HESA Committee Meeting
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Standing Committee on Health
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EVIDENCE
Thursday, November 7, 2024
[Recorded by Electronic Apparatus]
[English]
I call this meeting to order.
Welcome to meeting number 138 of the House of Commons Standing Committee on Health.
In accordance with our routine motion, I'm informing the committee that all remote participants have completed the required connection tests in advance of the meeting.
Pursuant to the order of reference of May 29, 2024, the committee will resume its study of Bill C-368, an act to amend the Food and Drugs Act regarding natural health products.
I'd like to welcome our panel of witnesses.
Today we have Joel Thuna, general manager, Pure-lē Canada. Representing the Canadian Lung Association is Sarah Butson, CEO. She's appearing virtually. From the Heart and Stroke Foundation of Canada, we have Foram Patel, policy analyst. From the Hospital for Sick Children, also appearing by video conference, we have Dr. Charlotte Moore Hepburn, medical director of the child health policy accelerator, and associate professor at the department of pediatrics, University of Toronto.
Thanks to all witnesses for being here today. You will have up to five minutes for an opening statement, followed by rounds of questions from the parliamentarians here.
We're going to begin with Mr. Thuna.
You have the floor, sir.
Thank you for inviting me here today.
My name is Joel Thuna. I'm a fourth-generation master herbalist and the general manager of Pure-lē Canada, my family's small business. We directly employ 10 people in our building, and we indirectly help employ many more Canadians through our distributors, brokers, farmers and supplier network, which is in every province. For 135 years, my family has manufactured what are now called NHPs in Canada. We are a compliant company with over 500 product licences.
In my 50 years in the industry, I have seen the landscape change time and again. I testified before this very committee 26 years ago regarding the inappropriateness of Canada's regulations that treated NHPs as drugs. This committee consulted with Canadians and issued a report, “Natural Health Products: A New Vision”. In 1999, the Liberal government's Minister of Health, Allan Rock, announced that the report and all of its recommendations had been accepted by this House.
The report's guiding principles included the following:
...NHPs are different in nature from and must not be treated strictly as either food or pharmaceutical products....
NHP regulations must not unduly restrict access by consumers....
NHP regulations must not place inappropriate cost on industry, consumers and government....
Information regarding decisions and the regulatory system must be readily available to NHP stakeholders.
As an industry, we had high hopes that the resulting legislation and regulations would, once and for all, be appropriate to NHPs. The NHPD was set up. Through wide consultation, Canada achieved the enviable. We had laws and regulations that protected consumers and gave them access to the products they wanted, all with industry buy-in. Businesses were licensed and products required pre-market licensing. Repeatedly, we heard that Canada had regulations that were the envy of the world.
Over the past four years, multiple laws and regulations have been introduced without meaningful consultation or proper economic impact assessment. This patchwork system is causing me and my colleagues to question the viability of Canada's NHP sector. I was asked to estimate the cost to my small business. We estimated the first-year cost to exceed $500,000, with annual costs exceeding $300,000. These days, no small family business can survive with these additional costs.
Classifying NHPs as drugs is inappropriate. One complication of this is putting NHPs under Vanessa's Law. This is using a jackhammer to swat a fruit fly. Existing measures, such as inspection, stop-sale, seizure and licence suspension, are rarely used. Regulation without enforcement is meaningless. Health Canada has the power to suspend licences, if required. Industry is happy to consult on appropriate regulations for recall.
New requirements for drug labelling are to come into force. These regulations do not provide any new information to consumers, but rather make the packages confusing and increase costs that are going to be passed on to consumers. Additionally, these regulations will reduce the likelihood of package recycling, needlessly increasing our industry's carbon footprint.
Foreign actors see that the easiest and cheapest route for Canadians is through the personal use importation framework. A significant portion of Canadians now buy product not captured under Health Canada regulations, exposing themselves to unacceptable risks. In the past, I have questioned Health Canada: If a product is potentially harmful, how is it potentially harmful only when manufactured in Canada but not when imported? The big sticking point I have is that Canadian companies are investing to be compliant yet losing a lot of money and jobs. Canadians who buy NHPs outside Canada are bringing in a combination of products they can't get here and products they can. They do this to reduce their shipping costs. This is destroying Canada's retailers. Do you understand the depth of the problem? There are foreign companies with warehouses in Canada for their non-licensed products, so customers can get fast, no-border-issues shipments. This means no tax revenue and no Health Canada oversight.
In the end, Canadians want what they have today: access to safe, well-made products. Bill C-368, along with extensive and meaningful stakeholder consultation prior to new regulation and law introduction, is a good starting point to bring Canada back to the guiding principles that are supposed to guide all legislation and regulations for NHPs.
Thank you, Mr. Thuna.
Next, on behalf of the Canadian Lung Association, we will go to the screen and hear from Ms. Butson.
Welcome to the committee. You have the floor.
Thank you very much.
Thank you to the committee for inviting me to speak here today. My name is Sarah Butson. I'm the CEO of the Canadian Lung Association.
Our organization has spent almost 125 years focused on helping Canadians breathe. We do this by funding research, leading advocacy and providing health information to Canadians. We have a long history in tobacco control, given its devastating impact on the health of our lungs. Still today, it remains a leading cause of preventable disease and death in Canada. In particular, it is a primary cause of lung disease.
With that context, I am pleased to speak to you today regarding Bill C-368, an act to amend the Food and Drugs Act. Our concerns with this private member's bill rest primarily with the potential unintended consequences should the bill be adopted in its current form, and its potential to undo important new restrictions put in place through a ministerial order called the “supplementary rules respecting nicotine replacement therapies order”. This order restricts the availability and appeal of some orally administered forms of nicotine replacement therapies, such as nicotine pouches. This keeps them out of the hands of children and youth.
We are appearing today to urge that if Bill C-368 is adopted, it be amended so that it would not impact nicotine products.
In the fall of 2023, Imperial Tobacco Canada announced that it had begun selling nicotine pouches under the brand Zonnic. Zonnic had been approved under the natural health products regulations. Soon, these products were available at local convenience stores, sold beside candy, with enticing flavours, packaging and promotion seemingly aimed at a younger generation. It also meant that there was no minimum age of purchase, marking the first time in modern history that a nicotine product owned by a tobacco company could be sold to minors.
