Everyone is talking about the recent peptide updates, but has anything actually changed? In this episode, Partner Samuel Pondrom breaks down the latest recommendations from the FDA advisory committee involving six popular peptides (BPC-157, KPV, TB-500, MOTS-C, Epitalon, and Semax). Learn why these recommendations are only one step in the regulatory process, and why state law, patient-specific prescriptions, reliable sourcing, and accurate marketing still matter. Discover how practices navigate emerging peptide services without mistaking regulatory movement for a green light.
Listen to the full episode using the player below, or by visiting one of the links below. Contact ByrdAdatto if you have any questions or would like to learn more.
Transcript
*The below transcript has been edited for readability.
Intro: [00:00] Welcome to Legal 123s with ByrdAdatto. Legal issues simplified through real client stories and real-world experiences. Creating simplicity in three, two, one.
Brad: [00:13] Welcome back to the Legal 123s with ByrdAdatto. I’m your host, Brad Adatto, with my co-host, Michael Byrd.
Michael: [00:19] As business attorneys for health care practices, we meet a lot of interesting people and learn their amazing stories. Brad, this season’s theme is “What Now?” Each episode will involve a real client story with a high-pressure moment for that practice.
Brad: [00:34] Yeah, and what now is exactly what happens, I mean in our inbox almost in any given week. But sometimes a drastic shift happens in the industry that makes our, our inbox explode with what now questions.
Michael: [00:45] Yeah, usually it’s triggered by a new state law or a new federal law.
Brad: [00:50] Yeah, and for those who’ve been kind of paying attention, a committee at the FDA just did some stuff on peptides that people we’ve been waiting on for years, which triggered lots of emails and calls to us.
Michael: [01:01] So exciting, and it’s why we didn’t want to wing this one. So we had to bring in the person who actually lives in this world.
Brad: [01:08] We did. We did. That’s a good call that we brought him in. Please welcome back to our show our partner, Sam Pondrom. Longtime listeners will probably remember that Sam actually joined us in Season 22 for a deep dive on what peptides are. And now right on, right on cue, the FDA hands us a sequel. Sam, so welcome back.
Sam: [01:25] Well, thanks for having me.
Brad: [01:27] Now, Michael, we’re going to put him to work here. We’re going to hit him with some quick questions. But before we can bring him on, I want to ask you a question, Michael. Have you ever sat down at a fancy restaurant, like imagine, I don’t know if you’ve ever been, but they have white tablecloths. The waiters get all fancy. They describe the dishes to you for like four straight minutes, and then you look down after you order, and you generally cannot tell what’s on your plate?
Michael: [01:52] Yeah, I discovered what I would call false advertising of going to a Michelin star restaurant when I went to Europe a couple years ago because that’s exactly what happened. It looked like they went out into the field next to the restaurant and plucked grass to put on our appetizer/salad and my family was extremely proud of me because I ate it all because it was Michelin star, and I had no idea what I was eating. Although I was pretty sure I didn’t spot any mayonnaise.
Brad: [02:24] Oh, yeah, see. I knew this article I read recently was actually written for you. So going to your statement, there was a Michelin star chef in Seoul, Korea, who landed in a very sticky situation.
Michael: [02:37] Mm. Sticky how?
Brad: [02:39] He has allegedly been sprinkling dried ants on his fancy desserts.
Michael: [02:44] Did you say ants? Like the ones that we spray for in our house?
Brad: [02:50] Yes. Well, exact ones maybe. Not a garnish here or there. Prosecutors say that the restaurant imported around 49,000 ants over a four-year period.
Michael: [03:03] How could you even know that? And I will say, I think I want ants over mayonnaise. Just saying.
Brad: [03:14] Fair. Now, the chef’s defense here is that the ants add a zesty kick, and that ant-topped dishes are common in high-end restaurants elsewhere in the world, and he truly believes he did nothing wrong here, guys.
Michael: [03:30] Zesty kick. I feel like I had that happen to me in my Michelin star experience. I wonder if I inadvertently ate ants without knowing it.
Brad: [03:39] Oh, yeah. Here’s the real problem. Ants aren’t approved for human consumption in South Korea. Huh. Who would know? So no matter how zesty of a kick it is, the authorities say basically you still can’t do that.
