implementation. There have been instances of delay in the integration process from the government side, with reduced initiative to jumpstart integration at peripheral pilot hospitals. The integration is mostly occurring in urban areas and not rural places, even though they require these kinds of therapies the most. The National Health Insurance Scheme does not encompass all the HMs being used by different units so sometimes there are cases that patients must pay out of pocket to access these in comparison to those who obtained treatment from physicians offering conventional care. Over time, there has been an increase in the lack of trust between healthcare professionals in the two units: biomedicine and HM, with many not being on the same page about the integration process. With a lack of funding, there is a hardship in herbal medicine registration and improving existing frameworks. Lastly, due to a lack of awareness about the integration and training on HM at hospitals, it has severely restricted the integration process by reducing the approved herbalists proficient in HM training.

da Justa Neves et al. 2015 [34]

Information reported by the US Food and Drug Administration was utilized which classified dietary supplements into the following main categories: sexual enhancement, weight loss, and muscle building. Sexual enhancement products included sildenafil, tadalafil, vardenafil and their equivalents, alone or in combination. Weight loss products majorly contained sibutramine. Muscle building products contained either an anabolic steroid (not mentioned) or an aromatase inhibitor. Legislation data related to supplements in Brazil, European Union and the United States were also analyzed.

Normally, in the European Union, information and notifications are collected through a database known as Rapid Alert System for Food and Feed. The research was conducted using ANVISA database where the researchers looked for technical reports about dietary supplements with prescriptions. Any information about those product samples that were seized by the Federal Police force known as Brazilian Federal Police Department was accumulated from its Criminalistics System (SisCrim).

The legislation about Brazilian supplements was examined using the ANVISA database, as well as the European Union using the Rapid Alert System for Food and Feed and the United States using  the Food and Drug Administration. This was to garner enough info to make comments on the global condition of supplement contamination, and examine those substances that were seized by the Brazilian Federal Police Department. The legal standards for the three countries were also assessed: dietary Supplement Health Education Act for the United States, Regulation (EC) 178/2002—Council of Europe for the European Union, and the Decree-Law 986/1969 for Brazil.

Consumer markets have had a positive reaction to regulations whenever a new product is released. Consumers are also more inclined to believe that since HMs are sometimes categorized as “food”, they have little to no side-effects and the adverse effects, if any, are rarely displayed on product labels. With improved regulations, it will minimize the amount of adulterated dietary supplements. With current regulations that are not as stringent, has been shown to lead to greater adulteration cases. Increased strictness is a point of emphasis as currently several products are sold as dietary supplements without any comprehensive research being conducted beforehand. This especially is an area of concern for the United States which currently has rigorous lab and data accuracy measures compared to the European Union and Brazil.

Presence of varied universal regulatory assessments and policies. This causes a restriction in regard to judging and implementing a robust HM policy system in Brazil. Thereby, some products that are “harmless” could be deemed as irregular or unsafe and will be excluded from accepted HMs in novel policies (implying decreased variety for consumers).

Carvalho et al. 2014 [26]

The study assessed various documents obtained from the World Health Organization. It also identified the requirements for HM registration in different countries including those in Europe as well as, Australia, Mexico, and Canada. The following document from ANVISA was also analyzed: “Guide for the conduction of non-clinical toxicology studies and safety pharmacology required for the development of medicines.”. Governmental documents were analyzed like chromatographic profiles of HM species, usage restrictions, and daily dose.

Official documents were gathered from the World Health Organization along with papers elucidating HM registration processes and directives in international legislations including the European Community, Australia, Mexico, and Canada. The ANVISA database was also used for information gathering.

ANVISA created a survey for use that was adapted from the World Health Organization along with papers elucidating HM registration processes and directives in international legislations including countries in Europe, as well as, Australia, Mexico, and Canada. Rules and guidelines of these countries were examined, and listed down the main arguments.

Brazil policies and public opinions have both favored the research, development and implementation of the regulatory framework of HM. The government has also incentivized various research departments and institutions for performing scientific research with medicinal plants, emphasizing the nation’s biodiversity. Hence, ANVISA has made great efforts and is always on the lookout for improving current frameworks, prioritizing being in-sync with international drug regulatory authorities. This will do wonders in promoting safe access and rational consumption of HM products. Many legislative bodies are simultaneously working on revisions to Brazilian regulatory systems. These new frameworks will enhance regulator measures in lieu of appropriate technology transformations, permitting the expansion of such products to the general population.

