ISURA Supports Natural Health Product Research Society of Canada

Marisa Nichini
July 13, 2021
                           
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ISURA was pleased to be a Platinum Sponsor ($10,000 level) of the Natural Health Product Research Society of Canada’s 2021 conference.

The mission of the Natural Health Product Research Society of Canada is to promote scientifically rigorous research and education on natural health products (NHPs), develop a national multi-sector research community, and support national research priorities that enable the informed and appropriate use of NHPs. To deliver on their mission, the NHPRS has been bringing together leaders in NHP research from Canada and around the world through their annual conference. ISURA is proud to have been a conference sponsor for the past few years.

The NHPRS welcomed almost 200 participants to the 17th annual conference entitled “Canada and the Changing Global NHP Landscape”, hosted virtually by the University of Ottawa, from June 7-9 & 14-16, 2021. The program featured exceptional plenary speakers and panel discussions that addressed the many advances and challenges in NHP research, industry and regulation. The virtual format enabled wider participation from across Canada as well participants from outside of Canada, and involvement by student and indigenous researchers. The conference co-chairs were Dr. Cory Harris (University of Ottawa) and Prof. Thor Arnason (University of Ottawa).

Learn more at the Natural Health Product Research Society of Canada website: www.nhprs.ca

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Health Canada’s Natural Health Products Program – What the Office of the Auditor General Found

Marisa Nichini
June 9, 2021
                 
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What report?

On April 22, 2021, the Office of the Auditor General or OAG tabled a report on an audit they had conducted investigating how effectively Health Canada ensured that natural health products (NHPs) available for sale in Canada are safe and accurately represented to consumers. The report also contained recommendations to the federal government as to how these issues could be addressed as well as the government’s response.

 

What is the Office of the Auditor General of Canada?

The OAG is an arms-length organisation that serves parliament providing it with “objective, fact-based information and expert advice on government activities”[1]. It does this by conducting audits on activities across the federal government as well as certain crown corporations, the territorial governments and numerous territorial corporations and agencies. Increasingly it explores environmental matters and in fact the recent report was conducted by the Commissioner of the Environment and Sustainable Development which is part of the OAG.

Something of note is that while the OAG may comment on policy, it does not set policy, that is the role of the elected government. In effect, the OAG assesses how the government does something and not why it is doing something.

 

When and how was the audit conducted?

In addition to assessing existing materials (e.g. regulations, policy documents and guidelines), the audit also included various information gathering exercises such as interviews and surveys to assess whether Health Canada did what they were meant to do with respect to the regulation of NHPs. More details can be found in the report itself: 2021 Reports 1 and 2 of the Commissioner of the Environment and Sustainable Development.

Though most of the audit was conducted between February 2017 and December 2019, additional information was gathered in the Spring of 2020 in order to assess the impact of the COVID-19 pandemic. All information was gathered before December 3, 2020.

 

Did the audit have a specific focus or scope?

The audit did not examine all parts of the NHP regulations but rather focused on the pre-market approval of NHPs and site licensing as well as how Health Canada ensured that products were safe and accurately represented and that there was industry compliance with the regulations. A number of topics were not included within the scope of the audit such as

  • the proposed self-care framework,
  • classification of self-care products, and
  • non-NHP items such as cosmetics and consumer health products.

 

What did the audit find?

Unfortunately, apart from the response to the COVID- 19 pandemic, the report was not glowing for Health Canada or, indirectly, the Natural Health Products industry. The general finding was that while the current approval process of products for both safety and efficacy was based on evidence, there were serious failings in a number of areas. In particular, the report noted that Health Canada fell short in ensuring products on the market were safe and effective.

