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Heart Coherence & Healing: Deborah Rozman on the Power of the Heart-Brain Connection
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Join Deborah Rozman, President and CEO of HeartMath, for an eye-opening conversation about the power of heart coherence and its transformative impact on health, emotion, and consciousness. In this episode, Deborah shares the groundbreaking research behind HeartMath’s techniques and tools—like the Quick Coherence® technique and HRV biofeedback—that help regulate stress, support cardiovascular health, and reconnect people with their inner wisdom.
Learn how heart-brain-body synchronization leads to better decision-making, improved emotional regulation, and deeper resilience—whether you're a healthcare professional or someone seeking more peace and vitality in your life. This is more than a wellness conversation—it's a guide to rewiring your inner operating system with compassion, clarity, and coherence.
🎧 Bonus: Deborah leads a live heart-focused breathing session to help you reset and rebalance in real-time.
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Premier's Approach to Quality & Personal Stories
Speaker 1Nick Lubinsky, as some might say, the most interesting CEO on the planet. It's a pleasure to be back with you today. You know, last time we were here we really took a deep dive into the history of Premier Research Labs kind of the story, your story, why you're here. We got to talk a little bit about products and you know our company is built on changing lives. You know our company is built on changing lives and I wanted to maybe start today's conversation with maybe getting back into that personal side for you and a moment in your career and your tenured career with Premier Research Labs our story around our products and how they've changed the lives of people using them.
Speaker 2So how has our story or our products changed the lives of people that have used them? There's so many of them. Honestly, through the last 16 years of being at PRL, it's hard to really pick, but I have to say that I've heard so many practitioners that I've heard so many practitioners either at local events or practitioners that onboarded with us, such as Dr Klein who does podiatry, and he, you know, was wondering how does a, for example, a vitamin C, help with something that doesn't seem like it should help with it? And you know my answer to that whenever he asked those questions, is that you've patient, never experienced true clean nutrition before. You know the level of detail that we go into when trying to test quality in our product to make sure there is no adulterants. Less than one percent of the industry is doing that and that is a generality that we heard from a, from a auditor, so he doesn't really know. He's basically saying that there must be somebody doing that.
Speaker 1I don't know.
Speaker 2I mean, we do stuff that literally nobody wants to do. They're actually turning a blind eye to, for example, aflatoxins, right, like we talked about last time. But it goes beyond that and I think that we hear these stories and here's a good example of what happened to me many, many years ago. Uh, this is 2013. I was, uh, about to propose to my, my wife and I decided to try to teach myself how to scuba dive. Um, always had problems with my eardrums long story but went through the training and, unfortunately, at the very end, I ruptured my eardrum during the training, like the very last test. It was very frustrating, but I remember going home that night and I came in the next day. My ear was bleeding all night because I ruptured it pretty bad and Dr Marshall looked and he goes, oh, he goes. He gave me a bottle of DHA and he goes. I want you to take most of this bottle today and just take it all. And I was like what? Take the whole bottle. I was very, I was kind of shocked.
Speaker 2But I was like okay, I mean this is, I know you, shocked. But I was like, okay, I mean, I know DHA is great for membrane health. I definitely ruptured a membrane and I said, fine, I'll do it. What had happened, which was interesting, I had a follow-up appointment to the ear doctor later that week just to see how my healing was going and he said he looked in there and it actually healed too fast. It actually accelerated the healing so fast that he had to go in there and pierce it to get the blood that was caught behind the eardrum.
Speaker 2And that's a personal anecdotal, you know, this is something. But the power of whole food nutrition that's at the right potency. And I think what's out there in the industry and there's good brands out there, don't get me wrong but there's a lot of, unfortunately, brands that are fly-by-night companies or really taking advantage of the consumer by giving subpar, sub-quality stuff, why, most of the time it's to put more money in their pocket. Right, if I sold you something that they say is berberine but it's actually only 50%, I just made a lot more money per pill, even though I'm selling it at the same price point as somebody else that's selling it 100%. But I think there's a lot of those companies, and we see this with the Amazon effect right, where people just kind of throw brands up there. Anybody can start a private label.
Speaker 2There's a whole argument in this industry whether there should be more restrictions. You know you have to submit product, but there's a whole slippery slope there that I think there should be I mentioned this before Some kind of accountability, some kind of proof that this is what it's supposed to be, either from a, c of A Don't know if we really need to submit labels, but that all being said, I think that there's been so many stories with practitioners getting healed by our products and when I say healed, I mean they're supporting something that they've been working on for a while and our products seem to have helped accelerate it. But was it that? I can't prove that, and I have to make sure it's very clear that this product gives your body the support it needs and a purity that has not experienced before, because there's very few companies probably out there that are doing what we do to level.
Speaker 2We're doing it, and you just haven't had that either from the food you eat, because, remember, a lot of the stuff that we test are whole foods. Right, I'm buying rosemary, I'm buying cayenne, I'm buying turmeric, it goes into probably the food that you eat somewhere else, and then all the bad stuff. You know, I guarantee you the restaurants are not testing for any of the stuff I'm talking about, and that's something I'm hoping to change through this, and then you'll start seeing healing or support across the world. What's the hope? We want to change lives, not just here, but we've got to change lives across everywhere and hopefully, with the increased awareness that we can make that change happen it's true.
Speaker 1I mean I feel that we as an organization and the practitioners that we serve, and beyond, there's this vision that our food supply itself, right, is the ultimate catalyst to the healing potential that the body naturally has. We each have this marvelous machine when nourished properly, has truly extraordinary results, and so talk through, you know, I think maybe let's granularize it a little bit. In regards to our quality system, this is one of the. You know I love going to events and love interacting with trade, you know, at trade shows and with people at the booth, and you know, one of the things we always talk about right is our intense less than 1% quality system that we operate here at Premier, and when I start to get into it there's so much depth to what that really means. But maybe for today's listeners, let's define. You know you have a botanical that's coming into our facility. You know let's talk about the Premier quality system and talk about, you know, what tests are we running on that and what's different than the rest of the marketplace.