CLA was among a group of concerned national health organizations that immediately urged the government to take action. Swift action was indeed taken. This demonstrated the commitment by decision-makers to protect young people from the influences of the tobacco industry. These products should never have been made available in the manner that they were. As an organization that has dedicated decades to protecting lung health, we were deeply concerned and outraged about the potential for this product to hook a new generation, which may lead to a lifelong battle with nicotine addiction.
The ministerial order that I mentioned above puts in place several important measures. It ensures that nicotine pouches are available for sale only behind the counter at pharmacies, and it limits the available flavours to only mint and menthol. We know that limiting access and reducing the appeal of products are policy measures that can have an impact on the likelihood that young people will use these products.
The order also places limits on advertising and promotions, with requirements of warnings and advising statements. Importantly, this order does not negatively impact other forms of nicotine replacement therapies that are currently available—we know that the over three million Canadians who currently smoke and may want to quit may need to access those supportive cessation aids—while at the same time it ensures that a new generation is not enticed.
The ministerial order righted a wrong that should never have occurred. We want to ensure that those protective measures stay in place. As a result, we would once again urge that, if adopted, Bill C-368 contain an amendment that it would not apply to nicotine products.
I thank you for your time and consideration. I would be happy to answer any questions.
Thank you, Ms. Butson.
Next, representing the Heart and Stroke Foundation of Canada, we have Foram Patel.
Thank you very much for being with us. You have the floor.
Thank you, Mr. Chair and committee members.
The Heart and Stroke Foundation appreciates the opportunity to appear before this committee to discuss Bill C-368, an act to amend the Food and Drugs Act regarding natural health products.
Let me be clear. The Heart and Stroke Foundation is not against improved access to natural health products. I'm here today only to address the unintended consequence that this bill would have on the regulation of nicotine pouches and on other new and emerging nicotine products that could lure children and youth into nicotine addiction.
As it stands, the bill would exclude natural health products from the definition of therapeutic products. This change would be problematic because of its implications for the government's ability to regulate nicotine pouches and other nicotine replacement products, which are currently classified as natural health products. The Food and Drugs Act applies only to therapeutic products, so if natural health products are no longer classified as therapeutic products, there would be no act under which the government could regulate all these products. This is a gap that leaves our youth especially vulnerable.
In August 2024, Health Canada adopted the supplementary rules respecting nicotine replacement therapies order. It includes many provisions intended to keep nicotine pouches out of the hands of young people, such as requiring nicotine pouches to be sold in pharmacies only and to be placed behind the counter, banning flavour descriptors that can be appealing to youth and only allowing mint and menthol flavours, adding health warnings to the nicotine pouch packaging, and banning advertising, packaging and labelling that can be appealing to young people.
Prior to this, the unregulated sale of nicotine pouches such as Zonnic posed a danger to young people in Canada. As health advocates, we are long familiar with the methods of the tobacco industry and how it uses tactics to hook young people onto its products. First, it was cigarettes and chewing tobacco. Then it was vaping. Now it's nicotine pouches that risk addicting a whole new generation.
We know that nicotine is one of the most addictive substances on earth. It affects adolescent brain development, particularly the parts of the brain that control learning, attention, mood and impulse. We now have important measures in place to protect young people from these harmful products that research has shown to be potential gateways for future use of vaping and tobacco products. However, these measures are currently being threatened by Bill C-368.
To conclude, I urge the committee members to support an amendment to the bill that would address the concerns that have been raised by health groups, especially with regard to nicotine products. We urge you to keep in place the supplementary rules respecting nicotine replacement therapies order. No one was prepared for the aggressive marketing that the tobacco industry would use to target our teens, and now we have some of the highest teen vaping rates in the world. We can't repeat this mistake with nicotine pouches. Children and youth deserve to be protected from the predatory tactics of the tobacco industry, which is now trying to skirt the rules with nicotine pouches and other nicotine replacement products.
Thank you.
Thank you, Ms. Patel.
Next, we're going to go back to the screen for Dr. Charlotte Moore Hepburn for The Hospital for Sick Children.
Welcome to the committee, Dr. Moore Hepburn. You have the floor.
Good afternoon, everyone, and thank you for the invitation to appear.
My name is Charlotte Moore Hepburn. For the last 18 years, I've practised pediatrics at the Hospital for Sick Children, which is Canada's largest children's hospital. I'm also proud to serve as the director of medical affairs for the SickKids child health policy accelerator, where our mission is to bridge the gap between medical evidence and public policy in order to optimize health outcomes for Canadian children and youth.
As it stands, we have serious concerns about Bill C-368. We feel this bill would significantly weaken the regulatory protections over natural health products in Canada, reducing the essential safety and quality standards that are currently in place. This would fundamentally compromise both provider trust and consumer trust in all NHPs.
Since I became a physician almost 20 years ago, our understanding of and appreciation for natural health products has substantially increased. The evidence base supporting the use of NHPs has expanded over time, as has an appreciation for the importance of identifying and reporting adverse events and drug-NHP interactions. As a pediatrician, knowing that NHPs are well regulated, I'm comfortable recommending NHPs to my patients when and where appropriate. We also now actively train medical students to make sure we ask all patients, without judgment, if they are using natural health products in parallel with the therapies that we prescribe.
Should NHPs fall outside of the definition of therapeutics under the Food and Drugs Act, and should those critical regulatory standards and safeguards no longer apply, my comfort and ability to recommend NHPs to my patients would have to change.
In addition, and importantly, Bill C-368 presents a serious and immediate risk to children's health, given the current regulatory status of synthetic nicotine as a natural health product. As pediatricians, my colleagues from across the country and I see first-hand the devastating impact of nicotine addiction in our patients. We care for seventh and eighth graders who started vaping even before entering middle school, who now require professional support in their efforts to quit. We care for young people in high school with disrupted sleep, decreased appetite and poor academic performance, all of which can be attributed to their nicotine addiction.
Sadly, we've stabilized not only teenagers but also toddlers suffering from intentional or unintentional acute nicotine toxicity secondary to nicotine exposure. We failed our children so profoundly when the threat of novel nicotine delivery systems and other non-combustible nicotine-containing products first presented itself. As mentioned by others, Canada now sadly leads the world in terms of youth vaping rates.