The OAG condensed what they found into three findings:

  1. Health Canada did not directly verify that facilities followed good manufacturing practices before products arrived on the market. The audit identified that Health Canada depended largely on manufacturers’ attestation that they were following guidelines rather than actually inspecting sites (as is the case with other regulators such as the European Union and Therapeutic Goods Administration in Australia).
  2. Health Canada did not check natural health products after they entered the market and was not always successful in responding to:
    • serious problems identifying inaccurate/poor information on labels;
    • advertising that was not in keeping with the product’s licence application; and
    • there was limited monitoring of products once on the market, as well as limited monitoring of unlicensed and unauthorised activities and
    • only partial success on dealing with such issues once they were identified.
  3. Health Canada responded effectively to natural products related to COVID-19 in that it exercised due diligence implementing a risk-based approach for the manufacturing/sale of hand sanitizers and identifying/acting on companies making false claims.

In addition to these findings, the OAG identified a number of challenges with the current regulations and policies that, as noted in the report, hindered the regulations from being effectively implemented and enforced. These included:

  • absence of mandatory on-site inspection of manufacturing facilities,
  • lack of mandatory recall provisions for NHPs together with low financial penalties for infringement as compared to other health products,
  • lack of financial resources needed to effectively manage the regulatory framework due in part to the last of a cost recovery system,
  • significant workload caused by the sheer number of product licences submitted for review especially when many were for products not brought to market by the sponsor.

 

How did the federal government respond?

The government accepted all the recommendations and laid out the actions that they will take moving forward. For a number of the recommendations, the government tied the actions to work either underway or already planned by Health Canada. These include:

  • the Plain Language Labeling of NHPs,
  • the pilot on-site inspection program,
  • increasing powers and fines for NHPs included within Vanessa’s Law[2] and
  • developing a cost recovery model.

 

Final Thoughts

The OAG report contains some important messages for both the government and the Natural Health Products industry not only with regards to how the current regulations are implemented and enforced but also as to improvements that need to be made.

While an OAG audit and report does not always result in change, it is a good bet to think that changes will be in the cards with such things as a push for NHPs to be included under Vanessa’s Law and the start of discussions around appropriate cost recovery to cover implementation of the regulatory framework. The OAG report also identified examples of serious concerns related to product labeling which need to be urgently addressed. From the government’s response, it looks like Health Canada is taking the OAG report as providing tacit approval for the Plain Language Labeling initiative currently underway.

One recommendation, long advocated by many parts of the NHP industry, is to look at the current largely documentation review-based approach to obtaining a site licence. The use of on-site inspections to confirm compliance with regulations is a fundamental quality management approach and is already utilized by most other jurisdictions such as the USA, Australia, and the European Union. It is long past time that Canada implemented a similar system. A current pilot project underway of site inspections to complement the current site licence approach is a good start, with the support of industry more needs to be done.

 

Download a PDF copy here.

 

About the author:

Michael Smith trained as a pharmacist and as a naturopathic doctor. He is recognized internationally as an expert in natural health products and complementary & alternative medicine. For more than 10 years, he worked in senior regulatory positions at the then Natural Health Products Directorate, Health Canada and the Therapeutic Goods Administration in Australia. In addition to his international work as a consultant, he is an Adjunct Professor at the National Center for Natural Products Research at the University of Mississippi, USA and an Adjunct Fellow at the National Institute of Complementary Medicine at Western Sydney University, Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

 

[1]https://www.oag-bvg.gc.ca/internet/English/au_fs_e_371.html

[2] The Protecting Canadians from Unsafe Drugs Act known as Vanessa’s Law strengthens Health Canada’s ability to identify and respond quickly to serious health risks caused by a drug or medical device. More information at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/education/module-1.html

 

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How do you know Natural Health Products can work – The Question of Evidence?

Marisa Nichini
April 19, 2021
                         
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What is evidence?

The Oxford English Dictionary defines evidence as “information indicating whether something is true or valid”. It gets more complicated when you look at the different ways evidence can be obtained and the many forms in which it comes.

 

Efficacy vs. Effectiveness

Talking about definitions, two terms that are often wrongly used interchangeably are efficacy and effectiveness. Efficacy is how useful something is found to be under ideal conditions such as a randomised clinical trial. Effectiveness is how something performs in a real-world situation. This often means that an intervention (a drug or a procedure) in an efficacy or an ideal controlled study performs somewhat better than in when used in everyday care. We all experience something like this when we look at the mileage posted for a new car. The posted number is the best possible outcome under ideal conditions. In our real life driving with all the extra variables we usually don’t achieve the same mileage number. However, the standardized numbers (under ideal conditions) enable us to compare the performance of one car with another.

