Peptides are powerful and often misunderstood.
SPEAKER_01And we're here to change that one conversation at a time.
SPEAKER_00I'm Dr. Kylie Burton. And I'm Jessica Brickie. This is Pep Talk, Peptides Impact. Science Made Simple, Results Made Real.
Happening July 23rd and July 24th, like right now, the FDA is holding a two-day hearing that directly decides the future of many of our favorite peptides.
SPEAKER_01Yeah, let's talk about this because I want to have everybody really understand what's happening instead of really being anxious about it because I've seen an enormous amount of misinformation about this, a lot of scare tactics around it, and a lot of really bad information around it. So we're going to clear all of that up. So we're going to back up. We're going to go backwards before we can go forward and tell you about where we are with the hearings that are happening.
So back in September of 2023, the FDA placed a group of peptides into a stricter classification called category two. That classification created a lot of confusion across the industry, and it led to some real pushback, including lawsuits from compounding companies who felt that the process wasn't handled really well. And then there's confusion around category two. I had it too. I didn't understand it until I dove deeper into the explanation. So here's the difference. The FDA compounding classification is completely different from the DEA classification. I didn't know this. I heard category two, and I thought it was all the same thing because that's all that you hear. Category two that we're hearing about most often is the DEA classification, DEA, Drug Enforcement Administration. They are a classification for controlled substances like our narcotic drugs or even testosterone, believe it or not, because that was abused way back when people were using it to build muscles, and that was not used well and does have bad side effects. So that got put into a category two from the DEA. But a category two with the FDA is a compounding classification, and it's for the section 503A of the F D C Act, and that governs what bulk substances licensed compounding pharmacies can use to make patient-specific prescriptions. All right, so the 503A compound pharmacies, those are the ones that are out there, like we work with, that are making individual compounds for people. So that's where they are coming in here. Now there's two relevant buckets that matter. So to explain, we talked about category one, I'll explain that in a second, what that means with the FDA, but FDA category one substances that are nominated with enough data that are currently under evaluation where the FDA has historically exercised enforcement discretion with respect to their use. And pharmacies can use those in generally compound with all of them. Okay, so category one, open for everybody, compounders can use them freely. Category two, which is where these peptides were placed back in 2023, these are substances that the FDA flagged with potential safety or quality concerns with compounding restricted while they undergo further review by the pharmacy compounding advisory committee, the PCAC. And this effectively is a don't compound this list, not a criminal schedule like it is with the category two from the DEA. Does that make sense? You're with me so far. I'm with you. All right. So that happened in 2023 under the Biden administration. In April of 26, just a few months ago, with the big push from RFK. Thank you, thank you, RFK, the FDA removed several of the peptides from the category two list classification, and then scheduled them for a formal review by this group that's called the Pharmacy Compounding Advisory Committee. Again, the PCAC for short. That's an independent panel of medical and scientific experts. Now, if you're wondering what this list of peptides are that we're talking about that got moved into category two that are now in this under review, they are BPC157, TB500, KPV, MOTS C, DCP, CMAX, Pitolon, LL37, Dihexia, GHKCU, PEG, MGF, and Melanitan 2. All right, you've heard us talk repeatedly about a lot of these peptides. They are out there helping so many people. But although the FDA already removed these from the category two, that removal alone doesn't put them into the automatic 503A list or into a category one. Okay, so they're sitting in this regulatory gray zone pending the PCAC meeting and then beyond.
There's a lot. We're still here, right? Got it? On July 23rd and 24th, 2026, the PCAC will discuss bulk drug substances that are being considered for inclusion on the 5038 bulk ingredient list. Even if the committee votes favorably and they love it and they say yes, that is not an automatic light switch that everybody has a go. If they recommend adding these to category one and the FDA agrees, notice and comment rulemaking is still required, which can take more than a year to happen. So the PCAC recommendation is non-binding, non-binding. Though the FDA usually follows the committee recommendations in practice. All right.
SPEAKER_00Yeah, so it kind of sounds like category two are more controlled. So we really want to get them into a category one. Correct.
unknownOkay.
SPEAKER_01Yeah. How do we accomplish this? All right. So it there's a lot of steps that are involved in here, right? So first, this is going to give the entire industry clear, formal, long-term framework for pharmacies and providers and for patients. It's going to take something that's currently decided piece by piece and put it on solid, permanent footing, right? It's really important for this to happen. But even if a positive recommendation happens, it's not the finish line. So it's just going to kick off this formal rulemaking process at the FDA, which includes public comment period and a final ruling. So that just takes time. The hearing is a huge step forward, but it unfortunately is not the final word.
SPEAKER_00It's really about building long-term certainty more than it is about a light switch flipping at this hearing on the 23rd and 24th.
