THE STANDING SENATE COMMITTEE ON FISHERIES AND OCEANS
EVIDENCE
OTTAWA, Thursday, October 19, 2023
The Standing Senate Committee on Fisheries and Oceans met with videoconference this day at 9 a.m. [ET] to examine and report on Canada’s seal populations and their effect on Canada’s fisheries.
Senator Bev Busson (Deputy Chair) in the chair.
[English]
The Deputy Chair: Good morning. My name is Bev Busson. I am a senator from British Columbia, and I have the pleasure of chairing this meeting this morning.
Today, we are conducting a meeting of the Standing Senate Committee on Fisheries and Oceans. Should any technical challenges arise, particularly in relation to interpretation, please signal this to me or to the clerk and we will work to resolve the issue.
Before we begin, I would like to take a few moments to allow the members of the committee to introduce themselves.
Senator Cordy: I’m Jane Cordy, a senator from Nova Scotia.
Senator Ravalia: Good morning and welcome. Senator Mohamed Ravalia from Newfoundland and Labrador.
Senator C. Deacon: Colin Deacon from Nova Scotia.
Senator R. Patterson: Rebecca Patterson from Ontario.
Senator Kutcher: Stan Kutcher from Nova Scotia.
The Deputy Chair: Thank you, senators.
On October 4, 2022, the Standing Senate Committee on Fisheries and Oceans was authorized to examine and report on Canada’s seal populations and their effect on Canada’s fisheries.
Today, under this mandate, the committee will be hearing from the following witnesses from Health Canada: Kim Godard, Acting Director General, Health Product Compliance Directorate, Regulatory Operations and Enforcement Branch; Lisa Lange, Director, Bureau of Product Review and Assessment, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch; and Shawn Lawless, Acting Director, Bureau of Licensing Services and Systems, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch.
On behalf of the members of the committee, I thank you sincerely for being here today. I understand that Ms. Godard will be delivering some opening remarks. Following your presentations, members of the committee will have questions for the witnesses.
Ms. Godard, you have the floor.
[Translation]
Kim Godard, Acting Director General, Health Product Compliance Directorate, Regulatory Operations and Enforcement Branch, Health Canada: Thank you, Madam Chair. It is a pleasure to be here today to speak to you about the role that Health Canada plays in the regulation of seal-based health products.
My name is Kim Godard, and I am the Acting Director General for the Health Product Compliance Directorate at Health Canada. I am joined by my colleagues Lisa Lange and Shawn Lawless, both directors at the Natural and Non-Prescription Health Products Directorate.
[English]
Health Canada is responsible for the regulation of natural health products — which we often term NHPs for short — which include products like vitamins, minerals and supplements, as well as seal oil-based natural health products. Natural health products are subject to the Food and Drugs Act and the Natural Health Products Regulations.
Health Canada is committed to protecting the health and safety of Canadians by reviewing the safety, efficacy and quality of health products before they enter the Canadian market and by continuing to monitor products and taking action when a risk is identified after a product has entered the market.
In Canada, seal oil-based products are considered to be natural health products if they are promoted and sold with claims of restoring or maintaining good health. They may come in a variety of forms such as capsules, gummies and liquids.
To be legally sold in Canada, all natural health products must have a product licence number — known as a natural product number, also termed as NPN — on the label. To get a product licence, applicants must give detailed information about the product to Health Canada including medicinal ingredients, source, dose, potency, non-medicinal ingredients and the recommended uses. Once Health Canada has assessed the information and determined that the product is safe, effective and of high quality, it issues a product licence along with the NPN.
The NPN assures consumers that the product has been reviewed and approved by Health Canada. In addition, Canadian sites that manufacture, package, label and import natural health products must hold a site licence from Health Canada. To obtain a site licence, applicants must demonstrate that sites follow appropriate good manufacturing practices.
Good manufacturing practices are measures designed to ensure an effective approach to product quality control and risk management. Namely, they set standards and practices for product testing, manufacturing, storage, handling, distribution and recall management.
[Translation]
With respect to approved seal oil products, to date, Health Canada has licensed over 600 natural health products containing seal oil as the medicinal ingredient.
In addition, Health Canada has published two monographs with seal oil identified as the medicinal ingredient. A monograph is a written description of ingredients that are already known to be safe and efficacious, pre-cleared by Health Canada to support the safe and effective conditions of use of an NHP.
[English]
As with all health products, Health Canada monitors the safety of natural health products, including seal oil products, through its surveillance activities such as receiving and reviewing adverse reaction reports submitted to the department. Should there be issues identified, Health Canada takes actions, as appropriate.
[Translation]
In addition, Health Canada monitors compliance, undertakes enforcement activities, and works towards preventing non‑compliance for NHPs, including seal oil NHPs. This is done through a combination of reactive and proactive activities, including inspections.
When risks to health are identified, inspectors take appropriate actions to protect Canadians’ health and safety, which may include product seizures, recalls, public communications and licence suspensions.
In all cases, the department’s actions are based on the best available evidence, information and science, with the goal of using the most appropriate level of intervention based on the risk posed to the public. Health Canada is not involved in developing markets for NHPs.
Thank you, Madam Chair. We would be pleased to answer any questions the committee may have.
