Peptide Law Update: FDA Changes and Protecting Your Practice

If you work in wellness medicine, run a peptide clinic, or prescribe compound medications, what we're covering today directly affects your license, your patients, and the future of your practice. Over the weekend, RFK's junior appeared in the Joe Rogan podcast made a stunning announcement, suggesting the FDA could soon restore access to up to 14 peptides that were swamped off the market under the category 2 band. And that raises a normal legal and clinical questions for practitioners, and there's no one better to answer those questions than my guest today. Jeff Cohen is the founder of the Florida Health Care Law firm and co-founder of the American Peptide Association. Although over 35 years representing clinics navigating FDA scrutiny, pharmaceuticals, cease-and-assist letters, and state board investigation, Jeff has seen it all. He's seen the regulatory landscape from every angle. So putting it simply, if there's one person one explaining what this announcement means for your practice, where the rules stand while we wait for the change, and how to protect yourself in the meantime, it's this man. Let's get to it. All right, Jeff, welcome to the show. Thanks, Greg. Thanks for the invite. No, no, of course, man, of course, I've heard you speak on a couple of podcasts just listening in, and I was at a conference in New York, and heard you speak there, and I was like, wait a minute, this guy, this guy knows what he's talking about here. I should have been 30 years. It's been 30. I was talking to somebody today. It's so funny, man. This guy, he's lawyer, and he said, you know, I finally retired after 37 years, and I'm like, dude, I'm in my 39th year. I'm not thinking about retiring, but it made me feel like, yeah, that's an in-it-a-while. Hey, you have, and that's crazy. You've been in attorney for nearly four decades, and from reading your bio and hearing you speak before, you've been in the healthcare space that whole time. But what's really cool about law, kind of like medicine, there's a lot of different branches of that tree. Yep. So, and healthcare law is vast, right? So what led you down the path of working with wellness clinics and practitioners and compound pharmacies? Well, you know, I could make it sound like it was me, but I don't think it was me, you know, it's got it's a funny journey, but when I was a kid, my mom's a dental hygienist, my dad's a pharmacist, and, you know, and I'm living a life that's really kind of traditional medical. And that put me in the hospital quite a bit, and I was, I had asthma and allergies and all kinds of stuff, you know, and I was a kid that ran into the stuff, trees, and was always breaking something. But, you know, on the wellness side of things, my dad did what he could and he gave me all this medicine, and I didn't realize until I was about 18 years old and went to live in Arizona that boy, I felt like shit my whole life, you know, I just, I really wasn't well. But I get to Arizona and I'm not having asthma attacks and I'm able to run around even in the cold and I can breathe and I'm cycling and I'm, boy, I feel great. And I realized something that, that I felt well because of a different lifestyle and a different approach to healthcare. I wasn't taking medication anymore, I didn't need to do it. And I was, I just started feeling well. And it kind of seeped its way into my thinking that I got very interested in what made me feel good, what made me well, and it wasn't what was generally available. And it wasn't generally, you know, stuff that people spoke about. So I got interested in herbs and things that worked, that at an early age. And of course, you know, 18 years old, I wasn't thinking about being a lawyer. I never met a lawyer. I had no idea what lawyers did. That wasn't on my radar screen at all. But when I put together that kind of background and I'm, and I start working for the Florida Medical Association, working for the statewide organization for doctors, I just loved working with people that helped people. And I found my calling. I was just solidly in healthcare. And it was meaningful to me. It wasn't just a way to earn a living. It was something where I felt like I was really making a difference. And I just fell in love with working for doctors principally. And that turned in over, over the years to working with doctors that did weird stuff like chelation or hormones or stem cells. And I just couldn't get enough of it. And for the last, I don't know, 30 years. I've worked with people that were doing HRT. It wasn't called HRT then. It was called testosterone. And I'm just a curious person. I'm very intrigued by what works. I usually find that it's not, that it's a little off the beaten path. And you have to go looking around corners and under rocks to find stuff that works. And I'm fascinated by it. I have been for a long, long time. I just love it. That was awesome. And you speak in my language. You say chelation and I'm like, ah, Scott speaks the language here. He speaks our native tongue. That's right. The position here. It's cool, man. My undergrad degrees in biomedical engineering. And I remember I was taking one of my last classes and I can't remember this guy's name. One of my professors, he was like, look, I know you guys want to be engineers while you hear. Now this is, show my A-share, man. We're talking around like 2000. Not like on 2000, right? He's like, look, you need to get, you need to look into this whole patent law thing. It's going to explode. I'm just telling you guys, you write your own ticket. But he was honest. He's like, it's going to suck. You're not going to have fun with this. But man, you're going to have a great career. And I was like, yeah, he's selling this too hard, man. He's so so you got you got you got you got interested in unique approaches to health care when you were in school and biomedical. Really? Yeah. Yeah. So for me, I never thought I was going to be a physician. I never thought I was going to be a physician, man. I was in the military. I did nuclear engineering. When I got out of the military, I went to aerospace engineering. I'm not always joke. I'm not supposed to be here, man. I made a wrong term at wrong term, albuquerque, and it was a med school. And then next thing, you know, I'm interviewing you on a podcast. How do we get here, Jeff? I don't know. I know. Listen, you know, in the in the in the yearbook, it'd be like, you know, next year picture, they would have the like these