 

What is a Randomised Controlled Trial or RCT?

Put simply, in an RCT the participants are randomly assigned to different groups. One of the groups receives the product you are researching and one, the control group, does not. In research for medicines, participants in the control group typically receive the standard treatment for the illness you are researching or a substance which has no therapeutic effect called a placebo.

Regardless of whether you are investigating the efficacy of a drug or Natural Health Product (NHP) or any therapeutic intervention for a specific clinical condition, the RCT is the best tool to utilize for these investigations and as such is referred to as the “gold standard”.

 

Isn’t a RCT the same as Evidence Based Medicine?

No, this is not the case. Evidence Based Medicine or EBM is a term used to describe the method of arriving at the best form of treatment. In its simplest form it is based on the integration of three key elements – clinical judgement of the practitioner, the best and most relevant external evidence (in published medical studies for example), and the individual patient’s values and preferences. Though it may not appear in the definition of EBM, data gathered from a RCT is the best form or external evidence for most therapeutic products notably pharmaceutical drugs.

 

I have heard that NHPs cannot be researched using RCTs?

No, this is not the case. Though there are important steps that needed to be taken for NHPs that are typically not needed for drugs, such as identification of plant materials when investigating an herbal medicine, numerous RCTs have been conducted, and are currently underway, investigating NHPs. In fact, RCTs have been successfully used in the research of many types of complementary and integrative health care such as yoga and acupuncture. Yes, there are challenges that must be overcome but the RCT is a very adaptable tool.

 

Why doesn’t Health Canada use the same approach for NHPs as for pharmaceutical drugs?

Health Canada did not utilize the same approach regarding evidence for NHPs as was used for pharmaceutical drugs based on the input Canadian consumers gave Health Canada when the regulations for NHPs were developed. Unlike pharmaceutical drugs, NHPs are a diverse group of products including both traditional health products with a long history of use as well as new and innovative products wishing to make a new health claim. Canadians demanded a regulatory approach which reflected and respected the full range of evidence including that from traditional forms of health and healing such as traditional Chinese medicine and herbalism as well as evidence from more typical medical research tools such as RCTs.

 

How is evidence for traditional medicines assessed in support of a Product Claim?

Though traditional medicines may have been used for many years, their use for self care without the supervision of a healer or practitioner is relatively new. This makes linking traditional evidence to a claim made on an NHP a very complex question. Health Canada has developed criteria about what sort of evidence can be used to support a claim such as:

  • how long the product has been used in history?
  • is it from single system of traditional healing?
  • if it is a traditional formula and, if so, has it been modified?

These criteria and guidelines make full use of the traditional medicine resources, such as reference books and pharmacopeia, and list approved resources which can be used making a product application to Health Canada. In addition, many of the Health Canada NHP monographs make use of traditional evidence and list the resources that were used in their development. More information about how Health Canada looks at traditional evidence and traditional medicines can be found at https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-traditional-medicines.html#a2.5

 

What evidence is required by Canada’s NHP regulations?

As with every other aspect of the NHP regulations, when considering evidence the aim is to respect the health care choices of Canadians and support them in making informed choices about their health care options. To do this, the claim on a NHP must be clearly linked to the type of evidence used. A consumer should be in no doubt that a NHP that has a health claim that is based on traditional evidence is clearly identified as a traditional medicine. A product that states that a claim has been scientifically proven must be supported by evidence from RCTs or other recognised research approaches.

 

How is this approach to evidence working out?

