Bill C-368

An Act to amend the Food and Drugs Act (natural health products)

This enactment amends the Food and Drugs Act to provide that certain natural health products are not therapeutic products within the meaning of that Act and therefore not subject to the same monitoring regime as other drugs.

[Flory Doucas]

I want to make sure I understand. Are you talking about excluding nicotine products from the scope of Bill C‑368 ?

[Luc Thériault, Bloc, Montcalm, QC]

Okay. It's important to clarify that, because you know we're going to make an amendment to Bill C‑368.

My understanding is that you haven't explored all the problems surrounding the intent of the bill. Based on what you're telling us today, the current wording of the bill has the adverse consequence of cancelling the ministerial order, which made it possible to better control nicotine products.

Did I understand you correctly?

[Flory Doucas]

Sure, it would be great if we had a framework, but we don't, and we just can't afford to wait for a framework. Nicotine is highly addictive, and that's what the ministerial order tried to tackle in a prompt way.

I think the idea here, should BillC-368 go ahead, is just to carve out nicotine products.

[Pierre Chen, Registered Traditional Chinese Medicine Practitioner and Registered Acupuncturist, Traditional Chinese Medicine Association of Canada]

Thank you so much for having me. Today we're talking about Bill C-368.

I am an importer of Chinese medicine. I'm also the founder of the Canadian College of Traditional Chinese Medicine. I have a master's in Chinese and integrative medicine. I'm also a Harvard medical educator. In non-profit, I set the standard at the Standards Council of Canada for TC 215 and TC 249 in Chinese medicine.

What we're looking at today is a regulatory mismatch for natural health products—putting them into a drug model and into Vanessa's Law, and treating food items and herb items as pharmaceutical items, which they are not. Do you have the package I sent out on food safety in Chinese medicine? If you go to see a Chinese medicine practitioner with kidney problems, they might prescribe you kelp or seaweed. If you have lung problems, they'll prescribe cinnamon, ginger, onions, etc. These are the natural health products we are using.

In Ontario, there are 2,700 Chinese medicine practitioners and acupuncturists. In Quebec, there are about 1,000. In B.C., there are 2,000. If you move down through the slides, out of these practitioners in Ontario, 65% are female. On direct job impact, the Job Bank of Canada record for 2021 shows that there are 66,000 Chinese medicine and acupuncturist natural practitioners in Canada. On indirect job impact, we have herbal farmers in Canada. There are over 2,000 individuals under the Good Agricultural Collection Practice. In Saskatchewan alone, there are 30,000 acres. In Ontario, there are about 150 ginseng growers. We are the purchasers and users of these natural health products, so all of those farmers would be out of business if we didn't support them.

We need something tailor-designed for natural health products. Right now, what we have works. It's going to affect us greatly if we don't pass Bill C-368.

Under the 60,000 practitioners, most patients are women, seniors and minorities. Most of us have hundreds, if not thousands, of patients. All of these patients would be affected without access to natural health products.

If you move down, there's the proposed amended fee. These are some of the companies we're looking at. Most of these companies annually renew. It's very common for us to have around 1,000 licences. We don't use all of the licences simultaneously—only if we need them. We need the licence to have access to herbs. For upkeep, you're looking at $130,000 to $200,000 annually just to keep the licence. That's not including the application fee, which is another $100,000 to $200,000.

This means that most households, especially lower-income households, would not have access. It would push us, as importers, into the black market. To avoid the $100,000 to $200,000 fee, people will sell online. They would not apply. That means the food items we want to have health claims for.... We're trying to do the right thing. We're going to be forced to sell them as food items, and we're going to say, “It has no effect.” All these practitioners would not have health claims on the items they're prescribing.

On the next slide, you'll see the example of Jia Wei Xiao Yao Wan. It's a pretty standard formula. Right now, on the market in Canada, it's about $9 or $10. With the proposed fee, we're looking at close to a $50 to $100 increase per product, because we use a lot of these licences. To keep those licences, we're going to look at $50, plus the $10. It would make it hard for people to purchase and use these products.

The purpose of natural health products is so food items and herbs that we're prescribing, as practitioners, have a health claim. It's not so drug items can escape responsibility as a drug. I saw previous experts talking about nicotine. I totally agree with them. Nicotine is highly addictive, and in a lot of countries—Australia, Japan and Thailand—it is considered a drug. They have a separate regulation, like our tobacco act in Canada. We use it to protect our public. A natural health product is not an escape to avoid the necessary law.

We also talked about evidence-based medicine. We want to have that in natural medicine, too. We hope to have grants and research funding, which we don't have. However, adding an additional law—Vanessa's Law—to this would only push us to the black market, to the other side of the border. We're going to have to sell from the U.S. where these $10,000 to $100,000 regulation fees are not realistic, and we're going to have to sell from other countries to Canada where people can have access from illegal markets, avoiding these costs.