SPEAKER_01Yeah, it's just really the best way to think about it. So, regardless of where this regulatory process lands, I'm gonna bring it back to something that we've talked about before on the
show. So peptides, like one of our favorites, BPC157, have circulated in the compounding world for years. For years. This is not new. And TB500 traces back to research on the stymusin beta 4, that's TB500, going back decades. That's real world history. That's part of our historical use factor for the committee. They're gonna weigh that. But it also doesn't replace the need for randomized trials. So the again, the difference, we've talked about this in another podcast that we're gonna, it's this is it's gonna come out after this, I think, because we're gonna fast forward this episode. But just real quick, it's worth understanding the difference. Observational studies and randomized control trials, they are not the same thing. It explains a lot about where these peptides actually stand, though. So an observational study comes first, almost always. That's what happens when clinicians and patients start noticing patterns in the real world. Someone's using a compound for one indication, and then providers start noticing it's doing something for entirely different beneficial needs, completely outside of what it was originally being used for. So that's not a flaw in the process, it's actually how medicine has always moved forward. Real world use generates hypotheses, and then randomized trials are what's supposed to come after to confirm these things more rigorously. And to be clear that those RCTs, they really are important. They need to happen. And nobody's saying skip that step, but here's what's getting lost in a lot of the peptide conversation. We're not talking about brand new untested molecules. Many of these have been in human trial for many years, some for decades. Insulin, we talk about this a lot, which is a peptide, has a hundred-year track record. So when critics point to limited clinical data as the whole story, it's worth remembering that a massive amount of real world world observational data already exists. It's just that the gold standard RCT machinery hasn't caught up to all of that yet. And it's a gap that is about funding and prior prioritizing them as much as it is about safety.
SPEAKER_00So you've got insulin and you have collagen. People don't think about that one either. They're peptides. And just as a refresher, what a peptide is structurally, so think about uh protein as like an entire 12-inch ruler. An amino acid is like a one millimeter piece of that 12-inch ruler. You have to have lots of amino acids that are bound together to create the protein. A peptide is like a one-inch on the ruler, it's just much smaller compounding amino acids. So structurally, think about that. Okay.
SPEAKER_01That's a great way to put it. It's the first time I've heard it put that way. That's I love that ruler analogy. That's good. Did you just come up with that right off the cuff like that?
SPEAKER_00Nice. I did. I usually tell people in person when I use my hands. So let's think about a ruler because this is audio. So a ruler, 12 inches versus a millimeter versus an inch. But that's really all they are just we can put together.
SPEAKER_01We can also look at it from a prescription standpoint, too.
SPEAKER_00That's really what this is about, is prescription standpoint. This is what it's about.
SPEAKER_01But if you have nutraceuticals, like our vitamins and minerals and supplements, and then you have prescription grade medicines, usually synthetic, forcing action in the body, right? Like Tylenol, for example. That is a forcing in action in the body to lower inflammation, to reduce pain. So we have nutraceuticals on one end and we have pharmaceuticals on the other, and then peptides kind of rest in the middle, kind of like that one-inch amino acidular. Oh, this hearings about the regulatory system catching up to something that's already been in use for a long time. We want to bring it to your attention so you can pay attention to what's happening. Our goal here is wellness and know what's available to you so that you can live longer better, and making sure that these peptides are available to all of us is a big part of that. So, this is a hot topic that we wanted to bring to your attention and follow us along as this unfolds over time and we see what the outcome is of these hearings next week.
SPEAKER_00And remember, you're going to see things, fact-check them. Because you see it doesn't mean it's real. This is just a starting point. And Jess, tell me if I'm wrong, but Honey, the CEO and the founder of our telemedicine company, is going to be there speaking.
SPEAKER_01She is. She was invited to be the speaker both Thursday and Friday. They split the peptides into two different days. So some of the peptides are being talked about on the first day, the other, the rest of them will be on the second day of the hearing. And she was invited to be a speaker on both days. It's a huge honor. As a matter of fact, I am going to DC the day before the hearings, and I will be there with a bunch of our colleagues as in a rally, and we have a lunch and learn to get a little more education around all of it. But we will be there to rally for everybody's health. Really, not just peptides, not just business, but I want to have access personally. Selfishly, you better believe my voice is going to be there.
SPEAKER_00Yeah, and access to safe peptides.
SPEAKER_01That's the other side of it. This, I'm glad you brought that up.
What has happened by moving everything to this category two is it has pushed everybody into this deeper gray market. So they're getting things where they're not knowing exactly what is in these research grade peptides that are coming from a country where even if they're saying they have a COA, it may not even be in English. They're not verifying the actual ingredients. Some companies are, not all of them are doing that, but some are. But even if you're doing that, you're still playing pharmacy in your kitchen. You are still relying on your buddy to tell you or Chat GPT to tell you how to reconstitute these things. You are playing Russian roulette. And because of this happening, going back in 2023 and pushing them into this category two, an enormous amount of people who have been using these for a long time were pushed into going and putting these things in their body. And we really just want to keep, we want people to have safe access and feel better. That's the whole point of all of this. Yes.
SPEAKER_00Okay. I have to say, coming into this refresher, I like staying out of the legal side of things. But you gotta know it. And so this was a good refresher on what actually is happening, despite all of the things that we're going to hear around it. And thank goodness we have RFK Jr. at the lead.
SPEAKER_01Yep, absolutely.
Well, if people want to stay informed over the next few days while this is going on, you can follow me on my Instagram because I will be there the day before the hearings. I will be at the rally. You can follow me on my Instagram, jessb.talkshealth, where I'm going to talk about all the things and try to keep you in the loop as to what's happening.
SPEAKER_00I will be at the lake in southern Utah, cheering you on. Okay, so Jess, remind them where your Instagram is.
SPEAKER_01Yep. Again, it's JessB.talkshealth. You can also follow me if you want. You can get all the information at my website, b2bwith.com.
SPEAKER_00You can find me at drkylieburton.com. Till next time.