Cost Recovery for Natural Health Products: Health Canada’s Proposal and its impact on the NHP Sector?

Marisa Nichini
July 13, 2023
               
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Health Canada published a draft of its proposed cost recovery fees for Natural Health Products (NHPs) on May 12, 2023. This is part of Health Canada’s ongoing updates to its management of NHPs as part of its self-care framework and in response to the report published by the Commissioner for Sustainability and Environmental Development in the Spring of 2021. The complete proposal can be found at https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products/fees-fee-policy.html. There is a 90-day consultation period with all comments required by August 10, 2023.

 

What is Cost Recovery?

Simply put, cost recovery is a mechanism by which a regulator can charge fees to either completely or partially cover their costs for operating a regulatory framework. The reasoning behind charging industry such fees is that these government functions provide direct commercial benefit to an industry and so it is fair that industry bear some of the financial burden. This is not a new concept – Health Canada has had a cost recovery mechanism in place for other therapeutic goods such as prescription and non-prescription drugs since the 1990s.

 

Is this new for NHPs?

Regarding NHPs, the need for a cost recovery system was identified back in 1999 as part of the 53 recommendations from the Standing Committee on Health. While the plan to include NHPs within cost recovery has been previously identified, this is the first formal “consultation” from Health Canada and was posted with little warning.

 

What functions does this proposed cost recovery framework cover?

The proposed framework will apply to NHP product licence applications; NHP site licence applications; and other on-going functions such as post-market activities which will be captured under a fee called Annual Right to Sell (RTS). In addition to these fees, the proposed framework also contains performance standards that Health Canada must meet. The framework also proposes a new class of NHPs for review called a Class III novel application – although there are few details available re the parameters for this “class”.

 

Who will have to pay these fees?

These fees will apply to any organisation with a Health Canada regulatory requirement. This includes sponsors of product licences, manufacturers, distributors, and importers of NHPs. Health care facilities that receive government funding or any branches of the federal, provincial, or territorial government will not be included in this framework.

 

How much will this cost?

The proposed cost recovery framework is very detailed with fees for a variety of functions carried out by Health Canada. Specific suggested fees can be found in the proposed framework at https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products/fees-fee-policy.html; some examples are:

  • an annual $542 RTS fee for each Natural Products Number (NPN) or DIN-HM (Drug Identification Number – Homeopathic Medicine);
  • an annual site licence manufacturing no sterile dosage forms of $23,071;
  • Class I application or amendment fee of $1,124;
  • Class II application or amendment fee of $2,761; and
  • $58,332 for a Class III novel application.

If the performance standards proposed in the framework are not met by Health Canada, they will remit 25% of the fee. An important point here is that Health Canada can “pause the clock” in specific circumstances.

 

What about smaller businesses?

As with other health products, the proposal contains a mitigation for small businesses: companies with fewer than 100 employees or between $30,000 and $5 million CAD in annual revenue. In these cases, the proposal states that “businesses would have fee remissions of 100% for pre-market evaluation fees for the business’s first ever NHP product submission; 50% for pre-market evaluation fees for all subsequent product submissions; and 25% for site licence fees and the annual RTS fee”.

 

How do other countries deal with cost recovery?

As is correctly stated within the proposal, differing approaches to regulation means that it is hard to make a comparison between different jurisdictions. This is further complicated by the fact that the terminology used in this proposal and by other countries is not consistent and makes an international comparison confusing. For example, what is called a NHP in Canada may or may not be called a dietary supplement in the USA or a complementary medicine in Australia.

While a detailed comparison of how different countries approach cost recovery would not be possible here, the main points are:

  • In the USA, since dietary supplements (products typically akin to NHPs in Canada) are not reviewed before entering the market, there is not a cost recovery mechanism in place related to these products and most manufacturing sites. For the small proportion of products that would be considered NHPs in Canada but are regulated as non-prescription drugs in the USA, the American cost recovery mechanism for non-prescription drugs is applied.
  • While most herbal medicine in the European Union (EU) is regulated as drugs, many herbal products are available as food supplements[1] For the relatively small number of traditional herbal medicines, a cost recovery mechanism exists for functions related to the product and to the manufacturing processes. This varies between different EU members states. Since food supplements are not reviewed, typically there is no cost recovery mechanism.
  • In Australia, for all therapeutic goods (this includes NHPs referred to as complementary medicines), one hundred per cent of the costs incurred by the regulator are recovered from industry. An error made in the document that in Australia Listed Medicines (which make up the majority of products equivalent to NHPs) stating that they cannot make health claims. In fact, they can make indications for a direct health benefit (e.g. relieves a cough) or more non-specific such as refer to general health maintenance.[2]. For listed medicines, which makes up the vast majority of complementary medicines in that market. The approval for uncomplicated products being quickly processed electronically through the Electronic Listing Facility. The relatively small number of registered complementary medicines must undergo a complete review. Irrespective of the type of complementary medicine, costs for inspections manufacturing sites are one hundred per cent cost recovered.