Thank you so much.

[Cynthia Callard]

I apologize.

I will just tell you that there are other products on the market that are sold at convenience stores beside the candy counter. They don't look like a pill. They don't look like a treatment. They look like something interesting. The other products that are on the market, the gums, do not seem to be a problem, and we have not called for new precision regulations to be placed on them, but we need the power to intervene if they were, if children were experimenting with them or if they became an on-road to nicotine addiction instead of people using them in the bar or somewhere instead of smoking. If there were reasons to have concerns about them, we would like the government to have the authority to come in.

In the U.S., the same product made by the same company is sold with the disclaimer that it is not an FDA-approved smoking cessation aid and it's not intended to be used to quit smoking, but, in Canada, the same product is sold as a smoking cessation aid. In the United States, it's sold as a way to enhance focus, boost your energy or relax.

Other tobacco companies that are licensed to sell NHP nicotine in Canada include Swisher Sweets Cigar Company and a Philip Morris International subsidiary. Turning Point Brands is a cannabis-focused company that has a licence also to sell NHP nicotine in Canada.

The ingredients of a drug product are only part of the risk. From a clinical perspective, nicotine replacement is a well-established treatment for tobacco addiction. It doesn't seem to make much difference how that nicotine is delivered to the body but, from a public health perspective, it makes a world of difference how the product is delivered to the market. The business model of those who make it and distribute it, how it's advertised, who sees the advertisements, whether influencers are promoting it, etc. are the aspects that make the product risky. The supplementary rules that were adopted for Zonnic are mostly about marketing; they're not about the product itself.

One reason these supplementary rules took months to prepare is that new legislative powers were required. These powers were part of the spring budget. Bill C-368 would take those legislative powers away, not only for Zonnic but for all the other smoking cessation products manufactured by tobacco companies or others for whom the clinical benefits risk being overshadowed by the overall health risks to Canadians.

The Food and Drugs Act was not designed to manage tobacco companies. Last week, I heard other witnesses being asked about consultation on the authorization. There is no consultation with any outside group when the department decides on whether to authorize an NHP. As I understand it, each application is confidentially reviewed against established clinical criteria, not public health criteria, and is decided on without input from other stakeholders or any public health impact analysis.

Canada is lacking an overall nicotine regulatory framework. The regulation and management of tobacco products and vaping products are in one branch of the department under one law and under a different minister than is NHP nicotine. This is a problem.

I think it would be wonderful if the committee could suggest to Health Canada that they start working on an integrated nicotine framework. The precision regulation was a bit of a band-aid solution, but it's a band-aid solution we urgently needed. It's a band-aid solution we continue to need. Until there's a more permanent solution in place, we implore you to not remove that and put Canadian children at additional risk.

Thank you.

[Cynthia Callard, Executive Director, Physicians for a Smoke-Free Canada]

Thank you very much for the invitation to appear.

For those of you who are not familiar with us, our organization is a small health charity with a 39-year history of providing information and advice on tobacco policy. Our members are all physicians, but I am not. My comments today are based on a policy analysis, not on the clinical use or on the overall implications of this bill for the NHP category. For those more general perspectives, I refer you to the brief submitted by the Canadian Medical Association.

I want to say that Bill C-368 has implications for tobacco control that go beyond the Zonnic or nicotine pouch issue. That's because most stop-smoking medications are licensed as natural health products. There are two categories of drugs, bupropion and varenicline, which are prescription-only drugs, that are licensed under the drug product regime. There are about 100 authorizations for stop-smoking medications under NHPs. The largest category are nicotine replacement products. This can be gums, patches, pouches or inhalers. There's a large category and there are more on the horizon, like nicotine pearls.

Another category is cytisine, which is a drug that's derived from laburnum trees. It has a proven efficacy and is a new drug in Canada with largely an unknown impact in terms of its overall use.

Then there are homeopathic and herbal medicines that are licensed, even though they're not considered to be a particularly effective treatment.

One thing that's important to consider is how the NHP smoking cessation market is changing. There are new products and new players, and these are posing new regulatory challenges. Stop-smoking medications are no longer manufactured and sold by consumer health companies. They're sold by tobacco companies, nicotine companies and even cannabis companies. Zonnic is the most recent entry, but it's certainly not the only one.

This package of Sesh nicotine gum I picked up at a Circle K last week was sitting on the counter right beside Reese's Peanut Butter Cups—

[Sylvia Hyland, Vice-President, Operations and Privacy Officer, Institute for Safe Medication Practices Canada]

The second key concern regarding Bill C-368 is the negative impact on the precision regulatory powers that are in place to address serious risks related to NHPs. These powers also depend on NHPs being defined as “therapeutic products” in the Food and Drugs Act.

