Peptides at a Turning Point: What the FDA Meeting Means for the Future with Jim LaValle

Welcome back, Senergy listeners, to the Senergy Podcast. I'm Kelly, and I'm here with Lori, my co-host and my BFF, and we're so glad that you've decided to join us for this important conversation. If you've been following the news around peptides, you've probably heard that there's been a lot of discussion since the FDA Advisory Committee meeting in July. There's been plenty of headlines, plenty of opinions, and honestly a whole lot of confusion. So today we get to go straight To the source. Jim Laval is going to be joining us. He was actually part of the conversation, and he's helping to shape history, and he's going to help us separate fact from speculation. We're especially excited because Jim has become not only a trusted friend of the Synergy Podcast— he's been on with us before— but he's also a mentor to both Lori and myself. And every time Jim joins us, we walk away learning something new. And we know that you do too. But for those of you that have not had the pleasure to meet him, let me formally introduce him. Jim LaValle is a globally recognized clinical pharmacist. He's a board-certified nutritionist, and he's one of the leading voices in integrative and precision health. For more than 35 years, Jim has helped everyone from elite athletes to individuals looking to optimize their health through personalized metabolic solutions. And he's an acclaimed author, he's an educator, and he's a creator of The Metabolic Code. That's a revolutionary approach to understanding and improving metabolic health. Today, Jim is going to give us an inside perspective on the FDA Advisory Committee meeting on peptides and what was actually discussed, why it matters, and why healthcare providers, patients, and anyone interested in peptide therapies should be part of the conversation. So let's just dig right in. I want to know, like, what happened in 2023 that was so profound with peptides? We're rocking along, we're doing great in clinical practice, trying out some peptides, seeing some amazing results, and then all of a sudden, Jim, what happened?

Yeah, the previous administration all of a sudden, obviously under the FDA, uh, said, you know what, these peptides that everyone was using in practice Patients were able to get them for human use compounded by pharmacies. Were not safe for human use, and there was no reason to say, oh, they're being used, but we have all these issues or reports of people, you know, having trouble or adverse events or safety signals. But it was just nope, category 2, do not compound. So I had to go up, and after that happened, the first time I had to go and testify for PCAC, Pharmacy Compounding Committee, you know, we tried to get some peptides back on them, back onto the list. TA-1, for example, which already had human studies on it, it's already an approved drug. Not quite understanding why that would be so dangerous if it was already an approved drug. But that didn't go so well. Uh, you know, actually in 2023, I felt, you know, like I, I didn't go— I don't think I went there prepared enough to understand how vehemently FDA at that time Was going to argue against it, and for whatever reason, right? I mean, it's like that whole thing of you know new ideas don't get accepted. You know, old people die sometimes, right? So who knows? Nothing against them. But so then what happened as a byproduct of that? Well, people were getting results from peptides, and their doctors weren't supplying them. Now some docs continue to do that through the gray market, which I you know was like wow that's. Was a little risky. But the bigger pharmacies that were kind of the reputable standards in the US, they chose to follow legislation and not make products that were no longer for human use. And that, I mean, that was a— to do that was a huge financial hit for those companies. But they chose to follow the law. So, um, so what happened was the gray market appeared, right? The, the ability to order peptides online. The word was out by then that, hey, these are really helping, these are great, gee, I'm not achy anymore, wow, my immune system's better, you know, all the things that we, we, we really loved about peptides and their ability to help us get people better quicker. And so they started buying them on their own. And the problem with that was quality control wasn't there. They weren't for human use. They said research use only, or not for human or animal use. And hundreds of millions of dollars a month were being spent by consumers On buying peptides that they sourced themselves.

Yeah. And still, I mean, that's still going on as of today. It's still going on. Yeah, absolutely.

Still going on.

Still going on.

And as they say, desperate people do desperate things. Back to what you said earlier, they had had profound impacts in such a favorable way. People were having tremendous improvements in function.

Yes.

So they didn't want to go without them, so they were going to figure out a way to get them.

Uh, and that's right. And that was part of the reason for the PCAC meeting this time, was to get this understanding of the FDA really doesn't need to get between the patient and the healthcare provider. A patient that's informed and wants to try something that's off-label, and a provider that's willing to write for that and inform the patient and track them They should have the right to do that if the compound that's being made in a 503, which is basically a pharmacy that makes things for individuals, can make it from an active ingredient that has a history of use. You can identify the molecule so you can test it to see if it is what it says it is. If there's historical data, and then the safety signal, while helps a lot, wasn't necessarily a bold requirement. But the point being is the the raw materials needed to be tested, and so what happened was a lot of these com you know kind of these. You know, lab-grade peptides. They didn't really go through the for-human-use kind of studies that shows you that makes it safe. So they ended up with, you know, forever chemicals in it, right? Trifluoroacetate, one of the compounds you use to make it, really not good to inject in your body. You know, not a good thing. Endotoxin. So endotoxin is one of the biggest disruptors to your immune system. So you inject endotoxin, it It can cause big problems, but it, you know, can also be life-threatening. And then was the active ingredient even in the bottle? So if you read all the reports of the last 6 months that have come out, it's justified that, you know what, these research compounds do not have to be as rigorously tested. The original active ingredient doesn't have to be tested as vigorously. And so it really left people with, boy, am I getting something good? Am I not? I know for me, you know, chairing the International Peptide Society, I'd have healthcare providers calling me going, I had a patient just come in. They're not doing very well. They feel bad. They just started doing these research peptides. I think it's it. What can I do? I said, well, do you have a bottle to go get it sent out? I mean, I don't know what to tell you because I don't even know what's in the bottle. I don't have an idea. And, and, and I'm— and, and that started happening more and more. And so the, the whole thing of going to this, you know, trying to get these to be validated again, basically for a PCAT to say yes, they can go on there. Now it's still not done. You still got to get final FDA approval on this. But for the committee to do it was because do we really want people buying things that are considered dangerous drugs? Anything you inject in your body is a dangerous drug. Do you really want to have people buying things that they can inject in their body online? I mean, nobody's research only. I mean, they don't have a, you know, a lab EIN corporate number saying they're a laboratory, right? They're, you know, so I think that was in the end, I think that's what created this. The taking away created the monster. And the solution was the monster— for the monster is to create a legal way for healthcare providers to feel like they're allowed to write for these things and not be in jeopardy, for patients have the right to get them, and for pharmacies to be able to provide a quality end solution or whatever dosage form it's in, but that it is what it says it is and it's made safely.