With synthetic nicotine products like nicotine pouches now on the market regulated as NHPs, with this bill we could risk failing them again. There must be comprehensive regulatory protections in place ensuring that young people, people who have never smoked a traditional cigarette in their lifetime, never experience the harms associated with nicotine.
This bill would remove the government's current ability to keep synthetic nicotine pouches out of the hands of children, and, more broadly, it would make it more difficult for the government to regulate emerging health threats in a timely manner.
I would echo the comments from others who have testified before you. The challenges associated with the current NHP regulations, including the regulation of nicotine as an NHP, all merit robust public discussion. However, as witnesses last week pointed out, Bill C-368 doesn't solve those problems. It simply weakens our ability to ensure that NHPs are safe for use and fails the next generation of children in terms of protecting them against the well-known and well-defined harms associated with nicotine.
I'll close my remarks by asking the committee to consider the impact that this bill would have on children and their health. It's critically important that we preserve access to safe, well-regulated NHPs that serve children and families well, while at the same time restricting the sale of highly addictive substances like synthetic nicotine to our youth.
I look forward to further conversations and questions about how we can improve children's health together. Thank you.
Thank you, Dr. Moore Hepburn.
We're now going to proceed with rounds of questions, beginning with the Conservatives for six minutes.
Mr. Moore, go ahead, please.
Thank you, Mr. Chair.
Thank you to all of our witnesses who have appeared today. Thanks also for your suggestions about amendments. I appreciate your coming here with those.
Mr. Thuna, we had an appearance last week by the Minister of Health—a very animated appearance—and he made some fairly outrageous claims, one of which certainly does not reflect what I've been hearing. I would like your comments on it as someone who's very vested in this industry. He said that the new regulations on natural health products would only negatively impact “people who are negligent and wildly out of compliance.”
In your opinion, is this a true statement, or does the minister not accurately reflect the state of the natural health product industry in Canada?
What I will say is that I can echo what has been said before this committee: that our industry is, on the whole, widely compliant. We don't sit around and question how to avoid the requirements; we question how we can keep up and stay with them.
With regard to not having anything to worry about if you are compliant, we live in a free democracy, and in a free democracy, that's a false premise. It's akin to asking, “If you're not doing anything wrong, why should you have an issue with random stops and searches?” I have an issue with them. The reason I do is that I live in a free country that's supposed to be based on appropriate laws, appropriate regulations and appropriate enforcement. We respect the many Canadians who fought and died for our right to live free.
Thank you.
I think you mentioned that you have 10 people employed at your location, and that's certainly reflective of what we're hearing and understanding about the industry in all corners of our many communities across the country. A lot of mom-and-pop shops and small businesses are impacted by these regulations.
Could you give some of your insights, from your perspective, on how Bill C-368 will help those shops and family-owned businesses like your own?
Bill C-368 will make it so that we have an environment similar to the environment we've been living under since the creation of the natural health products directorate. That is an environment where we know what is required of us. We know essentially what the goalposts are and we know how to meet these requirements. The problem is that once you start moving the goalposts and keep moving them, it's uncertain. With uncertainty, you're virtually creating a guarantee that companies that are trying to stay in compliance will not physically be able to.
We're a small company. We're actually larger than most of the companies in our industry on a number-for-number basis, but we're still a very small company. We're very proud of that. We do an awful lot with our small staff, and we're proud of that. The biggest challenge we have is keeping up and maintaining our high level of compliance, with the number of people we have.
We're very concerned about keeping as many businesses—small, medium and large—as possible in Canada. In today's day and age, businesses can move. What we've heard from industry in a survey that was done is that up to 20% of businesses would consider moving in the current context.
If Bill C-368 doesn't pass, what does the business case in Canada look like versus international competitors?
There's not much of a business case for Canada if this bill doesn't pass. If everything Health Canada and the government say they're going to put through goes through, there's not much of a case for staying in Canada.
To add to that, there is the aggressive nature with which American states are pursuing us. I, for one, have been approached by multiple states willing to give me the stars, the sun and the moon to move. They are willing to help in immeasurable ways economically to make it a no-brainer decision.
Finally, you mentioned in your opening comments that the government's approach is “using a jackhammer to swat a fruit fly.” Can you elaborate a bit on that and what could be done rather than this approach?
As a member of the industry, I would be more than happy to sit down—and I know many of my colleagues would be as well—with the government to work out a realistic and appropriate recall measure and system for natural health products.
Having said that, before that even begins, the government, through Health Canada, should actually start using the tools it has. Having regulations without enforcement is like saying, “Nobody go over 60 kilometres an hour, but there will be no radar and no police officers. We're going to just hope and pray that you don't.” How many of us think that's actually going to happen?
I want to thank all the witnesses for being here and for their testimony.
I also want to put on the record that we're dealing with Bill C-368 here. It deals with Vanessa's Law, which does not deal with the issue of cost recovery or labelling. I think the 20% number of businesses leaving was in relation to cost recovery and labelling.
Let me start with Dr. Moore Hepburn.
Thank you for your testimony. You said that you have serious concerns if this bill passes. You said it would undermine “provider trust and consumer trust”. I think that was your testimony.
In a brief that was submitted to the committee by the Canadian Medical Association, they took the position that “decisions regarding health care products, including NHPs, should be based on sound scientific evidence.” Do you agree with their evidence?
Absolutely. I can say that parents, patients and their care providers all need and want assurances that the products they would discuss and recommend are safe.
When you're talking about regulating all therapeutic products, we start on a foundation of solid scientific evidence. We build on that safety and quality, as well as regulatory oversight, to ensure that patients and consumers can be protected when need be.
CMA also stated in its written brief, “Completely removing NHPs from the definition of therapeutic products would effectively eliminate oversight of this industry and expose Canadians to unnecessary risk.”
Do you agree with that statement?
I think it's important that we recognize how, over the last many years, the ability and the confidence of medical providers to discuss and recommend natural health products for the right patient at the right dose at the right time has significantly increased. I would be concerned that if we dial back on regulatory protections, a lot of that trust would be compromised.
You also indicated that you feel strongly that Bill C-368 would undermine the ability of government to protect young people from a number of potential health threats.
Can you, for our benefit, elaborate further on the risks of passing Bill C-368 in its current form?
