Joe: On this episode of the "CBD University Podcast," novel foods and the CBD industry. What it all means, and how our products could be coming to more countries and consumers around the world in the months ahead, the latest step to how we are doing CBD right every day. This is the "CBD University Podcast," and it starts right now.

I'm Joe Agostinelli, host of the "CBD University Podcast," and if you are a first-time listener, we are glad you found our podcast on your platform of choice, and if you are a returning listener, welcome back to our podcast. And for those of you who like to watch video episodes of podcasts, if you have not yet done so, check out our YouTube page, the Global Widget YouTube channel, and the YouTube channels of our brands, Hemp Bombs and Nature's Script, for full video episodes of the "CBD University Podcast."

And this is another one of our Zoom episodes. We are joined via remote, and I'll introduce everybody in just a minute, but as the CBD industry continues to evolve, here in the United States and around the world, we are going international on this episode, as we discuss novel foods, what it all means, how the novel food status affects CBD, and what it means for our products getting into the hands of consumers outside of the U.S.

So, we' talking to United Kingdom specifically today. Joining me for this episode is our chief compliance and legal officer, Margaret Richardson, who's been on the podcast quite a few times before. Hello, Margaret. First time I think ever remote, though.

Margaret: That's true, Joe. Lots of fun.

Joe: And then Greer Deal is the director of Global Regulatory Services. Welcome, Greer.

Greer: Thank you very much, Joe.

Joe: And Dr. Rafe Bundy is an associate consultant at Global Regulatory Services. Welcome, Dr. Bundy.

Dr. Bundy: Hi, Joe. Nice to meet you.

Joe: So, let's first start off with Greer, and for our listeners who are not familiar with it, what are novel foods, and how does it pertain specifically to the CBD industry?

Greer: It's a very, very good question, because everybody thinks food is just food. And no, we have a regulation for food that is novel, and novel means that there's no significant consumption of that food or food ingredient in Europe before the 15th of May, 1997. Not quite sure why there's such an exact date, but there is, according to our regulations.

So, with respect to CBD, though, I think a lot of people are aware that it is available on the global market as a food, as an ingestible, and specifically with Europe and the UK, it is already on the market. But the novel food regulation, you're actually supposed to apply for approval, to convince everyone and demonstrate that the food is safe to consume, before you place that product on the market. But we have CBD products already on the market, so we're in this very unusual situation. There's a gray market, because strictly speaking, these products are not supposed to be there. They're illegal because they haven't been approved. They haven't gone through this full validation safety assessment process.

So that, it's a huge, and excuse the pun, but it is a growing industry. And it's great for economies, it's great for the health of people as well, so governments don't want to pull product from the market. So we're having to do things retrospectively. So, and when I say retrospectively, CBD was only announced as being novel in January 2019, so it's all relatively recent. And then, just to give you a little bit of history, then, last year, summer 2020, the EU Commission suddenly sat back and thought, "Ooh, actually, is CBD a narcotic, and not a novel food after all?" So the applications which had gone in for approval were all pulled, and it took a few months before the EU Commission, having consulted other bodies, etc., and there were a few other legal cases going on as well, they actually came back to the industry and said, "No, CBD is novel. So, carry on."

Joe:  And Margaret, we've talked in past episodes about our commitment to safety, quality, and compliance. How is this another step in the process of not only doing CBD right every day, but continuing to lead the industry in compliance?

Margaret: Yeah, well, I think, and Rafe can probably talk to this a little bit more, but in order to complete the application, we also had to do a number of different safety studies. And I think, you know, that, again, provides some comfort to our consumers that CBD is safe, and that there aren't any issues with it in terms of ingesting it in reasonable amounts. Of course, UK has put a limit in terms of the potency, the milligrams that you can take on a daily basis. So, you know, the products that we're looking at are, you know, in that band of safety that the UK has set up.

Joe: And how long, page-wise, how long is the document that has to get submitted?

Margaret: If you print it all out with the appendix, it's approaching, you know, 400, 500 pages. So, I mean, from a regulatory perspective, that's pretty common when you submit applications to regulatory agencies, because you've gotta include all of the data, and the backup data, and appendix, and all types of exhibits, but yeah, I mean, it shows that, you know, there was definitely a lot of work that went into it, you know, a lot of other activities that went to support that product, whether it was getting data from the very first, where the hemp came from, showing and proving that you grew it properly, and then of course, all the way to the isolate, and then how we manufactured and produced product that we later used in a clinical trial. So, it's a lot of detail that goes into that agency for review.

Joe: And Dr. Bundy, talk a little bit about the science Margaret alluded to, some of that on the different studies that have been a part of, from a scientific angle, what are all these studies about, and how are they conducted, and what are the objectives?