And, you know, we love having those in our hands as a clinician in practice, being able to use something. But when Patients are coming in and they're telling us they're getting it from XYZ Pharmacy online, it's research grade. We have no idea how to even follow that patient safely. And then what we're doing on top of that, right, treating them with hormones and things like that, it makes me really nervous for them because I've even seen some heavy metal situations from research grade.

Lead, mercury.

Lead, mercury, things like that. And so it's really a big deal and patient safety always should come first.

So, well, you know, you're, you're right. And what's interesting was we submitted, like, all the peptides that we submitted, we submitted safety data. Millions of doses in several of these were given with no adverse event reporting or, or, or minor side effects reported. And so You know, okay, we meet that criteria, but that what was what was happening there, they were trying to shove it into oh it should be a new drug application. So it should go through the IND, you know, you know, investigational. And the problem with that is is most of these have no way of being patented. Nobody's going to spend hundreds of millions of dollars to get a drug approved that can't be patented. And so that's where that crux was of no this is. Compounding. And peptides are natural compounds. Your body makes them. We're compounding a product that we know the body makes. We know it helps people. And providers want to be able to provide it to their patient. And it's why the compounding laws were there to begin with, to help the individual and the provider have that relationship. When I showed the You know, one of my tactics when I first did the first BPC testimonial was what FDA supplied to the PCAC committee was evidence that these things aren't tested rigorously. Well, they used a research lab. And then what I did was pulled that from their— what they had submitted. And I put, well, no, but this is a for-human Use certificate of assay. Do you see the difference in what's being assayed? Do you notice the toxins, endotoxins, adulterants, strength, molecular weight? Everything's being identified in the for human use over here. Not so much over here. And and I think in the end that that's I mean I actually at the end of the two days. It was exasperating. I felt like I ran a marathon in 2 days. I was super jacked up. I couldn't, you know, and, but in the end, I thought it was really collaborative. It seemed like there was a spirit of collaboration that took place, whereas initially I thought the FDA was doing what they did 2 and a half years ago when I went in front of them. I was like, oh boy, are we going to be in this situation again? And, and instead it came— I thought it came to a collaborative effort.

I was just thinking about what happened at that meeting too, just watching it from a distance. It was pretty exhilarating, as we mentioned on the live the other night, you know, from afar. Number one, being super excited that you guys had the opportunity to do that, and so grateful that you did that because it was— I can only imagine even the preparation being exhausting. You probably needed some peptides for your recovery and mitochondria after all of that. But we were super excited to watch it. And I think as a clinician, one of the things I want to go back to that you guys have both said is that I do, or alluded to it, or one of the concerns, you know, you had mentioned, you know, heavy metals and the other exposures that our patients unfortunately are getting exposed to when being so desperate to feel better and to utilize these things and actually creating harm. The other thing that I saw a lot is almost like a secretive nature to it too. Like they didn't wanna share. And that left us in a real bind when we're trying to use other modalities and other therapies and they're having reactions to them that were just not common, you know. So it just, it was, you know, the, the emotions around that, maybe the shame around that, or the guilt, or the, you know, the secrets.

Yeah.

You know, it really affected the relationship with us.