A good question with no simple answer. Canada was the first country to regulate NHPs as one class of products supported by different forms of evidence which is assessed by a regulator before the product is allowed to be marketed. In most cases this approach is working well, but there are definitely questions that need to be more thoroughly explored. Things such as how can traditional evidence for a product be used in a modern, self-care setting; how do you support innovation in the market place with a respect for traditional forms of health and healing; and how do you ensure people can make an informed choice about the evidence question regarding the NHP they decide to take. This is still a work in process and one that can only truly be answered by all parts of the NHP community – regulators, researchers, practitioners and consumers – working together

 

Where can I find out more about NHPs-focussed research?

There is a lot of research investigating all aspects of NHPs with many books and online resources available. In addition, there are many organisations focused conducting NHP research both in Canada and internationally. If you want to know more what is going on in Canada, the Natural Health Product Research Society of Canada may be a useful resource. Members of the society come from academia, industry, practitioners and government conducting world class research related to all aspects of the NHP sector. Recognising the importance of this research to the consumer, the society is committed to engaging Canadians. You can find more information about the society and its work at www.nhprs.ca

 

Final Thoughts 

The question of appropriate evidence supporting claims for NHPs is very complex. Unlike many other countries, Canada has a regulatory framework for NHPs that aims to balance the rigors of science with a respect for traditional forms of health and healing. While the regulations function well, they are still a work in progress. It is also important to ensure that Canadians are informed and educated about the NHP regulations; what is the evidence required to support NHP claims and how they can use this information to better navigate the shelves at their local health food store or pharmacy.

Download a PDF of this article here.

 

About the authors:

Michael Smith trained as a pharmacist and as a naturopathic doctor. He is recognized internationally as an expert in natural health products and complementary & alternative medicine. For more than 10 years, he worked in senior regulatory positions at the then Natural Health Products Directorate, Health Canada and the Therapeutic Goods Administration in Australia. In addition to his international work as a consultant, he is an Adjunct Professor at the National Center for Natural Products Research at the University of Mississippi, USA and an Adjunct Fellow at the National Institute of Complementary Medicine at Western Sydney University, Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

 

Dr Mary Hardy is the Founder/Director of Wellness Works and is on Faculty at the Academy of Integrative Health & Medicine in California, USA. Mary is recognized as an authority on integrative medicine and natural products. She is board certified in internal medicine, specializes in botanical and integrative medicine, and is a leader in integrative oncology. For more than 25 years, in both her practice and research, Dr Hardy has combined complementary & alternative medicine with Western medicine. Her current research interests include reviewing the evidence for the safety and efficacy of natural therapies, especially botanicals, as well as conducting clinical trials of dietary supplements and lifestyle choices to support conventional cancer treatment. Mary is a member of ISURA’s Scientific Advisory Committee.

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Update on Proposed Regulation for Self Care Products in Canada: Impact on NHPs

Marisa Nichini
June 19, 2018
       
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What is being proposed by Health Canada?

It has been well over a year since this process started, so this update also includes some useful background information on Health Canada’s consultation re. self-care products.

In early September 2016, Health Canada published a consultation document titled Consulting Canadians on the Regulation of Self Care Products in Canada proposing the replacement of existing individual regulatory approaches for non-prescription drugs, Natural Health Products and cosmetics with an overarching system for all self-care products.  In this new system, products would be categorized as being either lower, medium or higher risk self-care products. Categorization would depend on such things as the type of claim being made and the ingredient it contains.

In this initial proposal, for lower risk self care products, Health Canada proposed a notification system with no pre-market review of information by the department. In this category, products would not be able to make claims about the diagnosis, treatment, prevention, mitigation of a disease or condition and may need to carry a disclaimer saying that the claim has not been reviewed by Health Canada. In effect, this is a similar approach taken to that in the United States.

For medium and higher risk products, Health Canada would review applications and allow a higher level of indication referred to as a Health Claim. Health Claims would need to be supported by “scientific evidence” or “scientific proof” either supported through approved monograph[1] or review by Health Canada or individually reviewed by Health Canada.

In addition to this classification system, Health Canada also plans to create a more comprehensive and consistent approach to items such as recall provisions, authority to require labeling changes, and cost recovery mechanisms.