[English]
The Deputy Chair: Thank you very much for your outstanding presentation. I can see in the room there are lots of people interested in asking questions.
Senator Ravalia: Thank you very much. That was very informative. Could you give us an update on the current status of Health Canada’s regulatory framework for natural and non‑prescription health products, and any recent changes or reforms, particularly in terms of monitoring potential interactions with therapeutic agents?
Ms. Godard: I will start and then pass to my colleague Ms. Lange. There have been a few reforms with regard to natural products. One that comes to mind is an ability to order recalls. If you think about the framework a year ago, the only tool we would have to get products removed from the market would be getting a voluntary recall, meaning collaboration from the company. Through Vanessa’s Law, which now applies to natural health products, we have the ability to recall products when they do pose a safety risk to Canadians. Ms. Lange, anything to add?
Lisa Lange, Director, Bureau of Product Review and Assessment, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch, Health Canada: We have also done some revisions to our labelling requirements, essentially making sure that labels are easier to read.
You have to have clarity, a minimum font size and colour contrast to make sure that when Canadians pick up labels and are buying products, they are doing it without the intervention of a health care practitioner. It allows them to be able to read that label, be clear and understand what the product is being used for.
Senator Ravalia: I was also wondering whether Health Canada engages with Indigenous communities and stakeholders in the regulation and oversight of seal products in particular, considering the cultural and economic significance to these communities.
Ms. Godard: At Health Canada, with respect to natural or any health products, we always attempt to engage broadly, which includes Indigenous communities. A recent example of that is a consultation that was launched in May where we sent the consultation documents to anyone who had a licence or a product and also to interested stakeholders such as the ones you are mentioning today.
Ms. Lange: These products, obviously, are products that are authorized. They have been approved by Health Canada. Before we authorize any of these products, we look at the safety, efficacy and quality of the product. Once we’ve been given all the information — active ingredients, the dose, the source of the active ingredients, the uses — we would then authorize a product and give it a natural product number.
With respect to Indigenous communities, there are certainly some traditional products. But with respect to seal oil, there are no traditional products authorized under our jurisdiction at this point.
Senator Ravalia: Thank you.
Senator Cordy: Thank you very much for being here. In our study of seals, these are certainly some of the things that we have been asked about when we travel.
You spoke about the approval process and how you go through the approval process. Can you give us a timeline on how long that usually takes to get approval? That was one of the frustrations we heard from people doing the health care products related to the sealing industry. Seal oil capsules would be one example of the timeline and how to get approval. Maybe it doesn’t take long. You tell us.
Ms. Godard: Through the approval process for a product specifically, we look at safety, quality and efficacy. That does take some time to ensure products are safe for Canadians.
Ms. Lange: We have three classes of products. The first class of products is the simplest. Those have a 60-day authorization; class 2 is 90 days; and class 3 is a full review, which is 210 days. The seal oil products are what we have a monograph for. This is like a recipe that the companies follow, and it is already laid out. This monograph is published online, and anything that follows the monograph is the 60-day authorization. We currently have 614 products, I believe, that are authorized that contain seal oil, all of which would have gone through that monograph process, which is the 60-day authorization.
Senator Cordy: So from the time they would come forward to the department until the time they would get approval is 60 days?
Ms. Lange: That’s correct.
Senator Cordy: I am wondering about the reactive actions and the proactive reactions. Can you go into more detail about the difference between them and what happens?
Ms. Godard: Certainly. With respect to the oversight of natural health products, which would include seal oil, we have various approaches to ensure products on the market are actually of safe quality and effective.
When we talk about reactive approach, that’s when we will receive a complaint, for example, and Health Canada inspectors will go in and investigate. If the complaint is substantiated and there is a risk to health, we have multiple tools to mitigate risk to Canadians. For example, we can seize the product, stop the sale and pull the licence. We can do voluntary or now recalls.
When we are talking about proactive, we could be talking about an inspection that would be meant to look at good manufacturing practices in the context of the manufacturer of the product. That is when an inspector will go on site and make sure that all the standards are being followed so that the products are consistent and the products are always safe.
Senator Cordy: If you are doing an inspection to determine that the facility itself is in good stead, do you give notice or do you just show up?
Ms. Godard: Our inspectors use various tools. Normally, we give notice. If it is a good manufacturing practice to see if things are going well, we typically give notice. It is usually a few weeks to a few months in advance. When we have reasons to suspect that perhaps we need to go unannounced, we also use that tool but that’s usually when there is a complaint or a reason to follow-up in quick order.
Senator Cordy: So that one would likely not be given notice?
Ms. Godard: Exactly.
Senator Cordy: Thank you.
Senator Kutcher: Thank you all for being with us this morning. I will curb my appetite to delve into the NHPs as a general thing and just focus on the seal oil. I haven’t seen the copy of the monograph that you just mentioned, and maybe I didn’t look carefully through my reading list, which happens occasionally, but if I haven’t got it and if you could get that for us, that would be fantastic. Thank you so much.
I am interested in the kind of communication that Health Canada and your branch in particular have with other regulatory agencies in different jurisdictions, specifically the EU, the U.K. and the U.S., which are areas of product development for the seal industry. Do you have discussions with your colleagues on NHPs that are regulated in Canada that contain seal oil products? Are they automatically given a fast track in the other regulatory bodies? Have you noticed any pushback from NHPs in other regulatory jurisdictions because they contain seal oil? Those are some issues I would like to know about.