Michael: [03:53] Oh my gosh.
Brad: [03:55] Thank you, Sam.
Michael: [03:56] Yeah.
Brad: [03:56] But it gets worse. Testing found elevated heavy metal levels in some of the insects, so prosecutors are now seeking jail time and fines for the chef.
Michael: [04:06] Well, maybe it’s just a sourcing problem with the ants, Brad.
Brad: [04:09] Maybe.
Michael: [04:10] Metal should not be natural to ants. I would not think.
Brad: [04:13] I agree with you on that.
Michael: [04:15] Yeah.
Brad: [04:15] All right. So Sam, we’re going to welcome back again as our resident peptide and compounding expert. Have you ever heard about the great Seoul ant scandal, or did Michael and I just ruin desserts for you forever?
Sam: [04:26] No, that’s a new one for me. I’ve heard of bugs being used, but yeah, I think I’d like to know ahead of time.
Michael: [04:36] Disclosure, I like it. All right. Well, let’s jump into today’s topic.
Brad: [04:40] All right. So let’s set the table then, and obviously not the non-ant kind here. Sam, as I mentioned, you were on with us back in Season 22 walking us through what peptides even are and why medical practices in America suddenly wanted to offer them. Since then, the space has really, really changed a lot, almost like a regulatory rollercoaster.
Michael: [04:58] Yes. For those that do not know, in the month of July 2026, for a timestamp, the FDA’s Pharmacy Compounding Advisory Committee met and voted to recommend that six popular peptides be added to what is called the 503A bulk list. Now, I’m going to save us all the potential laughter of trying to pronounce all six of these, so we’ll just leave it there.
Brad: [05:24] Yeah, that works for me. So there’s a lot to unpack here, and that’s exactly why we have the right person coming in to help unpack it. And Sam, we have about 229 questions for you, so you ready to get to work?
Sam: [05:35] Let’s do it. I’m ready.
Brad: [05:36] All right. All right. So let’s go back to the very beginning. So for those who missed Season 22, tell the audience what a peptide is and how they are commonly offered, just as a refresher here.
Sam: [05:47] Yeah. So peptides are just short-chain amino acids. A lot of them are naturally occurring, and they are used in a variety of situations. Mental clarity, GI issues, strength and focus, things like that. Typically they are injected. Some of them you can take as a pill or something like that. But they have become very popular for really everything at this point.
Michael: [06:24] Yeah. For those on video, if you want to know what a Wolverine stacked body looks like, just take a look at Brad over there. No, seriously, let’s walk us through, Sam, what actually happened at that July meeting. So which six peptides got the thumbs up, and what does the 503A bulk list even mean in plain English?
Sam: [06:49] Yeah. So it’s a good question. And the important thing here is, and I’m going to lead with this, and we’re going to hit on this a couple of times, is nothing really, really changed. So when we’re talking about the bulks list, there’s basically three categories. One is approved bulk components used in compounding, one is bulk components that have shown some risk of harm, and then one is kind of the, “Meh, we just don’t know enough about these.” And they’re literally one, two, and three. So one is approved, two is some risk of harm, and three is we don’t know enough. The really important thing to understand here is just because something has been pulled off two or has been moved to one is not approval as a drug. It’s just approval as a component at the FDA level.
Brad: [07:42] Got it. And for our audience members that really want to know what these six peptides are that may be approved, we’ll make sure that we’ll add that to the show notes, so you can go down-
Sam: [07:51] Thanks.
Brad: [07:51] And look at them, and therefore none of us have to try to pronounce them and get them all wrong. As I’ve said before, I thought one of them was C3PO, but they told me that was incorrect. So all right, Sam, to be clear and correct, being on this list is basically the FDA saying licensed 503A pharmacies are allowed to use these ingredients to compound for a specific patient. Is that correct?
Sam: [08:13] That is correct, and that’s a very simple way to look at this. It’s federal-level approval for inclusion in a drug, and that’s it.
Brad: [08:22] Right.
Michael: [08:22] And that’s just for the ones that are in category one?
Sam: [08:26] Yes. Yeah.
