Joe: On this episode of the "CBD University Podcast," CBD and Liver Health, it's part three of our series looking at an industry-leading study that our brands were a part of. What do the preliminary results show? How can such data help product development and shape industry regulation? This is the "CBD University Podcast," and it starts right now.

I'm Joe Agostinelli, host of the "CBD University Podcast." If you are a returning listener, we welcome you back to our podcast. If you are a new listener, we are glad you found us on your podcast platform of choice. Don't forget that you can watch full episodes of the "CBD University Podcast" on the Global Widget YouTube channel and the YouTube channels of our brands, Hemp Bombs and Nature's Script. We continue our podcast series we first launched last year on episode 35, continued on episode 41 regarding an industry-leading study looking at CBD and liver health. Now, the preliminary results from that study are in and joining me today, once again on our podcast to discuss it all and what it means for consumers in the industry is the CEO of ValidCare, Patrick McCarthy and Global Widget chief compliance and legal officer, Margaret Richardson. Welcome back to both of you, even though, Patrick, it's been a little while. We just had Margaret on last week, we always have Margaret on. But Patrick, welcome back to the podcast. It's been a bit.

Patrick: Thanks. Great to be back.

Joe: And Margaret, welcome back. Even though you're not in studio, we're all remote this time because it's a Zoom episode, it's good to see you as always.

Margaret: Yes.

Joe: So, Patrick, first off, and now we're approaching, hard to believe, episode 70, so it's been a little bit since we've discussed this study. So, let's get some background on the study to refresh the minds of our listeners and our viewers. What were the goals of this study? What was the time frame of this study?

Patrick: Okay, sure. So, goal of the study was to help collect data for FDA, and the data that they want is around liver safety for folks that use CBD orally over the long run. So, it's a minimum of 60 days the way that we measured it. And the reason they're looking for this is because in a prescription drug called Epidiolex, in one of their research studies, they gave huge amounts of CBD to sick kids that were on anti-convulsive drugs and otherwise, and they saw some toxicity issues. So, once hemp-derived CBD came to market after the fact, there was no data or evidence to show to the contrary on this and the FDA is saying, we don't know where safety is and where safety isn't. So, they asked industry to put forward data, and that's when we responded by putting together what I call a crowdsourced initiative to bring the industry together to get the information that FDA needs. And so, with that, we started in August and we were originally supposed to start this time last year, but that little virus got in the way. And in August, we started with 12 different brands and 34 different products and rolled through what we call Cohort 1, and finished on Groundhog's Day ironically. So, with that, we had targeted 681 participants or consumers. Those of you listening that participated, thank you very much. It was overachieved and we hit 839 people. So, the statistical relevance of the data is really, really strong.

Joe: Patrick, first with you, what do the preliminary results show? And then we'll follow this up with Margaret about, you know, our brands being 1 of those 12 brands in the study, what it means for us. So, Patrick, you first on what the results show.

Patrick: Yeah. So, first and foremost, and there's a few pieces of good news in the results. One is there is no evidence of liver disease or toxicity across the entire cohort. All 839 people, no one presented with liver disease or toxicity. So, then we look at, well, is there elevation in liver function tests? And yes, there was in 77 people, slightly above normal. There were 3 people that had what would be called clinically relevant levels of elevation. And with those, those people happened to be on medications that do elevate liver function tests. And there may be some lifestyle things in there. So, our investigators continue to investigate what the etiology or what the cause of that is. We don't know what it is, but there was still no disease or toxicity, which is great. The other big take of this is we went out believing we were going to hit a really generally healthy adult population. What we found is 70% of the people that participated were on 1 or 2 medications and under the care of a physician. So, the good news of that, and you say, well, wait a minute, why is it good news that people were under care? Well, you would expect those people would be more susceptible or demonstrate higher liver enzymes just because they're on other medications and still didn't. A statistical sample of that population, there's studies out there that show in 200,000 people that look like that, you should have some sort of elevation in 11%. We only saw 9%. So, it's right within the clinical range of normal. And it was very, very surprising, but good news, I think for all involved.

Joe: And as one of the 12 brands involved, Margaret, what do those preliminary results mean for our consumers?