Ms. Lange: We certainly do work for other jurisdictions. Just a note that natural health products are regulated in Canada. We are one of the few jurisdictions that have that pre-market authorization process. I know in the U.S. most of these products are considered dietary supplements, and they don’t have the same oversight that we have in Canada. Australia also has some jurisdiction over these products, and they tend to do a risk-based approach.
I think your other question was related to whether we discuss whether the product can be brought back and forth between the two countries. In order for it to come to Canada, it needs to have a natural product number on it to be sold in Canada. That is a requirement. Mr. Lawless, do you have anything to add on that?
Shawn Lawless, Acting Director, Bureau of Licensing Services and Systems, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch, Health Canada: I think part of the question is about export. Most other jurisdictions respect the Canadian regime in terms of how we authorize these products. If they see an NPN on a product and it is manufactured at a site that has a site licence, then, typically, those countries would ask or look for export or import into their country, knowing it has been authorized and approved here in Canada.
Senator Kutcher: Help me out here. If an NHP that contains seal oil products and has received the good manufacturing practice, or GMP, seal of approval — sorry about that — the other jurisdictions wouldn’t necessarily create regulatory barriers to that product coming into their jurisdiction? Particularly, I am interested in the EU, the U.K. and the U.S.
Mr. Lawless: I’m unaware of anything in the EU or U.S. that would have barriers to that. Most interactions that we’ve had have been such that if they see it has been approved here in Canada and it has a site licence for that, then that’s usually enough for them to import the product from Canada.
Senator Kutcher: If I could run the train of thought a little bit more — this is asking you to speculate, and I realize that may not be appropriate — if a producer of a seal oil product for NHP use has achieved the standard that Canada sets — they see the product identification number — in order to do that, would it be a market advantage for that producer then to export their product to other jurisdictions or other countries because Canada has given it a particular stamp?
Ms. Godard: Maybe I can start on that one.
As Ms. Lange was indicating, the frameworks are slightly different between the U.S., Canada and Europe. As she said, in the U.S., most are considered dietary supplements, in which case, I think, the requirements are very similar or a bit inferior to what we would expect in Canada. That’s positive from an export perspective.
When we talk about the EU, many of the products we consider natural health products in Canada are actually considered drugs. In that case, there would be perhaps onus on the exporter to demonstrate to the European regulator that their product meets their standards.
Senator Kutcher: That would be consistent for all NHPs, not just NHPs that contain seal oil?
Ms. Godard: Exactly, that is according to the European definition of what is a drug and what is not.
Senator Kutcher: So a producer of an NHP with seal oil in Canada wouldn’t automatically be disadvantaged because there is seal oil in the product but would have to meet the European regulatory standard, which I know is higher than Canada’s?
Ms. Godard: Yes.
Senator Kutcher: Great. Thank you.
Senator R. Patterson: This is an important piece of the puzzle when we look at seal harvesting and what it means for Canada. I want to dig down deeper. Efficacy is an interesting thought when we look at natural health products. I look at you grinning because we understand how do we prove efficacy of a natural health product? It doesn’t necessarily go through the same rigorous testing as prescription drugs or over-the-counter drugs. However, it is a very good point.
When we are talking about research in terms of efficacy — using seal products as the primary focus, but the omega-3s, et cetera — my first question is, how do you do that? The second question is how do you find complaints? You won’t go out trolling, looking for how people are responding for a natural health product. So how many complaints have you received about issues with seal oil products knowing their distribution across Canada is not very broad? How does that come about?
Thanks.
Ms. Godard: Thank you for the question.
I’ll first ask Ms. Lange to address the efficacy, then I’ll move on to the complaints.
Ms. Lange: As I noted previously, we have the monograph. The monograph is basically based on pre-cleared information that the department has already determined that this product is safe, efficacious and meets quality. The monograph has many references that are sourced by the department. Essentially, we have checked those references giving us evidence to know that there would be efficacy for the use of that product.
Senator R. Patterson: So when we talk about, again, standards — I have a health standards background — how do you establish standards? Because that is part of efficacy. There’s research and then there’s establishing parameters and standards for manufacturing, consumption, et cetera. How does Health Canada play into that? Is it voluntary — make it according to the monograph — but how do you deal with standards? That may be a hard question. I may have worded it poorly.
Mr. Lawless: Maybe I will expand a little bit on the monograph aspect, and what is included in that monograph. As part of the process to develop that monograph, there is a thorough literature review and that evidence — usually clinical evidence — is used to support that. The monograph includes information on the uses or purposes of those particular products. For seal oil, in this case, the monograph includes various indications towards health, all based on the omega-3 fatty acid content, specifically EPA, DHA and DPA, those three fatty acids. Those conditions are used depending on the amounts, quantities and ratios of those omega-3 fatty acids in the product, which would allow for certain claims to be made. So claims in cardiovascular health, also claims towards reducing serum triglycerides and then there are claims for a children’s subpopulation — from 1 to 12 years old — that helps in nerve, eye and brain development, so nervous tissue development. That’s based on the literature that’s peer reviewed, standard evidence and clinical trials that have been done on similar products with that profile of omega-3 fatty acids.