Cumbersome and time-consuming research and policy approval process discourages organizations and academic institutions from performing research. This is especially the case when a number of permissions are to be acquired from ethics committees before beginning the research trials. Sometimes, these approvals are required before each of the phases I, II, and III to protect the population undergoing the study.

Awodele et al. 2014 [7]

In this study, actors such as health professionals and key stakeholders (directors, policymakers, etc.) were identified from the following institutions: Federal Ministry of Health (Herbal Medicine Division), The National Agency for Food, Drugs, Administration and Control (Herbal Medicine and Pharmacovigilance Division), The National Association of Nigeria Traditional Medicine Practitioners and the Nigerian Institute of Pharmaceutical Research and Development.

An organized questionnaire using the World Health Organization’s official documents was formulated to aggregate perspectives of relevant stakeholders in Nigeria working in policy-making or regulation within the field of HM. The questionnaire contains various sub-sections such as; National policy on Traditional Medicine, Law and Regulation on Herbal Medicine, Safety of Herbal Medicine, National Programme and National Research Institute on Traditional Medicine, Registration and Manufacture of Herbal medicine.

An organized questionnaire was provided to relevant stakeholders in Nigeria working in HM policy-making or regulation within the field of HM. The data obtained from the questionnaire were analyzed using simple percentages to document the perspectives and answers of the stakeholders.

Health authorities are now eyeing both the safety and effectiveness of HMs as important health concerns for the general public. This suggests that the vitality of instilling robust policies for the regulation of traditional medicine have become more important than ever. A fair and equitable framework development has been pushed for by the government that is reasonably regulated to ensure quality control requirements are met. In recent times, there has been a rise in collaboration with tertiary stakeholders and establishment of workshops to educate the public about the access and safe use of HMs. There is a critical need to ensure Nigeria contains some of the effective and high-quality medications as many respondents (68.7%) feel that the country lacks appropriate regulatory regimens.

In the study, about 62.5% of participants felt that limited research information could be a deterrent. About 31.3% see lack of professionals and knowledge within the health authorities as a challenge. The respondents seemed to have below average apprehension of the regulations as lower than 38% of respondents were aware of the National Agency for Food and Drug Administration and Control (Scientific Committee on Verification of Herbal Medicine).

Sahoo et al. 2013 [24]

150 Indian herbal drug companies that are involved in one or more activities of raw material collection/ trading, extract preparation, drug manufacturing, or contract manufacturing only. Responses were collected by email, telephone, and personal interviews from June 2009 to August 2010. Responses were mainly collected from the directors/proprietors/research and development heads of the companies as applicable.

A questionnaire-based survey was developed. It comprised 24 points and was administered to Indian HM firms involved in one or more of raw material obtainment/trading, extract preparation, drug or contract manufacturing only. The questionnaire constituted three different stages. The first component asked details about the representatives and information on general aspects of the company . The second module gathered information pertaining to any challenges faced during any of the following stages of raw material acquisition to marketing of the products and quality control procedures. The final part evaluated the export and import processes (submission requirements, review of timelines and its appropriateness, and support required from the government). Details from other organizations displaying good notions about Indian manufacturing companies were also noted. Data in the context of India’s GMP regulation and legislative procedures for HMs were also examined.

A questionnaire was used to gather information on challenges faced during production, commercialization, and marketing approval of HMs in India and foreign countries. These responses included opinions from 150 different companies and were collected via email, telephone, and in-person interviews from June 2009 to August 2010. The data obtained were examined by the researchers and key takeaways were drawn.

India’s governmental authorities have done their share of work by assembling organizations, events, workshops, exhibitions, research opportunities all while providing technical and financial support to universities. These initiatives can facilitate the scientific approval of Indian HM frameworks globally. However, inadequate safety control measures in different areas of manufacturing remains an important concern as over 60% of participants indicated that additional quality control proceedings should be developed. Devising harmonized regulations, and defined timelines, will assist in reducing the number of errors and outliers in the context of state-licensing laws. Not only will this remedy problems like product contamination, but also resolve issues such as substitution.

The survey conducted unveiled how regulatory compliance remains the number one challenge for exporters. Like many other countries, the inconsistency in GMP is outlined as the primary impediments for Indian manufacturers. Conflicting regulatory procedures worldwide and application delays were another area of concern. Worldwide variability in herbal medicine approval process: loose laws in India, whereas in the European Union it needs to successfully pass through a full regimen, requiring exhaustive safety and efficacy data. In addition, there exists a scarcity of herbal practitioners. Drug manufacturers are not able to keep up with increasing standards for herbal medicinal products. There also exists inadequate research and development, and slow pace of modernization.