sayings like least likely or most likely, I'd be like least likely to become a lawyer, least likely to want to become a lawyer, let alone become a lawyer, you know? So, you know, I don't know about for you, but I remember in high school, I'd see these kids and they knew what they wanted to do and what they wanted to become and they were on it and they were dialed in. And I was so jealous and I was so envious and I wish I knew, but that's not how life was for me. You know, it was like 50 feet at a time, you know? Yeah, but hey, man, I think those are the best journeys and the best stories. Now, as I was getting ready for our interview, I had a whole list of questions and I was, oh, I'm asking to be great. We're going to talk about this, this, and this. And we're recording this on Monday, March 2nd. And two days ago, there was a podcast. It was a, we'll call it a bombshell podcast. So, our case, junior was on the Joe Rogan podcast and he dropped this bomb. He stated that the previous administration's move of these 19 peptides to the FDA category, two lists was illegal because they didn't have a safety signal. They didn't have the safety data to justify the ban. Then he said, hey, within a couple of weeks, the FDA is going to announce action to make about 14 of these peptides accessible again. So, as an attorney, defending clinics that prescribe these peptides, what was your immediate reaction to this news? Relief, you know, we've heard the, the, the rumor since I'd say October. I mean, I heard it from a very reliable source that 20 to 23 peptides are going to move from category two suspect chemical list to the, to category one. And of course, you know, and I got in my hand on the a list and somebody augmented it and what have you, but we were all kind of guessing. But I heard it from a very reliable source that was going to happen. It was going to happen in January. And of course, everybody's looking at their clock in January. It's like, when's this going to happen? Yeah. I let everybody know through the American Peptide Association. This is coming because I heard it from a source where it wasn't really a rumor I knew it was coming. And then the issue was, well, what's going to be on it? And I knew there was going to be some weird stuff on it. Like I knew everybody knew that the, the stuff that everybody wanted, you know, the TB 500s and BPC 157 and stuff like that. We knew that was going to be on it. But then there was some weird stuff that was going to be on it, like Clotho. And I'm, and I mean, I, I heard that. And I just thought, boy, that's, that's all because there's not a whole lot of people talking about Clotho, other than maybe Jay Campbell and, and Biolungella. But I just thought, wow, I was just super excited and as a lawyer relieved, because people talk about Category 2 and the risk of their license and the risk and the risk and the risk. And of course as a lawyer who practices deeply in this space all over the country, I'm like, what are you talking about? There's like no regulatory activity at all on the Category 2 issue unless you live in a weird, far-mod dominated state like Indiana or Ohio. I mean, there's just like no movement on this issue. So I couldn't understand. It was hard for me to appreciate the kind of anxiety that clinicians and clinical platforms had about Catt 2 products. But thank God that's happening. It's really impacting our clinical clients more than anything else because we represent pharmacies and peptide manufacturers and distributors and every link in that chain, API importers and things like that. But it's really the clinicians, for example, the franchise, the multi-location franchise is the clinical franchises that we're like, where do we want to be on this issue? And they've really been ringing their hands for really a couple of years on this issue. And now I think you're just going to see that space flood, the Catt 2 product space flood, those 14 products, it's like finally. So it's a relief. And I think the good thing for me, the excitement is that now those products will free flow because there's been some constriction in that regard. And that's been frustrating, I think, for a lot of us. So I want to take a step back because for those who are not pharmacists or physicians in a lot of it, a few physicians don't know this too. When you say Catt Catt 2, Catt 2, and Catt 1, what does that mean? Well, Catt 2 is Catt 2 of the 503B bulk substances list that the FDA puts out that's applicable to compound pharmacies, 503A, 503B pharmacies. And Catt 2, and so Catt 2 is what we call suspect chemicals. Catt 2, or the approved chemicals. And the frustration for clinicians and many others in this space is that if you look at the Catt 2 category chart, it'll say next to each chemical, well, there isn't enough evidence to indicate that it is, that it's safe. And I'm, you know, I remember when they got moved there because a lot of these chemicals got moved there under the Biden administration. And I remember when they moved and I'm looking at them, I'm going, the reason for the movement is there isn't enough information to demonstrate that it's safe and there isn't enough information to demonstrate that it's effective so you make it a suspect chemical. And it was odd because it was an aggressive move at the regulatory level to move things for which I thought there was an insufficient basis to move to the suspect chemical list in the first place. So it's great that it's relaxing and we're going to see a move back to one. Yeah. And that was the crazy thing when the move happened when all the peptides went to the category 2 list because it was like, and I understood that this meant that there was some type of safety concern or harm to the public, but I couldn't find it anywhere. I think I was like one, no, like girl hormone peptide IV, which was like, wow, wet shit, it's a massive dose and it was like no one in the right mind would do it. I knew you were going to ask this on the call, but I got to read it because it's kind of funny to me. It's like, so for example, BPC 157, this is a classic thing. Here's the potential significant safety risks that the FDA identified when they stuck it on cat too. Ready? FDA's identified no or only limited safety related information for the proposed routes of administration. And they go on to say that it lacks, they lack sufficient information and know whether the drug would cause harm when it administered to humans. And I'm like, well, then why is it on the suspect chemical list if you