100%. And I, and I think what I came out of it was because, you know, when we asked, like, you know, the, the committee didn't get everything we submitted to them. And so when the PCAC members were asking the FDA, well, why didn't we get those? And then have you read those? And the answers, you know, from one of them was no. And then when a PCAC committee member would ask a question, the FDA was— they didn't have good answers. I think that's where the tide shifted, where it's, where it's, hey, the PCAC members are clinicians. Yes, they use peptides in their practice. Does that mean they're bad people? Wouldn't you want people who use them to be weighing in on the vote? Is that yes, I think this is good and safe because I've used it several thousand times and found it to be effective and safe clinically, not through randomized trial? Because we have to remember that what the FDA is doing is trying to say Is this peptide good for a condition or disease? And what we're looking at peptides as is more of a pleiotropic effect. Hey, we want to use it because it helps people to stay well. It's working on several pathways, and we're trying to get people back and restored. And that isn't so easy if we're doing several different things at a time. And applying a peptide, right? It's a different methodology to getting people well. That's not how it's viewed at FDA. That's what we need to develop, right? What we need to develop is that type of criteria where, oh, this person walked, took vitamin D, took ashwagandha, took BPC, and oh, their colitis went away, or for whatever reason, right? It's that. It's more of that understanding that needs to take place. I thought it created a really momentum. And I think there was an appreciation from actually from FDA for the clinicians who are asking very smart questions and are in the front line. They're in the front line. I mean, you guys are sitting back in the office. That's, that's different. Yeah. And so I think your observations were really keen. It's like there was this distrust that happened. But like in 2023, there is distrust and there shouldn't be distrust. Like we need the FDA to go into a compounding pharmacy and look at the standard operating procedures and make sure that that peptide is being done right and it's safe. But you know, what we don't need Is the FDA saying they're not allowed to use that peptide if there's no reason not to to utilize it because there's evidence from the compounding pharmacy perspective of being able to make it and the provider wanting to use it, and that was where that juxtaposition was going on the whole time. So it was it was interesting. It really was. I I swear it was more than I can't remember the last time I had that big of like a. Kind of an emotional— that emotional letdown after you've been working on it so hard. It's been 2 years of working on it, supplying the monographs, the papers, the written material, testifying. It was— and I didn't realize it for myself that how, how much it was really buried in me, the, uh, the importance of this. You know, I, I— that's what I really came away with was, you know, we did something historic.

Right.

You're making history, that is for sure. So what happens next? What's the next step in the process of getting these available again?

Yeah, next step is FDA will approve for it to go on to the, you know, basically Category 1 or the approved bulk substances list. If they don't approve that, then that would go to Secretary Kennedy and he would have the option to Override that and say it can go in. I you know, I I honestly think historically when something gets passed at FDA to go into bulk, it the FDA usually you know they they bless it. So we're gonna see. So and and and the other one is I don't know whether that's gonna be one month, three months, or twelve months. I have had no intelligence. I'm and if I did get intelligence on it, they'd probably tell me don't you dare say a word. So but I can tell you honestly. I don't, I don't know yet. I mean, what I'm being, what I'm preparing for now is submitting. There's 5 of them that were involved in a lawsuit. So Kispeptin and TA-1 and ipramorelin and CJC lawsuit with FDA with some compounding pharmacies. So those 5 have to be addressed. And then I'm the law firm that was behind this, Lee Rosebush and his team, Sarah, she's fantastic. They asked me to put together the list of what we should be going for. So I just sent them a preliminary list, and I just look. I made a list of 15 peptides that you could go for. Why don't we get this circulated around the compounding pharmacies and providers? See what are the most likely ones that people really need. Here are the ones that I listed ones that I thought were pretty strong, and then you know with a team of people we'll put together all that information. Uh, to present again, uh, February— I think it's February 23rd. So what's next is go for more peptides, finish the job on the ones that got the approval, right? Uh, make sure we can, you know, the approval from the PCAC committee, not full approval yet. And then, uh, let's, let's start to really collect information on the value of them because they do accept real-world evidence.

So since 2023, and we got the injectables, the non-compounded, off the list, and we couldn't get them legally or safely, there's some interesting technology that developed with being able to take some of them orally. So the snack technology—

Absolutely.

There's some formulas that got developed there. So some good things have happened from this little journey too, I think. Some Oral dissolvables have happened.

Yeah, absolutely.

Yeah. So have you used any of those and what's your take on those?

Yeah.

Well, we're working with the liposomal tablet technology that, you know, being straightforward, as a part of bringing that into the market and because it's, you know, basically encapsulates 100% of the active material. And so, yes, we've played with With those, I mean, you still run the like what's not clear yet. Just what what I hope comes out of all of it: PPC is naturally occurring compound in your body. Glutathione is a naturally occurring compound in your body. You could take oral glutathione; it's a dietary supplement. You inject glutathione; it's a dangerous drug. So what I'm hoping, right?

Or or is it? Or is it?

Well, anything that's injectable. No, it's not dangerous. It's not dangerous. But legally, anything you inject in your body, they consider it a dangerous drug because you guys should be overseeing it when it's being injected into someone's body.

For sure.

I like that. I like—

so I think we agree.

I think that peptides that could qualify Now, obviously, GLP-1s are not going to be that because they're a manufactured peptide. You know, they're not— it's not a fully 100% just natural compound, unlike, say, KPV, which is a 3-amino acid peptide made in your body. BPC, same thing.

Mm-hmm.

So, when you think of it, I hope that what happens is we get oral guidance That hey, these peptides can be made orally as a dietary supplement. I was just at the Nutrition Business Journal Summit. Everybody's interested in that. I can tell you it's a big topic. I did not think I was going to get that many questions asked in the hallway, and I sure did. And so one of the biggest things that you can do, like, and now there's this whole thing of growing out the other aspects, like. There's plant peptides. There are peptides that come from, say, fish that qualify as new dietary ingredients. So I think this— the whole area of peptide research is going to continue to explode, right? I mean, the Gila monster venom is where GLP-1s came from. Not that you're taking venom, but that is where that research came from. And so I think there's a lot going on there that, you know, I mean, we developed a topical that's pretty promising right now to drive peptides deep into tissues.

Yeah.

And we're preliminarily, we're seeing some really interesting things happen. But I really— this is such a fascinating time with peptides.

It really is. And I think, you know, in the same respect that medications, in the way that you deliver them, right, there is a different outcome. And I think that's the question that all of us are asking is for this condition, or as you mentioned earlier, this synergy of conditions, right? Because that's really what you said. It's unlike a drug to treat a particular symptom. This is really a synergistic effect with the other things that they're doing.

