Herbalism And Health Canada's New Self Care Framework - What You Need To Know

Hello, welcome to a conversation between myself, Malcolm Saunders, owner of Light Cellar, and Yara Willard, the director of Wildrose College, as well as owner formulator of Harmonic Arts. But what we want to do is go into, you know, why that is, what we're seeing as somebody on the kind of the retail side, as well as somebody on the kind of, you know, production wholesale manufacturer side. We'll be sharing kind of our industry insights and what we've been gathering by going through the literature. So there's going to be three areas that are very pertinent that you'll want to know, learn about. So Jaro, let's maybe start with, you know, what, you know, from your experience as a manufacturer, what you have to deal with currently, you know, with Health Canada and what we call NHPs, Natural Health Products. selling enough of that one herb to be able to afford to pay for the fee structures. Yeah, absolutely. So let's dive in. I'm just going to bring it up on my screen here. We have three areas that we're going to talk about that are, you know, again, going to be taking this even further beyond what it is, which, you know, I think you already did a great job kind of painting a picture of kind of the challenges and you know, the barriers that currently exists and how that has narrowed, what is being proposed and a part of what has already been passed, will only continue to further this. So let me just bring it up. I'll share my screen. The first thing, which is something that has already passed, and this was done at the end of June. And it was kind of snuck in the budget bill. So Bill C-47, as you can see, this is a, you know, parl.ca, this is an official government website. The Bill C-47 received a royal assent, passed right through just this small little section. So now the wording that we want to send to our MPs that we want to send to Canada's health minister is to be able to repeal this section. And so it's section 500 to 504, amendments to the Food and Drug Act. The 500, the definition therapeutic product in section two of the Food and Drugs Act is replaced by the following to mean therapeutic product means a drug or device, any combination of drugs or devices. So now therapeutic, you know, like that, which used to be, you know, so 501, the definition of a therapeutic product used to be means a drug or device, any combination of drug devices, but does not include a natural health product within the meaning of the natural health products regulations that's been repealed. So that but does not include that's gone. So now that definition, the first that I read, therapeutic product means a drug or a device or any combination of drugs or devices. So now massive, like, yeah, this is massive. I just I want to say that this is the snow, the beginning of the snowball where now those herbs are considered drugs, and they're going to have to fit a whole nother reform, really disempowering Canadians from using plants as medicine in a huge way. Yeah, so that that was kind of laying the groundwork for everything else to come about. So that was Bill C-47. And the requested action is for you to contact your MPs, contact the health minister, Jean-Ives Duclos, I'm not pronouncing his name correctly, but we'll have those links for you to, you know, send that and say this needs to be repealed, because that has now laid the foundation for the other two components, which are the self-care framework, which basically aims to, you know, harmonize how the natural health industry is regulated to exactly the same as the pharmaceutical industry, which, you know, does have much higher vigorous standards, because it's a much higher risk of category. We're talking about dealing with new and novel drugs, right, that have never been used or tested, or they've just been created, and they have to go through a much different process than herbs, you know, rightly so. It's totally different in terms of their risk profile. You mentioned, you know, traditional use, something is deemed traditional use if it's been around for 75 years. That will all change because of this wording and what is coming next. But let's talk about, before we get into that, let's talk about the next thing on the kind of proposal is the proposed fees for natural health products. Now, this is something that they want to implement come April 2025, so we do have a little bit of time. We can see it. What's that? Just scroll down on that page, so we can see. Yeah, oh absolutely. So this, again, we'll have these links Canada.ca, and this is the proposed fees for natural health products, the fees, the fees policy. You can scroll through here, and Jaro's going to kind of walk you through what that means for like kids. Oh, go ahead. I was just going to say that, like, yeah, what that means for us is a minimum, if we don't make any brand new products, if we stick with just the ones we have on the market currently, no new innovations, status quo for just our site license and our, what we have, then we're going to be paying this $23,000 as the manufacturing plus 542 dollars per year per product. This is a very big bill to swallow. That alone will cost a company like us $80,000 a year, and all that is is for Health Canada to check off and say, yep, you already have your site license. Yep, you've already got your NPN. It doesn't, they don't actually do anything with that fee, that $80,000. They don't do anything for us, so they're basically taxing us, and, you know, I have my hunches around, like, why do they need to tax the natural health industry so much? Well, maybe Health Canada's offside with their budgets currently by spending money on other things, so there's this, like, other side to that, but then if you go to get new products, and maybe just scroll up for a second, you'll see that if we wanted to actually make a new product, most of them are going to be class 3 applications for any formula, and that means minimum $7,000, but