An example is, as we heard just now, the recent ministerial order for requirements regarding the sale of nicotine pouches and the risk to kids. The order requires that nicotine pouches be kept behind the counter in a pharmacy and not sold in convenience stores.

To provide another example, serious risks related to pseudoephedrine were addressed by the May 2024 interim ministerial order. However, it will expire.

To be clear, these are only examples of where the ministerial order may be required to address emerging serious risks related to NHPs. Precision regulatory powers are needed when risks arise after a product has been approved to be marketed for an intended purpose and the product is being used in ways other than was intended and approved. We can anticipate that other serious risks related to NHPs will arise in the future.

Health Canada must have the authorities to conduct the post-market regulatory activities that will identify serious risks with NHPs and be able to take timely action to address these risks when needed in urgent situations.

In conclusion, the Vanessa's Law authorities and the precision regulatory powers that we have highlighted today should remain in place. Bill C-368 would reverse regulatory changes that are needed to protect the health and safety of Canadians.

Thank you.

[Carolyn Hoffman, Chief Executive Officer, Institute for Safe Medication Practices Canada]

Thank you, Chair.

On behalf of the Institute for Safe Medication Practices Canada, we appreciate the opportunity to provide our perspective regarding Bill C-368.

ISMP Canada is a pan-Canadian, not-for-profit and independent organization established in 2000 to improve the safety of drugs and health products for Canadians. Our key activities include expert analysis of error reports from consumers, providers and health care organizations to learn about the risks related to these products; to share evidence-informed recommendations for improved safety; and to work with consumers, care providers and other health system partners to reduce preventable harm.

We recognize that access to safe natural health products is important to Canadians. Through our work and that of others, we know that the manufacturing of NHPs and the use of NHP products are not without risk.

Many Canadians may not be aware that NHPs are a broad category and include more than vitamins, herbal remedies, traditional medicines and homeopathic medicines. For example, acceptable medicinal ingredients also include scopolamine, pseudoephedrine and methyl salicylate.

Consumers have shared with us that they believe that Health Canada has rigorously checked and approved all NHPs for safety. They also assume retailers will sell them only if they're approved by Health Canada and that they are safe for sale. Consumers said, “I trust what is on the shelf is good for you”, and that they are “safe since they are on the shelf.”

Over 700 incident reports related to NHPs have been reported to us, including 400 since 2019. Of these 400 reports, over 15% indicated some level of harm. Most were mild harm; however, two were reported as contributing to a death. Importantly, there is under-reporting of incidents to us.

We have two key areas of concern regarding Bill C-368. The first is that natural health products will be exempted from the important regulatory provisions under Vanessa's Law. We provide four specific examples of the impact.

Health Canada would no longer have the authority to recall a product from retail settings if there is an identified serious risk.

Health Canada would no longer have the authority to compel a label change if there is an identified serious risk.

Health Canada would no longer be able to advance new regulations that require licence-holders to conduct additional tests to help inform Health Canada's risk assessments.

Health Canada would no longer be able to advance new regulations that require that serious NHP adverse reactions be reported when a patient is seen in hospital. Reversing this capability is concerning because this information is essential to better understanding the magnitude and impact of the risks related to NHPs.

[Flory Doucas, Co-Director and Spokesperson, Coalition québécoise pour le contrôle du tabac]

Thank you, Mr. Chair.

Good morning, everyone.

I am Flory Doucas, co-director and spokesperson for the Coalition québécoise pour le contrôle du tabac. The mandate of the Quebec coalition for tobacco control is centred on reducing smoking and nicotine addiction. We therefore do not have a position on Bill C‑368 as a whole.

However, if the bill were to be adopted as is, it would severely undermine current federal efforts to protect youth from nicotine addiction. Bill C‑368 would cancel the supplementary rules respecting nicotine replacement therapies order, authorized last August under section 30.01 of the Food and Drugs Act, under which the Minister of Health can impose additional rules on therapeutic products by means of a ministerial order. This authority is what enabled the precise and tailored regulatory rules that address the potential harms resulting from the irresponsible promotion of nicotine-based therapeutic products that glamorizes and promotes their recreational use.

These measures were in response to the introduction to the Canadian market, in October 2023, of Zonnic, a nicotine pouch that was commercialized by Imperial Tobacco Canada and that was approved for sale by Health Canada as a natural product in July 2023. The promotion of Zonnic, with its brazen lifestyle advertising, bright colours and exotic flavours, such as Tropic Breeze and Berry Frost, clearly evoked themes like pleasure, lifestyle and youth. Images of young people in social settings populated these promotions, clearly painting aspirational lifestyles for youth.