That's right.

But in what way of delivering is the best way to do it? BPC-157 is a great example of that, I would imagine, for colitis, microscopic Colitis, those types of things, I do and have seen amazing results from taking it orally. But when it comes to joint conditions, people are still getting benefit. And I don't know if this is what you guys are seeing as well, but the injectable was far better. I mean, far better.

Yeah, I agree. I think what we found with the liposome technology, because it distributes, it doesn't go through first-pass effect, any of that. We got a little bit more on joints and connective tissue, but in the end, if you have an injury or you're trying to repair, the injection was the way to go. Gosh, we saw so many. I mean, I could show you guys. Well, if you've been in, you have been in my talks and you have seen if I've ever pulled out the pictures of some of the people that we were, that we were able to do things with. Before the legislative change. After that, I stopped doing it, like in the clinic. My doc stopped doing it. My NP stopped doing it. I mean, it was like, you know, we can't do it. And that's unfortunate because, you know, I mean, 16 million doses of BPC were cataloged with only 3 minor adverse events.

Wow.

16 million.

Hmm.

You know, and let's face it, what's the alternative for the person? The way I look at it is most people that are in chronic pain, all right, they try doing an NSAID, successful or not, eventually they're gonna get a bleed, right? You got 150,000 hospitalizations, some, you know, I think the, the statistics is 30,000, 35,000 deaths. So that's not always a good option. And then what am I going to do, put them on opioids so they can get addicted? That's not a good option.

Well, let me tell you a better story, Jim, for our listeners. In one week, I had 3 patients over the age of 70, all female, that came into my practice, all that had gotten steroid injections back to back to back. One had severe gastric ulcers. arthritis, was having a hard time even consuming water. She was so messed up. The other one, flatline cortisol, pain from head to toe, joints a mess, right? And it's like, why are we doing this to people? Why are we giving like 4 steroid injections back to back a month apart in different joints? Same clinic, but a different doctor every time.

Wow. Wow.

And you know what's really sad about that is even if you got to use the steroid, if you did BPC with it, the BPC is going to protect the gut.

Yeah.

Protects the gut and the actual joint so you don't get the dehydration of the collagen matrix.

Right.

So, I mean, that's what's— yeah, I know. It's just an interesting— I think we're just living in this time of the next level of innovation and In medicine, we happen to be caught in that construct that finally raised its ugly head. That said, conventional, like my I love conventional medicine. I really do. I went from my my brother; his life was saved by it. My father's life was saved by it. Really good. But in terms of how do I really stay well? You know, the kind of the emperor has no clothes now. You know, you have enough people saying, you know what, this is what I did for my health. But then we have to filter out the bros and the affiliates and the influencers and, you know, hey, put my code in, you can get my peptide stat just for you. I just, I have the hardest time with it because They're, once again, they're dangerous drugs. People with licenses that are allowed to use dangerous drugs should be in charge of doing that. Yeah.

Well, that's the secret to individualized, personalized care.

Yes.

Right. So, and we need to keep saying that because, you know, they are really good, but, you know, in the wrong toolbox or with the wrong person carrying around that toolbox, they can be very, very dangerous. And, you know, I think that that's one of the things moving forward when we look at the 6 out of the 7 that you guys got at least to this next step, I think have a ton of great research and we can't wait to have them back.

Yes.

Immediately.

Well, you think of, you know, BPC as just like, no kidding. And you know what? A lot of studies are getting translated from You know, Russian and Croatian, and actually even have documents being translated from the discoverer of BPC. So a lot of that's starting to also come to bear. But C-Max, awesome, great for mood, great to help reestablish brain chemistry normalcy, right? Really big. I, I loved all of them. That made it— I'm a huge KPV fan. All right. I mean, I just, I don't know. I just, you know, love KPV. So that was fantastic because there's so many people with, you know, GI issues that are inflamed. And you can, if you could combine BPC and KPV and allowed to be able to do that. Wow. Right. Really big impact.

Yeah. Lowering that immune threshold. Right. Right. With KPV as well. When you add it with that BPC combination, it's so beautiful.

And we're doing that now with oral.

But the reality is we know the difference. Again, we're doing the best we can with what we can do right now because that's all we have right now. But the reality is it's going to be so much better. What were you going to say, Kelly?

I was going to ask about MOTS-c. You know, I had just started tiptoeing into MOTS-c prior to 2023 and just got a taste of restoring mitochondrial function and energy and vitality for our patients that have been chronically ill and chronically fatigued that just wanted their life back. And then to have that taken away as a tool was just so sad. So what would you say about that?

Well, I mean, all chronic disease ends up with mitochondrial dysfunction, right? There's really no disease where that's not happening. So I think SS31 being approved as a drug, right? So that got approved as a mitochondrial peptide. About five months ago, and then the ability to have MOTS-C, you really now have a like a complementary ability to restore mitochondrial function in people. Once again, I think it's in providers' hands because the you want to find out well why or why is that mitochondrial damage going on? And then and then oh I need to do phospholipids for a while to restore mitochondrial membrane integrity. Before I start firing these mitochondria up and throwing off a bunch of electrons and making free radicals, right? So, so I love MOTS-c because of just that reason. I mean, I would say a lot of people over the age of 40, their mitochondrial content, the quality, the density of mitochondria is starting to go south unless they're really taking care of themselves. And that's what invites chronic disease is when You, you can't make the energy you need for each cell to do what it's supposed to do.