Dr. Bundy: Well, I guess the overall objective really is just, is to prove safety. So, really, that's what the regulators, that's the bottom line for them, you know. Is the product safe? Is the CBD safe? So, I won't kind of go into all the technicalities of the studies, but you basically have studies to look at, they call gene toxicology, which is, like, does it affect the gene level, the DNA, you know, in us? Does it affect our organs, and, there's, kind of, studies that are done in a test tube, in vitro. Sometimes, unfortunately, studies have to be done more in vivo, and potentially animal studies. It's kind of the same thing that you would do if you were testing a drug, if the FDA were testing a drug for the market. And it's really just to kind of cover all the bases, and make sure that, you know, there's nothing there, which, as Margaret said, the FSA in the UK have set a limit of 17 milligrams per day, but they just want to ensure that over time, if we took 17 milligrams a day every day, then nothing bad's gonna happen to us.

Joe: And just a quick, and either one of you can answer this question, when it comes to a limit a day, so, is that on the consumer to keep in mind what the limit is per day, or does that go into the labeling and packaging requirements on the products out there? How does that work?

Dr. Bundy: Yeah, so, it's a kind of, it's a sort of double approach, really. So, I guess the labeling is very important, and the labeling is there so the consumer knows exactly that that's the limit, and that's the, kind of, what's suggested as the maximum. But I guess also the products are designed so it's kind of hard to, like, exceed that limit. You know, you'd really have to kind of go a long way to, like, take more of the product than you needed to. So it's kind of like a double approach.

Joe: And what was is the current limit per day?

Dr. Bundy: So, it's 17 milligrams of CBD a day is the limit that they've set in the UK, so we're all kind of conforming to that, and all the products are really in that range, so that, you know, if you took, say, two or three gummies, or, like, half a mil of oil, then you'd be getting around, kind of, that maximum limit.

Joe: And Margaret, when it comes to science, we've talked about science driving the research and development products here at Global Widget. Talk a little bit about the processes like the novel foods approval in regards to that.

Margaret: Yeah, I mean, from Global Widget's perspective, and also other CBD companies, I mean, you know, we want the consumers to feel comfortable with the products on the market. So this is just one of many types of studies that we're doing. As Rafe mentioned, there are still some studies to be done in animals, and of course, we've also participated in clinical trials with humans. And there are other consortiums in the CBD industry that are looking at other studies, to look at dosing, for instance, in pets. That's a really important question that's not answered yet. And there's still some questions about, in particular, reproductive toxicity, especially in males, that I think, you know, the FDA is wanting to get some data on. And that's what the agencies have said, I mean, they want to make sure that the product's not gonna have any kind of chronic toxicity issues, because the... Most people take CBD on a daily basis. And so, if you're gonna take it every day, we wanna make sure that if you do it for 10 years, that you're not gonna have some kind of negative health outcome, you know, 10 years from now.

And, I mean, those things are reasonable. When you go to the store, whatever product you purchase, aspirin, or Tylenol, whatever it is, you wanna believe that if you follow the dosing instructions that it's gonna be safe and effective for whatever purpose that you're taking. And our products need to be identical to that, and that's why we work on making sure that we understand how CBD works. And of course, there are other cannabinoids, also, that are being studied right now, and you see just in general, on the research side, you know, there's a variety of different, you know, researchers that are looking at how those work and what they're effective for, and so, we'll continue to see this type of research, and we'll continue to be involved in it.

Joe: And Greer, we talked about, you know, what goes into this process, the large document, the scientific studies behind it, and you talked a little bit about some of the dates, you know, leading up to the deadline. What goes into this process? What's the timeframe of having something like this approved for a company? And are there other countries where this is replicated, or does everybody have their own, you know, whole new process?

Greer: So, the novel food regulation is a European-wide regulation, but of course, everyone knows now that the UK is now outside of Europe, so we're not part of that, although we have adopted the novel food regulation into our own law. But it does mean that the UK has a unique mechanism, and the unique mechanism is that the Food Standards Agency is allowing this admission of incomplete dossiers to be submitted to them right now, and as long as they're being submitted by the end of March, this year, and product was already on the market on the 13th of February 2020, then the product can stay on the UK market. That is unique to the UK. That's nothing to do with Europe, but it's a way of getting the industry to be compliant with the regulation to ensure safety.

In terms of timelines, with the actual application process, it's very similar in the UK and in Europe. So, you make your submission, there's a short period of about eight days for an administration check, and then this is where there's a slight variance, I believe, in that the validation phase, so, checking that all the data is there, or should be there, or as agreed, in the UK, they say that's 30 working days. In Europe they say it's one month. Now, that's a subtle difference, because 30 working days actually means, you know, a longer time than just one month.