have no information to suggest that it's harmful? That's basically what they're saying. And by the way, it's like the vast majority of the products that got moved, the peptides that got moved in cat too. That's the same language for all of them. And I hexa on all of them. It was nonsense when I read it. And it is nonsense, honestly. Yeah. I love the BPC 157 one because it's like, hey, this might be harmful and then you start thinking like, wait, is it 157 in my gut right now? Right. Right. Right. What's happening here? Right. It was complete insanity with that. Well, you know, so made more sense to me if there was a pharmaceutical company that was going after synthesizing these chemicals and then claiming that they own them, right? That would make more sense to me. It's like, oh, okay. They've influenced the FDA once again to kind of, you know, mark their financial territory and protect them. All right. But no, Pharma's not up in that space. They don't want that. No, no, no, not at all. Now, in that same interview, he also noted that these category two band directly created this black market of this, the substandard, I guess they call it the gray market, which is kind of weird name. It's kind of like it's in between. I was in a black market. That's not called a gray. It's black. And it kind of, and I've said this on like two different on the podcast, actually two different podcasts. Once there's a gas and one says as a host, where it's like, when this happened, the first thing I thought was like, man, I guess we didn't learn ship prohibition because when you ban something, you create that market. And this is an alcohol. We're talking about things that were actually helping people. It's the snake eating its own tail because if this is helping people, they're saying benefits, you take it away, there's always going to be a market for it. There's always going to be a way for people to get it. Does his observation about this kind of gray black market, what I want to call it? Does that align with what you see in practice with some of these RUL or research only peptides? Does it align with that? Does it kind of say, hey, now we're going to get, let me ask this a different way. When this change happens and it says, okay, we're moving the awful cat to, let me ask a direct question, is it going to stop the research only peptides? Nope. But let me, I love RFK Jr. what he stands for. I have great respect for his curiosity and his free, unattached way of finding truth and finding answers to questions that we all have. I feel the same way about Marty McCarrie, Dr. Marty McCarrie at the FDA. Hearleism by both those guys to have the balls to just ask questions and say they want the truth and not be owned by other interests around the government or around the industry. I mean, I think they're extraordinary guys, really. Here's where I go, I depart. I don't think RFK has that right at all. You know, the notion that RUO means substandard is absolutely a function of lily and nova norris, but primarily lily, lying to us. Honestly, you know, we make regulation in this country by having the regulated industry have a seat at the table with the regulator. We do it in agribusiness, we do it in the defense industry, we do it in the healthcare space. That's just the way it is. We call it collaborative. The regulated industry and the regulator have a collaborative relationship and sometimes it goes too far and it moves from collaboration to corruption. We saw that with the FDA and OxyContin, Purdue. They just went too far and it was just pure ass corruption. In this situation, when I hear a comment like that from RFK, it doesn't add all along with how I see the reality in this space. I know the stakeholder that has a reason to influence RFK and other regulators that way and that's pharma. The truth is, and I'll explain, the RUO space research use only, that's there. It's got nothing to do with research. It's there because years ago when these companies were looking to figure out how to get into business and stay in business in a safe way, they went to FDA lawyers. The FDA lawyers told them, label your research use only not for human consumption and the FDA will probably be okay with that. So it was at a time when the regulations were who knew and the enforcement was zero. So everybody was kind of guessing and the FDA lawyers did the best they could to advise this emerging industry, the peptide industry. The RUO labeling is the right way. The result of talking to lawyers to try to figure out how to do things compiliently and stay in business so that the FDA doesn't shut you down. That's why they did it that way. It has nothing to do with research. It has nothing to do with the quality of the product at all. Let me contrast that. 503A and B pharmacies, compound pharmacies. Modest clinicians and most laypeople are raised to think pharmacies good, non-pharmacies bad, pharmacies safe, non-pharmacies are not safe. Well we represent manufacturers that make RUO products and also PUO products and we represent compound pharmacies. What I can tell you is there are plenty of pharmacies that are selling stuff with endotoxins and low-potency. And there are plenty of RUO manufacturers that are not CGMP and they're selling stuff that is low-potency and has endotoxins in it. And conversely there are pharmacies that are selling things that are great potency and they're clean, no endotoxins. And there's also the manufacturers that are not pharmacies that are products that are labeled RUO and PUO and their potency is great. There's no endotoxins in it. There is no uniformity in the space and I think that's an accurate statement. But to say that it gave rise to a manufactured product that isn't a pharmacy and they're just shit products is overstating it. It's not true. And the quality safety issue does not line up pharmacy versus CGMP manufacturer or non-CGMP manufacturer. It just isn't that linear. It just isn't. So let me ask this as a practitioner though because when that manufacturer or that company puts that label on the vile for research only not for human use. And it could come from the mounts of a lepis and it could be the purest thing in the world. But if something who knows how that something can happen and let's just say it ends up at the medical board's desk and hey Dr. Jones gave this patient a research only peptide. What does that mean for the practitioner from a liability or an exposure standpoint? It's a problem. If they prescribe the product. Honestly, it's a problem. And I'll