That's right.

And where I saw people get stuck is the fatigue and the post-exertional fatigue. They're kind of stuck. So being able to use something like MOTS to reboot some of that so that they can get back to exercise, which is going to make more mitochondria, was kind of like, you know, once you get to your point, all the foundational things done, like you've done the hard work. But they're still kind of stuck there.

You need that kickstart.

Right? And you need that little bit of a boost to help get them over the hump. So yeah, it's not the first tool you would pull from, but it's certainly one that can make a life shift and give them their energy and vitality back.

Yeah, and you know, I think in the era of like the post-COVID era, I mean, it's not a secret that if you read the clinical trials, that, uh, it created a lot of mitochondrial dysfunction. And it's some of the reasons for the foggy brain and the fatigue and the, you know, neurologic issues. And, you know, I don't think it's being controversial to discuss that because it's been published over and over again. And it's the same thing with neurodegenerative disorders, you know, where it used to be thought of as strictly genetic, and now they're figuring out that, uh-oh, the cells are being poisoned typically by pesticides or metals that's damaging mitochondrial output. You lose the mitochondria, you lose the energy efficiency of the neuron. That neuron's going to die and split apart and release a lot of compounds that are going to trigger more damage.

So what do you think is going to happen in regards to cost with these changes? Do you think that the economics of this is going to shift a little bit with having access? I'm just curious because I know that's a question. Like, a lot of people look at these and think of these as boutique-ish. Right, like, out of my ballpark. I can't afford them. And we know the cost of being sick, that's quite expensive too. But, you know, I'm just curious if you have any insight to that.

Well, what's made that hard is that when you can buy research-use-only things that aren't being manufactured correctly, but can be bought at a significantly lower price.

Yeah.

So that's one issue that's there in the consciousness of people. And I talk about the need for quality on a post, I get the research you saw, people chiming in like, oh, it's just part of pharma. And I'm part of safety.

I don't know.

I'm about just, am I injecting something that's safe?

Which is the same discussion around supplementation as well, right? We know that in supplements too is that you're going to pay for quality. And I think our consumers are beginning to really be— they're gonna, they're gonna see that. But still, you know, I'm just curious if now more pharmacies having access to this raw material and the quality, will that change the pricing a little bit? The competitive nature of it, I guess?

I mean, I think GLP-1s are a good example. GLP-1s being a peptide. I mean, when you think of where they started out pricing, And where you can get them now, it's been a pretty big shift downward. So I do believe it'll get somewhat reasonable. I mean, one of the issues though is with compounding pharmacy, they have a lot of regulation that they have to follow. So in order to make it, the amount of like tests and like the operating procedures they have to go through in order to guarantee it, it can be Expensive.

Yeah.

And so you have to prove each validation of every dose. I mean, it's a lot.

Yeah.

And so I do think you have to— we have to weigh that in, that it's not being mass manufactured. And because it's not being mass manufactured, it's probably going to be a little bit more. But I look at— I don't know, I look at it like, is it really? You know, I've been doing this now 40 years plus, and My argument with people all the time is, A, what's your health worth? B, can you look around and see what other things you're doing that maybe you might curtail that'll save you some money this month? Like, maybe, maybe don't go out to dinner and spend $200 on a dinner.

Or don't order drinks.

Don't order drinks. Don't order appetizers, which you shouldn't be doing anyway because you're eating too much already. Yeah, right. I mean, just You know, I— but, but I think it's important for people to assess how important is my health to me. And I know it's expensive. I mean, I, I, I understand. I think pricing will be somewhat better. I think that it's the cost of getting a compound that could be truly transformational. And, and the other thing is many of these peptides you're only using for a short period of time.

Yes. Yep, yep. And I want to add something to that, is that you do— and just to reiterate what you're saying is You get what you pay for. You get what you pay for. And we do want regulations and we want to make sure because, I mean, even if you pay— I tell people this all the time— if you pay $1 for that supplement and that $1, right, you have, you know, forever chemicals or you have glyphosate or whatever, that's the most expensive $1 you've ever spent. So to your point, quality—

That is a mouthful. That is good. Yeah.

Quality. Quality.

Right on. Yeah, no, I couldn't agree with you more. I mean, it's— I, I don't think people realized it until the studies started coming out on the amount of lead, the amount of mercury, the— and remember, when you're injecting lead or mercury, it's a little bit different of a reaction than eating a piece of sushi. Yeah.

Right.

So I think that part's so important for people to, to keep in mind and Yeah, I don't think the research use only market is going to go away.

I wondered about that, like how— what's going to happen to that?

Yeah, I think it's going to be significantly reduced. I think there'll be clandestine research use only, which may suffer higher penalties if they get caught. Like, I personally think that they should just all be closed down. Yeah, if you're going to do research, On a peptide, you can do an IRB, and you can collect data, and you can present real-world evidence. And then short of doing a drug study, and you can, you know, you're able to add to the bucket list of things that we're allowed to do, right? I mean, I just, I think it's going to be very difficult, though, to police it all because there's so much of it.

I agree. Yeah.

And who isn't on retinol? How many people—

I was just about to bring RETA up because I was like, we cannot stop this conversation without talking about RETA.

