The FDA is responsible for insuring that foods and drugs are safe. Until the FDA is confident that CBD is safe for human consumption it's future is uncertain. Patrick McCarthy joins Joy Beckerman to provide an in-depth analysis of FDA's process. They discuss the app that ValidCare has created called CBD+ME that allows users to provide confidential information about their experiences which ValidCare then provides to the FDA to assist in their process. Produced by PodCONX https://podconx.com/guests/patrick-mccarthy
The FDA is responsible for insuring that foods and drugs are safe. Until the FDA is confident that CBD is safe for human consumption it's future is uncertain. Patrick McCarthy joins Joy Beckerman to provide an in-depth analysis of FDA's process. They discuss the app that ValidCare has created called CBD+ME that allows users to provide confidential information about their experiences which ValidCare then provides to the FDA to assist in their process.
https://podconx.com/guests/patrick-mccarthy
Dan Humiston: [00:00:07] Welcome to another episode of Hemp Barons on today's show, join her guest, have an in-depth conversation about the process of working with the FDA and what steps the industry will need to complete to get CBD and other cannabinoids approved for human consumption. They discuss one of the most important next steps is collecting and consolidating user data and how CBD companies are working together to assist in the process. Let's join Joy's conversation with Patrick McCarthy from Valid Care in the CBD. Plus Me app.
Joy Beckerman: [00:00:46] Well, hello, Patrick. Thank you for being with us on Hemp Barons.
Patrick McCarthy: [00:00:49] Hey, thanks for having me, Joy. Really, really appreciate it.
Joy Beckerman: [00:00:52] Valid care and particularly the app that Solitaire has created CVB Plus Me is really taking on some of the most important work as we undergo this public health revolution and the discovery of the embryo cannabinoid system and this incredible non intoxicating compound within the Hemp within the genus candidates called cannibal guywho or CBB. And as we know, the FDA has been saying for some years now that it is illegal to market CVB is a dietary supplement or a food.
Joy Beckerman: [00:01:25] And they say that for two reasons.
Joy Beckerman: [00:01:27] One, of course, the statutory function within the Food, Drug and Cosmetic Act known as the i and B or investigational new drug preclusion, basically in layman's terms, to simplify it as much as possible as a substance hasn't been marketed as a dietary supplement or food prior to research being made public to create a drug with it or to apply as an investigation on the drug. It cannot be marketed as a dietary supplement. And having said that, the FDA has authority within that same statute to break that rule, change its mind and say, you know what, we believe this is a safe substance, despite the fact that it has been applied for it to be a drug which we all know at the dialect has been approved as a drug. And that is a pure form, an isolated form of the CBD molecule. Hey, you can also be marketed as a dietary supplement or food. And what they are what we're waiting for and what they are demanding.
Joy Beckerman: [00:02:24] The FDA is safety data that will make them comfortable with the low risk and public health of of CBD.
Joy Beckerman: [00:02:36] And what they are waiting for and what they've been asking for is safety data so that they can make a determination as to the safety level at CBD and be assured that there is no risk to public harm. Having said that, of course, the World Health Organization performed a critical review on CVD. They published that in June of 2009 18 and came to the conclusion that this is a safe compound, generally well tolerated, with no real potential for abuse or dependency, and that there is no evidence of any recreational use of CBD. But here we are meeting to compile the safety data. Patrick McCarthy, between the important work that voluntary is doing and that the toxicity studies, only half are really building that bridge and doing some of the most important work to build the Hemp accept and help the industry valide care, of course, engages and detains client conduct, market intelligence and clinical research and really has some of the most important advocates we have right now. Patrick, tell us a little bit about what Valiquette Care is doing and then explain to us the CBD plus me app, which is available in the line.