There are ISURA information pieces about the US approach to regulation of NHPs/dietary supplements at https://isura.ca/2022/04/12/comparing-nhp-regulations-from-canada-and-the-usa/ and the Australian approach to the regulation of NHPS/complementary medicines at https://isura.ca/2022/11/05/comparing-nhp-regulations-from-canada-and-australia/

 

What needs to happen before this cost recovery framework to be approved?

While inclusion of NHPs under the proposed Health Canada cost recovery model will require a regulatory change typically through the Canada Gazette process, the minister themselves have the authority to set and adjust the fees.

 

If successful, when will this cost recovery framework come into operation?

The current proposed implementation date is April 1, 2025.

 

Final Thoughts?

While the document states, “multiple factors are considered, such as financial or competitive advantage, market access and innovation development in Canada” there is limited, detailed information about how this has been done:

  • What impact will this implementation have on the Canadian NHP industry, both manufacturing and retail and if the impact is negative, will any revenues lost from cost recovery be offset by the impact it has on jobs and taxes?
  • Without any data protection for NHPs, what effect will this have on innovation, not only with the impact on developing new products but also the employment opportunities for Canada’s strong NHP research sector?
  • How will these changes affect access to NHPs which are high quality, safe and efficacious products including traditional medicines such as Ayurvedic medicines and traditional Chinese medicines.
  • Finally, and something that goes to the heart of the reason for regulations – risk to the consumer, will this decrease the number of NHPs approved and limit access by Canadians to approved products. Will this in turn push consumers to further increase the online purchase of NHPs from jurisdictions with less rigorous oversight than Canada, and will this put Canadians at risk?

To be successful, any regulatory framework needs to have a stable funding base. Obtaining stable funding from industry through a transactional, fee-based cost recovery system is one option used by governments. At the same time, for a fee-based cost recovery system to work,  a relevant regulatory framework must be established and be efficient, reflecting the work required with the risk proposed by the product. This is not the current situation given the very inefficient review process currently in place and the fact that Health Canada faces significant backlogs in many parts of the existing approval process. In addition, with all the other work underway including changes to NHP labelling and an ambitious work plan already in place, implementing a new cost recovery plan could hinder these planned initiatives.

Before a cost recovery process can proceed a number of questions still need to be answered and the current system has to be made more efficient. For the moment, it would be wise for Health Canada to wait, continue their improvement agenda and complete the implementation of the self-care framework and then conduct an open and collaborative consultation process with respect to a cost recovery plan.

 

Download a PDF version of this article 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 Associate Professor at the National Centre for Naturopathic Medicine at Southern Cross University, Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

 

[1] https://www.efsa.europa.eu/en/topics/topic/food-supplements

[2] https://www.tga.gov.au/resources/resource/guidance/permitted-indications-listed-medicines#:~:text=’Indications’%20are%20statements%20that%20describe,refer%20to%20general%20health%20maintenance).

 

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Designing Vitamin D3 Formulations: An In Vitro Investigation Using a Novel Micellar Delivery System

Marisa Nichini
June 23, 2023
           
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Abstract: Vitamin D is an essential nutrient with important immunomodulatory properties. As a fat soluble compound, Vitamin D (and its D3 form) is immiscible with water, which presents challenges to absorption. In an in vitro setting, the current study characterizes novel micellar formulations of Vitamin D3 designed to improve absorption. Techniques used to evaluate and compare the micellar formulations against a non-micellar formula include the following: cryo-SEM to determine morphology; laser diffraction to determine particle size and distribution; zeta potential to determine stability of the particles; solubility assays to determine solubility in water and gastrointestinal media; and Caco-2 cell monolayers to determine intestinal permeability. Results show advantageous features (particle size range in the low micrometres with an average zeta potential of –51.56 ±2.76 mV), as well as significant improvements in intestinal permeability, in one optimized micellar formula (LipoMicel®). When introduced to Caco-2 cells, LipoMicel’s permeability was significantly better than the control (p < 0.01; ANOVA). Findings of this study suggest that the novel micellar form of Vitamin D3 (LipoMicel) has the potential to promote absorption of Vitamin D3. Thus, it can serve as a promising candidate for follow-up in vivo studies in humans.