I'm glad y'all brought it up. It needs to be brought up because it's every single day and it's friends and it's like, and I'm on, or, and I'm like, I'm on RT3.

So you talk about what is RETA for those of you that don't know.

It's the latest GLP-1. It's called a triple-action agonist. And they'll look— the data is great. Lilly has, you know, put millions and millions of dollars into doing their research on retatrutide, and it defats the liver, helps with weight loss better. Um, there's just significant benefits for retention of lean mass. So it's also going to be very expensive. I think they're trying to make it a biologic right now so that would preclude anyone from compounding it. But in the research use only side, it's everywhere. And there's a part of me that goes, you know, Lilly did spend a lot of money making that. So I think there's, you should, even though they're the big, I know the big empire, right? I mean, I'm not, But, but I still think compounding pharmacies should be allowed to compound it if they truly are doing it 503, individualized because, because of dosing. Now, I, I also believe that the big pharma companies got wind of that. Now they're making multi-dose, you know, containers that you can do, you know, titrated dosing. So I, you know, but though I can't believe how much, how many people, how much of it is out there. You know, people will just come up and go, hey, I'm on a retinol.

Yes. And they're getting it from their gym. They're getting it from their gym, right?

A guy.

They got it from a guy or their spa.

I mean, yeah, I got a guy. No, I mean, they—

I—

it's pretty unbelievable the amount of peptides that are going out through the gym world. Actually, and it's because they get an affiliate link, they hook up with a lab, and they're making real money.

But let's be honest here. I think just— and this might have to be edited out, so I'm just going to put it out there because I'm just very transparent. Sorry. But I look at the news because we shouldn't read the news, honestly. We have to take more adaptogenic and all of the things to calm us down after we watch the news. But, you know, you watch the news of so-and-so that just, you know, just keeled over dead, you know, yesterday, you know, young guy this who you would never expect it. And in my mind, I can't help that the first place my head goes is, what are they mixing? What are they using? Who's not monitoring them? You know, and it just, it just, it crushes me. It hurts me to watch because it's all in many, in many respects, It's all in the name of getting healthier. I feel better. I'm getting it from a guy. I mean, that guy would never do me wrong, right? He's doing it too. You hear me? And it's sad. It's really sad. And I've just seen it. I've just seen a lot, so much lately.

Oh, no, I know. I think it's because so much of it is being used and there's attention to it. There's awareness finally, and there should be. I mean, I think More people need to hear exactly what you said.

Yep. They're mixing drugs. They're mixing peptides. They're mixing. They're not monitoring hormones.

Yeah.

Yeah.

I know. So the question for our listeners that they need to be asking is, what am I trying to accomplish? Right? With whatever plan you you have developed for yourself or your wellness plan, what am I trying to accomplish? To Jim's point earlier, many of these peptides are designed for cyclic. use, not to be on continuously. I think GLP-1s are kind of in a category on their own because obviously some of those— some people need to stay on those long term. But most peptides are for a purpose and for a time in the season to accomplish a specific goal. And so, you know, make— being true to yourself, being honest with your provider about what you are doing— we're not here to penalize you. We want to understand better so we can help you better. And always make, make sure safety comes first.

And monitoring. No judgment. For sure. No judgment.

No judgment. But definitely monitoring.

I mean, I just say in closing, I think sometimes it's easy for us to point the finger at the consumer, but the consumer cried out for help over their weight. They went to the gym, they changed their diet, they did everything they thought humanly possible. And felt defeated. When the GLP-1s came out, they were like, this is my lifeline. Unfortunately, there wasn't a complete thought around it for people like us that want to get a whole health perspective. What are all the things you should fix so that you have a day where you can get off that GLP-1? If you're not a person with diabetes, you know, you, you may require that medication forever, and that's great. That's what it's there for. But I think consumers were fed up. You know, when you feel bad, like you said, if you're feeling tired of feeling sick and tired, you're you're gonna do something. And and we kind of we were I mean our part of the world, you know A4M International Peptide Society, the clinicians that go through and get great training, we're prepared for it. But then when we got our tools taken away. It was, it was unfortunate.

Yeah, for sure. For sure.

Talking about being prepared for it, I think Lori and I attended the peptide conference in October 2023, and the week after that peptide certification, I think it was our class number 2 peptide certification, is when it all went down. I was like, oh man, yeah, we were so ready to get started.

We had our notepad of the ones we were Ordering. Like, we were headed out. We had clients' names on the list of those we were going to call. No, didn't work out with us.

Womp, womp, womp.

There you go. Believe me, you wouldn't believe how hard it was to keep the peptide classes semi-full so that you don't want to kill it.

That's right, because we got to be ready.

And you can't reboot it because we know it's going to come back. So I thought I was really proud that A4M really supported continuing the education on the peptides that you could do. And then how do you combine the peptides that you were allowed to do with kind of more strategies for healthcare, right? So you then became more educating on the complete, you know, picture. So from that, it ended up working out. I hope it— the finish line here, it works out. And, uh, we're just going to keep plugging away at it. It's that simple. We're not going to stop. We can't stop.

And for the providers that are listening today, um, A4M is hosting another peptide conference in September in Nashville. So I have a feeling Jim Lavalle will be there teaching. We will be there stalking, of course, lined up with our questions.

Right.

And so, yeah, that continuing education must happen whether we're prescribing them or not. We need to understand what these substances are doing so that we can help patients navigate the course that they're on. And so we're obligated as providers to to keep that education going.