Margaret: Well, I think, you know, for all of our customers, they should take it as a...you know, the product at least as it relates to liver, is safe. It should give them confidence when they're taking the product that they shouldn't have those interactions that you might have expected if you were taking other medications. As Patrick said, I mean, it is interesting that so many of the folks were under physician care. I mean, we always recommend to our customers, you know, talk to your physician about what you're taking, let them know, you know, that you are taking CBD products. Most of the physicians, you know, they're aware of CBD and they can help you in terms of...you know, with dosing and things like that. So, I mean, again, as we always say, although our product was tested with others, the good news is consumers should start to really feel like, you know, they can confidently purchase product and there's good quality products out there, and ours and you know, other people are doing that.

Joe: We often talk about industry regulation and what can come from the FDA in the coming years. So, Patrick, how was this data shared with the FDA and you know, what will they do with this data?

Patrick: So, the information was shared via teleconference on March 15th, and this is preliminary data. So, there's a lot more data to come out of this. We studied liver safety, we're also looking at sleep, and we're looking at some other things in there. And we're actually going to start a second cohort to get more data on some of those secondary measures. But with that said, we shared the preliminary results in what's called a manuscript and an abstract, which would typically be used for scientific publication. With the FDA, they have what used to be called the CBD Work Group. It's now called the Cannabis Product Council. Dr. Amy Abernethy who chairs it, she's with the agency only...and actually, I think today's her last day.

Margaret: Yeah. She's leaving.

Patrick: She's heading out. But they had a team of 27 people on the call with us and we reviewed the results. We had our principal investigators and program director on the call. They had an advanced copy so we could have a really good, collaborative discussion. And we did just that. They gave us some feedback and asked us to dig a little deeper into the data to get some things. And then they suggested the Cohort 2 to kind of firm up some blind spots where people may have dropped out of the study and/or these secondary measures. They said that would be very helpful. So, we were able to accomplish that on a call. I have to say the FDA has been really collaborative with this. They've given us a lot of direct feedback. And while I know there's definitely tension between industry and FDA, they've been really, really great to work with to date.

Joe: And Margaret, how does Global Widget use scientific research such as this in our commitment to compliance and safety in our products and everything we do here?

Margaret: Well, you know, one of the things like I said is that it does help us in terms of the safety profile. So, as we start to formulate new products, it gives us an idea of, okay, at least for this range of potency, you know, we have some data to indicate that, you know, you're not going to have significant adverse events, which I think is really important. We would definitely include that in our pharmacovigilance information and, you know, it gives you some direction in terms of dosing. We've also provided that information to the U.K. with our Novel Foods dossier application, and it'll be included, you know, as we continue to look at submitting to Europe and Australia who had mentioned that, you know, they're going to have a path to approval for products. So, I think, you know, we are planning to use it in a variety of different ways. I mean, as Patrick mentioned, you know, the FDA...hopefully, this is information that they can use as they start to build out their regulatory pathway. I think, you know, everybody in the industry, at least all the significant players, you know, what they really want is the FDA to just say, you know, this is what we want from you. And I think everybody is really...you know, they want that. You see it happening in other countries, as we mentioned, with, like, the U.K. and Australia. So, it's better for everyone, consumer, the companies, you know, physicians to have a regulatory pathway so that we can provide good quality product and we know what we're doing.

Joe: And for more information on that Novel Foods dossier that Margaret just spoke about, you can listen to the episode previous to this, that would be episode 68. We're joined by global regulatory services in the U.K. for that episode of our podcast. That's episode number 68. Patrick, you alluded to this a little earlier on, and I just wanted to go back to the point and maybe talk about what's next, but was the study any more difficult because of, you know, what had happened with the pandemic last year? And what is next? As you talk about Cohort 2, what does that mean for folks?