Abstract Excerpt from: Nutraceuticals 2023, 3, 290–305. https://doi.org/10.3390/nutraceuticals3020023

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ISURA-supported article re Flavonoid Supplementation published in International Journal of Molecular Sciences

Marisa Nichini
May 16, 2023
           
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Consideration for Flavonoid-Containing Dietary Supplements to Tackle Deficiency and Optimize Health

Abstract: Randomized clinical trials (RCT) and observational studies have highlighted the importance of flavonoid consumption for human health. Several studies have associated a high intake of dietary flavonoids with (a) enhanced metabolic and cardiovascular health, (b) enhanced cognitive and vascular endothelial functions, (c) an improved glycemic response in type 2 diabetes mellitus, and (d) a reduced risk of breast cancer in postmenopausal women. Since flavonoids belong to a broad and diverse family of polyphenolic plant molecules—with more than 6000 compounds interspersed in the human diet—researchers are still uncertain whether the intake of single, individual polyphenols or a large combination of them (i.e., synergistic action) can produce the greatest health benefits for humans. Furthermore, studies have reported a poor bioavailability of flavonoid compounds in humans, which presents a major challenge for determining their optimal dosage, recommended intake, and, consequently, their therapeutic value. Especially because of their scarce bioavailability from foods—along with the overall declining food quality and nutrient density in foods—the role of flavonoid supplementation may become increasingly important for human health. Although research shows that dietary supplements can be a highly useful tool to complement diets that lack sufficient amounts of important nutrients, some caution is warranted regarding possible interactions with prescription and non-prescription drugs, especially when taken concurrently. Herein, we discuss the current scientific basis for using flavonoid supplementation to improve health as well as the limitations related to high intakes of dietary flavonoids.

Abstract Excerpt from: Int. J. Mol. Sci. 2023, 24, 8663. https://doi.org/10.3390/ijms24108663

Adapted entry also available at https://encyclopedia.pub/entry/44528 Scholarly Community Encyclopedia

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Isura®

Comparing NHP Regulations from Canada and the USA

Marisa Nichini
April 12, 2022
                                   
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As with other health products, the manufacture, sale and distribution of natural health products (NHP) is now truly international. Though the market may be global, their regulation is not, with most countries having different regulatory frameworks for these types of products. Given the complexity of the sector and differences between the regulatory approaches, comparing national approaches does not make for easy reading. Instead, this article will provide a high-level understanding of how the regulatory approaches for Canada and the United States of America compare with one another by looking some common features:

  • Terminology and classification
  • Who manages the regulations?
  • How are the regulations applied?
  • What claims/use can products make?
  • How they must be made and inspected?
  • What must be on the product labels?

Links to more resources that provide more details about each regulatory approach can be found at the end of the article.

Terminology and Classification

Both Canada and the USA take a similar approach in grouping different types of products under an umbrella term – Natural Health Products in Canada and Dietary Supplements in the USA. These terms capture the same types of products in each country notably vitamins, minerals, nutritional substances, probiotics, traditional medicines and herbal medicines. The one exception is homeopathic medicines which are NHPs in Canada but are not considered dietary supplements in the USA. Also, by definition, dietary supplements only include products that are taken by mouth and so exclude products used topically such as creams and ointments, as well as sublingual products.

In Canada, a specific set of regulations – the Natural Health Products Regulations (NHPR) implement the law called the Food and Drugs Act. Under the law, NHP are considered to be a subset of drugs. In the United States (US), dietary supplements are also covered by a specific set of implementing regulations created in response to revision of the law called the Federal Food, Drug, and Cosmetic Act. The revision is the Dietary Supplements Health Education Act (DSHEA). Note that there is a misconception that dietary supplements are not regulated.  This is not the case.

Who manages the regulations?