Since the ministerial order issued last August, these nicotine replacement therapies, NRTs, remain available for smokers across the country, but across all provinces, they must be sold by a pharmacist and be kept behind the counter. They cannot be sold with flavours other than mint and menthol. They cannot be advertised in a way that is appealing to youth. They require a warning on addiction, and they cannot come in packaging that has youth appeal.

By amending the definition of therapeutic products in the Food and Drugs Act to exclude natural health products, Bill C-368 would eliminate the effect of these new regulations. The lack of federal measures would also serve to undermine stricter provincial regulations, such as those that exist in Quebec and in B.C., by creating enforcement challenges resulting from online interprovincial sales and promotions.

Should Bill C-368 be adopted without an amendment to carve out NRTs from its scope, Health Canada's current ability to enact mandatory recalls of NRT products when deemed necessary to prevent against injury would be eliminated. Health Canada would be prevented from vetting promotional materials before new products hit the market. Industry could roll out new NRTs with all kinds of flavours that could be enticing to youth.

The effects of adopting an unamended Bill C-368 would be felt beyond Zonnic pouches. There is actually a global corporate campaign to reframe nicotine as a more benign and ordinary consumer product akin to caffeine, with beneficial effects such as “helping adults to relax”, as Imperial Tobacco Canada states on its website.

Tobacco industry documents reveal that the introduction of novel nicotine products aims to compensate for decreasing smoking rates around the globe by creating addicts to new nicotine products. We've seen this with vaping. For this reason, the Quebec coalition, without endorsing either the adoption or the rejection of the proposed legislation, respectfully asks that, should Bill C-368 go forward, the Standing Committee on Health amend it to carve out nicotine products from its scope, as provided by the legislative text found on the first page of our written submission.

Nicotine is a drug that causes harm, not only through addiction, but also in terms of physical and mental health, especially among youth.

In a January 2024 policy brief, the World Heart Federation wrote, “For decades, the tobacco industry has promoted the myth that nicotine is as harmless as caffeine. Nonetheless, evidence shows that nicotine is far from innocuous, even on its own. In fact, numerous studies have demonstrated that nicotine can harm multiple organs, including the respiratory and cardiovascular systems.”

Meanwhile, numerous other scientific publications have confirmed how because their brain is still maturing, nicotine exposure during adolescence alters cognitive function and attention performance in youth.

Should Bill C‑368 go forward, it should be amended so as to carve out nicotine products.

[The Chair, Liberal, Sean Casey]

I call this meeting to order. Welcome to meeting 139 of the House of Commons Standing Committee on Health.

Before we begin, I ask all in-person participants to read the guidelines written on the cards on the table. These measures are in place to help prevent audio and feedback incidents and to protect the health and safety of all participants, including the interpreters.

In accordance with our routine motion, I'm informing the committee that all remote participants, with the exception of Dr. Powlowski, have completed the required connection tests. We're going to proceed with the opening statements and check in with Dr. Powlowski at the end of that, just to try to move things along.

Pursuant to the order of reference of May 29, the committee will resume its study of Bill C-368, an act to amend the Food and Drugs Act (natural health products). Before we begin, I remind members that clause-by-clause consideration of the bill is this Thursday. The deadline to submit amendments is in 53 minutes from now. The amendment package will be circulated as soon as possible after the deadline.

I would now like to welcome our panel of witnesses.

From the Coalition québécoise pour le contrôle du tabac, we have Flory Doucas, co-director and spokesperson.

Representing the Institute for Safe Medication Practices Canada are Carolyn Hoffman, CEO, and Sylvia Hyland, vice-president, operations and privacy officer. On behalf of Physicians for a Smoke-Free Canada we have Cynthia Callard, executive director. Representing the Traditional Chinese Medicine Association of Canada is Pierre Chen, registered traditional Chinese medicine practitioner and registered acupuncturist. Mr. Chen is joining us via video conference. Thank you all for being with us.

We're going to begin with opening statements of up to five minutes in length.

We'll start with the Coalition québécoise pour le contrôle du tabac.

Welcome, Ms. Doucas. The floor is yours.

[Sonia Sidhu, Liberal, Brampton South, ON]

Ms. Patel, what are the risks associated with Bill C-368 if it's passed?

[Luc Thériault, Bloc, Montcalm, QC]

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.

[Luc Thériault, Bloc, Montcalm, QC]

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.

[Luc Thériault, Bloc, Montcalm, QC]

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?

[Luc Thériault, Bloc, Montcalm, QC]

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?