Senator R. Patterson: Have you received any complaints?
Ms. Godard: To put my answer in context, with respect to the natural health products, we have received about 5,000 complaints over the past five years. Of those, nine were for seal oil-based products.
Senator C. Deacon: Thanks to the witnesses for being here.
I am a former entrepreneur, and I will focus on interoperability between jurisdictions because it would be great to expand the market for our producers into other countries. When you talk about the recommended dosages and other things that are in your monograph, have you looked at how those are interoperable between jurisdictions?
I want to also talk about the use of standards and certifications, and how they go across jurisdictions.
Let’s start with the monograph and talk about how those align with similar rules, dosage levels, applications and health benefits that are recognized in other jurisdictions.
Ms. Lange: We currently have approximately 300 monographs, and as we go through having more products on any given ingredient, then we have more pre-cleared information that would give us the ability to create more monographs.
But with respect to looking at other jurisdictions and similar monographs, that’s not normally something we would do unless there was some kind of study that we were doing collectively. To my knowledge there has not been anything that we’ve done with respect to seal oil.
Senator C. Deacon: Two areas of Health Canada that recognize standards and certifications that are seen to be equivalent to regulations are the use of pharmaceuticals and medical devices where the minister has advisory panels that can say to the minister, “Yes, if this product has achieved this certification, it is deemed to be equivalent to our regulations.” That’s very useful for those organizations that want to sell their products across jurisdictions. It gives Canadians access to products from other jurisdictions in an easy but confident manner, but it also gives Canadian organizations the ability to know that if they meet the standard recognized in Canada, they will automatically qualify in other jurisdictions.
So it is a really important economic and, in this case, social development tool to make sure that the entrepreneurs who are developing these products in rural communities, Indigenous communities and others have one path to follow versus multiple paths, each of which comes with a big cost, a barrier and a timeline.
Is there any plan that you are aware of in Health Canada to expand that practice that has been well-used by Health Canada into natural health products?
Ms. Godard: Maybe I can start and then look to my colleagues to see if they have anything to add.
The certificate program that you have described speaks to frameworks that are similar across the globe. What we would consider a natural health product in Canada may be considered as a dietary supplement in the U.S. and may be considered as a drug in the EU. I will check with my colleagues, but I’m not sure any work is being done.
Mr. Lawless: Certainly, from a global standard for NHPs, Canada has the highest standard on proving safety efficacy, and also along with the quality of the products having to undergo and have a site licence to manufacture these products under our regulations. Our standard is already quite high with this, but there is that difference between how other jurisdictions regulate, interpret and view these products which creates a gap.
Senator C. Deacon: So currently there are no discussions or efforts on the part of Health Canada to get that interoperability globally as it relates to these products. That is, the recognition that you give a product is perhaps accepted in other jurisdictions? However, there’s no effort in that regard right now.
To follow on the same line for a moment to the site licence. Is that all internal regulations that they have to meet or is there any global standard or certification level that an entrepreneur could be adhering to that you would then recognize?
Mr. Lawless: For site licensing, they have to demonstrate they meet good manufacturing practices. A number of those are standards across the globe for different things, but it’s slightly different for NHPs. It’s less than it is for pharmaceutical drugs or products like that. There are standards and they have to demonstrate they’re able to meet those good manufacturing practices that ensure the product is of high quality, which follows through on ensuring the safety and efficacy of the product.
To your question, our standards are aligned across the globe, but not necessarily in all particular key areas because it’s in relation to products being produced in Canada and our regulatory standards.
Senator C. Deacon: But there isn’t any effort at this point in time to align Canadian standards at a high level in a way that could then be recognized internationally?
The point is we’re not doing anything at this point to reduce the number of hoops that an entrepreneur meeting your high standards must jump through as they move from jurisdiction to jurisdiction.
Mr. Lawless: Understood, yes. At this point, yes.
Ms. Godard: Our number one priority will always be to keep Canadians healthy and safe. The standards in Canada were developed with that in mind. Looking at our standards, and looking at what other countries are doing within their standards, we will need to ensure that our standards always meet that bar.
As I said earlier, in the U.S., some may be considered dietary supplements; in the EU, some may be considered drugs.
Senator C. Deacon: To be clear, I don’t think you’re hearing in my question anything about lowering our standards in any way, shape or form or putting Canadians at risk in any way. I’m trying to see whether or not Health Canada is prioritizing development of industry in Canada as it relates to products that bring benefit to Canada not only in terms of wealth but also in terms of community development, traditional practices, et cetera.
Ms. Godard: That’s a very good question. That wouldn’t necessarily be under the purview of Health Canada. It may be under the purview of Innovation, Science and Economic Development Canada.
Senator C. Deacon: That’s one of the challenges we have in our country. We are so siloed between departments that a priority that meets a Canadian need doesn’t get captured by any one group. We have to find a way to get some cooperation between departments which then slows everything down to zero.
Thank you very much. You’ve certainly answered my question.
Senator McPhedran: I want to follow up on questions posed by Senator Patterson. You mentioned there were nine complaints about seal oil products. Could you give us an overview of the nature of those complaints?
Ms. Godard: Absolutely. Thank you for the question. Some of the complaints concerned unauthorized products. We described the process to get authorization to sell the products in Canada. We got complaints of products that had not gone through that process. There were complaints about products that perhaps had claims on the label that had not been approved. In one case specifically, the dosage on the label was the wrong dosage. That’s the type of complaints we’ve received.