In Canada, as with most other types of health products, NHPs are primarily regulated by the federal government. The responsible department is Health Canada (HC), and the primary centre of excellence therein is the Natural and Non-Prescription Health Products Directorate (NNHPD).   The NNHPD is responsible for issuing product, and site licenses, conducting post market health hazard evaluations and providing policy support to post market operations.  The organizations responsible for the post market operations are the Marketed Health Products Directorate (MHPD), responsible for adverse drug reaction monitoring and the Regulatory Operations and Enforcement Branch, which is responsible for compliance and enforcement actions (a role it also plays for the majority of other therapeutic products).

As with Canada, in the United States the regulation of dietary supplements is primarily the responsibility of the federal government through the U.S. Food and Drug Administration (FDA). Though many different parts of the FDA as well as other agencies and departments of the federal government have responsibilities for the regulation of dietary supplements, the primary centre of excellence is the Office of Dietary Supplements Programs within FDA’s Center for Food Safety and Applied Nutrition. Responsibility for enforcement of various FDA regulations is FDA’s Office of Regulatory Affairs.

How are the regulations applied?

In both Canada and the US criteria are used to determine whether a product is or is not in compliance with the law. However, in Canada, a pre-market application and licensing process is used to determine if a product meets standards prior to it being sold in the market. Sites where products are made must also be licensed under Canadian regulations. In the US, products that do not meet regulatory requirements for finished dietary supplements are subject to regulatory action. This is similar to how the majority of all food products are regulated in both Canada and the US and reflects the difference in how the products are legislated. In order for either the Canadian or US system to be effective post-market validation must occur.

In both countries, a risk-based approach is taken with required monitoring for products on the market. Each country has specific requirements for reporting adverse events and side effects. Again, this is a very high-level overview, and both sets of regulations are far more detailed.

What claims can products make?

In Canada, NHPs are the same as any other non-prescription health product in terms of the claims they may make. They must make a claim, that is, an NHP cannot be sold as a medicine without any supporting proof of what it does or investigation into its safety. The use may come from the full gamut of treatment, altering function, risk reduction and health promotion. NHPs can also make claims based on traditional forms of health and healing such as western herbalism or traditional Chinese medicines. The type of claims must be reflected in the type, quantity and quality of supporting evidence submitted for review by Health Canada. For example, the traditional evidence that is accepted by Health Canada is that which reflects scientific principles of reproduceable results, integrity in the dosage form and consistency in the patient population over decades of recorded study. For any use, additional data must be produced and considered to support more specific clinical claims. Health Canada has developed specific review pathways including use of monographs to facilitate this process. This approach to evidence means that there are no disclaimers on the labels of Canadian products related to the product’s safety, efficacy or quality.

In the United States as dietary supplements are considered to be foods, they are far more limited in the claims that they can make and in fact do not need to make a claim at all. Dietary supplements can only make claims related to structure and function, and are prohibited from making disease cure, treatment, or prevention claims. In addition, if a claim is made, the label must contain a disclaimer that it has not been reviewed by the FDA. An additional disclaimer that “This product is not intended to cure, treat, mitigate, or prevent a disease” is mandated on finished dietary supplement products in the US.

How must these products be made and inspected?

Both countries have specific requirements for Good Manufacturing Practices (GMPs) which manufacturers, importers and distributors must ensure are being followed in order to maintain required site licences in Canada or facility registration in the USA. In Canada, with its pre-market approach, a site licence must be issued for the manufacturing facility before a NHP is allowed to come to market. This is an unvalidated review approach as there is no systematic government led/managed on-site/physical inspection required. In the US, the FDA do conduct onsite/physical inspections as part of GMP enforcement.

In a world where product quality is one of, if not the largest risk to health, many in the industry question whether either approach is adequate. To ensure quality, this has led many manufacturers to obtain inspections from valued third parties such as the United States Pharmacopeia (USP), NSF or ISURA.

What must be on the product labels?

While requirements for what needs to be on a label exist for both countries, the requirements for Canada are far more detailed and rigorous than in the United States. In the United States, under DSHEA, labels for dietary supplements are required to contain:

  • the statement of identity (name of the dietary supplement)
  • the net quantity of contents
  • the nutrition labelling
  • all other ingredients
  • the name and place of the business of the manufacturer, packer or distributor.

In addition, there are additional requirements under food regulation to ensure safe use. Dietary supplements also need to have a supplements fact table on the product label, based on the Nutrition Facts panel required for conventional food, but this is only required to contain very limited information. The label must contain a disclaimer that any claim has not been reviewed by the FDA and that the product is not intended to cure, treat, etc.