Speaker 2Yeah, well, I want to also start just a little bit farther back and talk about where we came from and where we are today Right, and where we are today right. We came from pre-GMPs, where Dr Marshall was doing his own testing, doing QRA, doing quality testing, but outside of a GMP-regulated environment, and so when he came into GMPs, we had to start from the bottom and build a system. Was it perfect when it first came out? Absolutely not, and I have to say that we had auditors come in and they had findings in the very beginning, in the very like I'm talking about 2012, 2011, because we were building a system. We learned over time how to make the processes, because there's two things you can test, which is good. Testing is honestly, testing is the one thing nobody's doing, so I have to say that's very, very important. And if you don't test, how do you know? But also the processes for manufacturing the GMPs, the investigations.
Speaker 2Things happen, accidents happen. I mentioned previously before about, you know, ground glass being found in products. That wasn't intentional. That was something that fell into a batch would, probably when it was grinding. It was the inability of the vendor to admit faults and say you know, oh, we made a mistake. You know, when something like that happens, you do something called a ncmr non-conforming material report and you investigate it, figure out why, and if it's a something that could be systemic, you turn into like a kappa and this kappa report is. You do the investigation to try to prevent that from happening again. Now what are you doing to make sure it doesn't just repeat itself?
Speaker 1in the future.
Speaker 2A lot of companies don't take that extra step. They find it, they have an issue. They kind of say, okay, here's the problem. I see the problem. This is what I'm going to do to fix it immediately but they don't take that extra step, say what's going to?
Speaker 1what are we going to do to fix it? In the long run, would you say that's taking like a scientific method to the manufacturing process you know quality a little.
The Evolution of Premier's Quality Systems
Speaker 2Not necessarily quality by design, that's the whole system, but it's definitely building quality into the the process to make sure you know you you can produce things all day long and just fix it and always be reactive. It's about being that proactive aspect of uh, getting ahead to make sure you know if you see this problem, what else could happen and how do you prevent those from happening. All this costs money, too. From a business standpoint. You want to prevent these actions, um, so we had to get there. I wanted to say that you know it wasn't perfect always. The testing, dr Marshall was ahead of his time, the purity ahead of his time. You know so many things, but I have to say that we came from a humble beginning of learning, because GMPs were new, trying to understand how to implement everything, and we're still learning. It's a continual process of learning, honestly, of how we can be better, and I always encourage audits from these third-party agencies, from customers or anybody that actually has any expertise, because that helps us grow. I think you should always be willing to continuously learn. Take constructive criticism and we get to that point.
Speaker 2Now, speaking about what we do differently from a testing standpoint, let's say that alfalfa. Let's take, for example, one of the things we do for botanicals. We do orthogonal testing. What is testing? This is taking multiple testing techniques. So, for example, botanicals, alfalfa we do microscopy and hbtlc. What is that? So hbtlc is high performance thin layer chromatography.
Speaker 2This is a literally kind of a fingerprint of the plant's active phytochemicals that you pull out with a solvent system. Depending on the solvent system pulls out different ratios of whatever it is. And what happens? You plot it on a you know, to make it really simple on this plate that gives these little bands and you compare it to a standard, something that's been identified by a botanist, that this is alfalfa, and you have yours, which is unknown, right, we're seeing if it's alfalfa and it says does this match this? Like my 6 and 7-year-old probably could do this, if it looks at it, does it look the same? And sometimes what you see is that the phytochemicals that are supposed to be there are gone because maybe they extracted it out or you see other extra bands because it's not the right plant part.
Speaker 2Maybe it's supposed to be leaf and you got root, or maybe you got both. Remember, the plant part is a requirement by the food regs which is still under. You know, a requirement by the food regs which is still under. You know, the supplements are under food and they're in between foods and pharmaceuticals. We're in this weird gray zone.
Speaker 2So we kind of have to adhere to a lot of the food stuff as well for labeling at least. And labeling the plant part is necessary. So the plant part, if it says it's, you know, root HPTLC can show you is it really root or leaf Microscopy. But it misses some things. It misses certain adulterants like silica or sand or maltodextrin or ground glass or anything else, or even excess foreign organic matter, when you know you made it get alfalfa and this happened to us, that you know that's our rosemary we had that was 70% rosemary, it was 30% other foreign organic matter. What was that other foreign organic?
Speaker 1matter.
Speaker 2We're not going to spend the thousands upon thousands to figure it out. It's not pure, so we rejected that. Rosemary right, that's, you wouldn't be able to do that with the HPTLC. There may be a lighter band but it would pass. So you need kind of this multiple testing technique.
Speaker 2So the microscopy looking at basically the cells, the histological features of the plant to ID it, but also sees other things, and then HPTLC to make sure the phytochemical's there gives you the complete picture of what that. It's really alfalfa and that's something for us that catches a lot of the adulteration, because people are usually doing HPTLC. It's very common. Ftir is another type of analysis that's done. It's a spectroscopy that looks at, basically you know, the vibrational wavelengths of the plant to give you an idea of what the plant is. But it's not specific enough. It's hard to tell between maybe similar species like HPTLC was.
Speaker 2So there's a use of that. That shouldn't be used in the raw material space, unfortunately, because it's cheap. It takes like 30 seconds, there's no solvents, it's all about cost. I mean a lot of things. Everything I say are the issues here, Everything actually, if you look at the adulteration, everything goes back to money literally, and I always said, the food industry, supplement industry, are the major cartels. Right, especially food, because everybody has to eat, right? So, and where the adulteration can happen, when a trend happens, that's where you see issues. But back to this orthogonal. So we do that. Sometimes we'll be doing ash and acid and soluble ash. What is that? That's looking? That's basically vaporizing, to keep it simple. The material to see what the organic materials in there, excuse me, the non-organic materials. So the minerals. So when you do it initially, you get all the calcium, all the total mineral content in there. There's a certain percentage. If there's a lot of it, maybe they weighed it down with some kind of calcium powder to make it heavier.
Speaker 2There's adulterations. We've seen that. We saw this calcium oxalate due to. That was in the Siberian ginseng a long time ago. That was pretty much almost 5% in every barrel. The vendors like they don't know how it got there. It was literally. It had to have been blended in because it was almost exact for every barrel.