Senator McPhedran: To pick up on that, how is it determined what is the correct dosage?
Ms. Godard: That’s a great question. Ms. Lange and her team look at the science. When someone submits an application, they will submit what they believe to be the right dosage. Ms. Lange and team then look at the dosage, look at the research and look at the monograph to make sure it’s the right dosage. Ms. Lange, anything to add?
Ms. Lange: No, that’s right.
Senator McPhedran: If I’m understanding the answer correctly, the determination is in-house to your department, not necessarily to professional nutritionists or to people that have a professional qualification around determining appropriate dosage?
Ms. Godard: I will answer that with two answers. First, when someone submits an application for a product, they tell us what the dosage is and then the scientists at Health Canada validate that it is safe and efficacious. What you’re describing with respect to nutritionists and health care professionals is very much under the practice of care. That is under provincial and territorial jurisdiction, so Health Canada doesn’t rule on that at all. We look at the application we receive and if the application we receive with respect to the claims as to the dosage is supported by science.
Senator McPhedran: To pursue this further, you get a complaint about the dosage and you respond to that complaint using the internal, professional resources that you have. I’m feeling a little confused about exactly how you get to that decision.
Ms. Godard: Thank you for that clarification. I now understand your question. The complaint with respect to the ones that were about dosage was that what was approved was a certain dosage and what was on the bottle was a completely different dosage. The dosage on the bottle was way too high and did pose a risk to the health and safety of Canadians. In that case, we worked with the company to remove the product with the improper dosage and to relabel it with the proper dosage.
Senator McPhedran: Interesting. So there’s a very informed consumer out there who is making the complaint.
Ms. Godard: Yes.
Senator McPhedran: Thank you.
The Deputy Chair: Thank you very much. Before we go to the second round, I have a question as well that I’d like to pose to all of you, and I’m hoping I can frame it properly.
Health Canada has a lot of responsibilities beyond dealing with natural health products. I know this is your area of responsibility, but within your department, are there other people engaged in approving meat products and other protein products for consumption in Canada? Is there any group that is dealing with seal meat or seal protein product as a subject of investigation or consumption in the Canadian market? Does anybody do that?
Ms. Godard: Ms. Lange, do you have any thoughts?
Ms. Lange: Our food directorate is also part of our branch. They look at foods being consumed by Canadians, but I can’t speak to whether or not they would be specifically looking at seal protein. Mr. Lawless, do you would have anything to add?
Ms. Godard: We will verify this, but my understanding is that would be under the Canadian Food Inspection Agency. We will double-check. As Ms. Lange said, we do have a group that focuses on food, for example, they’re the group that comes up with the food guide and those types of activities. We will come back to you on that.
The Deputy Chair: Also, I’m assuming that you don’t deal with pet products at all, this is definitely just human consumption?
Ms. Godard: We actually have a directorate that deals with veterinary products.
The Deputy Chair: Excellent. Thank you very much.
Senator Kutcher: Thank you to the analyst who got me the monograph. That was amazing. I actually had a chance to skim it quickly. Pardon me if a question isn’t good, though, because I do skim and not always properly.
As I understand it — and this follows on Senator Patterson’s question — it’s the class of product you use, not the specific product itself that’s been studied. That is, for the class of product, you could state the EPA, DHA and DPA amounts in the product because they have shown in other research studies to have a positive impact on human health and that product contains those components. That meets your effectiveness criteria, right?
Mr. Lawless: I can certainly answer that. You could consider it a class of product, but the monographs are based on specific medicinal ingredients contained therein and their dosing, which is then applied to the research that’s been done and seems to say, “Okay, this particular ingredient at this dose has shown effects on cardiovascular health.” Then they can begin their approval.
We review that information, and we have a high degree of confidence that it is accurate. We publish these monographs, so that it can be kind of a fast track, if you will, towards receiving a licence because it’s known, pre-cleared information.
Senator Kutcher: I think that’s one of the big issues we need to understand in this committee: That is not the same kind of approach that the EU uses for drugs. You’re giving this stamp to the class of products, not each specific one, because each specific one has not been tested for efficacy or effectiveness, but the class —
Mr. Lawless: In a manner of speaking. Every single individual product needs to come in with a product licence application. Their application is to gain market authorization to get their NPN so they can go on the market. Their particular application will indicate their dose, the conditions of use — all of those things that would be, say, in line with the monograph.
Then they would get authorization for their individual product. So their individual product has been shown, through the monograph and the evidence that is out there, that it will be safe and effective when used according to those conditions of use.
We also have other review streams that are there. As was mentioned earlier, there is a class 2 or a class 3 product. Specifically, a class 3 product would undergo a full review for that particular product because it has conditions of use outside of the particular monograph. That would be reviewed based on that, that dosing and the conditions of use for that particular product.
Senator Kutcher: That’s very helpful. I think that might clarify what Senator Patterson was getting at.
Does Health Canada actually do analyses of what is actually in the product? You’re all familiar with the echinacea story; my colleagues might not be so familiar. It was a fascinating research study — bottles of echinacea off the shelf, and 10% had no echinacea in them. Only half of them actually met minimal criteria for the dose in them, and 43% didn’t even meet the GMP.