if it's a novel application like Lion's Mane is a novel food they're proposing, then it's a $58,000. This is super unviable for new innovation. You have to sell, if you put a dollar per every product, $58,000 of that in your first year, and then at least $500 every year to cover the ongoing NPN, let alone the site license, so there's a lot of costs there, and this is only just one side, so class 1 applications are super easy. Those are herbs that are already in monographs, or like B vitamins, they already have monographs for. They're easy to get, but they've also gone, and not only have they said, we're going to charge you a lot more money, in most cases they've made the, with the existing level of performances, they've increased to new performance standards, which mean taking longer to even approve, so say we go get a class 3 novel application, we spend $58,000 to get that application, this is what their proposal is, and now it's going to take up to 300 days for them to review that, and if we make one spelling mistake, have one punctuation issue, one thing they don't like, they throw it out, and we have to reapply. This has been the challenge we've already faced with Health Canada, is that they will throw things out for the most obscure reasons, and then you have 24 hours to rebuttal it, or it's gone, you got to reapply for it, and so it's been really challenging for companies. This industry, just to have products on health food store shelves, has spent hundreds of millions of dollars over the last like 10 years. It's insane how much has already been spent on outside consultants to to meet this structure, and whole new companies have been built just to deal with the legal ramifications and the logistics of it. This is one side of what they're proposing, and the other one is the plain labelling, which is a much bigger thing again, because where the plain labelling comes in is that they want to put on a different form, they call it plain labelling, but what it is is it's part of the self-care framework that they want to change the way in which these products are labelled, and most of the claims that you used to be able to make, they're going to take that out, so you can't make the claims for a lot of your traditional use of plants and herbs and other things like that. They can only be based on scientific new data, new clinical studies, and new peer-reviewed studies, which for anything that's not your top 20 herbs, very little money is being spent towards studying these plants, so that means none of those will be available for people to even work with or access, and the barrier to entry is really high. Plus, because of the new framework, they want to change the way in which they're labelled, which means every company has to go in and change their packaging, they're wanting to take up a lot more space, which means every supplement that you might be buying right now, the capsules in a bottle, maybe you have 60 capsules in a small bottle, well the size of that bottle is going to have to double in order to cover the new labelling requirements, so they call it simplified or plain labelling, but really what they're doing is asking for much bigger labelling, meaning twice as much garbage in the packaging, so it's like reverse to what the environment needs, which is us to create less packaging, now they're saying you need double the packaging, and in tinctures, for example, there's no way to fit it on a bottle, it's going to have to go into a box, many things will have to go into blister packs with extra big packaging, so it's going to radically change that, which will cost industry quite a few more million dollars just to reform and cost the environment twice as much waste in health stream for natural products, this is the opposite of the direction we want to go, and hence why this call to action is now, it's because you have the opportunity to give them your feedback, so the government has put out this proposal, there's a whole setup on the government website here, and we'll put the links in here for you to give feedback on this, we really invite and ask, actually request that you try to give your feedback on this form, it is time sensitive, by August 10th is the last time they've extended this form a little bit, but still not very many people have been filling this out, most people are unaware of this happening, this radical reform that's actually going to massively affect our entire industry for generations to come, if not changed, we already have been dealing with something for the last 10 years that's been very challenging, and maybe coveted by the World Health Organization and other governmental legislative bodies that want to put in their own process, but now with this reform it's even more challenging, so please fill out this form by August 10th at the very least, that's the one kind of call to action we ask for you to just give your feedback, how does this affect you, how do you think this proposes this proposal, good or bad, and obviously in our minds this is bad, our industry, the CHFA is the Canadian Health Food Association, they have put together a series of kind of documents here, you can go to this link which is saveoursupplements.ca, they built a whole series, there's an action plan, there's all about the regulations, you can learn more about this, lots of resources, they have a full downloadable kit of resources for stores, for individuals, for practitioners, for manufacturers, they have this, this is another call to action, let's just scroll down a minute there, welcome to the send to your MP, oh yeah I guess it's up here too, you can send a letter to your MP in one minute, takes one minute to fill this out, to click that link, send it to your MP, and it's just to let them know, now this may not do a lot, because a lot of the MPs, some of them might not be informed about this, or they don't have as much current power, the better thing is to actually write your own individual letter, but this at least lets your