Speaker 2There's no way in nature. You see that uniformity at all it doesn't happen. But you know we're the only ones testing for this. Oh, I don't know why you're seeing this. That's the answer we get all the time. But that all being said, ash, that's part of that. So that helps me see that issue. And then sometimes we take it another step, basically diluteduted in sulfuric acid, which then tells me about silica sand. And we've seen issues like that where it's actually almost a catch net, because when I told you about the microscopy, we're going from 2,000, 3,000 kilos of materials to like 25 milligrams. That's a that's a huge reduction to get the sample size.
Speaker 2So you can imagine, if you're not subsetting properly, that you will sometimes miss maybe something because you take this little piece of it and it was over here. You just miss it because it wasn't mixed properly or something human error, right from, even from the analysis or lab. And that happened to us once where everything passed except the acid and soluble ash and when we looked at it under the microscope we could see these bright spots. The bright spots usually mean that it's like silica of some sort of sand. So we matched it up on FTR. This is where the appropriate use is of a single unit kind of material and it matched up to silica, which means that it was sand, and we went back, pulled more sample and we found the issue which we had missed it on the first one because of sampling.
Speaker 2So it's almost like a catch net, almost, yeah, um, so these suites of tests and that's, you know, this is the basic high level. Some stuff like turmeric we may do illegal dyes on. Uh, we may do specific rotation and we, we do a suite of tests rather than just one. And why? Because there is no silver bullet. There's not.
Orthogonal Testing Methods & Detecting Adulterants
Speaker 2Everybody's been looking for it for a very long time. You know where's the, the, the black box that tells you all the answers, the oracle uh, it doesn't exist. Uh, as much as everybody wants, and they hope that maybe their CSI-looking report overcomes the. You know somebody questioning what they're doing. But you know, if you have some kind of background in this, you understand, and that's what I was very blessed to have Dr Marshall train me up on all this and all the instrumentation. And also I'm very much a student of James Neal Kababic, who's been trained by the FDA and he's one of our best minds of the industry. We always try to partner with the best minds across the board and I'm always learning and you know he helped me understand the need for this, especially in this botanical industry.
Speaker 1He's been looking at this for 40-plus years. I just, you know, as you go through this, I wish there was a technology where you could literally, you know, scan it with one scanner and it like vaporizes it into particles and you see everything like the polyphenols, the flavonoids, the alkaloids, you know all these different compounds that make up the true essence of the plant. But we're not there. I mean, we're not. Yeah, and you know how, as a you know, there's so many companies out there that probably say they have really good quality, yeah, but they may be bluffing because they're just running one test, like they could just be standardized to HPLC for their entire. You know botanicals. You never know how, as a consumer or health professional, like, what do you do to like educate yourself, like what's the best course of action?
Speaker 2you know, one of the easiest ways to it depends where your your material is. Um, if you have a pure, like alfalfa and what we saw for the carrot, for example, um, the carrot that came in that was actually colored maltodextrin, uh, with fragrance in it. When you put in water it literally like the dye came out, like you could like if you put a in water, it literally like the dye came out. Like if you put a dye into water, you know the little bloom that comes out. You can literally see that.
Speaker 2So if you're buying it pure of anything and it says nothing else is in there, put it in water. As long as it's not water-soluble, like you've got to be mindful of extracts that might be water-solu, may go into solution and may cause other things. But if it's like a botanical and you just put it in water, see what it does, it's a very simple analysis that anybody can do and if it all of a sudden like dissolves, or if it, you know, dissipates or it turns into a blob or like it blooms out, start questioning it maybe that's maybe you know, and just we got to look at the label and make sure.
Speaker 2But if it's a pure botanical shouldn't do that. Um, you know, may go into, you know, disperse into the water. That's fine maybe for certain materials, but a lot of them they're not going to do that. And if it's pure and I have to be very you know I want to reemphasize that if it has other things in there like excipients or it says on there flavors which may have color, it could do weird things like that. So you got to be careful. But I'm talking about pure materials. What we do at like, literally in quality, we could do and we saw that with the carrot that it literally you could watch the dye come out. It's a simple cost you one capsule, you know. Maybe that's something you do at home and easy to tell.
Speaker 2You know, take our. You can take a ginger and compare it to ours.
Speaker 2Use ours as standards Until you compare it. This is the way you're supposed to look to it. Hopefully you just buy ours, but you know, at the end of the day you can use this simple technique to see if the pure material is really pure. You see something. It's something you question. Ask the manufacturer. You know they should be very happy to answer those questions. Maybe it takes a little bit of time to get back to you, but they should be able to answer to you. If they don't, I would question it.
Speaker 1Yeah, and it's not just about.
Speaker 1I think something really maybe important to reiterate is it's not just the tests that they're running, but it's the, the SOP and like the operating procedure around their entire quality system and like the redundancy, I mean what you talked about, and how they pull batch sizes and subsets, and that's really, really important because if you're not doing that at a clinically significant, you know, kind of strat like from a strategy level, pulling that you're not, you could easily miss an adult trend Right.
Speaker 1So you know, I do want to get into finished product testing a little bit too, because I think that there's kind of two sides when we look at supplements. There's the raw material, what's going into the product, and then you're assembling that, manufacturing that and putting that into a finished product. That's a whole different quality game in my opinion. I mean you may run similar tests, but that's a whole nother world right game in my opinion. I mean you may run similar tests, but that's a whole nother world right. But back to the raw materials. What happens? I mean, first I want to for people listening in how frequently are we re-rejecting materials if somebody doesn't know our stats?
Speaker 1oh well, and then yeah and then for the rejected material. What's happening to that once we fail it?
Speaker 2Noted the raw material was from. This has been. I got to look at the exact number, but approximately about 70% of the samples that we get from around the world generally fail some kind of test. That could be our microscopy, like I said, or it could be a heavy metal. Just one of the quality tests, which includes also energetics, fails. So we get a measly 30% to pull from which we're always looking for better suppliers, better partners, and especially if we deal with some distributors, sometimes because they're pulling from different sources. So there's that, you know, kind of first cutoff Once we actually qualify a vendor. You know we it's.
