Natural Health Products Regulations Research Articles

Assessing Canadian regulation of muscle-building supplements: Identifying gaps and recommendations for improvement to protect the health and well-being of young people

Muscle-building supplements are a vast group of dietary products purported to aid with muscle-building and performance enhancement. Legal muscle-building supplements, such as whey protein and creatine monohydrate, are commonly used among young people (i.e., adolescents and young adults ages 10–29 years), particularly boys and young men, and are correlated with many adverse health effects. In Canada, these products are regulated by the Natural Health Products Regulations. This policy analysis aimed to investigate current Canadian policy related to muscle-building supplements to identify key gaps that expose Canadians, particularly young people, to potential risks. Several gaps were identified, including an over-reliance on industry to provide accurate product and manufacturing site testing, no age restrictions on product purchasing and use, no warning labels on products related to known risks, and lack of regulatory control from individual provincial health ministries. Given the gaps, specific policy recommendations are provided to strengthen the current policy, reduce use, and minimize negative effects of use. There is an urgent need to strengthen Canadian regulations of muscle-building supplements to protect the health and well-being of young people.

A Mini Review of Underutilized Native Plants from East Malaysia’s Rainforests as Potential Hypertensive Drugs

Abstract: Hypertension is a risk factor for cardiovascular diseases, which are on the rise throughout the world at an alarming rate. As a result, a variety of techniques to help in the prevention and control of hypertension have been tried, one of which is the use of natural medicines derived from medicinal plants. The relevance of plant-based medicine is now recognised by western countries, as seen by Canada's Natural Health Product Regulations, which were promulgated in January 2004. The Southeast Asian rainforests, notably in East Malaysia, are home to a diverse range of medicinal plant species with endless potential as pharmacological candidates, particularly as antihypertensive agents. The indigenous ethnic groups of East Malaysia have long utilised a broad variety of medicinal plant species to treat hypertension, thanks to their extensive usage of traditional remedies and in-depth understanding of ethnomedicine, which are fundamental elements of their culture. However, scientific understanding of ethnomedicines used to treat hypertension, particularly the processes underlying their antihypertensive action, is inadequate. Based on previous scientific studies, this review aims to address the antihypertensive effects of medicinal plants used by indigenous ethnic groups in East Malaysia, Sabah, in order to provide insights into the mechanisms of the plants' antihypertensive activity for the development of antihypertensive agents from these native plants.

Evaluation of the Canadian natural health product regulatory framework in academic research: A scoping review

IntroductionTraditional, complementary and alternative therapies, many of which incorporate natural health products (NHPs), are widely used and relied upon globally. In Canada, NHPs were first regulated in 2004; prior to this, they were regulated as either food or drugs. The objective of this study was to summarize the peer-reviewed literature on the evaluation of the NHP regulatory framework in Canada. MethodsWe conducted a scoping review of academic research evaluating the NHP regulatory framework in Canada. Only peer-reviewed research studies were eligible for review. Our approach followed the five-stage methodological framework proposed by Arksey and O’Malley. ResultsOne article was eligible for review, which highlighted perceived challenges by industry and government regarding NHP regulations. These included significant delays in authorization for sale on the market, industry perception that the provision of research evidence to support their health claims was overly demanding, and understanding how NHPs were now defined as part of this new category separate to food and drugs. ConclusionsStudies evaluating the Canadian NHP regulatory framework are extremely limited; further research is needed to inform and optimize the regulatory process. Academic research in this area should be supported, especially in conjunction with consultations with stakeholders, so that an awareness of past research is present and can identify both positive and negative aspects of the current framework, and inform areas for improved regulation of NHPs in Canada.