Does Health Canada do the same kind of thing for natural health products, and would you look at seal oil products in the same way? Do you actually pull products off the shelf to do the analysis to see that what is on the label is actually in the product?
Ms. Godard: I can address that.
As I mentioned in my opening remarks, we have oversight of the natural health products in Canada. We, at times, pull products off the shelf to verify that what they say they contain is actually what they contain. We have a laboratory that specializes in testing those products.
We will test those products to get a better line of sight on a particular area of the market. Also, we will test products if we have a complaint or if we have a reason to believe that perhaps the product does not contain what it should be containing.
Senator Kutcher: It’s not just a routine random selection process that continues all the time, then?
Ms. Godard: Not at this time.
Senator Kutcher: No, okay.
As a follow-up to that, of all the products that contain seal oil, when you’ve done those analyses — first of all, have you done the analyses? I shouldn’t assume you have. Second, if you have done those analyses, how have those analyses confirmed or not confirmed what is on the label?
Ms. Godard: With respect to seal oil products specifically, we have not done a market analysis, which would have included a lab analysis. We don’t have that.
Senator R. Patterson: That answered part of my question, thank you. It will let me focus on a follow-up from Senator Deacon, which is very much about manufacturing quality and site visits.
Because it’s a natural health product, are the standards used to look at a facility food grade or are they drug grade, as in pharmaceutical grade? I need to understand more how you do that. We know we have silos in Canada, but because you would have the lead on it — is this a pure product — what standards do you use, and does it make a difference?
Ms. Godard: I can start, and Mr. Lawless can maybe add.
The standards we use for natural health products are actually outlined in the Natural Health Products Regulations, and they would fall between the food grade and drug grade. Recognizing that the risk profile for natural health products is perhaps not as high as for drugs, the standards are a bit lower.
Mr. Lawless: No, that’s actually a really good answer to that.
Senator R. Patterson: Are they Health Canada inspectors or are they the food folks who do the inspection on site?
Ms. Godard: They are Health Canada inspectors who work hand in hand with drug inspectors.
Senator C. Deacon: This has been really helpful. I’m still struggling with what actually happens in product testing when you’re approving a product. You don’t actually test each individual product?
Ms. Lange: Normally, if it’s a monograph product, we essentially have a recipe. In the case of this seal oil product, we have the monograph, the companies come in and they provide us the information, but we don’t actually go and test the individual product.
Senator C. Deacon: Are they tested independently to then qualify?
Ms. Lange: They should have done all that information on their own so they could qualify that, “Yes, I’m going to have this much in my dose and these are the omega fatty acids in the product” — that kind of thing. They should be doing that prior to providing it to Health Canada.
Senator C. Deacon: I was part of a company that made scientific equipment and we had to get a CE certification. That meant we went to an independent lab, and the independent lab verified the claims we made to get our CE mark.
Mr. Lawless: With every application that comes in — we’ve talked about safety and efficacy quite a bit, but there’s also a quality component. With every application, every applicant would provide a finished product specification sheet to which their product would adhere. That finished product specification sheet is all the quality testing that needs to be done on that particular product that should be done on a batch level every time that product is produced. Then it needs to meet those particular specifications.
Those specifications would include product quantity, any contaminants that might be in the product, stability testing — all of that. It’s their sheet of specifications that the product needs to meet, and they would have analyses done — and the company is responsible for doing analyses on that particular product from batch to batch — to make sure it meets those standards and those finished product specifications to which they need to adhere.
Senator C. Deacon: To get back to the original question, you’re not requiring that to be independently tested; each company attests to that.
Mr. Lawless: They attest to meeting that and meeting those standards for what they need to do. They’re supposed to be testing that product. At times of review, when we review for site licence renewals and even during inspections, we look and request that information to make sure their analysis records meet their finished product specification records to make sure the product is meeting the quality requirements.
Senator C. Deacon: So they have to demonstrate they used a standard test?
Mr. Lawless: Yes.
Senator C. Deacon: So you do have adherence to global standards in certain instances, so this is not something that you would not be familiar with conforming with, then?
Mr. Lawless: The certain testing methods and standards that would be there are individual to each ingredient or product type. Their standards would adhere to what’s appropriate for that particular ingredient. For example, they might need to be United States pharmacopeia standards for testing of that ingredient or another jurisdiction’s pharmacopeia standard. So there are quite a few common standard testing procedures that are used globally and across the board to ensure the quality of those products that are tested against.
Senator C. Deacon: That’s particularly important to me because what you’re saying to me is that there’s not an unwillingness on the part of your department to make the effort — or in your division of the department — to make this easier and more interoperable globally for our manufacturers in Canada because you’re already used to using global standards as being equivalent to your individual Canadian regulations.
The key here is just to open doors to markets easily for our Canadian producers. So it’s not something that would be out of the ordinary.
Ms. Godard: I think Mr. Lawless was describing that the standards being used to demonstrate that they meet the quality are, in some cases, globally accepted standards.
Senator C. Deacon: And you wouldn’t be against making sure that, in all cases, that was the case? There would be nothing to prevent it, from what I’m hearing, based on existing practice.