Most immediately, as the other witnesses have spoken to, the risk of synthetic nicotine is tremendous for Canadian children and youth.
I think all of our breath was taken away when Zonnic appeared on convenience store shelves. The idea of legally selling a product manufactured by the tobacco industry in a berry flavour to young children is truly breathtaking. Thanks to this government, with the collaboration of national health organizations, we were able to put into place protections to make sure that young children would not cause themselves undue harm as a result of these products.
Any move forward in the natural health product space must take into consideration the fact that nicotine replacement therapy and now novel nicotine-containing products like nicotine pouches are included in that regulatory oversight mechanism.
I'm sure you were probably concerned that, as I heard from many conservative MPs, including Dr. Ellis, they are against the action the government is taking to keep nicotine pouches out of the hands of children.
Why do you think this action is so important to protect our children?
I think that we so gravely failed children and youth when novel, non-combustible nicotine products first entered the market. There was an entire generation of children who had never touched a traditional cigarette and who are now grappling with [Technical difficulty—Editor] nicotine addiction, and they did it on our watch. We cannot let that happen again.
Nicotine pouches are a novel nicotine delivery system. We do not yet understand the full physiological consequences over and above how devastating and powerful nicotine addiction can be to young people. We know that it not only affects cardiovascular health and pulmonary health, but there are long-term mental and physical health consequences that we have yet to understand. There are also the consequences associated with potential accidental or intentional overdose.
They're enormously risky, and we cannot again fail our children by not regulating them appropriately.
I want to come to you, Mr. Thuna.
You spoke about enforcement. You said that regulations are important—I appreciate that, as a business owner, you want those regulations—but you said that there needs to be enforcement, that without enforcement they mean nothing. As I understand, that's precisely what Vanessa's Law does. It actually gives the power to recall a product in case it's not meeting the regulation.
Is it not precisely doing what you're suggesting should happen? There are regulations in place, and there's an enforcement mechanism. If we pass Bill C-368, that enforcement mechanism then is gone.
That's not exactly what I'm saying. What I'm saying is that Health Canada has been derelict for what I can safely say is my lifetime in enforcing the regulations with the tools they have.
I've been doing this for over 50 years. I can say that I have been a member of my family's company for 50 years. I haven't been inspected by Health Canada in 30 years. I'm in a compliant company. How on earth do you actually expect companies to be compliant if they're slightly less equipped than we are without Health Canada using the tools to help them become compliant and stay compliant?
I am actually inspected by four different agencies on a regular basis. Part of the reason we are so compliant with all four of those agencies is that I am regularly inspected. During those inspections, they find minor things that need to be adjusted, and they work with me to adjust them.
If you work on the premise that the companies are trying not to comply, then your solution.... If you're working on the premise that, as this House has heard multiple times, we are a compliant industry, then help us comply. Don't try to slap the living daylights out of us because you think we're not.
Thank you, Mr. Chair.
Thank you to all the witnesses for their informative testimony.
We move forward as we work in committee and study a bill. What I heard from all the witnesses, except perhaps Ms. Hepburn, is that, in its current state, the bill is unacceptable from the standpoint of health, specifically children's health, because of nicotine products. I've already announced that we will be moving an amendment to exclude nicotine products from Bill C‑368.
However, I heard an additional concern from Ms. Hepburn. I heard that you've been using natural health products and recommending them since long before Vanessa's Law was implemented, which was not that long ago.
Now, all of a sudden, you would have a problem recommending natural products. Why is that, knowing that the current regulations could wipe out several companies and have the unintended consequence of allowing foreign products entering the country to bypass regulations and inspections altogether?
[English]
I hope that I'm understanding your question. I'll try my best to answer it.
What I can speak to is the want for care providers, parents and patients to understand their products, the products they are buying and the products they are recommending, to be safe and effective. It has been quite a journey in the medical community to understand natural health products and the science that underscores their use. Understanding the basic pharmacokinetics and pharmacodynamics of natural health products has been a long time coming. It has only been more recently that we've had the scientific evidence base in pediatrics to quite commonly prescribe some natural health products, including things like melatonin in certain circumstances or probiotics in other circumstances.
What I can say is that it's important that we all [Technical Difficulty—Editor].
[Translation]
Yes, that was my understanding.
Even before the ministerial order, you were making those recommendations and using those products. Essentially, you trusted those products.
If we amended Bill C‑368 to maintain the minister's recall powers, would the bill be valid from your perspective?
What I'm trying to do is bring these different strands together to find commonalities. Vanessa's Law would not have been passed if there hadn't been issues with pharmaceutical products. You've been using those forever. There is no such thing as no risk. Pharmaceutical companies' products have many more side effects, which can be more serious and undesirable.
Why should an industry be considered on the same footing as pharmaceutical companies?
Would this amendment deal with this issue, in your opinion? The minister would retain recall powers, and we would make an amendment for nicotine products.
Would the parents you're talking about find that reassuring?
[English]
It's important that we all agree that any product that can have a therapeutic effect can have a therapeutic side effect.
You are completely right. There is not a single drug that we would prescribe that has a traditional DIN, or drug identification number, that doesn't have a side effect profile.
We don't need to think about drugs as good or bad; we need to understand drugs as being right for the right patient at the right time for the right indication in the right dose. With that frame of mind, understanding that there can always be a therapeutic side effect if there's going to be a therapeutic effect, it's important that we have equipoise in our regulatory oversight over the products we recommend.
Recall powers are incredibly important. While extremely rare events are extremely rare, they are incredibly important when that adverse event affects someone you love.
[Translation]
So the answer to my question would be yes. You would be reassured if we made an amendment to retain the minister's recall powers, while ensuring an appropriate regime for natural health products in terms of fines, and so on.
That's what Bill C‑368 does. It makes it possible to remove natural health products from the pharmaceutical products environment, while creating strict guidelines to ensure the safe sale and consumption of these products. Natural product companies value their reputation.
I understand that the answer to my question is yes in terms of the amendments I intend to make.
[English]
The regulatory protections that have been put in place over many years, most recently through Vanessa's Law, have heartened providers and provided added confidence to patients and consumers in the strength and safety of the NHP product supply in Canada.
[Translation]
Thank you very much, Mr. Chair.