The requirements for labels of NHPs in Canada are comprehensive including information such as:

  • all ingredients (medicinal and non-medicinal),
  • quantities,
  • dosage form,
  • recommended dose and duration of use,
  • indications/purpose of use, and
  • risk information such as potential drug interactions, side effects contraindications.

In addition, the label must contain lot numbers, an 8-digit Natural Products Number (NPN) or DIN-HM for homeopathic medicines issued by HC together with information on the manufacturer/distributor/supplier. As with all products sold in Canada, this information must be presented in both official languages, English and French.

There are major changes on the way with the recent publication of new regulations aimed at improving NHP labels. Amongst the changes are improved cautionary labelling around allergens; gluten and aspartame, use of electronic contact information; and in most cases mandatory use of detailed Product Facts Tables. These changes will come into effect in the next 3 years for new products with an additional 3 years for products that were on the market when the new regulations were published.

Final thoughts

The question everyone asks is which one is the better approach? In truth, both have advantages and disadvantages and were developed to reflect each country’s needs and priorities at the time. The original Canadian NHPR are almost 20 years old, and the US DSHEA came into force in the 1994. Both sets of regulations could be improved to better reflect a very changed world and market. In Canada, there are current discussions about what improvements need to be made, and in the USA, there is on-going debate as to whether DSHEA is still the best approach or whether a “DSHEA 2.0” is needed.

The information in this article provides a general comparison between the regulatory approaches of Canada and the USA. If you would like more information about any specific areas mentioned above or specific topics such as advertising/marketing regulations, you can find more details about the Canadian approach at https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation.html and the US approach at https://www.fda.gov/food/dietary-supplements

Download a PDF version of this article 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 Associate Professor at the National Centre for Naturopathic Medicine at Southern Cross University, Australia. Michael is a member of ISURA’s Scientific Advisory Committee.

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Chlorpyrifos Updates for the USA and Canada

Marisa Nichini
August 24, 2021
                 
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Chlorpyrifos is an organophosphate insecticide, acaricide and miticide used primarily to control foliage and soil-borne insect pests. In the past few months both Health Canada’s Pest Management Regulatory Agency (PMRA) and US Environmental Protection Agency (EPA) have taken action to cancel the use of chlorpyrifos. ISURA includes chlorpyrifos pesticides as part of the more than 700 pesticides and other contaminants for which it routinely tests natural health product raw ingredients and materials.

Read on for highlights from the EPA and PMRA websites and links to more information:

 

United States Environmental Protection Agency

Effective August 18, 2021

Excerpt from webpage: https://www.epa.gov/ingredients-used-pesticide-products/chlorpyrifos

“In August 2021, EPA released a final rule revoking all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. Read a prepublication version of the final rule: Chlorpyrifos; Tolerance Revocations (pdf) . In addition, the agency will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act to cancel registered food uses of chlorpyrifos associated with the revoked tolerances.”

 

Health Canada: Pest Management Regulatory Agency

Excerpt from webpage: https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/decisions-updates/reevaluation-note/2021/n-methyl-carbamate/chlorpyrifos.html

Re-evaluation Note REV2021-02, Update on the Re-evaluation of Chlorpyrifos

13 May 2021
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2021-2E-PDF (PDF version)

“Under the re-evaluation program, Health Canada’s Pest Management Regulatory Agency (PMRA) has reviewed chlorpyrifos and its associated uses and implemented several risk reduction measures over the years. In 2000, Health Canada removed all residential uses from chlorpyrifos labels…

[According to the May 13, 2021 Re-evaluation Note REV2021-02,] Health Canada has cancelled all chlorpyrifos uses/products, including those that remained registered following the environmental risk assessment, in accordance with paragraph 20(1)(a) of the Pest Control Products Act. The existing stocks of all chlorpyrifos products in Canada are being phased out with the following timelines:

  • Last date of sale by registrant: 10 December 2021
  • Last date of sale by retailers: 10 December 2022
  • Last date of use for all chlorpyrifos uses/products including canola (for alfalfa looper) and garlic (for darksided and redbacked cutworm): 10 December 2023

The intended work to update the human health assessment is no longer needed as all pest control products containing chlorpyrifos are being cancelled due to failure to satisfy requested data requirements. On this basis, the re-evaluation for chlorpyrifos is now considered complete.”