Speaker 2Things still happen. We had a just recently a vitamin E that failed for 20 years. It'd been fine but it failed. Things happen. We had a just recently a vitamin E that failed for 20 years. It'd been fine but it failed. Things happen. So less than 5% of the time once we qualify them, that becomes an issue. But we still have issues and you know everybody needs to understand that. You know if there's an issue we're back order for it's for a good reason. It's not. You know, an issue we're back order for it's for a good reason, it's not. You know we have high standards and we won't compromise on that. Um, in terms of the you know, the finished product testing that we're doing for this. Uh, to make sure, always remember the raw material side. We put a lot of effort on the raw material and why garbage in is garbage out period, I don't care. You could you know, if you have horrible material coming in, you're not going to dress it up and make it look good.
Speaker 1Um, there's no, there's no way, you're not going to do there's a lot of companies that do that, but we won't get that.
Speaker 2You know, there's a lot of companies that either they're intentionally doing or they're, you know, maybe it's a little bit of a I have to say a little bit maybe a lack of knowledge because they don't have the quality background or they don't understand.
Speaker 2They can get easily into this or maybe they're contracting it out and they don't even know. So I have to say some of the brands maybe just don't know and they're relying on the manufacturer. However, that's not good because, at the end of the day, fda has identified people that have their own brand. Even if you're not making anything. You could be Will Marsh's pills If he had that product. You would be responsible, no matter what happened. At the end of the day, if something happened to somebody, something like they got sick, ill, the fda would come to you. They would go to the manufacturer too, don't get me wrong. But they're going to come to you ultimately because, at the end of the day, you are having to make the final quality decisions. You cannot.
Speaker 2People a lot of times say well, I, you know, I worked with this manufacturer, so it's you know. I told them what I wanted and this is what I gave me. You cannot contract out your responsibilities. That's literally been written in these warning letters from the FDA to these brands and they actually gave a designation to these brand owners that are just virtual, if you will, called own label distributors. Like they actually gave him a designation because and they started focusing on that part of the industry because they have the least amount of knowledge, because they're not manufacturing, they don't have, they're not forced to try to learn what's happening and so sometimes they don't even see the product ever. That goes from you know the manufacturer that they're working with to the fulfillment house to you know the sales team. That's literally nowhere near this person who lives maybe even overseas. So they really hadn't made a focus. They're thinking that would help.
Speaker 2You know, with the continuous issue that they it's the same thing that fails for every year since the beginning of the gmps is really the testing issue, uh, the quality issue, and they started going into the quality systems. But back to you. You know the testing. We do a lot of the raw material in finished product. Even in process we're doing certain testing, you know, looking at weights, fill weights, make sure the process is reproducible, and we have a batch record for every part of the process. This is kind of a documentation of what's supposed to happen. Because you're making a recipe, let me give it that way. And if you don't have a recipe, and I don't know about you, but whenever I cook I don't usually use recipes. When I cook I have a recipe in my mind but, I'm always the you know, I make a little flair here.
Speaker 2you know I have my, and my wife hates that.
Speaker 1It's the secret sauce that can never be replicated every time.
Speaker 2I got to tell my wife that secret sauce. But that being said, it's a little bit different. And somebody asked me well, the 10th one you did a year ago, can you make that one? Absolutely not. I have no idea what that is. And that's the same thing with manufacturers If they don't have the proper documentation, they're not going to be able to reproduce that quality every time, unless it's some kind of natural process like a natural ferment. Yeah, then you're getting into some things that are there's other issues with that. That being said, that's, we have some batch records there. We have a master manufacturing record that oversees the whole process.
Speaker 2And you think about us. We're very transparent with these. If you're a partner with us doing, let's say, private label, um, we're going to share that with you. A lot of companies they don't you have to go to to them to even see it, or they, you know, only if the fda audits you, then they're going to release it. No, I mean, at the end of the day, if you're working with us, you're a partner here. You know, everybody that has a it's a manufacturer, can make these products. Um, it's the quality you choose to use, um, and a lot of them just don't choose to take the level we do. So we're very open. Once you have all that at the finished product, we test it again.
What Happens When Products Fail Testing
Speaker 2We go through another analysis of heavy metals identity. Usually it's high-performance liquid chromatography, which is kind of like the HPTLC I talked about before. Liquid chromatography, which is kind of like the HPTLC I talked about before, but this is more robust because we can basically extract out this finished product with multiple components to it and give me a profile think of a thumbprint. That should be consistent to lot. Now I've got to mention that with natural products every lot you get in varies a little bit because we're talking about natural substances and especially work with distributors. Right, they may get something from just making up countries here Lithuania to you know, brazil the profiles will change. It will still be that essentially that component has the main active chemicals, but there's a lot of other stuff that maybe it is to that region, the soil it grew in. So you have to have these standards that are identified because you're controlling it throughout the process and a lot of companies say, well, if I'm controlling it, then I don't really need to do a really comprehensive test.
Speaker 2Mistakes happen, people don't put the right material in. They document that they put a thousand keys of alfalfa. When by accident they put a thousand keys of barley and they wrote it all in, you would never know unless you did that finished product test properly. And if you only do something very general like FTIR, you're going to miss that mishap and it will go into the customer maybe and they're not going to get what they asked for. Uh, and you know, possibly if you're dealing with some more synthetic items, maybe you're giving them something that's not doesn't do well with their body type or what they're dealing with or the drugs that they're taking could have interactions.
Speaker 2So we can have, you know, effects beyond just oh well, you got barley this time. You know. You know effects beyond just oh well, you got barley this time. You know you got different greens. No, it can actually have much deeper consequences for people that use, for manufacturers that use other stuff in their process that they just don't know Two white powders. They actually put the other white powder in. Who knows what that white powder is. So we do that finished product test. We also do moisture, you know we take extra steps to make sure the quality is, of course, also visual. You know. If it doesn't look right. You know the label. We even have a metric for the label on the bottle. It has to be off. It can't be off more than I think one-eighth of a centimeter, or something crazy like that.
Speaker 2We want that accuracy and the capsule count. Make sure we actually count capsules in the finished product or in process too, to make sure you're getting exactly. We say 60 capsules, you're getting 60 capsules. We have very. We just invested over two million in new equipment. In fact the whole facility is new because we wanted the best accuracy, the highest accuracy that we could possibly find, and that's our capsule filling or packaging line is at that accuracy, like at 100%. I mean, you know that's what they claim, 99.9.