Patrick McCarthy: [00:03:51] Well, thank you, Joy. Yeah, we're really excited about the work that we're doing. Sometimes you find yourself in a place where there's a big need and without meaning to get there. And I think we found that we came into the marketplace about four years ago after monitoring folks that were signing up for orthopedic surgery, of all things. And Mary's Nutritionals CEO was across the street from me and said, I need that app for my consumers. And they said, what are you talking about? She said, we need to track them and help understand what they're using, why they're using and what it does for them, because we're not a lot of the market, but we sure can listen. And so with that, we took our health care based app platform and brought it over to the Hemp to write product area.
Patrick McCarthy: [00:04:41] And we've allowed brands to brand our CBD plus me app, which is in both Android and the App Store to their brands if they like. So any consumer can go to the app store now download the app and they can start tracking and seeing what certain products do for them. And they can they can actually report into why they're using products. And this is all done legally because it's consumers just giving insights back to the marketplace. For brands like and all in American Sharmin and other customers, they can actually customize the app toward their consumers and engage them in real time and push to them information on education or around product. But they can then glean those insights from the consumers as well and engage them there right now in the market with, you know, with the downturn. It's been really challenging for a lot of commercial brands and they're trying to figure out how to hold on to their customers. And so with this, you really are in the pocket of your consumer and you can engage with them in two weeks. Location safely without the restraints that are put on by Google and Facebook and other wise, we just make certain that everything is safe from an FTC perspective.
Patrick McCarthy: [00:05:56] So no one's making claims that the FTC or FDA would have an issue with. But all that said, the same app platform is used for clinical research coming out of traditional health care. We understand that there is a need for people to understand the effects of cannabinoids on the endocannabinoid system. And so certain brands have sponsored research with us to look at opioid addiction and how CBD can actually impact folks that are on Suboxone, for example. And so we've conducted some studies on behalf of clients that way. But as we saw what's going on with the regulatory path back in May, we submitted some of the data that we had and we asked the FDA, Hey, how can we help? And if we can get you more information, would that be useful? So we finally got a meeting with them in person in December, presented our data that we've collected to date and said, we hear you have concerns around liver toxicity.
Patrick McCarthy: [00:06:56] And if so, how about we put together a collaboration of industry brands to collect data from people that are already using CBD products and then measure liver enzymes after 30 days of use and see what we see.
Patrick McCarthy: [00:07:14] So with that, FDA was really, really excited by the news. And they've opened up a channel of communication for us to submit to them observational data plus blood results to help them really understand if there's a true concern out there.
Patrick McCarthy: [00:07:30] Like you said, they're just not sure if there is a public health issue. The data from the dialects in really sick kids on immunotherapy and anticonvulsants paints, too. There could be some liver issues. And so FDA is not a creative agency, nor do I think we want them to be that they make decisions off of data, off of science, and they're saying, gosh, we need the science.
Patrick McCarthy: [00:07:51] So we've now inserted ourselves to circle back to the beginning of the end of the middle of industry and said, hey, I think we can help. So we're trying to bring as many brands together to introduce us to their consumers and collect information from consumers through an observational study. And University of Kentucky is going to work with us as the host facility. And so we're really, really excited about getting this this data and then bring it forward. So no guarantees. It's gonna be good news or bad news, but at least we'll finally have the type of data that FDA is looking for.
Joy Beckerman: [00:08:26] It's so fascinating what's going on. And thank you for spearheading this so we can dial it back a little bit for the listeners when we talk about claims and when we talk about live and top stories to put that in perspective. Now, in the United States, we have laws and the FTC, we're talking about the Federal Trade Commission, FDA, the U.S. Food and Drug Administration. And we have laws around how we can advertise certain products and when and when we can. Ingestible products are human. It can only be one of two things. I don't wanna be a drug supplement or food. Food and beverage make up their own category. Those are the three things that you can be qualified as in the United States of America if you're going to consume it orally. The human is going to consume it. And if you're a drug, then approved as a drug, which means you've been approved to be able to make certain claims because you've done your clinical trials, you've gone through quite a rigid, stringent application process with the FBI and will have approved you to make certain claims about approved drugs.