Thank you to the witnesses for being here.
Your testimony is valuable and important.
As Mr. Thériault just said, we believe it is very clear that amendments must be made with respect to nicotine products. I think we all get that.
Thank you for expressing your point of view on that.
[English]
I want to start off by stepping back a little.
My question is for Ms. Butson, Ms. Patel and Dr. Moore Hepburn. This came from what Ms. Butson talked about. I was really surprised by the fact that nicotine products were approved under natural health products regulations. It was surprising to me that Health Canada would allow this product to be distributed.
My first question for the three of you is this: To what extent were you or your organizations consulted before Health Canada, under the natural health products regulations, approved these products? What was the timeline and to what extent were you consulted?
Second, in terms of nicotine products and nicotine replacement products and pouches, I want to completely understand your concerns in terms of health impacts. Obviously, it's a gateway product, but what are the health ramifications of the products themselves, the nicotine pouches? What are the consequences of consuming those products, even if the individual doesn't move on to smoking?
We'll start with Ms. Patel.
I'll start off with the health impacts of nicotine pouches, because that is the biggest concern here. Speaking from a cardiovascular perspective, nicotine by itself increases blood pressure, heart rate and cholesterol levels. These are important biomarkers that are concerning in the short term but over the long term can also create complications leading to increased risk of cardiovascular diseases down the line.
My colleagues have also noted the cognitive consequences of it, particularly on learning and attention. Especially when kids are in school, these are important functions for them.
By itself, using a nicotine pouch without graduating to other, higher-risk products like vaping and cigarettes would still be very harmful to young people's health, which is why these are very concerning products.
To answer your first question, we weren't much involved in the consultation process in deciding on the approval of these pouches, but hindsight is always 20/20. Now that we look back, we want to make sure that, going forward, kids are protected from nicotine pouches, because we've seen the grave concerns and the implications they have on children and youth.
With respect to the consultation process, similarly, the Canadian Lung Association wouldn't have been involved in those consultations. Part of it is because, under the natural health products regulations, these nicotine pouches, when they applied under those regulations, were under four milligrams of nicotine, which is what took them outside of the way we traditionally regulate nicotine or vaping products and allowed them to find that laneway under natural health products. We wouldn't typically consult there.
It is one of the best examples in my experience. From being made aware of this issue and raising awareness about it to government action and getting these products off the shelves, over the span of 10 months, it was an incredible effort and one that should be applauded.
With respect to the health impacts of nicotine pouches, of course, from a respiratory perspective, our primary concern is around exposure to nicotine early on. We know that the earlier young people are exposed to nicotine, the more likely they are to develop a longer-term dependence on nicotine. We're concerned about that leading to vaping use, which we know has respiratory harms, and, of course, tobacco use. I think some of my other colleagues have alluded to this. With vaping products, in some respects, we took a wait-and-see approach to determine what those health impacts were going to be, and that really did lead to a failure, so it's important that we don't wait and see. We have the evidence in our history to know that we need to keep these protective measures in place.
I'm not sure I have much more to add over and above what the last two witnesses said. From a consultation perspective, I'm unaware that there was any pediatric input in the approval process. That would certainly not be customary when it comes to the approval of a natural health product.
I would say that when these products came to market, they were positioned as nicotine replacement therapy, a therapeutic product to help people wean themselves off nicotine. We have seen that before. That was exactly how vaping products were introduced.
I agree that we cannot wait and see. We have to learn from our grave mistakes and ensure that nicotine replacement therapy products don't accidentally or unintentionally addict a new generation of children.
Thanks very much, Chair.
I find it fascinating that we have an incompetent Minister of Health, who allowed a new nicotine-containing product to be licensed for sale in this country and now we have three out of four “activist” witnesses, I'll call them, who are clearly not concerned about a $13-billion industry that's being dismantled by the incompetent minister, but only about their niche idea. Again, if they were involved in the early decision-making, shame on them.
I also find it fascinating that Mr. Naqvi talks about nicotine pouches, but he thinks it's okay to give eight milligrams of Dilaudid to kids for free, sponsored by his government.
That being said, this does affect the definition of what a therapeutic product is, which then leads down the cascading road of Mr. Thuna—the only person here from the actual industry—whose business will be decimated by the over-regulation of an industry. We have heard multiple testimonies that say these products are overwhelmingly safe.
Again, I'll hearken back to Dr. Sharma's testimony many months ago, when the original legislation was introduced in an omnibus bill. She tried to tell this committee that these products were incredibly dangerous, and refused to provide any proof.
We heard other testimony the last time we were here about how terrible Deloitte was and how their report, which was commissioned by CHFA, could not even be trusted.
Here again, we have single-entity witnesses—one who's clearly partisan, having recently worked for a minister of the Liberal government—trying to get rid of this legislation. This is shameful.
That being said, Mr. Thuna, tell us a bit about the industry. It's a $13-billion industry. My understanding is that it's mostly small businesses like your own, and many of those small businesses are run by women as well. What will happen to all these businesses?
What I can tell you is that we are classified as a small business, and yet we're still larger than most businesses in our industry. Most businesses in our industry employ, from my experience, three or fewer people. A lot of them are passionate people who get into the business because of personal requirements or family requirements. Many of them are led by women; I would say, from my knowledge, if it's not 50%, it's pretty darn close. A high percentage of them are run by minorities, and many also by new immigrants.
As I said earlier, we as an industry try to comply. Overwhelmingly we try to. I can't tell you the number of times I have had conversations with companies where they've asked me, “How do you comply with this part of the regulation? How do you comply with this? What do you do?” It's an industry where, not universally but frequently, we actually have conversations with competitors on how to do things better. It's friendly competition. That's the easiest way to say it. One of my best friends, for example, is one of my biggest competitors. We regularly talk about how to comply. It's one of our discussions.
That's great testimony with respect to the camaraderie and the desire to comply with regulations. I think you mentioned previously that if there are deficiencies at Health Canada, obviously you'll understand what those deficiencies are and will work towards correcting them—and correct them, not just work towards correcting them.
Of course, the issue with the demise of the natural health products industry in Canada is really related to online sales. As we heard in the House of Commons today, the dastardly carbon tax is also driving businesses south of the border. I mean, businesses from Canada will go either south of the border or elsewhere in the world. Of course, online sales are of absolutely unregulated products. Is that not true?
