Episode 35: CBD and Liver Health



Joe: On this episode of the "CBD University Podcast," helping drive the science and safety behind CBD, how Global Widget is taking part in an industry-leading study regarding CBD and liver health, and our ongoing investment and its approach to product development and from a scientific perspective. This is the "CBD University Podcast," and it starts right now.

I'm Joe Agostinelli, the host of the "CBD University Podcast." If you are returning listener, thank you once again for tuning in, and if you are a new listener, we are glad you found us on your podcast platform of choice. Don't forget you can also catch full video episodes of the "CBD University Podcast" on the Global Widget YouTube channel and the YouTube channels of our brands.

Little known fact, one of my favorite TV shows growing up was "Mr. Wizard," so it's always exciting to discuss the science behind your favorite CBD products across all of our product lines and to discuss a new study that some of our customers will be taking part in is our chief compliance officer Margaret Richardson, and our director of eCommerce, Gina Bongiovanni. Welcome to both of you.

Gina: Hello. Glad to be back.

Margaret: Yeah, always fun.

Joe: And so first, Margaret, let's talk a little bit about the study. Actually, hold on a second, there is something else we have to mention along the quality and compliance. There is something else, as I mentioned. This is actually your first podcast episode since you were recently honored by the "Tampa Bay Business Journal" as one of the Tampa Bay area's top corporate counsels. So from everyone here at Global Widget congratulations on the award. And Gina and I have the privilege and pleasure to work with you. But Gina, for our customers who don't personally know Margaret, talk a little bit about her commitment to quality and compliance and all our products and what that means for our customers, distribution, and retail partners? Wait a second, this wasn't in the pre-production meeting.

Gina: For sure. We had to hide this from you, Margaret. But honestly, it is truly a pleasure and I'm so proud to work alongside of you here at Global Widget. I feel like you are a true catalyst for change within our industry both for our compliance and quality, a real force for change and positivity as far as just really kind of taking us in the CBD space beyond where we are as a whole so not just for Global Widget, but across the board. You know, you keep us on the bleeding edge of compliance and superior quality of our products, our processes, pretty much everything we do around here. Personally, I want to say that I admire your commitment to your craft and as a female leader, you're somebody that I look up to personally.

Margaret: Thank you very much.

Gina: So thank you for all that you do to just keep us moving forward. Our customers, they don't realize all the behind the scenes work that really goes into the things that you've done and how far you've really grown our business over the past year. And I think the coolest fun fact about Margaret that I was really excited to learn was that if she were a baseball player, her walk-up song would be Guns N' Roses "Welcome to the Jungle." So she is not only an amazing, impressive corporate counsel but she's pretty hip and awesome too.

Margaret: I don't know if you can count hip and awesome a song from the '80s, but yeah.

Gina: Well, from one '80s chick to another, I think you're pretty badass.

Joe: Well, congratulations again, Margaret.

Margaret: Thanks, I appreciate it.

Joe: And now we'll talk a little bit about the study and what we had mentioned in the onset of this episode. So let's talk a little bit about that study, who was the study through and what is the objective of this study?

Margaret: Yeah, so the study is actually sponsored by a clinical research organization called Bowel Care, and it's actually a consortium of several different CBD companies that are sponsoring the study. And the goal...it's an observational study, first of all, which means that you're gonna observe those individuals that are already normally taking CBD and get an idea of how the CBD impacts, for instance, their liver and also their reproductive system.

So the study is really designed to last for 30 days, everyone who's participating in the study, they aren't naive, meaning they already take CBD, so we know that about them. There are some criteria that can exclude them from the study which is very standard. So it is being run like any other clinical trial that the FDA asks companies to run in order to get products approved. And that's really the crux of the study is to have data that we can then give to the FDA. And it's at that level of quality and compliance, no different than if Pfizer or GSK or any other big pharma are doing a study.

Joe: And Gina, as we always welcome and take pride in our customers' feedback, how did we reach out to enlist our customers to take part in this study?