voice be heard, and or to try and set up a meeting with your MP, if you're a practitioner, or a manufacturer, a health food store, you have some way to actually access your MP, inform them of the concern around this, so this is one on this website too, you can click through and find a bunch of different resources in the learn more section, and in all these, yeah in the resources section there, and there's a lot of news here, so please check this out, and then there's definitely people who have been spreading this whole education kit, and digital assets, and things to really learn more about, are here, videos and all, there's also people like the NHPPA, that Malcolm was going to share a little bit about, that have been talking about this for a long time, ever since the beginning, so maybe Malcolm if you could share a bit more about this website, that would be great, yeah totally, so this is Sean Buckley, the NHPPA, he's been on this since 2008, been really kind of ringing the alarm, so again another great website to go to, give you a lot of resources, probably the best, there are some webinars that he's done, he speaks to both practitioners, to just consumers, as well as manufacturers, industry, so you can kind of click on the links that are most relevant, and I think one of the best things he has, is his discussion paper, it's about 35 pages, to really kind of go through the details, and that's on there, we'll have that in the link, and you know, as you were saying, you know, if you go to Save Our Supplements, and you just, you know, the petitions are good, electronic, you know, mailing is one thing, but if you think about in your own life, right, if somebody just sends you some random like spam mail, right, but just like, oh it's an auto form, it's like, yeah, you're not really going to pay too much attention to it, somebody sends you a text, okay, maybe we'll get, you know, a phone call, you know, a meeting in person, all those levels up, you know, handwritten letter, will help get your MP's attention, and also to the health minister as well, another big thing here is, you know, that survey that we mentioned, and I'll just come back to this right here, so this is consultation on the natural health products fee proposal only, remember there's three things that we talked about, so this cost recovery fee proposal, that is absolutely huge, and would love your, to share your input on how it's going to kind of cripple the industry, and don't be fooled by, you know, as you read through it, it's like, well Health Canada has costs, and we need to recover these costs, you know, they're not adding any value, this is just layers of bureaucracy that are getting layered on, you know, of over regulation, we're already highly regulated, my argument, and I'm sure Yarrow agrees, is like, this is going above and beyond, this is going to stifle innovation, and any company that incurs these costs, they're going to have their own cost recovery, which means it's going to go directly to you as a consumer, if they even are able to pay those fees, if I know several people like, yep, done, I'm out, you know, companies in the industry like, no way, we're, why would we sell to Canada, right, like, yeah, especially bigger companies that have cool innovative products from Europe, or the States, they're leaving Canada over this, that's already been the case, that we've seen already with the first, and hence why he's been on it since 2008, that's when the first NHPD was kind of put into proposal, coming into effect further on, I think 2013 or 2014, it actually fully came into policing effect, but the reality is, is that what we have right now is working, it doesn't need to be changed, it is stifling innovation to a degree, but there's very little likelihood that they're going to go backwards on that at this point, what we can do something about is this over-regulation and over-taxing of the industry, remembering the key thing to this is, it's going to stifle innovation, it's going to cut down products that are available, it's going to take a lot of companies and put them out of business, and it's going to, in that sense, make products also more environmentally problematic with bigger packaging, plus in the end, the consumer ends up paying for it with the prices of things going up and having less access to what they actually want to work with, so in the end, you're the one who ends up paying for this, I'm the one who ends up paying for this as somebody who uses these products, even though this affects my company, it more affects the end user than anything, because half the companies out there, the way they're going to do this cost recovery is they're going to make their products weaker or less viable or have less therapeutic action in them and increase price and increase packaging, which is just a triple whammy that's going to make it a far less viable industry, anyway, for all of you listening, we really appreciate you tuning into this, all the links are below and we just want to get this out there, please let us know, comments, your thoughts, have you heard of this, what are you doing, do you have any other resources, add them to any threads or anything you can see around this content. Yeah, all right, well thanks so much again for tuning in everybody, please share this out, it's important, time sensitive on kind of a short window, as well as this long window, as mentioned, April 1st, 2025, even though that is the implementation date, things are already changing in the industry because of just the mention of this, just the rumors of this, as well as Bill C-47, you know, they're out on, the government's out on session during the summer, people are tend to, you know, be away, distracted, but it's really important that we get on top of this and yeah, so thanks for your time today, sharing Yarrow and thanks for everybody that has tuned in. Yeah, thank you Malcolm too for calling to action, what needs to be done around this. All right, we'll see you guys soon.