tell you why it's a problem. It's not necessarily a problem because the product's bad. It's a problem because the people that get to decide whether the product is a problem. They don't practice wellness medicine. They don't care. They get mesmerized with the label that says not for human consumption. And you as a physician and PEPA are giving something to another human being that says not for human consumption. I'm talking about the board of medicine, the board of nursing. They're going to look at that and they're going to shake you up. Or a plaintiff's lawyer. He or she is going to have a field day with that. That's why I tell clinicians, hey, when you're sourcing product, don't source product that says not for human consumption. That's a real problem. I think it's an invitation to a bad day for a clinician. Yeah. Yeah. I did. What did I talk? They were like, it was like, it's like jail. I was like, jail. Oh my God. You know, that might have been too extreme with it, right? Yeah. I mean, is there somebody that was out? That was the question early on, early on, all the physicians. But all physicians, you guys were asking stuff like, if I prescribe these products at all, am I going to go to jail? And am I going to lose my license? And the answer was no. But when you're using RUO products, there's a reason to be concerned if you have a license. It is not the right product to use if you have a clinical license. So you mentioned three words earlier and I want to circle back on that really quick and then we're going to get into some more about the conversation on that podcast. You mentioned professional use only or P.U.O. If that label is on the vial, does it change the regulations for the practitioner? Well, in my opinion, it changes the risk. The regulation is still the same. It's illegal to use category two products. It's illegal to, hell, it's not compliant to even order a compounded product unless there's substantial clinical justification and writing, which nobody puts in writing, right? So there's compliance, there's noncompliance. Let's talk about the risk of it. The P.U.O. issue, prescriber, professional physician use only, it's made by a manufacturer not a 503A or B pharmacy. It's incumbent upon you as a physician to audition the supplier or the manufacturer of that product to prove why their stuff is so safe and so good. That's your burden. Listen, when you're ordering wagovie, you're prescribing wagovie, you have no responsibility really, right? It visa me that product. Product work, it doesn't work, the product costs damage. That's the responsibility of pharma, not you. But when you're using a source, a compounded source for anything, you have a responsibility as a clinician to validate that source. You can't just say, hey, I'll just order your stuff. You need to understand about certificate of analyses. You need to understand about sterility and potency testing, the 3PL testing. You really need them to audition for you about why their stuff is so good and so safe. No, why? Why? Two words. Well, two concepts. Plain of lawyers, regulators. Plain of lawyers and regulators are all ready with the first argument that you can bet every time, which is the only thing you care about, Dr. Jones, is money. That's why you're using that product. The only way that I can counterbalance that, helping you, is to say, no, no, no, Dr. Jones, auditioned a number of suppliers, look at all this convincing stuff about safety and effectiveness of these products that are in writing that Dr. Jones received. And now we shoot that greed-based suspicion and story they want to tell. We shoot it right in the head. That's fascinating. So when it comes to that auditioning and the information that the practitioners can use to protect their patients and themselves, is it just a COA or is there anything else that we should be asking for? I think there's a lot more in that. It's COA is an issue. Do they third party test the product when it, prior to manufactured? Are they third party testing the APIs? Are they testing the ingredients? Are they testing it after it's freeze-dried, after it's liathalized? There's plenty, one of the things that the government should be concerned about is people insourcing finished product from overseas, not testing it, just selling it. That happens in this space. And that's a problem, which is one of the reasons why what we're going to really see this year is a lot of movement pressing into product sourcing and manufacturing integrity. Manufacturing integrity. There's a lack of specifics in those areas, which is one of the reasons why the American PEP type association has picked up the flag and says, you know what, we're going to define quality as it relates to API sourcing, as it relates to manufacturing, as it relates to every step of the way. We have physicians that will define best practices, safe quality practices. We have manufacturers and compound pharmacies that are members of the APA, and they're going to define quality. Because if you don't define quality for yourself, it's going to get defined at you by regulators that just don't have precision regulation. They're going to get it wrong. So I want to get a little clarity on the announcement that was made and just some of the things we've been talking about. So let's just say the announcement comes out. Here we go. Bam, these peptides are off category two, the category one. Barf K comes out like, hey, I want the 5.3A compound pharmacies to be the ethical supplier for peptides. This happens, rubber stamp, bam, it's happening. The companies that are basically selling research peptides online, you can go click button, here you go. Yeah, promise, scouts on it. I'm not doing it. I'm not going to use it in a human. You can order them, get them shipped to you, do what you want to do, right? Are those sites going to get shut down or those going to go away when this happens? I don't think so. I think the biggest issue in the RUO direct to consumer space is this, they carry products that compete with Pharma. That's the biggest problem they have. I believe that if they didn't carry Terzepetide, some Aglatide, Reditruide, and SS31, we wouldn't have heard about these dangerous research chemicals. That would not be the rhetoric. That would not be anything. You'd never have heard about it. The problem is that the direct to consumer marketplace that has RUO-label product on it, competes with Pharma, so Pharma has a beat on that. And Pharma is going to go after it. And I know that there's some serious