That's it.

I would love that.

That's an incredible point because the worst thing that could happen is a person comes in and says, "Hey, I'm doing VP 21. What do you think of that?" You're going, "Uh, la la la la la la." Let me look it up. Yeah, right. I mean, yeah, yeah. It's so important to. Just be up on it so you can talk about it with them and, you know, warn them of the potential risks.

Yeah.

Discuss where the opportunities are at, and and also see if you have other solutions for them if they were looking for a particular type of diet.

So true.

Other solutions that you could confidently guide them to. So thank you for saying that because I was very committed that people need to know about what the consumer is buying, just like with SARMS or. other categories of compounds, you got to at least know the lingo and understand it.

Yeah. Well, and in the traditional world, what, what they're not up on, they're always down on. And you know what I mean? So I do think it's really important that we don't automatically be down on something that we don't have awareness. And that's a default pattern, honestly, in most of the traditional world. I wanted to make sure that in some of the time that we have, because I know we don't have a ton ton of time. I would love to do almost like this, like, quick answer for a few, a few conditions.

Let's go.

So I, I would like to, like, Kelly and I can call out a few conditions and what would be your most promising peptides for the conditions. So this is going to be a little bit of a brain challenge because I know we didn't necessarily plan for this, but I've been thinking about it. So, um, we had a person ask about specifically about neuropathic pain and chronic pain, and you alluded to it on the live the other The other night, so I wanted to circle back to it. If you had to say the most, like, 2 or 3 or 1 promising peptide for chronic pain and/or neuropathy, what would you say?

Neuropathic pain, ARA-290. Chronic pain in the joints and shoulders, BPC, and then combine it with TB-500 and/or KPV. The other one for pain, opioid mechanoreceptor peptide, otherwise known as met-enkephalin.

That's awesome.

All right, so muscle preservation.

Okay, wait, wait, go. Yeah, you can go. Go, go.

Go for muscle preservation.

Uh, okay, so muscle preservation, I go PEG-MGF, mechanical growth factor. Uh, the secretagogues I think are, you know, really good. And then the up-and-coming one is follistatin. Which is a myostatin inhibitor. So it keeps your muscles from breaking down and signals your muscles to start growing. So those would be the dogs that I would run.

So you're saying CJC and ipramorelin, or so what are you—

Yeah, CJC or ipramorelin or Sermorelin. I mean, Tesamorelin is kind of out of it now, right? It's a biologic. So it was reclassified. So even though a lot of people are using it in the gray market or the RUL market, You can't get it. We're not going to get that. So ipamorelin, CJC, or sarmorelin.

Awesome. Okay. Colitis.

Well, that's easy. Yeah, that's BBC, KBV, and lirazotide.

Yes. Yes. And orally taken and/or injectable when we have it?

I would go oral. I would go oral. Absolutely go oral on that. And If it is like, if like there is an infectious component, then you think of LL-37. DSIP did not get approved.

We were trying to throw you a curveball on that one. So what's the backup plan?

Uh, I, I would say if I'm thinking peptides, I'm thinking Selank because, because Selank has really helped a lot of people with sleep. Uh, GABA mediating, right? So very much like Gabapentin, but a lot less powerful and side effect ridden. So I would probably go to Solanqa as my number one. And then if I was thinking of, oh, maybe C-Max during the day to keep the nervous system from getting too jacked up. And then the one, if you're a senior, you're over, if you're my age, right? If you're a senior, you think of Sermorelin or Ipamorelin-CJC. Because that helps to regulate that nighttime sleep. If you take it in the evening, people report that they get significantly better sleep as they restore their circadian clock. Which brings up one more, epitalon. So epitalon can be a benefit. Typically, I've used epitalon in more the traditional way, 10 to 20 days every 6 months. More and more people are using it more on a chronic basis to help just that. Chronic circadian disruption.

So I want to switch gears for a minute in our last minutes left, because we know that you walk the walk and talk the talk. And you may be a senior chronologically, but you are certainly not a senior biologically. I know your wearables are telling you that you are younger than your actual age. I can—

We should ask your telomeres.

Only imagine. Um, so what do you do? What do you do? What's been— what's your strategy for, um, overall health and wellness and then Peptide Yeast on top of that?

Well, thanks for asking. Um, I move. So this morning I put a weighted vest on, I did 20 minutes on my stair climber, and then I did another 15 minutes of interval sprints on my Assault Bike. Tomorrow I'll do some weights. Uh, I try to make sure I'm moving. Uh, stretch, move, all that stuff's good. Second, I always make sure I'm trying to eat better. I mean, I'm very committed to eating whole foods, less ultra-processed foods. I'm not going to tell you that I never have a cocktail and I never have a glass of wine because I actually enjoy that. But I don't do it a lot, right? It's not something that I have to have, but I like it. I try to sleep. Like, if I can get to 7 hours, I'm amazing. But I'm usually good at 6 hours and 30 minutes. But, you know, I really try to make sure I rest. Try to power down at the end of the day. Product-wise, I right now I'm doing our testosterone LPT, so I'm doing a liposomal tablet of testosterone. Getting great numbers with that, and I'm tailing it every day, so it's following a circadian pattern. I do that. I do. I'm currently using Tesofensin because I like the way I feel on Tesofensin, and if it. It helps me with appetite. I am on aged garlic extract. I take magnesium. I take Synapsin, which is ginsenoside R3. I take Landkind salidroside because it's a 98% salidroside, so it increases my endurance and stamina when I'm doing all these crazy workouts that I'm doing. Uh, I take glutathione. I use the liposomal tablet glutathione, or I'll do acetyl glutathione in a capsule. Or if I go and get my IV, which I'll go get ozone IV with terpenes in it about every 2 or 3 weeks, um, I'll do that. And then there's the usual suspects of, you know, make sure I get enough CoQ10. And, you know, I, I'm not big on taking multis every day. I don't worry about that. Do I take probiotics?