Michael: [08:27] Got it.
Sam: [08:28] Like you said, two is there’s been some risk of harm that’s been shown, whether it’s nominated anecdotally or there’s data, and then three is just not enough data.
Michael: [08:38] Okay. So here’s the question, Sam, that’s blowing up our inbox. I’m going to ask it as bluntly as our audience is asking it. Does this vote mean these peptides are now FDA approved, and is it game on?
Sam: [08:54] Unequivocally, no. That is the important thing to take away from all of this. It’s a step in the right direction, and depending on state law, it can be an avenue once they reallocate them onto, presumably, category one. But as of right now, nothing has really changed.
Brad: [09:18] All right. I was going to say it one more time so people can hear it twice. This is a recommendation from an advisory committee. It is not an FDA approval of those six peptides. So every med spa owner has been asking that question. Now, the next question they seem to be asking is they hear the term bulk. “Oh, if it’s on the 503A bulk list, I can finally buy them in bulk and keep them on my shelf for my office just to use when patients come.” Is that correct?
Sam: [09:47] That also is an unequivocal no. Yeah. So when they’re talking about bulk, they’re talking about the manufacturers, drug manufacturers themselves using these as parts of drugs they are creating through their systems that are obviously heavily regulated. And so we really just have to keep in mind the process of how these drugs flow through FDA approval down to use. And right now, essentially, this is an okay for them to be integrated into drugs that either are already approved or are going to be investigated.
Michael: [10:26] Okay. I agree, and I think the part that people keep missing is that a 503A pharmacy is compounding for an identified patient after a valid prescription. And so that means med spas, wellness clinics, and physician practices generally cannot buy these compounded peptides in bulk for office stock or general use. Every preparation has to tie back to a specific patient.
Brad: [10:54] Yeah. Michael, that’s a good point on focusing on a specific patient. Sam, helping out the audience, I guess, from a compliance perspective, what is a valid way, if we were advising a client, as to how do they look at a patient-specific prescription, what’s required in the real world? How should they be charting that?
Sam: [11:14] I mean, when we’re talking about a patient-specific prescription, we need to essentially have all the data that’s required by state law. A lot of it’s very common sense. Who they are, where they live, what it’s for, batch numbers, lot numbers, amount, concentrations, things like that. But then also, the medical side where they’re noting what these things are being used for, what the actual prescription was or what the actual diagnosis was that led to the prescription and making sure that, if there was any sort of audit or inquiry or anything like that, that they have all the data they would need to present to the board of pharmacy or medicine or whoever is regulating that particular piece.
Brad: [12:07] Yeah. The piece that I also was wanting to address is make sure everyone’s aware of is we’re talking about the GFEs here. So we have the pharmaceutical rules here, but still someone has to go through the process of making sure that patient’s a good candidate for those peptides, and that nurse practitioner, PA, physician, obviously depending on your state, still needs to be involved in that patient care.
Sam: [12:29] Yeah, absolutely. Patient flow does not change.
Brad: [12:32] Right.
Michael: [12:33] So we’re going to continue, and we’re really just as a step back, when we’re talking about peptides, we’re really today talking about V6 or other peptides that are not FDA approved and that are not on this Category One. So let’s, let’s kind of tackle the elephant in the room, there are doctors that are already prescribing these. So for a plastic surgeon or physician who is already prescribing these peptides today and before we have this expected final FDA action, what should they be doing?
Sam: [13:12] There’s a lot of background that goes into that. I think ultimately the first question is, do you have a state-law avenue to utilize those even without the level of approval? But I think the other aspect to that is sometimes in medicine things aren’t perfect. And so if you are doing this knowing that there isn’t necessarily an avenue or you’re not sure of that, I think the important part is to get everything else very correct. And one of the things that really helps with that is even if something’s not approved or you’re unsure of approval level, looking at benefit of use versus risk of harm and relying on supply chains that what you have is good and pure and is actually whatever it is you’re prescribing. And just making sure you’re ticking all of those boxes so that if there’s some argument about the regulatory side, there’s no other gaps in the armor, so to speak.
Brad: [14:19] Good. I think maybe the other elephant in the room, or maybe in this case dried ants on your dessert-
Michael: [14:25] Yeah. We just dealt with the elephant, now you’re going to dried ants.