Detection of Undeclared Halogen Substituted Drug Compound in a Natural Health Product

Introduction: The U-Dream line of products are marketed as natural health product sleep aids in Canada and as dietary supplements in the United States. Several user reviews of the product mention concerning side effects not typically associated with the listed herbal ingredients stated on the product label. Based on these concerns an analytical study was undertaken to determine if the products contained any undeclared pharmaceuticals. Methods: Product was screened by high resolution mass spectrometry (HRMS) for known pharmaceuticals with sedative and sleep promoting properties. Based on the mass spectral screens an unknown compound was isolated for characterization by nuclear magnetic resonance (NMR) and presence confirmed by Enzymelinked Immunosorbent Assay (ELISA). Results: The mass spectral analyses indicated the presence of an undeclared analogue of the pharmaceutical drug zopiclone within the product lot tested. NMR characterization confirmed the compound to be a brominated analogue of zopiclone and a commercial zopiclone/eszopiclone ELISA kit tested positive. Discussion: The undeclared compound was found to be an analogue of zopiclone whereby the chlorine atom was substituted with bromine. Given the results of the ELISA assay and the structural similarity to zopiclone it is likely the compound exhibits biological activity. Of considerable concern is not only the potential of the unknown compound to exhibit pharmacological activity, but the lack of a safety profile by which the risk can be properly assessed. Conclusions: The natural health product regulations provide a framework for high quality, safe and efficacious products to access the market. It is the responsibility of the manufacturer to assure traceability and transparency in their supply chain and establish verifiable compliance with GMP. This study illustrates the importance of careful evaluation of analytical data in order to detect undeclared adulterants and highlights the need for an active monitoring and surveillance system for potentially high-risk products.

A suggestion for evolution of Canada’s health regulatory system

Aspects of Canada’s health regulatory system are currently being reviewed. This is timely, as the regulation and definition of drugs, foods, and natural health products (NHPs) is in need of revision to facilitate greater transparency and less ambiguity. A number of studies have illustrated the importance of a nutritious diet to prevent and manage chronic disease. Therefore, legislation surrounding food health claims needs to be adjusted so that it is more informative for disease prevention and, in some cases, treatment. Canada is modernizing the regulation of self-care products, under which NHPs, including probiotic products, are listed. With the growing appreciation for the role that microbes play in human health and the recognition that many foods, including those containing probiotic organisms, can prevent or mitigate disease, this provides an opportunity to reassess regulatory categories.

Community Pharmacists' Views and Practices Regarding Natural Health Products Sold in Community Pharmacies.

BackgroundReports of regulatory and evidentiary gaps have raised concerns about the marketing and use of natural health products (NHPs). The majority of NHPs offered for sale are purchased at a community pharmacy and pharmacists are “front-line” health professionals involved in the marketing and provision of NHPs. To date, the involvement of pharmacists in pharmacy care involving NHPs and the degree to which concerns over the safety, efficacy, marketing and regulation of NHPs are addressed in pharmacy care in Canada have not been studied.MethodsUsing Qualtrics, a web-based data collection and analysis software, and a study instrument made up of fifteen (15) open-ended, closed and rating scale questions, we surveyed the attitudes and practices of 403 community pharmacists in the Canadian province of Alberta regarding NHPs offered for sale in community pharmacies.ResultsThe majority of pharmacists surveyed (276; 68%) recommend NHPs to clients sometimes to very often. Vitamin D, calcium, multivitamins, prenatal vitamins, probiotics and fish oil and omega-3 fatty acids were the most frequently recommended NHPs. The most common indications for which NHPs are recommended include bone and musculoskeletal disorders, maintenance of general health, gastrointestinal disorders and pregnancy. Review articles published in the Pharmacist’s Letter and Canadian Pharmacists Journal were the primary basis for recommending NHPs. The majority of pharmacists surveyed (339; 84%) recommend the use of NHPs concurrently with conventional drugs, while a significant number and proportion (125; 31%) recommend alternative use. Pharmacists in the study overwhelmingly reported providing counselling on NHPs to clients based on information obtained mainly from the Natural Medicines Comprehensive Database.ConclusionsThe study findings indicate a high prevalence of pharmacy care relating to NHPs among study participants. Although pharmacists’ practices around NHPs are consistent with the existing licensing framework, we found some involvement in problematic practices that necessitate further research and potential policy scrutiny. The study also uncovered patterns of recommendations, including sources relied on in recommending NHPs and in providing counselling to patients, that raise concerns about the quality and credibility of NHP-related care provided to pharmacy patrons.