Joy Beckerman: [00:09:29] Well, drugs involve, of course, DEA disease. They include in somewhat a valuable depression, pain, inflammation. Those are actual diseases. They will collapse. We're not allowed to confuse the American consumer by discussing the disease in the same conversation or label or package or marketing material or website as dietary supplements or food. And there are laws around that and so on. No one can have a dial, of course, on what the endocannabinoid system does to really dial it back. It controls homeostasis and homeostasis is the great regulator that is the master regulator for all of the body. And when we think about how complicated the inner workings of the human body are, how many different conditions. But we have to walk you through out the day, changes in temperature, changes in anxiety level. We're hungry or full of loaded or we get a headache, get everything within our body. Well, to operate optimally with breathing circulation. All of those things. And so that's homeostasis. And for us to have discovered the endocannabinoid system in our lifetime is sort of paramount to or analogous to discovering that the earth is round and not flat.
Joy Beckerman: [00:10:57] We have more of these and these Lababidi receptors in our brains than we do neurotransmitters and it's huge. So there is such a public health revolution going on and such a burst of research. And so it's very important that while all that's going on. You mean the battery of these products, of course.
Joy Beckerman: [00:11:15] Follow the law around craving attention.
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Joy Beckerman: [00:12:07] We also have this issue of safety and the FDA. We appreciate the FDA. We want our products in our highly developed country here to be safe, to be quality assured. We also get concerned about special interest, which is a legitimate concern in this country. I'm not a conspiracy theorist, but we certainly have to address the reality of corporate interests, special interests and the power of the almighty dollar. And I am suspicious with the FDA ongoing concern after they have then, in fact, provided with so much safety data from the industry itself. And so one example is full disclosure. Of course, in addition to my many, many nonprofit roles and pro bono roles, I've been in Hemp for 30 years. I'm also the regulatory officer in the industry liaison to of law, which is very happy to be using that CBD plus me app for our customers. But we, among many other industry leaders during the public comment period where the FDA was collecting safety data for Cannabis and Cannabis derived substances, provided them with safety data for our Hemp extract products. We don't make products like Epper dialect, which are pure isolated forms of CBD. And in those clinical trials, it's true that high doses of that pure form of CBD apparently did show river. increase liver toxicity in folks who already had liver toxicity or had liver problems or they had a contra indication with existing medicine. Again, without those high doses of the pure form of CBD vs. these Hemp extracts with naturally occurring or concentrated amounts of naturally occurring cannabinoids in CBD are within the extraction, for example, during that public comment period.
Joy Beckerman: [00:13:59] So and others provided safety data similar to we had one product, just a basic tincture, we gave a A if we sell many, many products, just one that one little slice was we took an 18 month period where we sold three hundred ninety thousand units of that product and only 12 complaints, never an adverse event. There have been no adverse events reported as far as we know. Certainly not to listen. All I mean, in the entire industry, we would you know what? We track every complaint, including the most prevalent complaint, which has no effect. So those three hundred ninety thousand units, so we had twelve complaints. Eight were no effect, which is common. And that can be preparing reasons to refer a stomach ache, one with a headache and one was for a blister on the top of that customer's foot. Now surely I think here was not responsible for the blister on the top of that customer's foot. But what's the massive safety data of the world health relation coming to the same conclusion? And yet here we have the FDA basically fearmongering at this point in its press release on November 25th, talking about male infertility. And of course, I feel like they intentionally get the the subliminal message of male veracity and male infertility and there to really get people subliminally in the rude shock. Right, to fear-mongering them talk about breastfeeding and lactation when in fact, while we're breastfeeding, our bodies produce.