Mr. Lawless: I’m trying to think how to answer that. Certainly, we would expect that the appropriate standards are used for these products and to test all these products. If it’s a globally or internationally recognized standard, then we’re not opposed to that, for sure.
Senator C. Deacon: That’s an important statement. Thank you very much.
Senator Cordy: Your comments today and your presentations have been very good. Thank you very much for that.
I want to ask you about health benefit claims that are made by certain products, and you spoke about mislabelled dosages and you spoke about not containing things that the products said they had in them but actually didn’t.
How do you determine whether the health benefit claims that a product is communicating, how do you ensure that those claims are being held? Do you do testing on individuals or what do you do?
Ms. Lange: Thank you for the question. If I understand correctly, essentially, if I was looking at, say, a class 3 application, which is the more complex one where we would be getting new indications, we would be looking at data and we would be reviewing that data. We would also be looking at other sources outside of what we have been provided to determine whether or not any given use or any given dose actually met that bar of efficacy, safety and quality.
So over and above what we already have in a monograph, which is generally pre-cleared information that we’ve already reviewed and we already have literature searches on, any additional new uses — if we’re looking at those — we would have data that we would be reviewing and supporting and we would be doing other independent research as well to determine whether or not we felt that those claims were justified and, again, would be efficacious.
Because, as Ms. Godard mentioned earlier, our main role here is to ensure that we’re putting products on the market that are safe for Canadians and that are going to help maintain their health.
Senator Cordy: You also get input from Canadians. For example, the dosage, when you said that somebody got in touch with you and said that this dosage is far higher than should be the case, do you also get people who say, “My aching bones are still aching after taking this product for two years”?
How does it work? Do you just do studies on your own?
Ms. Lange: In the situation Ms. Godard was referring to, it was actually a product that had been labelled above what was actually authorized by Health Canada as opposed to someone who might come and say, “I’m using the product according to the directions, but it’s not helping me.”
People have individual health needs, and so, obviously, what might work for someone may not work for others, and, certainly, in the case of chronic pain or chronic disease, sometimes people become accustomed to that dose and it’s not going to necessarily work for them.
Is that your question?
Senator Cordy: So you’re saying it’s pretty hard to deal with that because everybody is different.
Ms. Godard: Maybe I can add to that.
We receive complaints from various sources. Sometimes it’s from Canadians and sometimes it’s from other regulators. We also receive adverse reaction reports where something doesn’t go quite right when somebody takes the drug, and Health Canada investigates each and every one of them. We also receive correspondence that would say something along the likes of what you have described and when we receive a lot of those, we do investigate.
Senator Kutcher: Thank you for indulging my question. It comes from Senator Deacon’s question and Mr. Lawless’s answer. I thought I had it, and now I’m confused, so help me out with this.
Thank you, Senator Deacon, for confusing me, once again. You do that all the time.
You can tell we get along really well.
Senator Deacon was talking about a global standard for natural health products, but I thought there was no global standard. I thought Canada had a very high standard for natural health products, but there was no such thing as a global standard because — my understanding was — different jurisdictions deal with these things in different ways. So the U.S. Food and Drug Administration, or FDA, use a dietary supplement approach, but the FDA is looking at that now, as we know, because they’re worried about their standard. The EU has a completely different standard. Australia, again, has a completely different standard.
So I couldn’t understand Mr. Lawless’s response to Senator Deacon’s question because I’m not aware that there is a global standard that Canada should be using to test its products. My understanding was that Canada’s testing of natural health products is above some countries who do not classify them except as supplements and below countries who classify them as drugs.
Am I confused? What is happening here?
Mr. Lawless: There are the three components that we are talking about when it comes to the standards. There is safety and efficacy on one side, and so our standards — natural health products in Canada can make claims against those because they have demonstrated through safety and efficacy information or studies that those products work, do those things and they’re safe for use.
Then there are the standards for quality of a product, so good manufacturing practices and the quality standards used to test those ingredients to make sure that the product has what it says it has in it and also that there is no contamination or anything like that. Those are typically internationally recognized standards for testing certain ingredients or classes of ingredients or types of ingredients that are used and that companies need to adhere to to make sure that the quality of the product is the highest quality.
Senator Kutcher: Right, so that’s the quality purity aspect of it.
Mr. Lawless: Yes.
Senator Kutcher: And on that particular aspect of the trifecta, where does Canada fit in its assessment and — pardon my ignorance — is there a globally accepted standard that every country and every jurisdiction adheres to — or at least the Western world adheres to — and how do we fit in with that? Just help me with that.
Mr. Lawless: I would say that it’s not necessarily a globally recognized standard. It’s individual to each product or ingredient type and things like that, so there are different standards that are established for different ingredients, like the United States pharmacopeia or things like that for certain ingredients that are used and tested.
That’s, obviously, an accepted method by us because it’s a validated, acceptable test method when it is used in accordance against those particular ingredients.
Senator Kutcher: So with the good manufacturing practices, or GMP, is there a global standard for GMP that Canada hits or is Canada’s GMP actually higher than many other jurisdictions in terms of how we assess it for these products?
Mr. Lawless: I would that say it’s up there. It’s higher. There’s not a complete parallel standard across the board, but GMP standards are quite high.
Senator Kutcher: If I understand this correctly, Health Canada standards on GMP are actually better than what many other countries have? Higher? Nicer? Whatever?