thought about how they're going to do it, because we just saw on February 6th, Dr. Marty McCarrie let us know in a recent announcement that FDA is going to go after the mass-marketed compounded GLP. He's talking in code about RUO, but he's talking about it as it relates to GLP. And again, I think that's because the government has an obligation to constrict the supply of products on the direct to consumer marketplace that compete with Pharma. I don't think that the RUO platforms or the direct to consumer platforms are going to go away. I think the government is going to make it incredibly distasteful to carry products that compete with Pharma on direct to consumer on the RUO platforms. Fascinating. So let me ask you this question here. Because I always think about this when the category 2 ban came out and then me understanding who this kind of ban is targeting. Because from my understanding, when category 1 and 2 and 3, that is for pharmacists. This is on category 2. You cannot compound this. But as a practitioner, as if it's a physician or a practitioner, whatever it is, our board is going to say, "You can't prescribe this." That's not a decision they make, so that's directed towards them. So basically, where I'm going with this, it's not telling you what you can prescribe. So all the category 2 is a physician. It's like if it's my clinical decision that my patient needs this, I can do it because it's a clinical decision. And I should be able to have that right as a practitioner. It's that weird area where it's like, this is all I think about. It's like, "Okay, they can't directly say you can't prescribe it, but I can tell the pharmacy's not to make it." So it's an indirect -- That's right. So it's like, "I don't understand -- this is what I'm going." It's like, "How would I get in trouble as a practitioner?" It's like, "We're going with this. If I get a peptide from a compound pharmacy that's still in category 2 list, am I still exposed as a practitioner?" Depends on the state you live in. The truth is, the vast majority of the regulatory activity is happening at the state level, not the federal level. It's happening at the state level. There are a small handful of aggressive states that have a lot to say about what physicians are thinking and doing. And they're really pushing into the doctor-patient relationship. Indiana, Ohio, a little bit Nevada, Alabama, a couple other states. So we see that kind of movement, but you're absolutely right. The category 1, 2 issue, is directly pertinent to compound pharmacies. These are compound pharmacy-specific regs, guidance. It has nothing to do with a physician, MP, or PA, nothing. But it creates a lot of consternation at the clinician level. It's like, "Is it okay for me to use it?" The short answer is, the vast majority of states have exceptions to pharmacy-centric regulations in a physician office. So things like reconstituting or compounding, generally, you need a pharmacy license to do that, right? Well, guess what? The exception in most states, if you're a doctor and you're doing this in office for your own patients, there's an exception. Another way to say it, "Is any clinician ever used a medication for off-label purposes?" Yeah, all the time. As any physician ever come up with and try things because other things have not worked. Yeah, all the time. The issue for clinicians is, does your state take a hands-off perspective in terms of you doing what you do as a clinician? Now most states do, but some states are very intrusive and second-guessing and kind of disrupting the doctor-patient relationship. And in those states, I understand why clinicians are like concerned about, "Well, gosh, category too, is my licensing board going to shake me up?" And I live in Florida. You're talking. I think you're in Florida, right? How many Arizona? Oh, Arizona. Well, Arizona is one of those really respectful states that really takes a very hands-off approach to the doctor-patient relationship. Florida is another one of them. And so, incredibly unlikely that you'd see any shake-up in these states, but in a handful of other states, I get phone calls and sometimes the intrusion is surprising. So, speaking of intrusive states, let's talk about Indiana. Because also this weekend, and as a term, I know you've been following this, but there was a big decision made in Indiana, which also is the home state of Eli Lilly and there was a whole other thing there. And there was this safe act, was the thing that was being pushed through. So, can kind of give us that 10,000 foot view of what was happening in Indiana and that decision that was made this weekend and how that can impact practitioners and pharmacies and clinics. Yeah, essentially, you know, the safe act is Lilly's attack on the compound pharmacy space. That's really what it is. They put like caps on the amount of compounded GLPs that compound pharmacy can produce. It was ludicrous. And when I've spoken to regulators about that, they call it Lilly's Bill. And they don't call it Lilly's Bill with a smile on their face. They said, in fact, when it first was proposed, what I was told is it has no chance of passing, no chance. Because it's so obviously pharma protective and pushed by one company to protect their pocket, you know. So, I mean, that's Indiana though. And you know what? It's also Ohio. Ohio is home of lots of pharmaceutical companies and that's why you see laws being proposed like that that are incredibly nonsense. It's just what's the rationale for putting caps on compounding GLPs on 503A and B pharmacies? There isn't one. I just don't want them taking money from me. I mean, that's the real reason behind it. Yeah. And I've heard Ohio's rough and I've heard Ohio is hard. I have a lot of pharmacies like, yeah, we're not even going to go there yet. You know, and it's like once they, it just makes it difficult and it's unfortunate for the patients that live in Ohio because at the end of the day, that's who bears the brunt of a lot of these decisions. Right. It's not getting the care that can actually help them. Exactly. That's part of me. A lot of this is missing. Exactly. I mean, you think we're going to have a GLP shortage. If we constrict the ability of 503A's and B's and CGMP manufacturers to make it, yeah, of course we will. I mean, the demand, you know, this kind of the irony in this whole peptide space back in 22 when the government said, please help us. We're drowning. We can't supply people this magic elixir, the GLPs. Everybody ran to meet the need. And