Speaker 2And not only does it, it's good for business because you don't have to give overages and get people extra capsules because you're worried that's going to be low. But also the customer gets what they're paying for, what they're asking for, because that's what they want. Right, there's three things that any consumer wants. The FDA actually identified this. They want to make sure that what you're giving to me is what you say it is right. Nothing else You're not giving me. You know it's supposed to be alfalfa, but you gave me, I don't know, just rice bran and filler Two, that it's not going to hurt me whatever you gave me. And the third one is, if you say that it does something, that there's actually some science behind it. You know whatever that is and you're substantiating that. So to make sure that it is what it is, you need to have these steps in place, um, and it's what the public wants and what they need.
Speaker 1Yeah, so true, you know, um, we're not, we're not just chefing it up in the kitchen every time we make a run. It's like a very rigorous, standardized. It's like baking, but to the most professional degree.
Speaker 2Right.
Speaker 1And there's no baking, cause we're not heating the botanicals. But um, you know we were talking a little bit about. You know our rejection rate. What let's get very let's dive into that. You know, if we, whether it's at the raw material or the finished product stage, what happens when we have something that fails.
Speaker 2So we go through a whole I mean, the steps that we take when something fails is probably more than anyone that I know of does and we literally go through a full blown investigation and to make sure, first of all, when you do a test, you go through a process called out of specification, which is a part of the gmps. Like you go through this whole step. It's this is uh, there's an sop that governs this and there's a retest that happens on the original sample at the testing labs and you're basically eliminating lab error, make sure the laboratory did the right thing. Once that's eliminated and it's confirmed, um, and sometimes this this doesn't sound like it's a overnight thing. This could take up to 30, 45 days to really dive in, especially if there's an adulterant found in the raw material that we're unsure of, like something pops up.
Speaker 2We've seen it where we've and I'm not going to mention the material, but there's a very famous material out there that all of a sudden this random peak popped up for a organic. You know it was chloromethane. That shouldn't be there, like at all all, and we didn't understand why nobody had identified it before. We're the only company bringing this up to them because our laboratory said hey, they saw something on the chromatogram, the gc, that like that shouldn't be there. Nobody else pointed that out and we spent that was like three months diving into it to see what it is. We found out that it was a part of a process they did and basically we moved on to the next lot and that wasn't there. There was something that happened with that lot, but it was there, present due to some kind of processing. It wasn't toxic or anything like that, but we questioned it why? Because I'm going to eat that stuff.
Speaker 2I'm going to give it to patients, people that maybe that would affect their immune system or affect something else they're taking. So we have to ask those questions and a lot of people when I say people, brands or you know, especially the virtual brands maybe they're not going to ask their contra manufacturer. You know, have you tested? We saw this years ago melatonin having serotonin right.
Speaker 2They were saying it was adulteration. And so what did we do? We went and tested our serotonin, not you know. We didn't know. We heard about this possible adulteration and so we went and looked, knowing full well if we found it we'd probably have to do a recall, and we're not afraid of the recalls. I probably have to do a recall and we're not afraid of the recalls. Um, I think that's something as we learn, or something comes on the radar. Um, we're going to make sure we're protecting the public, protecting our patients, protecting our consumers, um, because we're here to help them and not, you know, possibly especially like allergens.
Speaker 2We had a we had a recall many years ago because we employed uh, we're one of early adopters for dna testing in this industry uh, working with a company that used to be around called often technologies um, you know, danica was the um, the owner, and we worked together and we identified through the dna testing an allergen. It was wheat, it was a wheat Basically DNA strand that came up and we're like why is that there? That should not be there. And going through this, we realized that this material it was being rolled in wheat flour and it's a traditional way of coating the material because it was a very sticky material and it was being rolled in wheat flour. It was a material called asafoetida, very smelly stuff.
Speaker 2If you've ever tried this spice, it's a spice that's used in very much an Indian culture.
Speaker 2Great for the gallbladder, but it was being rolled in wheat flour by the villages to help coat it as a cheaper way than using other excipients didn't tell us, you know, and nothing was any. There's no documentation saying there's any kind of wheat used in any processes. Done tests before, never saw wheat. But this one lot because we did an a and a, it showed us what happened. Well, found out it was used in, actually, the previous lot too. We had to recall we're not afraid to do that. Things happen like that. We're here to protect, we're here to support and help, enable practitioners to do what they do best and heal. And you can't do that if you're giving items that are allergens or unclaimed items to people and people wonder why the products don't do what they said they're supposed to do, or, if it does, it does something else somewhere else so true, and and the fact of the matter is is then, once we find that it doesn't pass, we reject it?
Speaker 2right, and a lot of times when we reject it, you know what happens. Where does it go? Like, you know, especially the stuff that we're the only ones testing, like if we're doing, for example, that siberian ginseng I talked about before, that calcium oxalate five percent, we rejected it back. Um, it was, that was from, I believe. Uh, that one was from china, not to say china is where, but just went back. Where do you think that you think they destroyed it? There's actually a whole program with ABC that you know the burn it don't return it Because if it can cause harm to human health in some way, these companies are just taking it back and giving it to somebody else that doesn't have the same quality standards, especially some of the testing we do, because they know nobody else is testing it and they don't test for it, so they just turn a blind eye and they send it over here, unless they're the ones intentionally doing it. Um, but that's we.
Speaker 2Right now nobody wants to uh, burn, unfortunately, a lot of money because that's what it is, a lot of times a pre it's pre-payment with the international accounts, um, and so we have to reject it back to them. Hopefully we can work with our vendors, especially distributors, and as they find stuff they're willing to not put it back into there and document that it's been destroyed, that it doesn't get back into commerce. Because I can tell you right now, if you watch the case studies that are on the website where you can see some of these adulterations, it's under the quality section. Always remember somebody's eating that somewhere or somebody ate that somewhere, because I don't buy everything and I promise you they haven't recalled anything. We can look up the recalls. None of that happens, and when I ship it back unfortunately right now, the way it's set up in the system they're probably shipping it somewhere else.