Walji et al. 2013 [29]

15 key informants were interviewed, including government representatives (n = 5), industry (n = 9) members from large and small companies and consumer groups (n = 1), with observation of a government consultation meeting. Analysis (n = 38) of public documents about legal and policy information with regard to NHP regulations.

Public documents on legal and policy information about NHP regulations were reviewed in their analysis. Semi-structured interviews with key informants were audio recorded and transcribed.

Semi-structured interviews with key informants were conducted from 2009 to 2010, audio recorded and transcribed, as well as observation at a consultation meeting with members of the industry. Documents of scientific, government, and grey literature for analysis were found through online search and referral from key informants. There were two researchers who coded the data collected from content analysis of policy documents and interviews, organizing the information in emergent themes within a regulatory context.

Industry key informants support the NHP regulations, agreeing that strict and rigorous standards of manufacturing and labeling were needed. Clear communication and consultations sessions during the regulatory process through feedback channels and increased interactions between stakeholders involved in refining the product categories

Clarification of definitions and pre-clearing information in product licensing forms support staff of companies through these applications as well as allow regulatory assessors to more efficiently review applications.

The Canadian government has had difficulty classifying NHPs, as the field of NHPs are labeled differently internationally, as well as difficulty keeping a set of rules of formulation and categorization consistent across the wide class of NHP products. Regulations regarding the level of evidence needed to support the safety and efficacy of products are in disagreement between the government and industry members. External groups have lobbied for strict compliance with regulation, creating conflict and tension. Classification of NHPs as its own unique category is ambiguous and blurred, creating confusion. Industry workers are concerned over possible delays in the authorization process.

Alameddine et al. 2011 [27]

Stakeholders of the complementary and alternative medicine market in Lebanon were interviewed (n = 16), which included decision-makers, representatives of professional associations, academic researchers from the faculties of agriculture, nutrition and pharmacy, owners or companies of complementary and alternative medicine product importers, policymakers from the Ministry of Health and Ministry of Trade, and a media representative who is familiar with the field.

Data were collected from semi-structured interviews with key informants, using ten questions. They were also asked about any relevant documents and additional stakeholders that could contribute to this study. Field notes were taken and analyzed, and along with the interview tapes and transcripts, recurring issues and data patterns were identified.

Sixteen semi-structured interviews with stakeholders of the Lebanese complementary and alternative medicine market, and these interviews were transcribed. The scripts were analyzed for any emerging themes, identified through recurring issues and patterns that were arisen from the data.

There was widespread agreement from most stakeholders about the existence of poor regulation and lack of knowledge of safe complementary and alternative medicine consumption among the public and those involved in the Lebanese complementary and alternative medicine sector, due to the lack of policies and procedures, as well as issues with compliance to existing regulations. There seemed to be support from stakeholders to adopt mixed and compulsory policy instruments by improving public and provider awareness on the safety of complementary and alternative medicine products, paired with strict governmental regulation of the complementary and alternative medicine market.

According to stakeholders, current regulations lack effectiveness due to complementary and alternative medicine importers’ poor adherence to existing rules and guidelines paired with loopholes in current regulations that restrict complementary and alternative medicine products’ entry through other venues. Other barriers included the fragmented healthcare systems and the lack of cooperation and coordination between the different ministries of health.

Moss et al. 2007 [31]

Canadian complementary and alternative medicine group leaders (Western herbalism (n = 9), naturopathy (n = 10), traditional Chinese medicine (n = 8), and homeopathy (n = 10)), were interviewed. This included presidents, chairs, heads or directors who were selected from a list of associations, schools and journals. A Green Paper (government document that details specific issues, outlining possible courses of action in terms regarding policy) was published in the Ontario Herbalists' Association quarterly journal and analyzed in this study.

Interviews with key informants were conducted, with questions about the participants’ perceptions of the NHP regulations. The interview transcript was obtained and coded by at least two investigators. Documents including the Green Paper were also analyzed.

Formal leaders were chosen from a list of associations, schools and journals in order to get participants from various different segments. Interviews with the leaders were tape recorded, transcribed, and inputted into a qualitative computer software program to be analyzed. Textual data, such as the Green Paper was analyzed based on the Western herbalists’ thoughts about the NHP regulations.

Development of a national standard of practice of herbal medicine by the national council could regulate practice standards and improve group cohesion. Western herbalists may be in a better position to implement the other strategies—improving practise standards, education standards, and engaging in peer-reviewed research—and thereby advance their professionalization by fostering group cohesion through a national council.