they were heroes, right? Back in 22, they were absolute here. You're going to get into the compounding space and you're a manufacturer and you're going to get us to Zepatide and some of GLP. Thank you. Thank you. They were hugged. They were just glorified, right? Two years later, they're dangerous. What? What are you talking about? Well, what happened is two years later in 24 when the shortage bite was declared to be over by the FDA. The very same group of businessmen that entered this space to fill that need and to answer the call were vilified. Immediately, the American Diabetes Association issued an announcement that all compounded GLPs are dangerous. Well, their corporate sponsors are Lillian Novonortisk. This Association of States Attorneys General issued an announcement that GLPs are dangerous. The Connecticut Attorney General sued all the direct to consumer platforms that were selling compounded GLPs into the state of Connecticut right after the shortage was declared to be over. So on the one hand, we need people to make these GLPs and to and really move the needle of wellness of Americans. And two years later, the shortage is magically over. By the way, they didn't divulge the reasons or the resources or the information that was reviewed to make that decision because they said it was all proprietary. And immediately eight minutes later, you had this barrage of self-interested organizations vilifying an industry that was created at the request of this government. That's really what happened. That was crazy. The town's man was like, that's what I was thought, like, wait a minute. Like, these are the same medications that he said you needed. All of a sudden they're dangerous. That was, it's all corporate man. That was such BSO. And then they started sewing people, which is really worth it. It didn't start with, hey, stop. It was like, oh, here's your lawsuit and deal with that. It was bad. It was really impressive. Yeah, we can be impressed. We defended those around the country. And it was some of the ugliest litigation that I've been involved in. It was bad. That was just punishing. It almost like, so because of the cost of it and the tenacity of Lily predominantly, it was so, I mean, it drove a couple of our clients out of business. Wow, that is sad. That's sad. But this is a good segue into kind of the next thing I want to ask you about because when it comes down to it, the way my opinion, one of the ways we can protect ourselves as practitioners is with our consents and medical waivers, right? But those standard consent forms, standard waiver forms, they don't really cut it in this space. No, no. Is there a way? So is there a way clinicians should structure or kind of manage their informed consents to protect themselves wherein the compound space and especially the peptide space? Yeah, it's a great question. Clinicians hate this answer, but one size doesn't fit all. I wish it did. But in the peptide space, it just doesn't. For clinical reasons and for regulatory reasons. If you've ever taken too much NAD or taken too fast, you understand what I mean. You end up on the floor. And some of those folks end up in the ER because they're so flipped out and they're so, you know, upset, obviously, by it. Has that been, that risk is that divulged in the informed consent or do you just have this general one? Well, they have to be customized, right? VIP, all the vasodilative stuff, you want around feeling like and looking like a tomato. You know, all of this stuff that is unique to unique peptides with unique symptoms or consequences, they have to be really divulged. In granular detail, number one, number two, regulatory reasons. If you're going to, if you think a compound of GLP is important for a patient and you put that in writing, what the clinical reasons are, that's great. You're halfway there. But did your GLP informed consent also give the patient access to a branded FDA approved direct to consumer peptide as well from Malily or Nordisk? It should. Why? Because the regulators are going to have a problem with you or a plaintiff's lawyers will have a problem with you by saying, oh, you're just pushing people to compounded sources. You're not giving, that you're not letting them know that there's also an FDA approved alternative that they can access themselves. Why is that because you're just making money off of the compounded source? So you create problems for yourself, regulatory problems and lawsuit problems that you really can help yourself with if you customize your informed consent. And so that's a lot of consent forms. Because you think about-- and so if I'm hearing you write, you're saying, hey, the best practice, if you really want to protect your practice, is to have it, if not an individual consent form, but maybe if you're going to say a growth hormone or at least, hey, here's my GHRH consent form, which covers like CJC and a parallel and a test and a parallel. So you can categorize it with that help instead of having 50 consent forms. Yeah. Yeah, I think clinicians, I think you have to ask yourself this question. Is there either a regulatory reason or a clinical reason to customize it for this particular product? That's what you have to ask yourself. And you're going to-- I mean, with a bunch of them, the answer is no. I mean, BPC 157, customize it for B-- I don't think so. But for certain other ones, there are regulatory reasons and clinical reasons to customize them. And it matters. It really matters. It's the protection, man, because I tell you, man, you guys ain't cheat. But you're not saying cheat. No, I think it'd be bad. I'd rather spend my time on a consent form than have to deal with that. So one of the things I've seen you mention in some other podcast is that-- and this goes segue into protecting the clinic-- is that our website is often that gateway to a bad day. It's the front door to bad things. That's right. And so when you're looking at a clinic's website, what are the biggest red flags you look for that say, hey, wait a minute, you need to take this down or you need to change this? The first thing I look for is claims. Are you making promises about anything? Because if you are, you run straight into the federal trade commission, and that's a pain in the neck to deal with. It's also upsetting. FDA sometimes, your state licensing body sometimes. And you have to understand, when you're looking at the neighborhood of risks, you're not just looking at regulators. You're also thinking about plaintiffs lawyers. You're