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Table 2 Eligible article characteristics (n = 15)

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

First author and year

Article title

Country where study was conducted

Countries discussed

Study aim

Conclusion

Alostad et al. 2019 [18]

A qualitative exploration of Bahrain and Kuwait herbal medicine registration systems: policy implementation and readiness to change

Bahrain and Kuwait

Bahrain and Kuwait

To evaluate the formation and application of recognized herbal medicine registration programs in Bahrain. This was done to formulate recommendations while analyzing the preparedness for implementing various herbal medicine categorization regulations in Kuwait.

By conducting a sound evaluation of the Bahraini drug regulatory authority, the study was able to shed light on current weaknesses of Kuwait’s unpolished HM system. It provides recommendations and demonstrates that the possibility of implementing new changes was high and how these learnings can aid other countries in improving their HMs policy structure overall.

Carvalho et al. 2018 [32]

The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines

Brazil

Brazil

The purpose was to evaluate the current conditions of herbal medicinal products licensed in Brazil and carry out a comparison with information collected in both 2008 and 2011. This was conducted to further address the progression of herbal licensed products in the country and the consequent ramifications of any new legislation being applied.

The weak points discovered suggest there exists a critical regulatory and manufacturing obstacle in the country due to various reasons. The primary reason being the presence of an increased range of supplement products and markets. Future studies should aim to mitigate these challenges in order to protect consumers’ health. It is also important to note that certain gaps within this regulatory work have not been completely resolved.

Molin et al. 2019 [18]

Regulatory framework for dietary supplements and the public health challenge

Brazil

Brazil

To further assess the proposition of new regulatory frameworks being developed for DHSs in Brazil. Their existing representation and obstacles posed by new legislation were also examined.

The Indigenous Plant Task Team serves as a predominant governing association for INPs in Namibia that provides a well-structured and multi-stakeholder online platform for resource capitalization and stimulation as well as knowledge exchange. Its processes influenced the development of many actions in the segment of policy production and execution.

Ndeinoma et al. 2018 [9]

The Governance of Indigenous Natural Products in Namibia: a policy network analysis

Namibia

Namibia

To discern the numerous governing bodies responsible for monitoring and coordinating the administration of INPs. The aim also included examining the physical relationships between different actors of this industry and the overarching effects they can have on the natural products’ regulation procedure.

The amount of herbal medicinal products approved in Brazil is small in comparison to other countries. Brazil also hosts an increased ratio of non-native medicinal plant species in terms of supplements’ categorization. The number of sellers in the herbal medicinal products markets has decreased from the past few years. However, the market value has risen, indicating that the profitability should be exploited in the years to come.

Alostad et al. 2018 [28]

International comparison of five herbal medicine registration systems to inform regulation development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain

United Kingdom

Kuwait, United Kingdom, Germany, and United States of America, United Arab Emirates and Kingdom of Bahrain

To implement a regulation methodology for HMs in Kuwait which is known for only importing these products. This research report assessed the similarities and differences between each of the five countries being studied: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain.

As a result of the varying definitions in other countries, it has become vital for Brazil to precisely articulate what comprises an HM and prohibit any misinterpretations. Furthermore, it seems that many HMs escape a comprehensive review and are rather portrayed as dietary supplements in some areas across the globe. This is a matter of concern when establishing registration policies in Kuwait, which usually imports such products and aims to evaluate these considering their governing context in their native country.

Appiah et al. 2018 [25]

Identifying strengths and weaknesses of the integration of biomedical and herbal medicine units in Ghana using the World Health Organization’s Health Systems Framework: a qualitative study

USA, Ghana

Ghana

To recognize the strengths and weaknesses of the government-led amalgamation of HMs into the current biomedical methodology in Ghana. This involved using the Health Systems Framework, created by the World Health Organization.

The intertwined relationship between the two healthcare systems depicted as biomedicine and herbal medicine has been critiqued by researchers for their respective challenges. The combination of the two frameworks can expose a variety of research opportunities within this field. Additional training for traditional health practitioners and clinicians in herbal medicine can pave the way for augmented coordination between the two units. Lastly, robust advocacy practices and public exposure is required to raise awareness and educate the general population on the homogenization and employment of the services offered.

da Justa Neves et al. 2015 [34]

Dietary supplements: international legal framework and adulteration profiles, and characteristics of products on the Brazilian clandestine market

Brazil

Brazil, United States, European Union

Assess the existing legislative framework on dietary supplements in the United States, the European Union and Brazil. The study also aimed to identify the description of adulterated and/or unconventional supplements within these markets.

There are varying levels of strictness between the nations being examined with the United States legislation exhibited as being more permissive, Brazil being more restrictive, and the European Union somewhere in the middle. However, there has not been a direct relationship established between the countries’ legal frameworks and its efficacy in preventing the sale of contaminated products. With rising notification and alerts from the US Food and Drug Administration and increased trend in data from the Brazilian Federal Police Department, it has been illustrated that the problem can be attributed to a rise in the contamination issue or an improvement of detection mechanisms. Next steps include educating others about possible risks associated with consuming adulterated or eccentric products and their impact on human health.