Download PDF of this document here.

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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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Developments in the regulation of CBD as a Health Product: An Update

Marisa Nichini
February 12, 2021
             
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Questions and Answers

Current Canadian regulations for cannabidiol (CBD)

Check out this previous ISURA online article from August 2019 for additional information – Q&A: Is CBD a Natural Health Product? Here’s a recap:

  • In recent years a constituent of the cannabis plant, cannabidiol or CBD, has gained a great deal of popularity both in Canada and globally for a number of health care uses;
  • Unlike other constituents found in cannabis such as delat-9-tetrahydrocannabinol or THC, CBD does not produce a “high” or intoxication;
  • In 2018 the Cannabis Act was passed in Canada which regulated CBDs as recreational cannabis products rather than as health products;
  • In response to concerns voiced by Canadians wanting to access CBD for its potential healing properties, in 2019, Health Canada launched a consultation titled Potential Market for Cannabis Health Products (CHPs) that would not require practitioner oversight;
  • While the consultation process was held, global pandemic meant that Health Canada was delayed in responding to the consultation: Health Canada published What we heard report in September 2020 capturing comments from the consultation with Canadians.

 

What did Health Canada propose?

The aim of the Health Canada proposal is to create a new regulatory category of health products called Cannabis Health Products (CHPs) which would include CBD as well as other active ingredients found in cannabis. CHPs would be suitable for use where practitioner supervision was not required. This new regulatory framework would combine elements found in the Cannabis Act with those for health products found in the Foods and Drugs Act. The result would be a range of regulatory approaches for cannabis products including CHPs, recreational cannabis products and those regulated as prescription drugs.

Some of the main points of the proposal are:

  • CHPs would be subject to certain controls under the Cannabis Act as well as provisions to allow for approval of health claims supported by scientific evidence;
  • CHPs would be allowed for both human and veterinary uses;
  • While general health claims would not be permitted, specific health claims supported by robust scientific evidence, for minor ailments and those appropriate for self-care, would be permitted; in this case “traditional medicine” evidence is not considered “robust” evidence;
  • CHPs could contain non-cannabis-related ingredients both medicinal and non-medicinal with cannabis-based components to be listed as active ingredients and be directly linked to the claim being made;
  • Before a CHP could be brought to market, the application would undergo a pre-market review (including that of the label);
  • CHPs could only be sold by provincially, territorially or federally licenced retailers or sellers of cannabis products. While in most places this would mean recreational cannabis stores, individual provinces or territories could extend this to include other retailers such as pharmacies, vet clinics and pet stores; and
  • Steps would be taken to protect young persons, as is currently required for recreational and medicinal cannabis products, including ensuring that labelling does not appeal to youth.

To reflect the different needs of various parts of the community, specific sets of questions were developed for three general stakeholder groups: consumers, industry and others (practitioners, academics, provincial/territorial government organizations, etc.).

The complete Health Canada proposal is located online at https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis/document.html.

 

What did Canadians say?

A summary of the response to Health Canada’s proposed “way forward” was published in September 2020. The report is quite detailed but does contain some very useful charts and diagrams including direct comments and issues raised by participants in the consultation process. You can access the report at https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/summary-report-consultation-potential-market-health-products-cannabis.html.

Here are some of the main points:

  • Consumers: This was the largest group of respondents and they were interested in CHPs for both human and animal use. The vast majority (92%) were in favour of access to CHPs with a number of potential therapeutic uses particularly for pain/inflammation, anxiety/stress/depression and sleep. Though a majority of respondents favoured oral dosage forms, a significant number also identified topical use as well as via vape or smoke. There was a general feeling that the current situation was not appropriate and that consumers were looking for a system that did not require supervision and better supported informed choice.
  • Industry: Many of the respondents from the industry group, notably the Natural Health Product (NHP) and cannabis sectors, voiced general support for the ability to market a “new range” of cannabis products. A significant number of respondents thought that CHPs should regulated distinctly from other cannabis products to “ensure consumer choice and better access to safe, effective, and quality products”. Some concerns were raised as to where CHPs should be sold – respondents indicated that CHPs should be sold through pharmacies (seen as #1 option) and health food stores rather than through approved recreational cannabis outlets. Concerns were also raised regarding the proposed packaging – a preferred approach was a system similar to that used for NHPs or non-prescription drugs. Many wanted to see CBD considered specifically with a number of the cannabis industry respondents proposing a two-system approach distinguishing between CHPs with THC and CHPs with CBD. Many industry respondents also raised concerns about the fact that generalised claims would not be allowed.
  • Others: Responses from the “Others” category (practitioners, academics and provincial/territorial government organizations) often differed from those above. They raised a number of concerns around safety, the lack of scientific evidence supporting claims re: CBD and the potential for addiction. This group also voiced support for practitioner sale or supervision and thought any regulatory framework should be distinct from that for drugs and NHPs – i.e. CHPs should not carry Drug Identification Numbers (DINs) or Natural Product Numbers (NPNs).
  • The question of evidence in support of the use of CBD as a health product was raised by many respondents in all categories as a significant issue to be addressed. While many consumers thought that historical evidence was sufficient, a number of industry respondents and the vast majority of responses from the academic and research community voiced the need for more scientific evidence and support for research in this area. Health Canada has already identified the need for advice here and will establish an external expert advisory committee to provide guidance on questions related to evidence and the science behind CHPs.