Joy Beckerman: [00:15:32] That's the only time since post prohibition here prior to the end of prohibition for Hemp that we were able to get cannabinoids in our bodies because it's human breast milk. Create those cannabinoids to deliver them to the breastfeeding child because they're so important for our developing bodies. And so then they talked about that we were toxicity. And I I'm going to come to a question here in a moment. I swear. But now my my point home, we've got acetaminophen, which most people know is Tylenol. Right. That's a generic form of Tylenol. It's available on every store. Your 5 year old can go and buy Tylenol. And the reality is that during those clinical trials, for safety to be to be able to be sold over the counter, three people died. I guess there's an average, according to the poison control center of 100000 calls a year to the poison control center with concerns about liver toxicity from acetaminophen. Again, Tylenol, an average of 56000 emergency room visits, which equate to twenty six hundred hospitalizations a year due to low dose item and liver toxicity. And then those there's an average of somewhere around 458 deaths per year. And this is Tylenol. And we've got the FDA giving us all of this trouble for CBD. Neither here nor there now. It's the trouble they're giving up. They want to human the liver toxicity studies. So please.
Joy Beckerman: [00:17:03] Tell us how how valid Tip came in here and is trying very hard to organize the industry. And it's really taken the reins on giving the FDA what they are really demanding in order to be able to create this regulatory framework.
Patrick McCarthy: [00:17:19] Sure, happy to. And that's a great overview. Their joy and I think, you know, as a background of the farm bill as it went through these scheduled cannabidiol from Hemp, but it didn't call the ball and say it's either a food or an additive or supplement or a drug, they just left it out there, which is what has caused the FDA to say, well, what is it? We've got to figure out. And they may go down. As you said, it could be a food, it could be a supplement. It could be a drug. They could decide all three things ultimately. But now they want data because the only way they've seen Canada dial before is on the drug route.
Patrick McCarthy: [00:17:58] So with that said, as we presented our data, as you said in May, you guys presented data and we did, too. And then this past fall, we collected similar data to what you saw. And we noted that we had less than 5 percent of four thousand people that reported using CBD. Having any kind of side effect, there were no adverse events and the side effects were really mild G.I. distress or confusion. And then what was really interesting, the people that were taking the product reported more than 75 percent of the time that they had a positive effect from the product for the reason they were taking it. But another 20 percent said they had a secondary benefit. So it does seem like there's a lot of really, really good news around Hemp derived CVD. All that said, FDA did does have the concern. And so here's the interesting part and it gets a little convoluted. They don't want individual companies coming forward with us, with Endi Eyes or I.A.D. Right now. They're really worried about a public safety concern.
Patrick McCarthy: [00:19:08] So as we spoke to them, we said, well, we can collect observational data from people that are using CVD from Hemp today.
Patrick McCarthy: [00:19:17] That's not a problem. But in order to collect liver information, we do have to take blood. So will you let us take blood? Because usually that is under an I.A.D. It definitely requires an internal review board or known as an hijabi through an institution.
Patrick McCarthy: [00:19:34] And they said, yes, we you don't have to go through the traditional approval process because you're not trying to get a product approved, but you're trying to get us information for the industry. So as far as I know, this is a first of its kind study.
Patrick McCarthy: [00:19:50] And with that, we we looked at normal. American humans have about 2.5 percent of us are walking around with some sort of liver toxicity and we don't know about it. So that being said, to figure out how many folks might have an impact from CBD, if they do, we're looking at a baseline of 2.5 percent and measure the difference. So in doing the math on what this called a power score or a PIN number, we're looking for a 2 percent deviation, which takes about 700 people to participate. So what we've done is put together a protocol for 1000 people to participate.
Patrick McCarthy: [00:20:30] We want them all to be healthy adults and we'll screen them on the front side. We know some people may have preexisting liver issues that they do. We expect there to be two and a half percent. So after we screened them, we asked them to keep taking what they're taking for the 30 days and and tell us every day via our app what they are taking. And at the end of the 30 days, go and give blood at one of the national laboratory chains. And that information will be then sent back to the university. And we can pull it all together and then we can see what we see. And so we're not telling people to take a certain dose. We're not telling them not to take certain dose. We just want to observe what's going on. And it's all oral consumption because that's the easiest to measure if they're also using topicals or creams or bath bombs.