You can get almost anything online, be it safe, legal or otherwise, when it comes to natural health products—or, for that matter, almost any product. We see it regularly. I do many store visits as part of my job, and I can't tell you the number of times I've gone into stores and had people hand me a packet and ask, “Can you do something like this? Can you make me this? Can you do this? Where did this come from?” I would say that well over 90% of the time, they are products that are not legally available in Canada. My only conclusion is that they came from an online retailer, and a consumer brought them in saying, “I want more of these.”
Dr. Hepburn, from the lofty Hospital for Sick Children, were you not ranked the number one children's hospital in the world, or do I have that wrong?
One aspect of Vanessa's Law that we haven't been talking about a lot is that Vanessa's Law requires that hospitals report any serious adverse effect of a drug, and if we were to remove Vanessa's Law from natural health products, that would no longer be the case.
You work at the lofty Hospital for Sick Children. Can you give me some examples where perhaps you've actually seen that at the Hospital for Sick Children, the adverse effects of natural health products, and have you reported them under Vanessa's Law?
I can't speak to any unique cases that our hospital would have reported. I can say, though, understanding the basics of pharmacokinetics and pharmacodynamics, that any product that has a physiological effect can have a physiological side effect.
At SickKids, we also care for medically fragile children, medically complicated children, many of whom experience what we call polypharmacy. They are on a number of different pharmacologically active substances that may or may not have drug-drug or drug-NHP interactions. It's incredibly important, especially as we care for the most fragile patients, that we understand drug-NHP interactions and that when a patient has an adverse event associated with an NHP or a drug-NHP interaction, it be reported so that we can better understand it.
Can you talk a bit about the known adverse effects of some natural health products? You're a doctor. You must deal with this at least from time to time. The whole notion that the poison is in the dose, which is what one toxicologist once said to me, I thought was interesting. Even water can be a poison, if you drink enough of it. Children, being small, are going to be particularly affected, potentially, by the adverse effects of drugs.
We're getting this narrative from the other side that these are overwhelmingly safe drugs. Can you give me some examples of where perhaps they're not safe drugs?
I agree that natural health products are safe. I feel comfortable recommending them to my patients—again, when it is the right product with the right indication and with the right evidence base to support its use.
That being said, extremely rare events are not unimportant events. In health care, we dedicate a huge amount of time, energy and effort to ensuring that extremely rare events do not happen. When they do happen, we report them, reflect on them, learn from them and act swiftly and accordingly.
Can you give me some examples of those extremely rare events with respect to natural health products?
I'm not in a position to give you case reports from our own hospital, but I can say that some of the natural health products that we in pediatrics are exposed to have been cross-contaminated with products that are unsafe for children. We have had children present with toxicity associated with contaminants from the natural health product.
We have also had children present with significant complications associated with drug and natural health product interactions. If, for example, a natural health product is competing for a metabolically active enzyme with one of their traditional DIN regulated products, they can have either an overdose or under-dose in terms of therapeutic effect.
You talked about contaminated products. Can you give some examples?
I think there's lead toxicity in certain ayurvedic medicines, but can you give me some other examples of adverse effects when there's a contaminant?
Heavy metal toxicity and heavy metal contamination would probably be the most common.
If it suits the committee, I'd like to regroup with my colleagues to see if they can help provide a more comprehensive list of ones that we've experienced, both at the Hospital for Sick Children and with colleagues across the country.
Yes, if you could table that with the committee, it would be greatly appreciated.
Can you talk a little bit about some of the common adverse drug interactions that you see with natural health products?
If you'll indulge me in a little basic metabolics physiology lecture, there are enzymes in the body—
No, Dr. Moore Hepburn, we don't have time for a lecture.
If you have a brief response, go ahead. Otherwise, I would urge you to provide it in writing. You can give us a lecture in writing.
Thank you.
Thank you, Dr. Powlowski.
[Translation]
Mr. Thériault, you now have the floor for two and a half minutes.
Mr. Thuna, you said earlier that, over the past 30 years, you have never been inspected by Health Canada.
Did I understand correctly?
[English]
[Translation]
The Auditor General's report noted that Health Canada was not doing its job. According to that report, there were audits of certain companies, but it wasn't the companies that were problematic. The problem was that Health Canada was unable to do its job to ensure the safety of products and carry out the necessary inspections to ensure that there would not be any problems related to natural health products.
In addition, the methodology was flawed. After 30 years without inspections, the government wanted a way to pay for inspections, so it implemented cost recovery, which is not at all appropriate for the industry. That's another issue.
Bill C‑368 would change the environment. It creates some distance from the pharmaceutical sector and considers natural health products on their own terms by imposing appropriate fines, appropriate labelling, and so on.
You haven't been inspected once in 30 years. That's hard to believe. That suggests the problem isn't you; it's Health Canada.
[English]
I would say that the way Health Canada has chosen to treat our industry is an ongoing problem. In my time, Health Canada has.... In the beginning, it didn't understand us. I would say it still doesn't, but in the beginning, it didn't understand us, so we were drugs. That's the box we fit in that was easiest for them.
However, with the consultation and the creation of the NHPD, that was supposed to change. It was supposed to be that we were treated...and regulations were created that were right for us. Health Canada was supposed to educate consumers, doctors and other medical staff so they could better understand the regulations, the products, how they're manufactured and how they were going to be kept safe.
Health Canada fell on its butt with that one.
Thank you very much, Mr. Chair.
I'm going to continue with you, Mr. Thuna. Thank you for being here.
You testified that the cost of compliance was $500,000 for the first year and $300,000 for each year afterwards. What are your total sales per year?
As we're a private company, I can't give exact numbers, but I can say that we're well under $5 million.
You also testified that you received inspections from four different agencies. Could you share with us which agencies?
We are regularly inspected by an international GMP agency called SGS. That is entirely voluntary on our part. We are also inspected regularly by The Kashruth Council of Canada. Again, that's entirely voluntary on our part. We are also inspected by both Ecocert USA and Ecocert Canada, which are two organic certification companies.
All of those are voluntary because we, as a company, like many companies in our industry, try to meet and exceed standards.