Speaker 1It's true. Yeah, what's kind of coming to mind is I'm thinking about the landscape of herbals and botanicals and the world we live in and how just the botanical world is so vast and even plant species are evolving, right, how do you innovate around quality and what's in your vision in how? How do you innovate around quality and how? How do we like what's our in your vision, in our vision, maybe for the listeners to maybe conceptualize it of how we're innovating that quality standard? Um, because, honestly, we can't stay static, you know, with what we're doing. Um, so you know, as we kind of map our path forward, you know continuing because, like you said, at the very beginning we had to build this system and now it's gotten us here and it's changing lives because of the quality that's into it. But we're still the cool thing is I see it every day we're still evolving that quality system.
Speaker 2We're always questioning. I think that is the number one thing. We don't just not question when something pops up or as science evolves and quality. It's interesting you brought up the whole if there was one device that vaporized and there's actually something James was working on that I think the universities were about direct ionization of GC and basically to really give that simplify that is basically incinerate it and the gases from it gives you an ID quickly.
Speaker 2And it's quick, though you know a lot of the testing here and Fortune Part takes like 10 to 15 days to get back because, of scheduling and everything.
The Art & Science of Supplement Manufacturing
Speaker 2The great thing about FTIR, why everybody wants to use it, because it's like 30 seconds and a lot of people could do it internally, even though maybe they don't have a trained spectroscopist, which you know, at the end of the day, you can have a lot of nice equipment, but if you don't have the people trained on it you know and have the experience you can get some answers, but you're not going to necessarily get the right answers. So always remember training, which is so important. Having the expertise is just as important as having the equipment and doing the tests, because you can have a very bad lab. That's dry labbing. That's true, that just giving you results. Oh, we're testing, but they're not actually, you know, doing the real test or they're not really identifying what it is. Sometimes they're not even testing at all and they're just printing for you.
Speaker 2That's that's a whole different subject but, you know, having that, that, that expertise on staff, is just so, so important to make sure that you can actually have that analysis. And you know, I think it's important to recognize that with the you know, advent of, as we continue to find new things, we're going to open Pandora's box a little bit. We got to be careful, right, because we don't know and I want to know and I want to understand it, and we also have to understand fit for purpose testing. So I can do a lot of tests, like I can use all this equipment, do all this test, but does it really answer what I'm trying to ask? The question, right, there's a lot of tests out there. Do I do DNA for oils? You can, maybe there's some evidence that works well, but it's not going to give you the same result of using a botanical that hasn't been refined.
Speaker 2Even with whole botanicals, when we did DNA testing, there was a lot of people who would call to ask okay, you have this TLC, this other test I talked about, or HPTLC, you have this, and they say it's this, but the DNA said this why? Well, it could be the quality of the DNA. Because this material has been treated so much, the DNA was broken down and then you had a little bit of this other stuff and that's why it showed up. And you have to have, you have to understand that the intricacies of that testing to be able to utilize it to its full potential. But you know, as new technologies come, as new science evolves, as studies come up, we have to stay ahead of it and actually that's the expectation of the FDA. I was told a story before about this company that apparently they had a death due to their supplement. This company that apparently they had a death due to their supplement and it was this material that basically had a toxin in it and somebody died and the DOJ was bringing charges against them and basically the argument from the defense was like well, there's only one case of this being identified. It was some weird academic journal that you and I probably don't read all the time. You know it's literally academia and basically what the fda said. They don't care their their expectations. You're staying ahead of what the science says. Right, it's been identified. That is now what you should be testing for, because it could be in your product. Maybe there's only found a one little one, but there's a chance and if it is and you get. You know if it happens to your product you're liable period. So they don't care. They don't care how much money it takes, they don't care how many, how many individuals it takes to do that.
Speaker 2So myself, our quality team, we try to stay ahead of the curve by, you know, being immersed into not only trade organizations to help stay ahead of that, but you know, the scientific articles questioning, trying new technologies and doing things that nobody else wants to do, because that's how you have extraordinary results, that's how you have to do extraordinary things. You've got to take some risk with that, because you know, opening Pandora's Box when we did first to Aflatoxin, we wanted to shut that real quick because I was like, oh yeah, we're backcourting everything, but we worked through it and there's that. And I think we're trying to open for everybody pandora's box so they can ask, ask the right questions, just ask your, your, even from the food side. Ask them why aren't you testing? Why aren't you testing for this stuff?
Speaker 1it's true, I mean because it's everywhere it's elevation of how you define integrity and like everything you do and honestly it. It can perhaps drive us all a little stir crazy because we're essentially asking these questions that are so like people. All the time, vendors, you tell me stories. They're like why, why even go there? Um, you know, one of the things that I always found really illuminate, like just in regards to how, how much we've refined or like refined our process in the art of making a supplement Right, a lot of people think it's just blending a bunch of powders together.
Speaker 1So we do the testing, right, we verify the material and then people I've heard this from practitioners and just other people that we serve it's just, oh, you're just blending the material together and then encapsulating it and then finish product testing. There's a whole we haven't even really explored it yet but the art of assembling materials together with blending, because there's friction forces and there's all these aspects to the science of menu, like Making the form, like the bulk powder that goes into a capsule or even gets put into a bulk powder.
Speaker 1Yeah talk maybe a little bit to eliminate that aspect of our quality system, because it's not just the testing, because I mean obviously it shows at the finished product stage, right, how you blend it, but maybe illuminate the science behind the blending and the assembling of ingredients, because that also never gets enough attention Absolutely, and it's not just, we're not just stirring them together in the back office and then putting them in the encapsulator. It's like a, it's a mapped process.
Speaker 2We try not to do the goulash.
Speaker 1This is what you get.
Speaker 2You know, whenever you're dealing with multiple components you have to worry about, not necessarily we look at blend uniformity to a level that how you can have a very small amount of material and you're claiming on the label that it's uniform, that each capsule has this much in it, and what are you doing to ensure that it is?