Patrick McCarthy: [00:21:16] We'll ask them to note that as they sign up. So we know there's a little bit of a deviation, but this gives us a way to go back to FDA and say, hey, you want to know if there's a public health issue?
Patrick McCarthy: [00:21:27] Here's what's going on in the public. Then we have brands like Seabee Distillery and Charlotte's Web and then Matara and Confusion already signed in. And we're going to go to see if we can limit it to 12 brands. But it would be ultimately great if we can bring 10 in. And so the enrollment period is going on right now and we would expect to have consumers start participating in or around April, collect data over 60 days. And then by this fall, we would expect to be able to have a published study with all the brands participating and get this info to FDA so they can do what they need to do. And so that's really the the mechanics of the process. And, you know, hats off to all the brands that are working with us. This is all funded by the by industry. Unfortunately, FDA didn't get any funding for this level of research. The farm bill only funded agrarian research for the for the growth and the harvest of of Hemp. It didn't do anything about human consumption. So there is no federal money is available.
Patrick McCarthy: [00:22:35] And so industry needs to step up to help itself. And it's you know, it's not a cheap venture and not everybody can afford it.
Patrick McCarthy: [00:22:43] For those that can really, really thankful that they're stepping forward and demonstrating leadership and you a valid can, Patrick McCarthy yourself have demonstrated so much leadership because of you. And then those of us industry leaders who don't know how important this work is. Have been really advocating for participation. Because without that industry participation, it cannot move forward. And again, the FDA is basically demanding and walking the halls of Congress, telling the lawmakers, listen, we don't want this forced on us. We really want the safety data. So please, you'll pass laws that force this on us. We want the human liver toxicity information for our good, necessary or unnecessary. That is the stance. It's been made loud and clear. And without your leadership and taking the reins on this, we wouldn't be as far down the road as beginning to to work on this on this important setting. You've already got the p_h_d_ and the University of Kentucky on this and all of the infrastructure and ducks in a row now just waiting for some additional companies to participate.
Patrick McCarthy: [00:23:50] You know, it's been it's great that way. And I know it was hard, I think, for a lot of the brands, as many have already gone down and NDA process or they've they've invested in the grass. And to be really loud and clear that the FDA is very clear with their communication and people should pay attention to them. But they said grass is not good right now. It's not going to get you there. And they don't really want in the eyes right now. They have to decide what pathways before they go for individual product approvals. And so that's the uniqueness of this study. But it's got to be frustrating. The number of brands that have spent half a million to a couple of million dollars on research that, you know, that research can't be used yet. The good news is if this gets done, there should be the ability for those brands to use that data and or that science that they've already invested in. So I do want to give hope there for folks.
Joy Beckerman: [00:24:46] Oh, absolutely. And and of course, particularly to say either all of that stuff graph process is important for investors. And other than that, this from the vitamin mineral and supplements safe and certainly pharmaceutical for them to recognize you because you are moving that process.
Joy Beckerman: [00:25:06] Of course, it has its benefits. But as we're clear, the FDA is saying animal liver toxicity studies are not meeting the benchmarks for us. We want human liver toxicity studies. And and, you know, in terms of the funding, it was in the report language, it wasn't really binding. But of course, they consolidated Appropriations Act that was signed on that on the 20th of December did provide 2 million dollars for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities, I'm quoting, for products under the jurisdiction of the FDA that contain TDE and meet the definition of Hemp.
Joy Beckerman: [00:25:46] But, you know, we're not quite sure what they're doing with that money and what they're doing with any of those non-binding directives, although there is scuttlebutt that we'll hear something within the timeline that that that non-binding language within the appropriations bill prescribed. Now, let's talk for a minute as we close up here on the CDC, put me out, which is such a fantastic app. And for industry who want to get involved with it, join the ACA or go through the ACA to Hemp.