Gina: Absolutely. So the sponsor of the study had some specific criteria for us, and that was that we pull customers who are known to have purchased within the past 60 days. So we pulled a list of folks from our email database that had purchased within those 60 days and we sent them just an email about it and let them know what the study was about, some of the qualifying components to that study and what they would need to do in order to participate. And I'm so excited to share with you that that email went to a couple of thousand folks and we got over 1300 respondents within just the first 24 hours of having sent that email. So people were really excited to share their story, and I think moreover be a part of a scientific findings around kind of supporting our industry and taking it that step further.

Joe: And just a cheap plug, if you want to visit the websites of any of our brands, sign up for our customer newsletters and that's how you will not only be the first to find out about special offers, but the latest news, new podcast episodes, everything that we have going on from all our brands and here at Global Widget but also have the ability not only to provide feedback but also take part in future studies. So do sign up for our customer emails. Margaret, what is the timing around the study and the results of the study? How long are we talking?

Margaret: Well, the study started just basically this week. As I said, the goal is to basically provide CBD, so they'll be observed for 30 days, so it essentially lasts for a 30-day period for all the folks that are enrolled. At the end of the 30-day period, those that completed the study which included logging into a phone app on a daily basis, talking about how they feel after they've taken the CBD, any kind of quality performance metrics, lifestyle-type metrics. And then at the end of the 30 days, they will then go to the doctor and the doctor will take two blood draws, one will be for liver panel and the other, if they're a male participant, will be testosterone.

So it's really to address two of the issues that the FDA has identified as a concern. One is liver toxicity, particularly with chronic use of CBD, and then the second is reproductive changes, particularly in the male participants. From our perspective, you know, we're not really concerned about the liver toxicity, as we know a lot of the individuals who use CBD have pain and so they're also using a lot of aspirin or acetaminophen and some other products which are known to have liver toxicity issues. So it's likely that it's more coming from that as opposed to the CBD and then as I said also looking at reproductive changes. So we feel very confident, we actually are doing, what's called two arms.

So total, we're looking at about 1200 to 1500 subjects from all the companies participating, we're gonna do one that focuses on our gummies. So our 30-milligram high potency gummies will be part of the study and then the second arm will be on the tinctures, our 1500 tincture. So again, just to get an idea of different potencies, different methods of delivery, all of those things can make a difference in terms of outcome, so we're really excited to get that information.

Once they get the blood draws, that information is then, of course, sent to the clinical research organization. They take all of that data, they're gonna put it together in a blinded fashion which just means that we don't know, you know, who the participants are but we can see the data. The goal is to have it complete by the end of November. That will be submitted to the FDA, as I said, to help them as they develop their guidance for CBD.

So we're excited to really be able to support the FDA in their role as a regulatory agency for CBD, as we've talked about it I think a couple of times, Joe. We really feel that that's important. You know, we welcome that regulation, we feel very confident that, you know, we're already in that...you know, heading in that direction, so no concerns for us but it definitely will make it better for the consumer. They will know with a 100% confidence that the product that they're purchasing, you know, doesn't have any side effects, that it's safe and effective for whatever they're purchasing it for. So again, probably end of November. And then, of course, we'll get some information on our products in particular and then we're looking forward to sharing that with everybody who participated in the study.

Joe: And then Gina began just taking part in this study, customers are always invited to offer their feedback, reviews, and experience, you know, using all of our CBD products, what are some of the ways that we constantly make the customer be a part of the entire CBD experience?

Gina: Absolutely, Joe. So our customers obviously are why we're all here and we want to make sure that we're providing them with the information that they need to feel confident and safe in taking our products. So some of the ways that you can stay in touch with us and provide feedback, also really get on the list to be able to participate in future studies and really be a part of this emerging science for us. You can stay in touch with us via email, there's a pop up that occurs in all of our direct to consumer sites, so you can go to hempbombs.com, perfectpawshemp.com or naturesscript.com, there's a pop up that invites you to sign up for email also offers you a little extra special discounts on that first purchase. So I encourage you to sign up there. If for some reason you don't see that pop-up, you'll also see an email sign up in the footer area, so the very bottom on the homepage of all of our consumer websites.