Speaker 2And there's aspects of how you blend the type of blender you have Like you have a V blender there's a certain level that you can't you know not, you can't underfill it, meaning that it has to be at a certain level. So the actual, the mixing does occur. Otherwise it kind of just kind of rotates on itself and whatever is in those two little spots will just be there and you dump it out and it looks like it's mixed but it's not really mixed. But also during the encapsulation process, how it flows through. Because we don't use traditional excipients and we have such controls over our humidity, put a huge system in to make sure we control down like to 30% or lower, even so we can actually encapsulate, because it used to be where it was a rainy day. It down like to 30 percent or lower, even so we can actually encapsulate, because it used to be where it was a rainy day, it was harder to run. Now we can have that control through this, this beautiful system we put in a couple years ago. But there's aspects over there of how the material like behaves in the hopper where literally you'll see some stuff where it's literally falls in the middle and stays on the sides, and there's a lot of aspects here of the technical part of putting it in a capsule.
Speaker 2It's not that simple. You know, nowadays you could buy this little thing at home where you can fill it yourself, and you know it's not that easy. You don't just pour it here, wipe it off and then put the capsule on. You know you could do that at home pour it here, wipe it off and then put the capsule on. You know you could do that at home. Now tell me that that capsule is uniform as this much material and that that capsule won't open. You've got to get a lock too, right, and so there's definitely a science behind how much you can get in a capsule changing densities.
Speaker 2I think that's one of the biggest issues with this industry is the materials are natural, so the density can change. Now there's things you could do to to process it further, to make it where. That's not a problem. But we try to stay in the whole food realm right, and when you try to do that like a capsule, um, even a bottle, um, we've had it where our greens all of a sudden you know it was looks like it's three quarters of the way filled and this density changes. On this another, you know, harvest, and now it's overflowing.
Speaker 1And so what do?
Speaker 2you do. We've got to look at changing the bottle, changing the serving size, because we don't want to change the material by doing some other process like roller compaction or something to to make it where it standardizes that, because it could actually hurt the, the essential components in there, the active phytochemicals, and degrade them. We don't, we try to keep it, not say raw, because you know they're processed, they're dried, but as close to what mother nature gave us initially right, and that means leaving it in that whole food form.
Speaker 2So we we modify it minimally, which causes a science there and then if you don't even use the regular excipients, like magnesium, steroid or whatever it is, becomes even harder, and then we use other materials that change naturally. So there's a whole part there that what is. And then there's also the interactions with the formula itself, like if you had a.
Speaker 2This is what amazes me, these, these formulas that have like everything in the kitchens, like everything like it's like three pages long to say that they don't interact and to test that one product probably would be like ten thousand dollars plus per run. Um, I just have a hard time believe that they validated that that material is, you know, actually within spec and they've done that multiple times to make sure you have reproducibility or, you know, if it's natural, then you can, you know, run it and label it as is, whatever you tested, and put it on the label. But you know there's interactions. We've we've had, you know, in R&D lab. We're actually make has a natural acid in there and there's interactions We've had, you know, in the R&D lab where actually you make it has a natural acid in there and then there's like a calcium, there's a carbonate which you know it's like the volcano you did in school, right, you put vinegar and you put the baking soda in there and boom, you have this little thing. Well, that can happen in products too.
Speaker 2You can have gas buildup and explosions literally in natural products, like I'm not talking about anything and this is just naturally acids that may be in the product that over time, with the moisture coming in, can happen.
Speaker 2We've seen it. So this stuff can happen. There's interactions and there's degradations, like just because you have everything there, it doesn't mean all that stuff is stable, right. And stability there's another part long-term stability, not only in process stability to you know when they release it, it's also once you hit that shelf. How long is it good for? It's good for a month, two months. You know we try to aim for two years for everything and hopefully that it is. But we got to look at that interaction and we we have actually two walk-in chambers that are set at basically room temperature but has high humidity to help evaluate long-term stability.
Speaker 2We own this. Not many pharmaceutical companies have this. We actually have reach-in accelerator chambers which we can do estimates and we're doing kind of the pharma standard. It's not pharma and why do we do that? Why do we take all those steps to make sure the product you have is what it says it is at the claim that I said it is and that it stays there. So whenever you take that product six months from now, it's still that product and not now. Just, you know garbage, because you know this issue with the berberines not being pure and you know they have this. Oh, this is a great product at the time of you manufacturing it. But what happens is six months or a year when that consumer patient actually gets the bottle in their hand.
Speaker 1It's true. I mean this is a really serious subject, you know, but I also there's a joy in us just going to this frontier truthfully, because I mean, the reason I got into nutrition was just it's this marvelous field where you get to understand the world of phytochemicals and how they work in the body and like how they really kind of stimulate all the or catalyze all these health processes. But those nutrient to nutrient interactions happen in the finished product and you know, and, and in the manufacturing process and all these different things, and you have to be measuring what's going on, you have to be looking at it and I think it just brings me a lot of joy and I feel like it helps maybe bring some maybe, I guess insurance to those listening that we're going to that level and then we're looking at that and looking in that direction. So, um, with that being said, I know we could continue going down this, this rabbit hole of quality, but I wanted to maybe close.
Speaker 1And talking about finished products, we actually have four of them here. They've been with us during the session and we've talked about a couple on our last. We went through a couple of them, but we have one that is going to be brand new to our audience. It's well-known within the industry, but would you like to talk about our Lion's Mane product?
Speaker 2So we've had Lion's Mane has become the medicinal mushroom star of the industry recently because of the properties that we've been using Lion's Mane for oh 20 plus years it's been in our coral.
Innovative Products for Brain & Overall Health
Speaker 2Calcium magnesium. It's called now a plus product, this with turkey tails not really turkey tails. Coriolis versicolor, another medicinal mushroom in reishi, has been in that product and several other products for a while. For a while. It's an amazing immunomodulator but also, in higher dosages, can help with the nervous system, with protecting the myelin sheath of the nerves, which helps with, you know, making sure the transmissions occur. It's great for cognitive function in your brain, but also it's a great immune product too, because it has beta glucans.