Joy Beckerman: [00:26:19] Industry Association is a nonprofit, a trade association founded in 1994 that I'm very privileged and honored to lead as president in the current day. We just had our twenty sixth annual conference and we have a great relationship in Dallas where our members, H.A. members can get special pricing on their company brand and CDC puts me up. And we also get a postseasons said a generous donation of a portion of those proceeds comes back to the Hemp Industry Association. So if I'm a consumer. Patrick, why is why is the CBD plus me app useful to me as a consumer?
Patrick McCarthy: [00:26:59] That's a great question. So, number one is it gives you visibility into the opportunity for visibility as to how any Hemp derived product is interacting with your personal endocannabinoid system. So you have the opportunity to. Log in and report why you're using a product. Maybe you just want to report it or you just want to track it and see what happens. Or maybe you have anxiety or maybe you have PTSD, but it then allows you to set a schedule where you report on a regular basis once a day, once a week, whatever it is, gives you reminders and then lets you see how you felt before and after because you're reporting that. And you can report on a number of different products we have about, gosh, you think 700 different product lines in there now. And if you don't see one that you're taking, you can always add it in. But it also then allows you to do a little research on products where you can go in and under the product area. You can get a full description and see if products are actually certified or not. So we are able to filter information so you can see whether a product is Hemp authority certified, for example, or if it's organic. And you can understand the difference between a full spectrum or an isolate.
Patrick McCarthy: [00:28:21] Other than the product search functionality, there's actually education and it's basic education, but it goes a long way on the end of cannabinoid system and cannabinoids in general. And the difference between CBD and THC, the difference between Hemp and marijuana. So it's a really great resource for you to get smart and take care of yourself. Then if you happen to download a version that has been from a sponsored brand like a Lix and all or Sharmin or other, they'll give you a code where that brand can interact with you more generously in terms of daily, they can push you information, including coupons or promotions or rewards. But most of the time it's pushing more custom education from that that customer base or from that product company. And what's need there is if you're interacting with your product company, your data is going back to help them to figure out the science about what products should they be building for people like you. And that's what we love is CBD. CBD plus me allows consumers to collect to those that care about them ultimately. And then that data can be used to advance product development and or research. So sorry for the big, long winded there, but that's really the value from a consumer's perspective.
Joy Beckerman: [00:29:43] Yes. Getting to know who we are. I mean, I think that we go through life under so much stress. And many folks are medicating with food, they're medicating with alcohol, they're medicating with prescription drugs and not really paying attention to what the reaction really is or how they're really feeling. And so this app allows you, I think, to learn your self and really get to know ourselves better. And I think that that's really the public health revolution that's under thinking right now on the planet and in a revolution of consciousness where we are learning self-care, we're learning to honor our bodies, to honor the planet.
Joy Beckerman: [00:30:24] And we're really becoming much more mindful in the way that we walk on the earth and the way that we treat ourselves on a minute to minute basis on that. And I think that's what some of the great promise of Cannabis medicine. Also the mycelium kingdom and the CDC plus me app is very helpful in that process. And it's great for consumers to use, which is fantastic and available on the app label CBD plus sign.
Patrick McCarthy: [00:30:52] Yeah. And best of all, the information that you provide, we key in on an email address as your identifier. So I don't know you by name or otherwise, but the data then can be aggregated and de-identified to use to better help the community in general. There's also functionality in there that if if you like the app going to a little green cross in the upper right and invite your friends to download it as well. And we're ultimately building a community of cannabinoid Ultra's to figure out what's real here. So I hope everybody's able to have a little fun with it and and really start tracking the impact on this on your health.
Joy Beckerman: [00:31:32] It's a win win win in every direction. Patrick, it's such a pleasure and an honor to work with you. And I mean that in every sense of the word. Thank you for everything that you do to advance its industry.
Joy Beckerman: [00:31:43] To rango the industry to be close on all these important elements and for really big polluters. We do thank you so much for being with us. I hope more help.
Patrick McCarthy: [00:31:54] Thanks for the opportunity, Joy, and for all the work you do as well. Have a great day.
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