The organic ones and the SGS one are annual. The kosher one is quarterly. Those are physical, in my building, going through paperwork and actually walking through my facility, talking to my people and inspecting.
The vast majority of companies in the natural health products sector, as you know, are fully compliant. When there has been a voluntary recall, they have complied. We have heard of three cases where companies did not comply. From what I understand now, all three of those companies no longer exist; they're no longer in business because other tools have been used.
Have you ever received a voluntary recall notice, or have you ever had Health Canada express any concerns about any of your products?
We have had Health Canada come in and question us regarding labelling. We have had Health Canada come in and question us over a name issue. However, both of those were, if I recall correctly—I am aging—in the 1980s, long before the NHPD existed, and they were resolved to Health Canada's approval. That's the wrong word, but Health Canada was happy in the end, based on legislation that existed back then.
Thank you, Mr. Thuna.
Thank you, Mr. Julian.
Next, we have Mrs. Goodridge, please, for five minutes.
Thank you, Mr. Chair.
I want to thank all the witnesses.
I really appreciate the conversations that we've been able to have here today. It's actually been really interesting because it's not necessarily on the subject at hand. It became on the subject at hand because the government decided to use a very blunt tool.
I'm just going to walk us back a little bit. In November 2023, it became known, and was called out, that the government was allowing nicotine pouches to be sold to kids, as has been pointed out by many of our witnesses, basically on shelves beside candy. The Minister of Health got all puffy and made a big deal, saying that this was absolutely unacceptable. However, Imperial Tobacco said that it simply applied to Health Canada and got approved.
It sounds to me like this was a situation where Health Canada could have intervened and chose not to, rather than “let's completely rewrite the entire natural health products piece”. Then it took 10 months before it actually came up with regulations, and the regulations don't actually deal with nicotine. As has been suggested by my colleague from the Bloc, instead of potentially having just a specific carve-out piece, it's been “Let's try to bankrupt a $13-billion industry.”
Mr. Thuna, you've been talking about how Health Canada hasn't come into your business since the 1980s, and 30 or 35 years ago was the last time you heard from Health Canada in your business.
That's correct.
From the conversations that I've had with colleagues—and I've had many—it's entirely commonplace for companies to say that. Health Canada is viewed as dropping the ball when it comes to enforcement for companies that actually care about the industry and care about enforcement.
As you've been sitting here, listening to the testimony.... Every one of the witnesses who are bringing up their concerns about nicotine pouches being sold to kids is correct. I think this is something that is deeply concerning to just about everyone sitting around the table. As our addictions shadow minister, I don't want to see children getting addicted to a substance that we know is addictive, but I also don't want to see good products, which people sometimes use to help cure themselves of their addiction, removed from the products available to them as a direct result of this.
Do you think that Health Canada should be doing more when it comes to inspections or using any of the other tools they have at their disposal?
Not only do I think they should do more, but I think they should actually do something.
My personal experience is that Health Canada does not use the tools at its disposal, yet waits until something is in crisis or near crisis mode and then pulls out the jackhammer.
Dr. Moore Hepburn, do you think that a 10-month delay from the time these pouches were on the shelves to the government finally acting was responsible?
As a practising pediatrician, what I can offer to the committee is that it's important that we have the complex and complicated conversation about how we're going to regulate nicotine more broadly and how we're going to maintain and preserve access to nicotine replacement therapy for those individuals who need it, while simultaneously restricting access to new and novel threats. I think that is a broader conversation that's important for the public to have.
Okay, but I'm asking you a very specific question. It took 10 months for the government to actually do anything to prevent kids from being able to access these products. Do you think that was fast enough? Would you have preferred it to be sooner, yes or no?
I think everybody, looking through the retrospective scope, would have preferred that the products not have been approved as they had been. Obviously, any time the products were available is too long a period of time.
Speaking to the speed at which government can and should act is outside my area of expertise.
That's fair enough.
My next question is for Ms. Patel.
The Minister of Health previously worked for the Heart and Stroke Foundation. Is that correct?
Thank you, Mr. Chair.
Thank you to all the witnesses for being with us.
My first question goes to the Canadian Lung Association.
Ms. Butson, do you think the government should be able to use an injunction to stop the actions of non-compliant companies if there is any immediate risk to human health?
That wasn't part of our particular call to action, although I did hear it referenced earlier.
Our speech here today was really with respect to the impact on the nicotine products, and the potential to amend so that this did not apply to nicotine products.
Ms. Patel, what are the risks associated with Bill C-368 if it's passed?
It would effectively orphan out nicotine pouches and nicotine replacement products. Right now, we regulate tobacco, cigarettes and vaping products under the Tobacco and Vaping Products Act, the TVPA, and then the NRTs, or nicotine replacement therapies, and nicotine pouches currently fall under the Food and Drugs Act. However, if natural health products are taken out of the definition, then we have no framework to regulate them under. As Dr. Moore Hepburn has repeatedly stated, these pouches are a big concern, and we want to keep these protections.
The tobacco industry is not going to stop at pouches. They're going to keep coming back with new innovative models. They'll try to, I don't know, inject nicotine into a candy apple and call it a nutrition-forward way to quit smoking. We don't want that. We want to be there to protect kids with regulations and ensure that the industry doesn't keep profiteering from nicotine addiction.
Thank you.
Dr. Moore Hepburn, in addition to the concerns raised already, how would this bill impact regulations on nicotine products? Are there any other concerns you have with how this bill could affect young people?
Again, I am a practising pediatrician who cares for patients. Many of my patients use natural health products. The Canadian data that we have is based on a single-centre study, which has inherent limitations. Best estimates are that up to two-thirds of families use complementary health practices in some form or another. This is a huge part of our patients' lives and their families' lives, and I am not here to stand in the way of that.
That being said, I think it's important for care providers, parents and patients to have assurances that the products they buy are safe. Rare events related to safety are not unimportant events, especially if that adverse event or drug-drug interaction involves someone you love.
If there is a call to have a broader conversation about how we can best regulate NHPs, I think it's important that the medical community be at the table. I would again emphasize the importance of addressing the synthetic nicotine issue as a part of that conversation, given how Canada currently provides regulatory oversight on synthetic nicotine.
Thank you.
I would like to ask Ms. Patel a question.