 

What will the Scientific Advisory Committee look like?

Recognising the many outstanding scientific questions about CHPs, Health Canada committed to creating an external scientific advisory committee as part of its proposed regulation and consultation about CHPs. This committee would have 8 to 12 core members with the option of consulting with additional experts in specific disciplines if needed. Members of the committee need to be familiar with the health products sector and should come from a range of disciplines including but not limited to cannabis and drug research, health law and policy, pediatric medicine, geriatric medicine and toxicology.

Though the call for nominations to the Scientific Advisory Committee went out in 2019, other priorities delayed the announcement of members until late in 2020. You can find more information about the request for nominations and the members of the committee at https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis/nomination-call-for-members.html and

https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis/membership-list-biographies.html respectively.

 

What about the economic impact of regulating CBD as a health product?

 In addition to the important potential therapeutic uses of CBD is the positive impact that regulating it as a health product could have on the Canadian economy.  A report titled Assessing the Economic Impact of Regulating CBD Products as Health Products was recently published by the prestigious Institute of Fiscal Studies and Democracy at the University of Ottawa. Commissioned by the Canadian Health Food Association, this report estimated that the regulation of CBD as a health product could have an economic impact of as much as $2.45 billion annually with the addition of over 20,000 Full Time Equivalent (FTEs) by 2023.

Though it should never take priority over the question of safe and appropriate use, the economic impact of regulating CBD as a health product rather than as a recreational cannabis product is an important one to consider. This report is an important step in answering this question but as identified by the report’s authors, more Canada focused economic and market research is sorely needed.

 

The report is very detailed and contains information about what a future CBD sector could look like. It can be found at: https://chfa.ca/Portals/30/RegAffairs/Cannabis/2020/IFSD_CBD_ECON_IMPACT.pdf?ver=2020-09-13-212538-793

 

Some final thoughts:

Health Canada has taken the positive step of asking Canadians for their opinions about CBD and other cannabis phytocannabinoids which could be used as health products in self-care. That being said, if they are truly open to making regulatory changes, there are some very basic points which need to be thought through in more detail.

While several phytocannabinoids may have therapeutic properties for use in self-care, the focus today amongst consumers, in Canada and globally, is almost entirely around CBD. In fact, most of the safety concerns focus on THC including its potential for abuse. Recognising that most of the safety concerns and potential for abuse rest with other phytocannabinoids in CHPs such as THC, as a first step, why not simply focus on CBD?

For all CHPs including CBD, the question of whether or not there is science-based evidence to support health claims, dosage and long-term safety in a self-care setting is a very valid one to ask.

The vast majority of consumers already have access to CBD products through recreational cannabis outlets and increasingly use it to address health care issues. What they don’t have are the tools to make informed decisions about its use for health and self-care. Nor do consumers have access to people who have training and experience in counselling consumers in the responsible use of such health products. Recognising that more evidence is often needed, and that Canada is home to many of the world’s leading cannabis researchers, now is the time for the Canadian government to support and fund a focussed research agenda.

The hope is that working with industry, academics and, most importantly, consumers the Canadian government will follow through with a strong commitment to develop and implement a regulatory framework for CHPs which provide consumers with access to safe and high quality products supported together with evidence based information and advice to help them decide whether or not to include a CHP in their health care options.

 

 

About the author: 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.

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