Carvalho et al. 2014 [26]

Regulation of herbal medicines in Brazil

Brazil

Brazil

Rich Brazilian biodiversity, for the Brazilian population, is known for being a reliable source of medicinal plants and traditional herbal supplements’ knowledge. In order to enhance the existing regulatory methods, ANVISA has decided to modify its legislation. This study envisions addressing these new Brazilian principles for the regulation of HMs.

Brazil has been modifying the legislative structures for HMs from the past few years. This change was made to synchronize with global HM definition and requirements incorporating the unique facets of the Brazilian HM industry. This reinforces safe access and appropriate consumption of herbal medicinal products and similar products by the public.

Awodele et al. 2014 [7]

Traditional medicine policy and regulation in Nigeria: an index of herbal medicine safety

Nigeria

Nigeria

To examine the current regulatory guidelines surrounding HMs in Nigeria. The aim of this study is also to employ this information and form a country-wide safety index for HMs.

There exists an urgent need for the Federal Ministry of Health to coordinate differing perceptions on conventional medicine and policy-making. This study was able to record this through workshops and collaboration activities on traditional medicines. The suggested solutions have been projected to remedy some of the challenges being faced and can ensure adequate safety and regulation measures of HMs in Nigeria.

Sahoo et al. 2013 [24]

Herbal drug regulation and commercialization: an Indian industry perspective

India

India

To identify the restrictions the Indian government and other constitutional institutions face in regard to manufacturing, commercialization and surveillance/supervision of traditional herbal medicinal products and drugs.

Inauguration of more robust guidelines on quality control and assurance elements as well as formulating marker-dependent procedures are critically needed to create a safe, and reliable representation of HMs in India. Coordination between legislative systems is important to lessen the impediments across different countries. Elevating population pressure for effective, collaborative and equivalent healthcare causes AYUSH (Ayurveda) to analyze and advance in research and development, clinical medicine, herbal medicinal products, to customarily amplify regulatory mechanisms.

Walji et al. 2013 [29]

Governance of natural health products regulation: an iterative process

Canada

Canada

To understand the contextual factors and major challenges involved in implementing regulation of NHPs in Canada.

Health Canada’s experience with implementing regulation of NHPs highlights several challenges including time to process applications, issues with defining the products and labeling. However, there is a need to monitor and survey any adverse effects in both passive and active manner.

Alameddine et al. 2011 [27]

Stakeholders’ perspectives on the regulation and integration of complementary and alternative medicine products in Lebanon: a qualitative study

Lebanon

Lebanon

To explore the regulation and integration of complementary and alternative medicine products in Lebanon, as an example of an Eastern Mediterranean Region country, by consulting stakeholder feedback on the barriers for proper regulation.

The current regulation of complementary and alternative medicine products in Lebanon, which is primarily done through the Ministry of Health, does not sufficiently ensure public safety nor support the integration of complementary and alternative medicine to its healthcare system. Therefore, there is a need for political resolve and cooperation from all the stakeholders for proper regulatory frameworks to be implemented.

Moss et al. 2007 [31]

The professionalization of Western herbalists: response to new product regulations in Canada

Canada

Canada

To assess Canadian Western herbalist leaders’ responses to the new Canadian NHP regulations, showing insight into the increasing organization of this healthcare profession as a result of new healthcare policy.

The extent to which Western herbalists have progressed with the professionalization process and whether this was due to the NHP regulations is unclear and will need to be explored. Western herbalists seem dedicated to continue with their practice to professionalization, but this progression will be affected by internal and external factors, such as cohesiveness of membership and barriers put up by other healthcare groups, respectively. It will be difficult for them to achieve state-sanctioned provincial regulation across Canada.

Laeeque et al. 2006 [6]

The Canadian NHP regulations: industry perceptions and compliance factors

Canada

Canada

To determine which individuals are in compliance with Canada’s new NHP regulations within the interview sample, explore factors that may affect this compliance, as well as to examine the industry’s response to the regulations.

The exit of smaller firms as a result of the Canadian NHP regulations may lead to industry consolidation. Exploration of Canada’s NHP regulations and the industry’s response can potentially inform other countries who plan to implement regulations for their NHPs.

Moss et al. 2006 [30]

New Canadian natural health product regulations: a qualitative study of how complementary and alternative medicine practitioners perceive they will be impacted

Canada

Canada

To investigate the perspectives of practitioners of complementary and alternative medicine with regard to new regulation and its effect on their practices and their relationships with patients and consumers.

There were concerns surrounding the new NHP regulations and their effects on accessibility to the products, which they need in order to practice effectively. Specifically, naturopaths, TCM practitioners, homeopaths, and Western herbalists were concerned. The naturopathic leaders in particular worried that their roles as healthcare professionals may be limited due to NHPs now being defined as over the counter products.

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