There was quite a response from Canadians —Health Canada received over 3,500 comments to the initial proposal document with about 70% of the comments coming from consumers. Health Canada collected and summarized the these comments and feedback in a What We Heard Report available online.

The consultation process continued in 2017 with Health Canada holding a series of national town halls, in addition to having meetings with groups from consumers, industry, academia. An updated proposal document has yet to be published, but various modifications to the original proposal document were presented at these town halls and meetings.

As for next steps, Health Canada is now planning to create a number of working groups and expert advisory groups that will work over the winter to come up with an updated proposal in 2018.

More information about what is being proposed and the process to date can be found at http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/selfcare-autosoins/document-eng.php

 What are self-care products?

 Generally, self-care products are health care products available to consumers that can be selected and used without direction from a health care provider such as a medical doctor, pharmacist, naturopathic doctor or nurse. In this document, Health Canada considers a self-care product to be made up of three different product groups: cosmetics; Natural Health Products such as vitamins, minerals, herbal medicines and traditional medicine; and non-prescription drugs such as acetaminophen and conventional cough remedies.

How are self-care products currently regulated in Canada?

 Though cosmetics, Natural Health Products and non-prescription drugs all fall under the Food and Drugs Act, they are actually regulated in three distinct ways:

  • Cosmetics are regulated under a post-market system, that is manufacturers and importers must notify Health Canada within the first 10 days a cosmetic is sold in Canada providing details of such things as ingredients and company contact information.
  • Natural Health Products (NHP) are regulated under the Natural Health Products Regulations (NHPR) that are the most current and up to date regulatory framework for any therapeutic product. The regulations are pre-market which means Health Canada is required to review information provided by the manufacturer or importer and approve all NHPs before they are allowed to be sold on the Canadian market. This information includes evidence to support the claim being made, as well as information about risks and dosage ranges. Companies must also submit information about where the product is made and a site license is required before a product can be sold. All approved NHPs for sale on the Canadian market must carry an 8-digit Natural Product Number (NPN) or a Drug Identification Number-Homeopathic Medicine (DIN-HM; for homeopathic medicines).
  • Non-Prescription Drugs are regulated largely like other conventional drugs. Like NHPs, companies must submit evidence to support safety and efficacy as well as information about where the product is made. Since all non-prescription drugs are conventional or mainstream health care products, unlike NHPs they only need to consider “scientific” evidence rather than that from traditional forms of health-care such as traditional Chinese medicine.

 Isn’t appropriate regulation of self-care products important?

Absolutely and in fact in its most recent strategy for traditional medicines, the World Health Organisation (WHO) has identified the regulation of self-care products as a key priority.[2] Health Canada should be commended and supported in recognizing the importance of self-care. The challenge is whether changing the newer regulations, such as the NHPR, should be the priority rather than continuing what was initially planned: to focus on revising the more dated regulations such as those for non-prescription drugs.

Why is Health Canada looking to change the way self-care products and NHPs are regulated?

Health Canada says that currently there are three separate sets of regulations—the cosmetic regulations, the Natural Health Product Regulations (NHPR) and the Food and Drug Regulations, depending on the type of self-care product. This may lead to confusion in market place making it difficult for consumers to understand how these products are regulated and what that means for product claims, the differences in the types of evidence used to support a use and what approval by Health Canada means for each of these three categories of products. There is also concern that the current complex set of regulations do not work well together and that there is the potential for the same product to be classified as a cosmetic, a NHP or a non-prescription drug depending on what claim the product is making and what ingredients it contains. Health Canada also cites inconsistencies in its powers to recall products deemed to be unsafe or to require label changes to reflect new evidence.

I thought the NHPR were very new, why change them now?

Yes, the NHPR are the most current and complete framework for any health product category in Canada and were developed through extensive consultation with all stakeholder groups, including the public. In addition, the NHPR were developed at the request of the Canadian government that recognized the importance of such things as the importance of evidence from traditional forms of health and healing.[3]

What is the problem with having claims based on “scientific evidence” and “scientific proof”?

