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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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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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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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Is CBD a Natural Health Product?

Marisa Nichini
June 6, 2019
                       
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With the legalization of cannabis in Canada, people also have questions about related compounds like cannabinoid (CBD). In particular, there are questions about whether CBDs are natural health products (NHPs) and what implications that might have in Canada and in the United States. Check out our Q&A for recent information.  Learn More.

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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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Canadian Regulation of Natural Health Products – Answering Your Questions

Marisa Nichini
November 27, 2015
   
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Recently there has been a lot of news about the regulations and quality of vitamins, minerals, herbals and other supplements available in Canada. To better navigate the market place, there are some important points that need to be remembered

Are vitamins, minerals and other supplements regulated in Canada?

In a word yes, these types of products often referred to as “supplements” are regulated as Natural Health Products or NHPs for short.

What is a Natural Health Product?

Natural Health Products are defined by Natural Health Product Regulations as:

  • Vitamins and minerals;
  • Herbal remedies;
  • Homeopathic medicines;
  • Traditional medicines such as traditional Chinese medicines;
  • Probiotics; and
  • Other products like amino acids and essential fatty acids

The regulations and Health Canada require NHPs to be “safe to use as over-the-counter products and not need a prescription to be sold”.[1] If a prescription is required due to such things as the amount that needs to be taken or the illness it is being used to treat, then the product will be regulated as some other form of therapeutic good such as a prescription drug.

How are NHPs regulated in Canada?

As with things such as drugs, foods and medical devices, in Canada NHPs are regulated under the Food and Drugs Act. In fact, unlike in countries such as the United States where products such as these are regulated as a type of food, in Canada, NHPs are regulated as a type of drug with specific regulations developed to reflect the sector’s specific characteristics.

The Canadian NHP Regulations take a life cycle approach in that they look at both what happens before (premarket) and after (post-market) a NHP is available for sale. Before a NHP can be sold, a product license must be obtained from Health Canada and requires information such as the product’s ingredients (both medicinal and non-medicinal), what it can be used for, any potential side effects or things that should be avoided and recommended dosage. When a NHP is licensed by Health Canada it is assigned a Natural Product Number (NPN) that must be displayed on the product’s label. Also, a site license providing details of the site where the product is made and verification that they follow recognized Good Manufacturing Practices (GMPs) must also be submitted and approved by Health Canada. Again, both of these steps must be successfully completed before a NHP can be sold.

Regulatory oversight does not end once the NHP is on the market. Products are required to submit any details they receive about unexpected or serious adverse effects they discover. This approach allows Health Canada to make sure the information that they have is current. At any point, if a problem is identified either with safety or product quality, Health Canada can take action to mitigate this risk. These steps can range from requiring new labeling to asking that the product be stopped for sale. More information about the Canadian NHP regulations can be found at www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php.

What kind of evidence is needed to support a product claim?

The NHP regulations recognize the importance of scientific research as well as a respect for traditional forms of health and healing. This approach supports innovations in the market place together with the health care traditions that reflect Canada as a multi-cultural nation. To do this, the NHP regulations balance the type and quantity of the evidence with the claim a company can make on the label.

For example, if a company wishes to make a claim based on traditional evidence, then the product license application needs to make reference to a set of approved texts being used. These claims are appropriately limited and must used wording such as “Traditionally used for………” If a company wants to make a specific clinically-proven claim, then in most cases, they must submit results from a high quality clinical trial for review by scientists at Health Canada.

Since there are so many similar products on the Canadian market, Health Canada has developed an extensive set of NHP monographs for the most popular ingredients such as echinacea, glucosamine and fish oils. These monographs are constantly updated when more information comes to hand. If a company wants to use one of these monographs in a product license application, then their product must comply completely with the monograph regarding such things as dosage, indication for use, usage and warning labels. Health Canada audits these types of NHPs once they are on the market to make sure that companies are following the contents of the monograph they are using. You can learn more about the NHP monographs at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.

Remember, a NHP cannot be marketed for anything but a self-limiting condition or for health promotion. So, for conditions such as heart disease, cancer and serious infections, the only route open for approval is as a prescription drug or biologic therapy.

Are the claims for NHPs evaluated less stringently than for conventional drugs?

The claims that specific NHPs can make are assessed in a way appropriate for the products themselves. For conventional prescription drugs, the evidence required reflects the serious conditions they are intended to treat together with the potential for serious side effects. This can only be obtained through extensive clinical trials. For a number of drugs used over-the-counter, many of which have been available for many decades, a monograph system is used just like with NHPs.

How were these NHP regulations developed?

Input from all sectors of the community was sought in both the development and implementation of the NHP regulations. This input came through numerous consultations held across the country ranging from large meetings to face-to-face conversations as well as information received on line. They reflect a gold standard in how to develop modern health product regulations.

How can I find out more about what specific products are regulated?

Health Canada maintains the Licensed NHP database which lists all the approved product licenses in Canada, and also provides some information as to whether the licenses are active or not. This database lists the NPN (Natural Product Number), approved claim, ingredients, recommended dosage as well as any possible side effects or safety concerns. This information being on line from a government agency is pretty unique in world. More information can be found about the Licensed NHP database at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php

Are the Canadian NHP regulations current?

Yes, they are very current and are considered by many to be cutting edge. They came into force in 2004 and are one of the newest regulatory frameworks for a therapeutic good or food in Canada at the moment. They are newer than the frameworks for prescription drugs, for over-the-counter drugs, biologics and foods, in some cases by decades.

These regulations are not static and change to reflect the sector. For example, some products in a food-like format such as energy drinks or supplements were initially regulated as NHPs. Since this may confuse consumers, these products are now more appropriately regulated as a type of foods. Also, Health Canada is considering whether they need to strengthen regulations around site licenses by requiring more detailed inspections.

How do the Canadian regulations compare to the regulation of similar products in other countries?

There is no uniform approach used around the world with respect to NHP regulation. Some countries simply have a basic registration system where companies must notify the national regulator if a product is marketed. Most countries have no specific process in place at all. Many countries have no specific process in place, not even a national registry for NHPs. Canada is one of only a few countries that have specific regulations for NHPs that ensure that all such products must be approved by a national regulator before they can be put on the market.

Should I be concerned about the quality of Natural Health Products available in Canada?

Though the Canadian consumer is in a better position than most consumers in other countries, concerns about quality should always be front and centre when you decide to take, or not take, a NHP. The market for NHPs is now global and very lucrative, with source ingredients and even finished products coming from places around the world. This has meant continued concerns about products containing or being adulterated by cheap ingredients, impurities or, in some cases, pharmaceutical drugs.

What should I look for in selecting a NHP?

Consumers should only take NHPs that are approved by Health Canada. For non-homeopathic NHP such as herbal medicines, vitamins and minerals, this can be confirmed by looking on the product’s label for an 8-digit Natural Products Number (NPN). An approved product has all the required information on the label including dosage, ingredients, and indications as well as any safety issues. Always remember to inform members of your health care team what NHPs you are taking.

[1] www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

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