Ms. Godard: Depending on how a country will characterize the natural health product will determine the standards that they use.
For example, in the U.S., if they consider them dietary, perhaps the standards will be lower. In the EU, if they consider them to be a drug, then the standards will, perhaps, be a bit higher.
Senator Kutcher: And that applies both to the safety and efficacy — because you don’t measure effectiveness; you measure safety and efficacy — and to GMPs?
Ms. Godard: Correct.
Senator Kutcher: Great. Thank you for helping me with my confusion. I appreciate that.
Ms. Godard: If I may, we have the response to your earlier question about meat approval. I can confirm that it is with the Canadian Food Inspection Agency.
The Deputy Chair: Because we have the luxury of a little extra time, I hope you can abide with us for a couple of other questions.
Ms. Godard: My pleasure.
The Deputy Chair: I know Senator Deacon is anxious to ask you another question, if you have time.
Senator C. Deacon: It’s only that I want to add to the confusion.
As I understand it — and this is really just back and forth between Senator Kutcher and I to get some confirmation — but there is a lot of individual testing to prove that you’re a good site. There would be a lot of different individual standards that you would be meeting, many of which would be globally recognized.
In testing a product’s safety, there would be a lot of individual standard tests that you could be using that are recognized in other jurisdictions and collectively meet the needs that align with your regulations. Is that correct?
So that’s the point: There’s not necessarily one standard to meet, but as long as they’re based on tests that are recognized globally, that streamlines the process when somebody goes to move to another jurisdiction because they can use the results from a test to get approval in Canada to get approval in another jurisdiction. They may have to add to that to meet a higher standard in Europe or provide even less to meet the needs of the United States, but they don’t have to do a whole separate set of testing?
That’s really the point I’m trying to get at is that that provides interoperability, is that fair? I just want to get that because I can see this as potentially forming a recommendation for us to make it easier for our manufacturers.
Senator Kutcher: Yes, but as I understand it, Senator Deacon, the Canadian standards on safety and efficacy and on GMPs are very high.
Senator C. Deacon: They are very high, but if they’re not based on those internationally recognized tests, then it doesn’t matter that they’re higher because they’re not going to be recognized in another jurisdiction.
They’ve got to start over.
Senator Kutcher: This is really important and the details are really important. I think Senator Deacon is talking about the actual specific tests that you utilize. My understanding is that, for these products, you don’t actually utilize your own tests. You go back to that scientific literature, which is global, and say, “These products meet the data of the scientific literature.” So you say EHA is a health supplement because, in the scientific literature, EHA has been shown to be, at this dose, in this population, for this age group — blah blah blah.
That’s how you do it. As I understand it, you actually don’t do a test for EHA to try to demonstrate to the world that this product meets a standard. Am I correct? So every country in the world would have access to the same scientific database that you guys are actually using?
Mr. Lawless: It’s not a scientific database, per se, but it’s the scientific literature studies, yes.
Senator Kutcher: I’m sorry, the scientific literature. I stand corrected. You use the same scientific literature that the U.S. uses, that Australia uses and that Japan uses because that is the global scientific literature. Okay, I think that helps clarify things.
Senator C. Deacon: Thank you, deputy chair and witnesses, for your patience in trying to break through on this.
The Deputy Chair: We are here to get the facts, and it’s important that we get to all the issues.
Senator C. Deacon: Just the facts, ma’am. That’s right.
The Deputy Chair: Before we close, I have a question as well. I am not sure I can phrase it properly because it entails all the other conversations that have happened in this room. I want to talk about the elephant in the room, which is the fact that seal oil products and seal products face marketing difficulties not only around the world but in our own country. What manufacturers there are, they are struggling to keep their heads above water to even make a profit and be viable in this country.
From your three perspectives — the safety, the efficacy and the quality — do you feel there are any barriers or any other factors that would explain this in the Canadian perspective?
Ms. Godard: Our role is very much to make sure that the products that are on the market are safe, effective and of high quality, so that Canadians are safe. In that, when we review a product, we make sure that it’s based on science. We make sure there are no false claims made. That’s the extent of our work, so I wouldn’t have a line of sight on that.
The Deputy Chair: Do your investigations satisfy that parameter?
Ms. Godard: Yes. Correct.
Senator C. Deacon: To follow that, deputy chair, it is a really important point about the elephant in the room. There is a lot of disinformation — this committee has found — around these products.
Do you have any other area where you have experience in fighting disinformation? There has been disinformation about vaccines and their safety, for example, in this country. Do you have information that could be helpful to us as we look to find ways to get the facts to be more broadly recognized and to have the disinformation diminished in its volume? Do you have advice, thoughts or things that are being done by Health Canada with regard to disinformation campaigns that are contrary to fact?
Ms. Godard: Thank you for the question. Health Canada takes its role as a regulator and as a public health player very seriously. In that, we try to make sure that Canadians trust the advice that is coming from Health Canada. We have a lot of communications on our website where Canadians can go and seek advice which has been validated by the department. Above and beyond that, I can’t offer any thoughts.
The Deputy Chair: Do any of my colleagues have any other questions they would like to ask?
If not, I sincerely thank our witnesses for taking the time to appear before our committee this morning. This was certainly informative and very helpful.
(The committee adjourned.)