Before we can answer this question we need to know what Health Canada means by these terms. Does this mean that the evidence used for conventional drugs such as randomized clinical trials can only be used to support health claims? Does this include scientific evidence currently respected within the NHPR? Should traditional forms of evidence such as traditional Chinese medicine and medical herbalism be recognized as valid proof by Health Canada and included in the definitions of “scientific evidence” and “scientific proof”. One question that still needs to be answered is why Health Canada has moved from recognizing a broader and respectful range of evidence for a claim base that includes traditional forms of health and healing to requiring that everything to be scientifically proven.

So, has any progress been made?

Until Health Canada provides a new proposal document (expected in 2018) it is difficult to fully answer this question.  Will it strengthen or limit consumers’ ability to make informed choices? We still don’t know.

Although Health Canada has presented various options at the town halls and consultations, they have been reluctant to share, officially, more detailed information. This includes the various presentations made at the recent town halls. The reason Health Canada cites for this is that the process is ongoing and that until they have reached a final proposal, they don’t want to confuse participants in the consultation.

From the presentations made at the various town hall meetings, it does seem that Health Canada have identified product quality as an important topic, especially as it relates to good manufacturing practices and site licensing. In addition, the importance of accurate labeling, the role of product identification numbers and the need to ensure that consumers have the necessary information to make informed choices have been identified as key.

Despite having gone through a number of iterations, the presentations consistently present the idea of a three-category system within one regulatory approach. This concept still implies that similar claims should be based on similar forms of evidence and that “scientific” evidence will be needed to support therapeutic claims. The fundamental role of traditional and historic evidence in supporting product claims and informing consumers is still uncertain.

So, what do you think?

From what we have seen to date, Health Canada still wants to make quite radical changes to how NHPs are regulated in Canada—a lengthy and detailed process. If this is the case then, just as when the NHP regulations were developed, Health Canada will need to publish exactly what they are proposing in the Canada Gazette I and then provide a limited time for Canadians to respond with their comments. Health Canada will also need to conduct a detailed analysis of what impact any changes will have on the NHP sector.

Big questions still need to be answered before any formal regulatory changes are seen. Most notably, the importance of evidence from traditional forms of health and healing in a multicultural Canada, the role of product identifiers, and what exactly needs to be on a product label. Hopefully these questions will be answered by Health Canada and if changes to the regulations or guidelines are proposed that they will share a new official and complete proposal so that Canadians know the plans for the future. If changes are to be made, they should not be rushed.

Though I still commend Health Canada for highlighting the importance of self-care products and agree with the need to update the current dated regulations for non-prescription medicines and cosmetics, do we really need to radically overhaul NHP regulations that only came fully into effect a few years ago? It does seem that what is being proposed is to replace a three-category system (cosmetics, NHPs and non-prescription drugs) with another three-category system that could end up capturing the exact same set of products.

Though the current NHP regulations are modern, “state of the art” regulations, they are not perfect. After being in force for a number of years, we now know what works and what doesn’t. We have an opportunity now to fix any problems as well as use lessons learned from the NHPR in updating the regulations for cosmetics and non-prescription medicines. This, in my opinion, is where the focus should be.

You can keep up to date with developments as well as the dates and times for the town-hall meetings by going to https://www.canada.ca/en/health-canada/topics/self-care-products.html. This is an opportunity for you to make your opinions heard.

 

About the author: Dr. Michael Smith is trained as a pharmacist and a naturopathic doctor and is recognized internationally as an expert in NHPs and Complementary and Alternative Medicine. For more than 10 years, he worked in senior regulatory positions at the then Natural Health Products Directorate, Health Canada and the Therapeutic Goods Administration in Australia. In addition to his work as a consultant, he is an Adjunct Professor at the National Center for Natural Products Research at the University of Mississippi in the USA and an Adjunct Fellow at the National Institute of Complementary Medicine at Western Sydney University in Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

[1] A monograph typically sets out information such as claims, dosage and potential side effects preapproved that are permitted by Health Canada.

[2] http://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/

[3] http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/53_recommend_nhp-cps_tc-tm-eng.php

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