Michael: [14:25]
Brad: [14:28] Dried ants.
Michael: [14:28] Yeah.
Brad: [14:29] A lot of the concerns out there especially with the FDA, was that patients were going to unregulated sources overseas or domestic suppliers. How big is that risk? And do you think this vote actually fixes this issue?
Sam: [14:48] Yeah. I think it helps. I think there’s always going to be that element of people who are kind of DIYers and they want to seek their own sources. So to answer your first question very specifically, the problem with doing things like that, with a patient going directly for whatever peptide they’re looking for is there’s no real supply chain, chain of custody, provenance, data there, where really they could be packaging anything and handing it to you. And there have been well-documented instances of people saying, “I’m taking whatever,” and they’re like, “No, that’s just B12,” or whatever they decided to put in there that was cheap and easy. But the other side of that is, okay, setting the drug aside, it still is intended to fix some sort of physical issue or whatever it is you’re intending to address, and that’s very much a practice-of-medicine issue, and so we have to think about things like, are you a good candidate from a health standpoint? Are you a good candidate from an interaction standpoint? Are there potential issues with it negating other drugs that you’re taking or things like that? And it’s really an area where we want to utilize the expertise of physicians, PAs, and NPs in making sure that this is doing what you want it to do, and it’s not creating other types of harm that you’re unaware of.
Michael: [16:29] There’s a real collision point, friction, whatever you want to call it, between the fact that this is kind of on the leading edge of innovative medicine. There’s not a ton of science behind it, and at the same time, this drive for demand by the patients is compounded by social media and a lot of influencer hope of what this can do. And so the danger, to your point, is traditional medicine. Does this… Is this a good medicine for you if you skip that process? But then you take it even further that there’s not a lot of science for some of these peptides, and you absolutely need a medical professional to help you weigh the benefits and risks.
Brad: [17:28] Yeah. And I’ll add to what you were saying, Sam, is we have had conversations with individuals who are buying it in bulk from China or Asia or wherever. You really don’t know what you’re getting because it’s not being sourced through an FDA-approved or state-approved pharmacy, so it’s unknown. And then to your other point, Michael, and you were just kind of alluding to, which I totally agree with, there’s no way to tell, is it really impacting a positive or, more importantly, a negative way, which I know there’s a whole bunch of people talking about some peptides maybe increasing your cancer growth. So you don’t know. So there’s a lot out there that we don’t know, which, going to your list that you already said, Sam, the one, two, three. The threes may be really, really bad. They just don’t even know yet because they haven’t done enough testing on the individuals.
Michael: [18:16] Well, let’s talk about marketing. So marketing is also an area where practices can get themselves in trouble. With these updates, Sam, what can and cannot a clinic say about compounded peptides in their ads and on their website?
Sam: [18:34] Also a great question. One of the things I actually really like about marketing discussions, it’s one of the few areas where you have a little pithy, like, “Here’s a good rule to follow.” And that’s don’t be false, deceptive, or misleading. And you’ll hear anytime we talk about marketing, some version of that comes out of our mouths. And so really just follow that rule. And part of that is understanding what’s happened. And so first and foremost, if it is not an FDA-approved drug, do not state or imply that it’s FDA approved.
Michael: [19:10] Ah, interesting.
Sam: [19:10] And that’s one of the things we will see are people saying, “Oh, the committee met, it’s approved.” And they’ll state that, and a lot of times it’s not even malicious, but it’s just born of misunderstanding. So 100% don’t state that. The other really important part of this, and one of the things my partners just touched on, is for even on List 1 peptides, some of these just don’t have great data. And if we’re going to make specific claims about any sort of drug, especially peptides, we need to have valid, scientifically valid substantiation. And if there’s insufficient data, we can’t make those claims without violating either FTC rules or state advertising rules. And so I think those are really the two big guardrails here are we have to be very clear about approval levels, and we have to be very clear about what we know from a safety and efficacy standpoint.