Joe: You get weekends off?

Greer: Yeah. Apparently. Well, I'm not sure that Rafe and I do, but the FSA does. So that's, so, let's say a month for the validation. And then there's the safety assessment phase, where the safety committee...this is the UK...the safety committee will have a look at all the data. Right now, of course, that data is incomplete. Margaret has said there's still data coming in from tox studies, so we're waiting on that. So, the committee in the UK are going to assess all that data, up to the point where they're gonna have to wait for the remaining data, and then they're gonna press the pause button, and there'll be a stop clock. But if there wasn't a stop clock, that whole process is about nine months, and that's in Europe and in the UK. And that's nine months without any questions, they accept all the data, they think it's great, etc.

And then, certainly in Europe, it then has to go round all the member states. So, assuming that it's, the recommendation is for approval, it then goes round the EU member states, to get them to say, "Yes, we agree that it should be approved," or they may raise more questions themselves. And that's about a seven-month process. So really, best case scenario, to get full approval, which I've gotta say, best case scenario's probably very unlikely, is 18 months, from submission to approval. It's likely to be at least two years. It could be longer. I'm aware that other novel foods, non-CBD, you know, they're three years on, and they still haven't got approval. So that's the kind of timeline you're looking at.

Joe: Yeah, and final question for both Greer and Dr. Bundy. Does CBD present unique and different challenges from other novel foods from what you've seen so far? I mean, we've talked about some products may already be on shelves, you know, over there anyhow, so what kind of challenges does the industry maybe have that's different from other novel foods?

Greer: I'm gonna let Rafe jump in here.

Dr. Bundy: I think, as Greer said, I mean, you know, first of all, this kind of regulation's being applied retrospectively. And it's kind of like a best fit, you know, so obviously, it doesn't fit 100%, and products are already on the market. So that's why, as Greer said, we've got this kind of unique position of, like the FSA is saying, "Fine. Get something in which is complete, and we'll let you keep your products on the market while we assess." So that's one thing. I think the other thing is, of course, you're aware that the difference with CBD is you can have different formulations of CBD. CBD, as a chemical, okay, than that's CBD, but as an isolate, it's, like, 99.5% pure, so obviously, I've been working with Margaret for, on the isolate that you guys do, but if you've got a distillate, that might be 90% pure. Or you might have an 85%. You might have a broad spectrum, you might have a full spectrum. You might have different minors. So although that's classed as CBD, when it's gonna be assessed, at the end, there won't be, like, one CBD and one specification. There's probably gonna be, like, 10 or 15 different CBDs from different primary producers, with different specifications.

So, this then gets a little bit complicated because of, like, you know, which final products have been linked to which primary ingredient. Eventually, I think the idea is that once they're all assessed, then, of course, a secondary manufacturer, so a brand manager, can go and say, "Well, I want that one. That one's been authorized, so we'll put that one in my product and we'll sell it." But obviously, in this point, that's quite confusing. If it was just one chemical, it would probably be easy, because it would be authorized, and that would be it. But when you're looking at having extra minors in there, like a little bit of CBDA or CBDB, obviously, that might change the safety profiles. That has to be assessed separately to the pure isolate, and hence the complexity.

Joe: Lot of great information. Greer, Dr. Bundy, I wanna thank you guys both. Even with the time difference, I know, five hours ahead of us, from the time we're recording, so I appreciate you guys taking time out of your busy days to join us for this episode of the "CBD United Podcast," our first guests ever from the UK, and we're now 67 or 68 episodes into the podcast. So, really enjoyed the conversation, and love to have you guys back again, as we go through this process to learn more.

Greer: Thanks, Joe. It's been great.

Dr. Bundy: Thank you very much.

Greer: Thank you.

Joe: And once along this process, and then, once the dossier's approved, we'll obviously share that news across our social media networks and our websites, and Margaret, as always, thank you for joining me, and I'm sure we will be getting together very soon for another episode of the "CBD United Podcast."

Margaret: Looking forward to it.

Joe: And don't forget, for the latest industry news and trends, product releases, everything CBD health and wellness, subscribe to our "CBD United Podcast" wherever you get your podcasts. You'll get notifications each week when new episodes are published, and as I mentioned on the outset, don't forget, full video episodes of our podcast available on the Global Widget YouTube channel, and the YouTube channels of our brands, Hemp Bombs and Nature's Script.

I'm Joe Agostinelli, host of the "CBD United Podcast." thanks for tuning in.

These statements have not been evaluated by the Food and Drug Administration. The CBD products are not intended to treat, cure, or prevent any disease or condition. Always consult your personal physician about CBD and using CBD products. CBD should never be used by anyone under the age of 18. This content is not intended to provide legal advice regarding the legal status of CBD and CBD products.