Speaker 2We've had a high potency uh extract from the fruiting body, um, which has, uh, I believe it's equivalent to about 71 milligrams every 1000, or basically, one gram of the extract is equivalent to 71 milligrams, 71 grams of the dried powder from natural, you know, the fruiting body. So we're giving you a pure material and this is, you know, not only possibly to take by itself but to be an adjunct with our couple other products. We have the Cognitropic there, which is our neurotropic. Taking this one, this one's amazing because this product is one of the best neurotrophics I have and it's completely plant-based to clinically studied patent ingredients. Pneumatics, which is a spearmint extract that has a certain amount of rosemary acid, which helps with acetylcholine, basically, I guess in production increases in acetylcholine Also. To add to that we have natural rosemary Kind of this is the product I was talking about earlier that we make sure it's pure.
Speaker 2It's the herb of remembrance, and why they call it that? Because it's really great for memory. It really helps with processing speed more than anything. The coffee berry, which is going to be our neuro factor this one is actually the fruit of the coffee, so coffee is normally. It's literally a fruit with a seed inside. The seed is what you drink and a lot of times people sometimes leave the mucilage on or they take it off completely clean it. That fruit is sometimes discarded a lot of times. But that fruit actually has a lot of properties for brain health.
Speaker 2And what they found was actually can increase bdnf, brain derived neurotrophic factor, which can help with neurogenesis, higher level thinking. It actually helps with your executive function. Pair that with this to help with, you know, not only the processing speed, but you're actually protecting myelin sheath. And then if you really want to take another notch it's not even shown here is take our Serovin-4, which has alpha-GPC in it, has rhodiola and several other and phosphatidylserine. That is a powerful combination for for brain health, one of the best neurotrophic stacks I know of. Um, but this is something I think you should be adjuncting with this or take it by itself every day for immunity and for brain health.
Speaker 1It's like a it's a double whammy, you get both.
Speaker 2You get both of them uh, no, I, I love it and we're trying to. We're really, as a company, trying to share the wealth. I think that's you're going to see a lot more of, uh, individual ingredients for practitioners to. Maybe somebody needs a little bit more support. Um, maybe our l-theanine that just came out to add as an adjunct to our trinquinol, because it does have l-theanine, but sometimes you need a little bit more sometimes you need in the morning to add into there.
Speaker 2Um, we're looking at doing straight run powders too, because what I told you about the aflatoxin I want to share the wealth. We have, this very pure material. When you want clean material to cook with, I do, I use mine. I want you to be able to enjoy that too, and we're gonna. You know it will be a limited supply because a lot of stuff we don't find a lot of, uh, because of the adulteration, but we're going to share it and you're going to see a lot of these innovations coming out that are simple but it will change the purity of what you're eating period.
Speaker 1I think that's so exciting and I love both of those products. It's kind of working to enrich the environment of the brain, the neuronal network, in terms of the efficiency. There's neurogenesis aspects and all sorts of good stuff and the thing that most people I think maybe to frame neurotropics a lot of neurotropics overexcite the brain. It just fires off neuronal transmission and you're just locked in but then you're burnt out right.
Speaker 2Yeah, there's no caffeine in this and even though I said the coffee berry fruit actually we tested it and we test these it's two milligrams of caffeine because naturally, the coffee berry has some. Just to give you perspective, decaf is 15 milligrams. So people say they feel something. Well, that's actually the coffee berry working. When we first came out with it, even the internal stuff was like whoa you sure there's no caffeine? Absolutely not, there isn't. In fact, you know it's pretty much all natural with the coffee berry. It has choline betartrate as well for structural purposes. So it's an awesome product, very simple, clean and of course, there is nothing else in there other than that. So if you look at the excipients, there's nothing there.
Speaker 1Back to the excipient free. You know, if I was going to start Will's Pills which I guess we coined it on this podcast that would be in my stack. We have two others. I know we talked about Max B and Adaptogen. Is there anything you want to kind of share in addition that you might not have shared on our last episode?
Speaker 2Well, I mean Max B. That's a staple. This literally is I take this every morning. This is awesome with our beets. I have to say that you're going to get multiple. I've not seen another supplement on the market that you get postbiotics, fermentation and plus you get all the active forms of B vitamins. With these N-chain forms in there, you get the methyl, adenosyl and hydroxycobalamin All the active B forms, the longest blood circulating, one which is hydroxycobalamin, all the active B forms the longest blood circulating, one which is hydroxycobalamin, which we actually produce during the fermentation. Methyl and adenosylcobalamin, which work in different parts of the body. So you get all of that. You get the B2 family.
Speaker 2It's not just riboflavin 5-phosphate, it's riboflavin 3-5-phosphate, it's all of them Same. 3,5-di-phosphate, it's all of them Same thing with B6. This is a very comprehensive plus. You get formal tetrahydrofolate. So people are always looking for 5-methyl tetrahydrofolate, which is absolutely awesome. If you have the gene that you're. Actually you have an issue with processing folate. This one also works alongside on the same pathway and you don't need to have that enzyme to convert it. So it actually balances 5-methyl tetrahydroxyl, what I always say. Take this with our complete B and you're going to have the 5-methyl and you get the formal. So you actually get the complete set, the most complete B vitamin complex combo you'll ever find. Period. So awesome, awesome combo.
Speaker 2Adaptogen that is my, so that's morning. Max B Adaptogen that is my afternoon. That is what I do to reset myself. I use the Adaptogen. It's actually it's a protocol with Adaptogen, our very famous Adrenavin, you know. That gives me the Cordyceps sinensis which is, you know, a great adaptogen. A lot of times they're using that in more sports athletes, increasing VO2 max.
Speaker 2But that combo with the rhodiola that's in their extract and getting about 500 milligrams of rhodiola extract, has shown to help with mental fatigue. So if you're, you know you're using help with mental fatigue. So if you're, you know you're using, you know your mind all day to whatever you're doing. If you're building something, you're running a company, or you know you're, you're using your intellect, you and you're having a long day. You want to reset yourself. Take three, take six capsules. You're only going to take that. Otherwise, take three of these and four of the adrenaline and you get an interesting combo there. That's what I take and that resets me so I can go home. Be a great father, you know. Try to be a great husband. I try, and then you know also, I go back to my work more, do what I love, but it helps reset me and I think it's an amazing, amazing product in high purity, but it helps reset me and I think it's an amazing, amazing product in high purity.
Speaker 1Nick Levinsky, thank you so much for your wisdom, your stewardship and your quality champion mentality. It's been an honor.
Speaker 2Thank you.