thinking about as well competitors, pissed off former employees, patients that are upset. So you have to kind of take into account the perspective that all these folks have when you're standing up a website. Are you, for example, are you talking about dosing and cycling on your website when it relates to peptides? It's an uncommon thing, but I've seen it. And I'm like, well, why is that there? Is that really essential? Because there are certain things that are attention getting in a bad way. The risk enhancing things. Claims about product outcome. Because there's this general prohibition against false deceptive or misleading advertising. So you really want to dial that back. The other thing I look for is anything that the FDA says they don't like, which changes from time to time, or that pharma says they don't like. Like back in the early spate of cease and desist and lawsuits, from pharma was, hey, you're using our words. You're using the word semaglutide and terzepetide and retotruthide. That's what we own that. That's our stuff, which is why the website stopped using those words and went to code, GLP1, GLP2, GLP3. They did that as a reaction. When we went back and scrubbed these websites, we were like, hey, you're going to get into trouble using these words. Let's use other words. Let's find other language. So I look for regulatory, dangerous language. I also look for lawsuit-attractive language, and we bring it to the client's attention and say, this is what I think you should change so you could reduce your risk profile. Those are probably the two dominant things that we look at. So I want to ask you this. So especially with the claim thing, unless you, because we've been talking about BPC157 a lot. If you go to a website, let's say I put them on website, BPC157 can help treat-- there's a different way. BPC157 can help with the pain associated with arthritis. BPC157 may help with joint pain. Would a regulator look at that as a claim? No. I say the may can or might. May can, arguably, has been reported to. Here's some clinical studies about it. You attached it to your website. Yeah, it's all about that nuance kind of language that makes all the difference between a lot of money and then you don't have to call me. So-- You got to get it. So yeah, it's like-- I just said it might. Exactly. It's a nuanced thing. It's like in the influencer space, because we represent a number of influencers in the wellness space. It's like, hey, the line that I tell people to walk is walk more closely to education than promotion and walk more closely to talking about yourself and what you're doing that's helpful for you than telling anybody else what to do. Now, as a physician, that might be a little confusing because your training is to examine, diagnose, prescribe, treat, and document. You kind of follow that. So you think that you have a free reign on your website or on your social media if it's you to talk about you, you, you. your patient relationship with that you. You know? So you really want to kind of dial it back as much as you can, which is hard for if your doctor who happens to be an influencer or a podcaster, it's hard because you get a lot of views and you get a lot of attention and you create a lot of impact based sometimes on being a little controversial, a little wild and that's great. But you have to be really, really careful because the people that are listening to you, you don't want them to say, "Hey, you got a degree, you got a license, you told me what to do, we had a relationship, you're responsible." And, that's incredible and as I put the whole nomadical advice on my site before I say anything and of course, as a physician you make a policy, you get the comments are all like, "How do you dose how do you take it?" I just don't answer that because I don't even want to have that perception. But speaking of social media and this leads me to a question that's thinking about it as you were talking. Let's just say I do a post and let's just say "Fimicinalfa1" and we'll switch peptides for the sake of this. I get on there and say, "Hey, it's Dr. Jones, I want to talk to you about thymicinalfa1, is this peptide, thymic gland, yada yada, it does all this, does all this, this is how it works, it's an mechanism of action, here's what the research shows that it can treat and I kind of end the post on the call to action. I don't say call me, don't say, I just say, you know, that's it, I just end the video." And let T1 is probably bad example because I got moved on, let's say, let's switch it to like GHK copper, still on a category 2 list, right? And I do this whole video on GHK copper. Does that expose me because I, as a physician on my doctor page, I talked about this category 2 peptide that's on that list with that, put some liability on me because I'm just speaking on it, I'm educating on it or does it change that because I'm a doctor and not a social media influencer. Very low risk to educating. There's a, there's an elevated risk to promoting element, which doesn't mean you're liable for anything. It just means your target profile just grew. That's all, that's all. Yeah, so you mentioned a peptide earlier and this is kind of the flavor of the muffin and comes to letters and is that's the 31? Because that manufacturer has been passing out season to cis letters like, like, like, can't, can't. Yeah, but they're not, they're not silly. Yeah, but it's going to be lawsuits frontier biologics. Yeah, but it's, it's scary when you get that letter, right? Yeah. Yeah. Especially, you know, if I got that letter object, oh my god, panic, what do I got to do? What do I do? Oh my god, right? And so I'm calling you and all this. Like, what do I do? Oh my god, this is it. It's the end. It's like a Fred Samp, or this is the end. I'm coming to the audience. You know, I got to see Andy Leather, right? So if a doctor gets a formal season to cis letter, a pharmaceutical company, how can we prevent that from escalating into this full blown lawsuit? Oh, you just lay down like a, like a German shepherd. You just kind of show him your belly. I mean, it's really the faster the more the faster you can comply and be really respectful, um, and complying the better off you are number one. Number two, you can do it yourself. Okay. But I don't advise doing that. Um, these companies behave and regulators behave very, very differently when you're, when the person speaking for you is a lawyer. They get very respectful, very cooperative, very reasonable, very fast because there's