Based on the interviews with Western herbalist leaders, there existed opposition to the standardization of NHPs used in their practice; they expressing their expectation of implemented regulations to properly reflect the risks involved with NHPs, which they felt did not happen. The new NHP Regulations’ requirements would be too rigorous for small-scale manufacturers, lowering compliance and causing many Western herbalists to go out of business.

Laeeque et al. 2006 [6]

Sixty-seven out of the 364 NHP businesses in Canada met the eligibility criteria. Presidents/owners, managers, and any quality assurance personnel from 20 of the 67 companies were interviewed. Eleven of these companies were based in Ontario, 3 companies were from British Columbia, and 3 companies were from Quebec.

Semi-structured interviews were conducted in-person or through the telephone, audiotaped and transcribed verbatim. Each respondent was mailed a survey prior to the interview to collect information on the size of the company, the number of NHPs products they sell, and details about the glucosamine/chondroitin in these products.

This qualitative study is an applied ethnography, interviewing key informants regarding satisfaction and compliance with the Regulations. Interviews were tape recorded and transcribed. Content analysis on the data was independently coded, and emerging themes were determined through team meetings held incrementally after 3–4 interviews.

All employees who were interviewed agreed with the goal of ensuring the safety, quality, and efficacy of NHPs, stated by the Natural Health Products Directorate of Health Canada. Many informants thought that the regulations could improve the public's confidence in NHPs, which will help the NHP industry. Specifically, strict regulations can cause marginal firms to exit the markets, in an attempt to protect consumers from these firms and their products. Submissions of producing licensing applications suggest generally positive views of regulations and better compliance, which the majority of the companies from the sample were doing.

Interviews revealed some disappointment and frustration with the slow pace of progress, specifically with the implementation stage. Some small and medium-sized enterprises representatives felt that the control of these regulations were at the same level as conventional drug regulations in Canada. There was also discontentment towards the government’s consideration of NHPs as a subset category of drugs as they were perceived by interviewees to have different volumes of sale, price mark-ups, and risks involved. Due to regulations, smaller companies may struggle with affordability and undeliberate failure to comply, and beneficial products could be lost. Many participants were worried that the regulations will be too strict, be limited in focus for one part of the NHP industry, and be reactive as opposed to proactive. Lack of compliance could result from a lack of knowledge on regulations from employees and owners.

Moss et al. 2006 [30]

Formal and informal leaders of 4 complementary and alternative medicine practitioner groups in Canada that use natural products as part of their core practice (n = 37) were interviewed, which included Western herbalism (n = 9), naturopathy (n = 10), traditional Chinese medicine (n = 8), and homeopathy (n = 10).

Semi-structured qualitative interviews with 37 Canadian leaders of four complementary and alternative medicine practitioner groups were conducted in the Fall of 2004. Content analysis was done by identifying themes, sub-themes, and any existing relationships.

This applied ethnographic study included data collected from qualitative interviews. The interviews were transcribed and analyzed independently by at least two investigators. All transcriptions were inputted into a qualitative computer software program, and themes were identified and reported.

Naturopaths have the ability to prescribe from a list in four Canadian provinces, seemingly legitimizing their knowledge claims. The public, without proper practitioner guidance and lack of knowledge, could be at risk of misusing herbs. Different health care practitioners with proper training should have access to high-risk products. Western herbalists expressed their view of pharmacists as inappropriate gate-keepers of NHPs with their inadequate knowledge of herbs, and TCM leaders were concerned that NHPs were not labeled correctly. Moreover, naturopaths firmly believed that NHP regulations will not harm their core practices, but rather strengthen their role within the healthcare system. Western herbalist leaders did not believe that NHP regulations would encourage self-medication herb use.

Regulation of naturopaths across countries is inconsistent, resulting in inefficient cooperation with naturopaths who are not regulated. There exists conflicting mindsets between Western herbalists and naturopaths in that herbalists want the public to be self-sufficient. There is also a fear from TCM leaders that the Natural Health Products Directorate will over-regulate NHPs, which may potentially eliminate certain supplements. Naturopaths, TCM practitioners, homeopaths, and Western herbalists seemed to disfavor the implementation of regulatory laws due to possible decreased access to products. It is difficult to define complementary and alternative medicine due to differing beliefs, principles or practices between complementary and alternative medicine practitioner groups.

  1. Abbreviations: ANVISA National Health Surveillance Agency of Brazil, DHS dietary and herbal supplement, GMP good manufacturing practices, HM herbal medicine, INP indigenous natural product, NHP natural health product, TCM traditional Chinese medicine