Canada's Natural Health Products: A Regulatory Overview

Since its inception in 2004, Canadian regulation of natural health products (NHPs) has been evolving. Implementation of the novel Natural Health Products law by Health Canada, the national regulatory agency, has been responsive to both consumer desires for novel products for health care, but also potential concerns over product safety. The agency has developed numerous webpages explaining its approach to this new regulatory category, which has included regulations and guidance documents and refinement of both. Due to its many layers, the information is not very transparent. In addition, the information has been changing and is constantly under revision. For this reason, a review of the legislation, regulation and policies was embarked upon which led to the preparation of an overview of up to date information that we hope will be useful to those who plan to pursue the Canadian NHP system.

Regulation of natural health products in Canada

Ethnopharmacological relevance/IntroductionIn Canada, all natural health products (NHPs) are regulated by Health Canada (HC) under the Food and Drugs Act and the Natural Health Product Regulations. All authorized products undergo pre-market assessment for safety, efficacy and quality and the degree of pre-market oversight varies depending on the risk of the product. OverviewIn Canada, over 70,000 products have been authorized for sale and over 2000 sites have been licensed to produce NHPs. In the management of NHPs on the Canadian market, HC employs a number of active and collaborative methods to address the most common issues such as contamination, adulteration and deceptive or misleading advertising practices. HC is currently evolving its approaches to NHPs to recognize them as part of the larger group of health products available without a prescription. As such, the regulatory responsibility for all over-the-counter (OTC) drugs, including non-prescription drugs and NHPs, has been transferred to a single federal division. ConclusionAs a result of this transition a number of benefits are being realized with respect to government efficiency, clarity for industry, support for new innovations and consolidated government interactions with the Canadian market.

Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey.

BackgroundThere has been a global rise in the use of natural health products (NHPs). Proper regulation of NHPs is pivotal to ensure good quality control standards, enhance consumers' safety and facilitate their integration into modern healthcare systems. There is scarcity of published data on the prevalence of NHPs usage among the general Kuwaiti population. Hence, this study was designed to determine awareness, patterns of use, general attitude and information requirements about NHPs among the public in Kuwait.MethodsA descriptive cross-sectional survey was performed using a pretested self-administered questionnaire on a sample of 1300 Kuwaiti individuals, selected from six governorates in Kuwait using a multistage stratified clustered sampling. Descriptive and multivariate logistic regression analysis were used in data analysis.ResultsThe response rate was 90.2%. NHPs were thought to be herbal remedies by most of participants (63.5%), followed by vitamins/minerals (40.5%), traditional medicines (21.1%), probiotics (14.9%), amino acids and essential fatty acids (7.2%), and homeopathic medicines (5.6%). NHPs usage was reported by 71.4% (95% CI: 68.8-74.0%) of respondents, and mostly associated with females (OR: 1.90; 95% CI: 1.44-2.51). Herbal remedies were the most commonly used (41.3%; 95% CI: 38.5-44.2%). The most common reasons for using NHPs were to promote and maintain health and to prevent illness and build immune system. Family members and/or friends and mass media were the main sources for providing information about NHPs. About 18% of consumers have experienced a side effect due to using a NHP. Attitudes toward NHPs were generally positive; with more than 75% of participants believing that the Ministry of Health in Kuwait should regulate the claims made by the manufacturers of NHPs and it is important to talk to a medical doctor or a pharmacist prior to using NHPs. Most of the respondents showed increased interest to acquire knowledge about different types of information related to NHPs.ConclusionsThe prevalence of use of NHPs among Kuwaiti population is high. The present findings have major public health policy implications for Kuwait. Therefore, there is an apparent need to establish effective health education programs and implement better and more regulated NHPs use policies in Kuwait.

Quantification of Three Chiral Flavonoids with Reported Bioactivity in Selected Licensed Canadian Natural Health Products and US Marketed Dietary Supplements

Research indicating potentially beneficial bioactivity of flavonoids has produced a market and demand for natural health products and dietary supplements containing flavonoids. Implementation of the Canadian natural health product (NHP) regulations in January of 2004 increased regulation and oversight of NHP manufacture and marketing leading many consumers and clinicians to assume a similar pathway of development and approval to over-the-counter or prescription drugs. Three stereospecific liquid chromatograph/mass spectrometry (LC/MS) methods were used to assess the flavonoids, liquiritigenin, pinocembrin, and pinostrobin, in selected Canadian licensed NHP's and US marketed dietary supplements. The present study quantifies bioactive flavonoids in these products and notes variability in flavonoid content. Efficacy and safety of NHP's and dietary supplements should not be assumed due to differences in criteria for NHP licensure by Health Canada as well as variation of flavonoid content between manufacturers and products with similar indications for use.

Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

Enforcement of natural health product regulations

As a long-time advocate for a consistent, risk-based approach to health product regulation, Consumer Health Products Canada applauds the basic thrust of the CMAJ editorial “No regulatory double standard for natural health products.”[1][1] Consumer health products used in the practice of self-

Challenges in the Authorization of Clinical Trials Involving Botanicals

Clinical trials involving natural health products (NHPs) in Canada fall under the jurisdiction of the Natural Health Products Regulations [1]. Plant identification is one of the most problematic issues observed during our assessment of >260 clinical trial authorization applications involving NHPs (e.g., Black Cohosh misidentification [2]). Botanicals and their extracts have more than one active constituent, and clinical trials may involve multiple botanicals, e.g., for Traditional Chinese Medicine, making assessment of identity, purity, potency, safety and likelihood of efficacy even more complex. Although guidance is provided [3], other regulatory challenges encountered include insufficient data for chemical contaminants (specifically heavy metals, solvent residues, pesticides, and mycotoxins), data to support the stability of the medicinal ingredients or finished products throughout the trial period, proprietary manufacturing information, potential for interactions and adverse reactions. Acknowledgements: Thanks go to our colleagues in the Clinical Trials Division, Natural Health Products Directorate, Health Canada.

Regulation of Natural Health Products in Canada

In Canada, there has been an increasing presence of and interest in natural health products (NHPs). While some of these products are deeply immersed in cultural heritage and have been used for decades, questions have emerged regarding the effectiveness, safety, and quality of these and other non-traditional NHPs. Some NHPs can cause adverse reactions when taken with other NHPs, prescription drugs, and even food; while others have been adulterated with contaminants. At the same time, Canadians are interested in health and wellness and are taking an active role in choosing products that may have a direct impact on their health. The Canadian government responded on January 1, 2004 by legislating the Natural Health Products Regulations (NHPR), whose main goal is to maintain the safety, efficacy, and quality of NHPs while allowing consumers to make an informed choice. The NHPR govern the sale, manufacture, packaging, labeling, importation, distribution and storage of NHPs; and provide regulations concerning licensing, good manufacturing practices, clinical trials, adverse reactions and health claims. The introduction of the NHPR is an innovative approach to regulating NHPs, but numerous challenges have emerged since its promulgation: processing backlogs of product licenses; classification and/or clarification of NHPs in food formats, of naturally-sourced prescription drugs, and of human-use antiseptic drugs; and knowledge dissemination of the safety hazards associated with non-licensed NHPs and previously licensed NHPs. This review outlines the regulation of NHPs in Canada and highlights some of the challenges and subsequent measures implemented to handle these issues.

Natural health product regulations: perceptions and impact

Health Canada's Natural Health Products Directorate introduced regulations in January 2004 concerning the production and sale of natural health products. The implementation period for the regulations will last until 2010. During this period, further regulatory changes may occur. One recommended change is greater distinction between foods and NHPs. This paper provides an overview of the current regulations, outlines ambiguities and explains the potential impacts on various stakeholders including industry, consumers, pharmacists and complementary health care providers. Overall the NHP regulations are an important step towards improving the quality of NHPs and giving consumers additional information with which to make more informed decisions about these products.

Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectivesThis article is one of a selection of papers published in this special issue (part 1 of 2) on the Safety and Efficacy of Natural Health Products.

Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human clinical trials for many NHPs present a challenge to consumers, healthcare practitioners, and federal regulators. Canada's Natural Health Products Regulations mandate NHPs to be licensed. As the currently available unauthorized NHPs are being brought into compliance in Canada, the transition has produced some challenges, requiring ongoing public communication and education to promote the safe use of NHPs. This article will highlight Health Canada's key postmarket initiatives in strengthening the regulation of NHPs.