Patrick: Yeah. And so...and, Joe, I realized Margaret covered for me there. Thank you, Margaret. I didn't answer your question fully on the last. So, the hope is FDA will decide one or more regulatory paths. For those that are interested, the last formal communication that we're aware of was last March, FDA sent a letter to Congress and said, here are the potential regulatory paths for CBD, but in order to go down any of them, we need safety evidence. And the supplement aisle looked like the shortest putt, to use layman's terms. And whether that's it or not, I don't know, but the data has been taken in by what was the Cannabis Work Group, what is now the Cannabis Product Council, and they've assured us that this will go to help them do that. So, check the box, sorry, new paragraph. In terms of more difficult, yeah, I think this was difficult on a lot of levels with, you know, you do clinical research and it's usually multicentered, right? So, it's different locations. This was completely decentralized. And when we look at what COVID did, it shut down most clinical research across pharma and everything and forced people to think out of the box. We were fortunate that our core business is run off of a decentralized clinical trial platform. But with that, we had to think, wow, how do I get product to North Pole Alaska, which is a reality in this one, and down to Miami, and all points in between? And so, it's getting product there, and then working with the big national laboratories, like LabCorp and Quest, and making certain that they were ready to catch people when they came in so they could get a free blood draw.

And so, a lot of logistics there as well as managing 10...or I'm sorry, 12 brands and the lot-specific products. So, really boring supply chain stuff that's very, very important and auditable and gets you in trouble with the FDA if you don't do it right. So, you know, and not being able to go and beat somebody about the head and neck because you're remote and you're socially distanced, you can't really do what you want to do to people that mess up. But, no, so it worked out quite, quite well. We had a couple of little snack foods in there, but Global Widget and other brands really helped us pressure test the operations. And then what was fabulous is we've had over 60% of the participants already contact us and say, "We want to be part of additional research if you do it. This was really easy and we liked being part of it." So, thanks to all that are listening that were there. You're heard and there will be more research coming, which segues to what you asked.

Joe: So, yeah, you know, and finally, Margaret, as Patrick alluded to, with more research coming, how important is it for not just our brands, but really, you know, in an industry like this, brands to come together to be able to partner with somebody like ValidCare on research such as this where we're using customer really driven data?

Margaret: Yeah. I mean, I think, it really speaks to the industry and you know, the industry, I think, in general, is really collaborative. They like to work together. I mean, certainly, you know, the companies that we interact with, we all know that ultimately we want to provide a high-quality product to the consumer. So, from that perspective, you know, as Patrick said, it was really great to work with everyone, get the input, you know, and it gives you, you know, a benchmark, folks to talk to. So, that's always nice. I do want to point out, as Patrick said, it was kind of a decentralized approach to the clinical research. So, I do want to give a shoutout to our distribution team and customer service team because we had a significant number of participants. We had two different products. It was pretty complicated to get the product out. And, you know, they did a great job even given all of the craziness last year to, you know, find the customers, get the products, and you know, track if there's a problem. So, I mean, it really was a unique effort. And again, I have to give props to the entire, you know, industry to step up to the plate and do something like this. Not all industries work together, so it helps.

Joe: Well, thank you, Margaret and Patrick. Thank you once again for coming back on our podcast. We'll certainly have to do this again as news evolves and additional studies are done. And I know, Patrick, you alluded to being remote, but hopefully, and we talked about this, I know we talked about this back in episode 41, 30 something episodes ago, but it hasn't changed yet, hopefully, the next time we're all together, maybe we can do it all locally. We'll see what happens.

Patrick: Yeah. I'm all for it.

Joe: So, have you in the studio.

Patrick: Show me an ocean, Joe. Show me an ocean.

Joe: There's lots of water down here. Lots of water. So, Patrick McCarthy, the CEO of ValidCare and Margaret Richardson, chief compliance and legal officer here at Global Widget, my guests on this edition of the "CBD University Podcast." And you can find more information out about this study and the press releases put out by both Global Widget and ValidCare by visiting each of our websites and following along on our social media networks. The links to those will be in the podcast description of this episode. So, once again, I thank you, guys, both for appearing on this episode. And I thank you all for tuning into this episode. And on behalf of both Margaret and Patrick, as Patrick mentioned, if you did take part in the study and you're listening, we also thank you for that. And a reminder that you can subscribe to our podcast and get notifications when new episodes are published each week on your podcast platform of choice and catch full video episodes of our podcast on the Global Widget YouTube channel and the YouTube channels of our brands, Hemp Bombs and Nature's Script. I'm Joe Agostinelli, the host of the "CBD University 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.