Nicotine products are right now classified as a natural health product, not therapeutic. If this bill passes, they will no longer be subject to Vanessa's Law. Do you have any recommendations on how nicotine products should be categorized for the purpose of regulations?
The Heart and Stroke Foundation is not too prescriptive in telling the government how they should be regulated. We just want to make sure that the regulations as they exist currently are kept in place and protected. Our concern is that the bill would revoke the existing ministerial orders that were put in place in August, which are vital in protecting kids and ensuring that these harmful products stay away from them.
I would agree in terms of not being prescriptive. We prescribe lots of things, but not in this space. I do think, however, that it's useful to consider having a broader conversation about how we can approach nicotine, as there is a clear chasm between what is regulated under the TVPA and what is regulated in the Food and Drugs Act.
There are many competing and important priorities that need to be balanced and, with this new threat, we need to have our eyes open and we need to not wait and see what will happen as it takes hold in our markets.
Thank you, Ms. Sidhu.
Colleagues, we're now through two full rounds of questions, and we have resources to continue. I know there are some people who are going to be heading to the airport fairly shortly, and I don't want to get cut off by a motion for adjournment without raising a couple of things with you, because we're heading back to our ridings next week. There are a couple of things I need to raise with you, and then I'm happy to continue rounds of questions or entertain a motion for adjournment, as you wish.
First of all, on the opioid study, because on Tuesday we agreed to extend that study, we need to have you replenish your witness lists. Can I suggest that we have new witness lists or supplementary witness lists to the clerk of the committee by next Friday, November 15? Does that seem like an acceptable deadline?
Some hon. members: Agreed.
The Chair: Second, in connection with this private member's bill, we are scheduled to do clause-by-clause examination of this bill two weeks from today, on November 21, so could I have the agreement of the committee to set as a deadline November 15 for amendments and the submission of briefs? Is everybody okay with the November 15 deadline?
There is a suggestion for the 19th. Can we set the deadline for briefs and amendments for November 19 at noon? Is everyone okay with that?
Some hon. members: Agreed.
The Chair: All right. That's what I wanted to get in before we adjourn.
Thank you, Mr. Chair.
Some of us have airplanes that are already moving down the runway. What I would suggest is two and a half minutes, and then two and a half minutes, to round it off from the two parties.
Can you keep your round to two and a half minutes, Dr. Ellis?
Okay, you have two and a half minutes. Go ahead.
Thanks very much, Chair.
Dr. Moore Hepburn, I had a question for you. You talked about the 20 years during which you've felt comfortable with natural health products. Do you think that this legislation is going to make them less safe?
My reference to my 20-year career was about how much has changed in terms of, primarily, the evidence base to support, or not, the use of natural health products. The regulatory infrastructure was stable for most of that time, but I would say that the broader medical community really celebrated Vanessa's Law and its inclusion of natural health products—
I have to cut you off there, Dr. Moore Hepburn.
You know, this is not about Vanessa's Law. This is about changing the definition of a therapeutic product.
That being said, I have one other question. I know this is not your area of expertise, but do you know how many seniors are hospitalized every year because of prescription drugs?
It's 13,000.
I guess I have a little bit of a problem, as you noticed in my first round, that you're here on one issue that's decimating a $13-billion industry, and you couldn't even provide any examples of how many children have been injured by natural health products.
Listen, this is not disrespectful. This is questioning testimony. Thank you very much.
Dr. Moore Hepburn, the question is about how many children. You couldn't even name a child or tell us how many cases you've dealt with. I find that disingenuous. I hate to say that to you, because our colleagues obviously believe in your esteemed nature, but please come to committee prepared when you're trying to decimate a $13-billion industry.
Ms. Patel, have you at any time worked for the government as a legislative assistant for any members of Parliament or any ministers?
It's just a yes-or-no question.
Thank you, Mr. Chair.
I'm attempting to understand the Conservative mindset, and that's an exercise rather like plunging into a labyrinth of illogical thinking and dead ends. Conservatives today are lamenting the 10-month delay, but they actually objected to the ministerial decision to put nicotine replacement products, the pouches, behind the pharmacy counter as a measure to prevent access by youth, because adults having a choice to use therapeutic nicotine products was deemed to be more important. At the same time, there is a very real problem of market influence from unregulated vape products, some of which are alarmingly potent, with up to thousands of hits per vape, and easy to access.
Hopefully I can take a little time with you, Ms. Butson.
Do we have the balance right between reasonable access for adult smokers to NRTs and limiting access for youth and preventing access to unregulated, imported foreign products?
I have to ask you to be very brief because time is so limited, and I want a chance for Dr. Moore Hepburn to comment.
Really briefly, with respect to the ministerial order, which we're trying to keep protected through an amendment in this proposed bill, I think the balance is struck there. The products are not banned. They are still allowed to be accessed by people who smoke and who are seeking to use them to quit, but they're not appealing to young people and they're not easily accessed by young people.
I would agree that we need to find a delicate balance. We need to make sure that adult smokers have access to NRT, but that it's packaged in a form and made available in places that would not be attractive or appealing to young people.
That's great. Thanks.
Dr. Moore Hepburn, I think you said that your appreciation over time for natural health products has increased, and knowing that NHPs are well regulated means that you're more comfortable recommending them. How important do you think it is for consumer confidence? You have a lot of interactions with patients and clients who are accessing these. How important is that added level of safety, do you think, for practitioners' and consumers' confidence in natural health products?
I want to be clear that I don't in any way wish to dismantle the industry. Many patients and families rely on these products, and they have become a part of standard medical practice in many specific instances.
I want to again state that my goal is to make sure that there is provider confidence and [Technical difficulty—Editor] children. We can recommend their use with the safety and certainty that the product they are getting is what it says it is and that adverse events will be reported when they happen.
Thank you, Dr. Moore Hepburn.
Thank you, Dr. Hanley.
Thank you to all of our witnesses for being here with us today, for your patient and professional approach to the proceedings and for your advocacy on behalf of the industry, your stakeholders and your profession.
As you heard, we're going to be wrapping up testimony at our next meeting and then moving on to clause-by-clause very shortly after that. The information you've provided today will be immensely helpful to us in that regard.
Is it the will of the committee to adjourn the meeting?
Some hon. members: Agreed.
The Chair: We're adjourned.
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