Women's Decision Making About the Use of Natural Health Products at Menopause: A Needs Assessment and Patient Decision Aid

To identify the decision-making needs of women about the use of natural health products (NHP) at menopause and to develop a decision aid responsive to their needs. A qualitative study using focus groups, key informant interviews and group consultation. Content analysis was guided by the Ottawa Decision Support Framework. Six focus groups with menopausal women aged 45 to 64 (n = 40) and key informant interviews (n = 15; physicians, nurses, women' s advocacy group, NHP stores owners, pharmacists, policy makers) were conducted in two Canadian cities. Two groups of menopausal women (n = 11) were consulted to obtain feedback on the acceptability of the new patient decision aid. The most common difficult decisions identified by women were: whether or not to take NHP; which NHP to choose; and whether or not to take anything for menopausal symptoms. In addition, key informants identified the challenge of choosing between hormone therapy and NHP for menopausal symptoms. The main sources of difficulty in making these decisions were the following: (1) inadequate knowledge and unrealistic expectations associated with NHP; (2) closed mindedness of physicians to discussion about NHP; (3) conflicting opinions of others; (4) inadequate resources to support NHP decision-making (e.g., information, finances, time); and (5) menopausal symptoms interfering with decision-making (e.g., lack of sleep due to hot flashes). To facilitate decision making, participants suggested the need for information about available choices, tighter regulation of NHP by the government, and access to health professionals conversant in NHP and medical options. The patient decision aid was developed according to the International Patient Decision Aid Standards and based on women' s identified needs. Women described the aid as easy to understand and useful for considering the decisions about NHP. Middle-age women reported difficulty when facing decisions about the use of NHP. Many sources of difficulty could be addressed in the patient decision aid. Subsequent studies should evaluate the effect of this decision aid on the decision-making process of women.

Natural health product labels: Is more information always better?

Objective To explore how the information provided on labels as mandated by the new Canadian natural health product (NHP) regulations impacts consumers’ perceptions of risks associated with using NHPs. Methods Six focus groups were conducted in three locations across Ontario. Consumers were asked to react to two labels for a fictitious product called Saturnflower that represented the “old” standards (label 1) and the new standards (label 2). Groups were audio-taped and transcribed verbatim. Qualitative content analysis was used to identify key themes. Results The 38 participants criticized label 1 for lacking information about the uses of the product and discussed their frustration at trying to obtain good quality information about NHPs. The lack of risk information on label 1 reinforced their perceptions of NHPs as natural, mild and safe. The majority of participants found label 2 much more informative, but a few were unsettled by the extent of the risk information, questioning if it was necessary. Conclusion The label requirements of the new NHP regulations were generally viewed positively by the consumers who participated in this study. Practice implications The additional risk information may generate more NHP-related questions for health care practitioners especially with respect to possible interactions between NHPs and conventional medicines.

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

New Canadian Natural Health Products regulations (NHP regulations) came into law January 1st, 2004 and will be implemented over 6 years. These regulations have the potential to impact a variety of stakeholders, in particular complementary and alternative medicine (CAM) practitioners. In this article, we document Canadian Western herbalist leaders' responses to the new regulations, so as to provide insight into how new healthcare policy serves as a stimulus for the organization of an emerging healthcare profession. The data are derived from key informant interviews with Western herbalist leaders in Canada (n=9). The NHP regulations include "good manufacturing practices" and Western herbalist leaders are concerned that many small companies, often owned and run by Western herbalists, will find the regulations too costly to implement, causing them to reduce the number and diversity of products they manufacture, or go out of business all together. Furthermore, lack of availability of whole plant products could severely restrict the practice of Canadian Western herbalists. In response to this challenge, herbalists are attempting to (i) organize as a more cohesive group, (ii) define their unique body of knowledge and (iii) increase the perceived legitimacy of their practices in the eyes of the public, conventional healthcare practitioners, and regulators, in an attempt to protect their unique practices. An examination of the findings reveals the extent to which external factors (i.e., the new NHP regulations) both provoke and shape the professionalization of this group of healthcare practitioners.

The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors

BackgroundThe use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.MethodsTwenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.ResultsThe major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.ConclusionThe Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.