Brad: [20:11] Yeah, I agree with that. And just to add to that mix, understand that this is, even if you’re a cash-based business, both the FDA and FTC will have a say, Federal Trade Commission, if you are doing false, deceptive, misleading advertising on that side. And then, you mentioned this too, but even your medical board, so depending if you’re a physician or a nurse practitioner or PA, depending on what board you have to answer to, they can actually go after your license on top of that. So there is some teeth behind what Sam’s describing and how important it is to not overly state the zesty ant stuff that we were talking about earlier from the marketing perspective. You have to be very careful as to how you’re marketing these peptides.
Michael: [20:53] I want to take a step back. So we were talking about sourcing a moment ago, and really we were focused on the patients going direct to these different sources to get the peptides. I want to talk about there’s a lot of misinformation and a lot of pressure about practices that want to offer these peptides. They can’t get it if they’re not on the approved list through a 503A compounding pharmacy. So talk a little bit about, do you know how they’re getting it? And then I definitely want to talk about some of the quote, “loopholes” that we hear about, like research only and animal use only and kind of the…There’s a lot of things that various suppliers are saying that they call loopholes that can get a practice in a lot of trouble.
Sam: [21:48] Yeah. So as far as the sourcing side of it goes, I think like anything else on the internet, if you look for something, you can probably find it. And so there are companies that are producing drug components that are offering these things. There are companies that are offering these things one-off. We actually have seen some pharmacies engaging in this, and so I think there’s a lot of sources for it. The problem is if we’re not utilizing sources that are really a part of an FDA-approved supply chain, we go back to those issues of purity versus contamination, proper substance versus fillers, anything like that that would potentially impact the safety or effectiveness of these drugs. And so it’s a bit all over the map in terms of sourcing, and I think honestly that, to me, scares me a little bit because if I’m going to someone I trust, for example, and saying, “Hey, look, I would need this,” without understanding that the supply chain isn’t in a good space and they’re handing me something and I’m trusting them to have done that due diligence, it really can go awry. And I think that’s one of the nice parts about this move is it will allow you to go through pharmacies to get these peptide drugs.
Michael: [23:24] Yeah. That’s great. And it kind of dovetails into the next part of our conversation, which is a practice’s liability risk for offering these. And certainly if they’re getting something from a non-credible source and that causes patient harm, we can extrapolate that there’s going to be risk to that patient, to that practice, to that physician that prescribed it. Let’s talk about just beyond that. If you’re a practice offering peptides, talk about the paper trail. Talk about the importance of the patient consent and other documentation if a state board or the FDA comes a-knocking.
Sam: [24:11] Yeah. So and there’s kind of two trails there. I would say one is upstream. Where are you getting this? How is it coming to you? And the other I would say is sort of downstream towards the patient. For the upstream side, we were very fortunate actually to have the FDA at MSS this year, and they were very candid about how they view this and what their emphasis is, and ultimately their emphasis was supply chain. And their take on it was if every step up the chain to the source is not FDA licensed or registered, then you’re doing it wrong, and that’s the way they’re going to view it. And because of the safety issues attendant, it’s their big focus of enforcement on sort of drugs on the edge like this. So getting that data, that upstream data, making sure that you have licenses or registrations, asking for purity analysis and things like that, anything to verify that these drugs are coming from a good source and they are what they’re supposed to be, you definitely want all of that internally.
Sam: [25:03] And once we’ve now turned downstream and head towards the patient, nothing changes. That’s the important part here, is nothing changes. Like Brad said, good faith exam 100%. We want to have an informed consent that has a very frank conversation with our patients, and it can be fairly short and sweet with highlighted sort of topics, but you want to have a good deep-dive conversation with them. You want to give them the opportunity to ask questions and have those answered to their satisfaction. And then, of course, we want to know medical history, current drugs, supplements, all those sorts of things. You want to have appropriate protocols in place for your practitioners that are executing on the treatment and then, of course, appropriate follow-up and documentation of that follow-up.
Brad: [26:18] That’s awesome. I mean, I don’t know about you, Michael, but I feel like I’ve learned a lot, and it sounds like there’s still a lot to go. But you’re taking some super complicated stuff, Sam, and hopefully making it easier for our audience members to understand what exactly to do with that. So thank you again for coming back and joining us again.
Sam: [26:34] Yeah, absolutely.