a, you listen, the one of the reasons why a C and D is sent out, for example, by frontier biologics for SS 31 is to intimidate you into being compliant, right? It's, you know, we just want you out of our space. Stop using that language, get out of competing with us. Um, the vast majority of, I don't think I had one client when, when frontier launched all those C and T's, C and D's, I don't think I had one client who said, screw them. I'm staying in it because I love it. I'm just going to say it. In fact, what I, what I heard from every client and we had quite a few that got those letters was, you know what? It's not really a big deal. Fine. So we immediately on their behalf would cooperate with frontier and they went away fast. They went, you know, and you see, I would say it's a general matter that, pharma is a little bit like a shark, but like a really angry shark, you know, sharks will bump you to see if you get, if they get resistance. They're testing you. Well, pharma is bumping into you to let you know they're going to take your leg. You know, it's not, it's not, let's see what you got. It's like, I'm going to bump into you because I'm taking your leg and you immediately get on the phone and say, hey, this is who we are. This is how I represent and you let them know and they go, oh, you, you want to be compliant. You want to be respectful. Great. Let's, let's get to the finish line on this. You want to do that fast. That's good. God sure. The owner of the battery. That's, that's great because I know those letters can be terrifying as a practice, a practice owner, as a practitioner, and it's great to know that. Now, before I let you go, man, you mentioned an organization earlier, the American peptide association. Right. For those who are not familiar with that, what does that organization do? And is it more for clinicians, pharmacies, manufacturers, or all of us? Yeah. APA is a new organization. It's just a few months old. It's all about quality safety and access in the peptide space. And to really understand what it's about, we realized that it had to represent every facet. So we have members that are manufacturers, members that are API importers, compound pharmacies, physicians, various other clinicians, distributors, influencers. It's every facet that has to sit at the table and dialogue and understand what does quality safety and access mean because everybody has a different perspective from where they're coming from. Our job this year is to define quality safety and access. In every aspect of the industry, we're agnostic in terms of how the public receives these chemicals. It could be a direct to consumer line or it could be through a clinician. APA doesn't care. As long as it's quality, safe, and it sure is access to people that want it and need it, great. We just have to take leadership for what quality safety and access really means through the eyes of somebody in the manufacturing, in the distributing, in the clinical side of it as well. We have to define it. In many ways, things like you guys are helping, I would say, like, right, but self-regulate, make sure we're doing things the right way. Honestly, the same people that stood up the American IV Association for the IV hydration industry were the same people that came from that. It's a similar kind of thing. It was a disaggregated industry that was waiting to be punched in the face. We're like, "We got a better idea." Let us. Yeah, exactly. We just didn't think that was a good approach and for IV hydration and we don't think that's a good approach for APA. So, yeah. That's what I'm saying. That's awesome. It's very new. You're at the end, Jeff. I promise. You're at the end here. It's very new. This is kind of how I let you get out of here. This is how I get you off the hook. For anyone that wants to know more about APA, but also your office, your practice, and the work that you do, how can we find out more? You know what? You can send an email to me and I'll get it to the right place. J-Coin, J-C-O-H-E-N, at FloridaHealthCareLawFirm.com. J-Coin, FloridaHealthCareLawFirm.com. Perfect. We'll put that in the show now so people can reach out. You may get a lot of emails, man. Be careful with your ass. That's okay. There's great team of people that I can get everybody helped. Appreciate that. Appreciate it. Hey, J-Coin, I want to thank you for joining me today. This has been awesome. The timing was for two of this, man. I was like, wait a minute, this just happened this weekend. Everything that happened with that podcast in Indiana. I'm really grateful that we're able to talk about this today because the big thing about that announcement and what's coming hopefully next couple of weeks is what does this mean for the practitioner? What does this mean for the patient? What does this mean for the space? Let's take away the business part of it. How does this help us help our patients? If access is the key and now we can, in obviously, our zone, like you said, is very much, "Hey, doctor, you take care of your patient, but for across the board, being able to help patients and get these medications, get these peptides to the people that need it, this is big news." It's big news. You know, there have been people in the supply chain that have been afraid to be in the cat-toe space. And so sometimes there's supply, hiccups, and constriction. This is just good news for everybody. Everybody wins. But it still depends on how you make the products, right? So yeah, there'll be a greater supply and I think clinicians are going to relax, not worry so much about what their licensing board is gonna do or their employers gonna do. That's awesome. And we've got some work to do to make sure that the best and safest sources thrive and the others go away. Perfect. Thank you. That's it. That's how it goes man. Thanks. I appreciate you. Yeah. And so I'm sure I'll see you around. I'm not going anywhere and you've been here 40 years. I don't think you're wanting any area either. We will cross paths. We will definitely cross paths. Maybe when I'm back in Florida, I'll stop by. Hopefully as a friendly visit, not a hey, look what I got in the mail visit. So hopefully it'll be very nice and peaceful, very calm, buy some coffee and just say, man, we're here and we made it. You bet. My pleasure. Thank you. Alright, everyone. This is Dr. Greg Jones. I want to thank you for listening in. So another episode of the Dr. Greg Jones, optimization academy until next time. Stay healthy. Stay optimized and I'll see you soon.