If you're connecting with us as a distributing partner, a distribution partner, or a white label, private label, or RA partner, they're on those sites as well. So the sites that you would go to would be www.gwcbd.com, as well as partners.globalwidget.com, same thing there's going to be a pop up that slides out where you can enter your email address, or you can always find our email sign up in the footer. That's just gonna keep you updated with the most current information. There's great tips from Margaret on different compliance-related aspects, all of our new products, we have all of our lab tests out there so you can feel safe and confident in the products that you and your consumers are participating in. So email is a great way. We also have social media platforms for all of our sites including our wholesale partner-related sites. So I encourage you to go to Facebook, Twitter, Instagram, as well as YouTube. And did I miss one Joe?

Joe: LinkedIn, wholesale side.

Gina: So please follow us there because we do put a lot of especially on the ones that are business-related, we do put a lot of information out there about the various studies in which we participate in different things that we're doing to just really kind of set the industry standard. And then if you are a customer of any of our brands, we encourage you to write product reviews and brand reviews, it's how we know how we're doing essentially. So you can write a review on any product that you purchase by simply clicking on that product details page.

There's also the options to review Hemp Bombs, Perfect Paws and Nature's Script, we want your honest opinions. Through customer feedback, we've been able to effect some really great changes related to our shipping and delivery methods to make those a little bit faster and more efficient and even within formulation, based on customer feedback to do certain things, to make the product done, you know, to really improve it and really get our customers excited about our array of products.

Joe: And that's a great transition to the next question because as we talk about formulation, talk a little bit about driving the science behind the development of our products with the creation of a new external advisory board?

Margaret: Yeah, so we have created a scientific advisory board and really the goal of that is to provide scientific strategy and long-term planning for the business. So looking at things like what's gonna be in the future for formulation, are there better ways that we can, you know, deliver CBD? So it has a better impact or more effect on the customer or consumer when they take it. Looking at formulation from the perspective of topicals, how can we ensure that the CBD is, again, permeating the scan, is effective in that particular product? So having a scientific advisory board that will include experts in formulation, experts in CBD, and the science of CBD, just the pharma kinetics of it, how does it work? How does that actual molecule impact people, and how does it impact our particular system? Those kinds of things make a big difference in terms of how we do formulations and hopefully future products that we can deliver to our customers.

Joe: And as you mentioned, this is just the start of the study, this will go through the end of the year and which means, you know, stay tuned to the "CBD University Podcast" and our social media networks on our websites for more information on this study as we chronicle our journey through the study, and then we'll get together again at the conclusion of the study for part two of this podcast to go through some of the results and maybe by then maybe something on the FDA, I don't know.

Margaret: You never know, I mean, they did send out guidance on some test methods which we're really excited about, we're gonna be commenting on those and we anticipate that, you know, the FDA is going to come out with some specific guidance as it relates to CBD.

Joe: So I thank both my guests, our chief compliance officer, and the newest member of the "Tampa Bay Business Journal's" top corporate counsel for 2020 Margaret Richardson, frequent guest here on the podcast and our director of eCommerce, Gina Bongiovanni. It's hard to believe, but we're gonna have to break out the holiday outfits pretty soon and do our holiday preview episode again.

Gina: I can't wait for it. We're gonna make it an annual event.

Joe: I'm ready. So I want to thank both of you guys for coming on, a lot of great information about the study and obviously how customers can become more involved across all of our brands and social media networks and customer email newsletters.

Gina: Well, thank you, Joe.

Joe: And I want to thank you for tuning into this episode of the "CBD University Podcast." Reminder, you can also leave your feedback by reviewing our podcast on your favorite platform of choice, or if you have questions that you would like us to answer on a future edition of the "CBD University Podcast," please email podcast@globalwidget.com. We'll be sure to incorporate some of your ideas into a future episode. And if you haven't done so already, subscribe to our podcast through your favorite podcast app or on our YouTube channel, you'll get notifications each week when new episodes are published. 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.