Michael: [26:35] Let’s go to break and then come back and have some quick final thoughts.
Sam: [26:38] Yes.
Access+: [26:39] Many business owners use legal counsel as a last resort, rather than as a proactive tool that can further their success. Why? For most, it’s the fear of unknown legal costs. ByrdAdatto’s Access+ program makes it possible for you to get the ongoing legal assistance you need, for one predictable monthly fee. That gives you unlimited phone and email access to the legal team, so you can receive feedback on legal concerns as they arise. Access+, a smarter, simpler way to access legal services. Find out more. Visit byrdadatto.com today.
Brad: [27:14] Welcome back to Legal 123s with ByrdAdatto. I’m your host, Brad Adatto, with my co-host, Michael Byrd. Now, Michael, this season our theme has been “What Now?” And we’ve been trying to figure out a lot this season and we’re ending this season with Sam coming in and really talking about the FDA advisory committee recommendations on these peptides. And there’s a lot out there unknown, but I think to kind of end this season, we’ve been talking about these three different personalities that people operate in, the pirate, the cruise director, and the Navy SEAL. Let’s look at it from those different perspectives as we close out the season. So start with the pirate first, Michael.
Michael: [27:47] First, let’s all just continue to acknowledge that being a pirate’s fun.
Brad: [27:51] Yes.
Michael: [27:52] And what would someone that likes to have fun do the moment that news came down from the FDA advisory committee? They’d be like, “Let’s go.” And so they would, they would, the cannons would be firing, and they would be off and offering peptides without anything more than just the news.
Brad: [28:15] Fair. That’s fair. All right. Then we’ve talked about the cruise director. How would the cruise director handle this news?
Michael: [28:20] I think the cruise director would, as always, have a false sense of security because they would try to paperwork their way out of the risk. And so they would think that, “If we just have all the consents and all the language in the consents, then everybody else is doing it, so we’ll be okay.” And that they would miss the bigger picture.
Brad: [28:49] Yeah. The everyone-else-is-doing-it defense is really still not a good defense.
Michael: [28:52] Yeah.
Brad: [28:52] And finally, and last but certainly not least, how would that Navy SEAL… Acting like a Navy SEAL.
Michael: [28:58] Yeah. I mean, the key word is strategy. And so when you think about offering a peptide, like anything that you want to add to your practice, you want to look at it through kind of a Venn diagram of the science, number one. Like, what is the efficacy of offering that? That’s the pros and cons, the risks and the benefits, and truly, is this good for the patient? And then the second thing is compliance. That’s all the stuff we’ve been talking about, both at a federal level and a state level, and understanding the risk from a compliance perspective. And then third, what we have talked about before, but not today, is your insurance coverage. How are you protected? Are you protectedby offering these services? Because a lot of malpractice carriers will exclude the riskier compounded medicines like this. And so there is a holistic strategy for someone who’s acting like a Navy SEAL.
Brad: [30:02] There you go. Slow is smooth and smooth is fast. So thank you, Michael, for that great advice. Thank you to our partner, Sam Pondrom, for walking us through. I guess using your advice, Michael, using your mayonnaise principle, if you can’t identify something, don’t eat it. Does that still work?
Michael: [30:20] Yeah. Well, mayonnaise is Satan’s spawn, as I’ve said multiple times.
Brad: [30:25] All right. Well, audience member, believe it or not, that is all the time we have for this season. However, we have a fan favorite coming back for our next Wednesday when we have When Your Employee Sleeps With a Patient.
Brad: [30:35] Thanks again for joining us today. And remember, if you liked this episode, please subscribe. Make sure to give us a five-star rating and share with your friends.
Michael: [30:45] You can also sign up for the ByrdAdatto newsletter by going to our website at byrdadatto.com.
Outro: [30:52] ByrdAdatto is providing this podcast as a public service. This podcast is for educational purposes only. This podcast does not constitute legal advice, nor does it establish an attorney-client relationship. Reference to any specific product or entity does not constitute an endorsement or recommendation by ByrdAdatto. The views expressed by guests are their own, and their appearance on the program does not imply an endorsement of them or any entity they represent. Please consult with an attorney on your legal issues.