Yeah.

But you know what I do anymore. I take fiber. I'm really big on getting sun fiber in me, about 18 to 24 grams of fiber a day. I get creatine in. Uh, I use something called Aquatrophen in the last 4 months. Um, you know, just full stop, my son's company has that, but $25 million in research, myostatin inhibitor, regulates GLP-1 and GLP-2 and upregulates IL-10 in the gut. So it's got a lot of these positive things that I like, and I have found that I feel really good on that. Peps, you know, it's interesting. I'm very selective about my peptides. I use them more as I need to use them, not because oh this is what's going to keep me young. So I like doing mitochondrial peptides. Have been using SS31 since it got approved. I will absolutely move to my SCH to use it. Love it. So I think mitochondrial peptides are important, but I do them intermittently. I don't need my mitochondria to run like a racehorse all the time, spewing out free radicals. So I do intermittency on my on those. I do epitalin twice a year for 20 days because I do believe that we need to regulate our circadian clock. BPC. I have a reserve stash that I, I knew it was coming, and even though it's kind of old, I had a tendon kind of minor tear, and it really was bothering me. And I injected some BPC, and you know, it's like I dealt with that for three weeks. It happened with like getting off my boat, and. Within three injections, my hand's ninety percent better. It was for human use. Froze it, brought it out. I know I wasn't supposed to, but I I have to have another way of keeping that around because as you you know as you do get older, you do you can risk injury easier. So that that's kind of it. If I like cold and flu season, I can't wait till TA one comes back because every three days I'm gonna do a little bit of TA one. I'm all over that. You know, I don't think we're gonna get cerebral lysine. If we got reliable cerebral lysine, I would really like that. But there's a new peptide. Coming out that I know I'm going to be on called P6C. P6C generates new progenitor cells in your brain, and it was developed by the doctor that discovered entangled tau. Yeah, this is going to be a biggie. So yeah, P6C. That's actually— it's actually oral.

So listen, I love that you started out with the lifestyle stuff. In your description, you started out with the lifestyle stuff. That's your foundation. That's what you live by day in and day out. And I love that.

Well, if you saw my recovery room, you'd think, okay, now the guy's a little wacky.

I've got a recovery room too.

Listen, wait a second.

I got my PEMF, I've got a biocharger, I've got a CO2— you get into the CO2 suit and I fill it up with carbon dioxide because actually carbon dioxide Creates through the Bohr effect, creates more oxygen than doing HBOT. Wow. So if you're healthy— so I've got that suit going on, got my infrared sauna with red light going on. Oh my God, it's crazy.

Listen, you're in light company though, because we're all about recovery rooms. I think so many people are all about the activity, and granted, we all need that. You spoke about that, but we need recovery. And in a world of just busy, busy, busy, go, go, go, rush, rush, rush. You know, we're not doing— most people are not doing those things. So I love that you have a recovery room. That's awesome.

I do too. And that's what I heard in your— in all of your statements and what you were describing is your ability to recover is your superpower.

You know what? It really is. People wonder how I could go so hard because obviously you guys have seen me. I get— I can get on stage and talk, you know, all day long, 3 days in a row. It doesn't matter. And in between, I'm proctoring classes. And I think it's because I keep my batteries charged because I Respect that your body needs to recover, and I think a lot of people to your guys' point too, a lot of people miss it. They just miss that, and it's I think it's key. You got to turn that brain off. I I one of the biggest things I did is I stopped doing work after usually it's actually after like six thirty, but at the latest it's seven. I never look at stuff. I want my evening to be calm, quiet. I live on a lake, so I want to I want to look at the water. I want to bring that parasympathetic tone in, balance out my brain. I measure my HRV with a Morpheus strap. I trained that so I make sure I'm not overtraining. But yet I don't worry about wearing— like, sometimes I'll wear a bunch of them because I got to lecture on it. I got to teach people about wearable devices. But I don't freak out about wearable devices. I want to use them as a tool.

That's right. Yeah. Cumulatively, probably on here today, we have at least 9 of them on ourselves. Totally, if not more. But to your point, that's, that's really good because you can't manage what you don't measure. And when we are working with people, it's important for us to be exploring it and living it ourselves, right? How could we coach people to the lifestyle if we're not living it ourselves? So thank you for being such an awesome example of all of that too and speaking to it, because everybody wants to know what's Jim do, because they say the same thing. Like, what's Kelly do? What's Lori do? So That's awesome. Well, thanks for being on here today. We will definitely see you in September. Thanks for always giving everything 110%, just in being a pioneer and, and just doing what you do. Keep doing it for us. Keep being our voice. We need you out there, and we love that we get the first up-to-dates. Like, we get, we get the news when it's fresh off the press.

Yes, you do.

You just You just ask.

You just have to ask for it.

You know I'm with you guys as soon as you call.

We love it. We will see you soon.

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