The peptide industry is exploding in telemedicine and wellness, but is it safe, legal, and compliant? Hosts Phoebe Gutierrez and Leo Damasco dive into the "gray" world of peptides, from RFK Jr.'s recent push to reclassify many from FDA Category 2 to Category 1, to black-market risks, shady sourcing, and why not all peptides are created equal. They discuss enforcement crackdowns, questionable telehealth practices, and why due diligence matters for providers and patients chasing anti-aging, recovery, and performance benefits.
What if the peptides you're injecting for wellness, recovery, or anti-aging came from a shady overseas lab with zero oversight, would you still take them?
In this candid episode of Telemedicine Talks, Hosts Phoebe Gutierrez and Leo Damasco unpack the realities behind the hype.
They explore:
Whether you're a provider considering peptides or a patient exploring options, this episode stresses caution, research, and compliant infrastructure in a space that's heating up and getting more regulated.
Three Actionable Takeaways:
About the Show:
Telemedicine Talks explores the evolving world of digital health, helping physicians navigate new opportunities, regulatory challenges, and career transitions in telemedicine.
About the Hosts:
[00:00:00] Hey, welcome back everybody to telemedicine talks. Today it is gonna be Phoebe and I Phoebe Gutierrez and Leah Damas talking about
Peptides and wellness.
Yeah. Yeah. definitely. like we said in the previous episode, wellness is a big topic, right?
Huge. Blowing up in telemedicine and it's funny, gosh, how many conversations have we had with people regarding wellness and how many conversations
have
I had with friends asking me about it now? To
be
truly frank, it's something that I've been researching but haven't necessarily delved into, but it's a hot topic people are talking about.
It's all over in the news, it's become a little political as well. So what do we got for peptides today?
Well, I think one of the things that's really interesting to me is the peptide industry is very gray. So I will just kind of like preface it. this kind of came about because I get a [00:01:00] lot of, clinics or physicians asking about peptides and like compliance with.
Prescribing different peptides, how all that works. And my big thing is like, this past week the Health and Human Services secretary, basically re-categorized a bunch of peptides and has moved them to a status that now makes it a little bit easier for people to get their hands on them and that they're actually able to be compounded at these pharmacies and kind of like shipped home.
a little background on that too, right? Before that, these peptides were categorized as an FDA category two. and it's a little bit more limiting in that category, but our health and human services boss person, I don't know where he gets his data, and
whatever we go, don't get me on that soapbox .
You almost got me there. But, Categorize it back to a category one right. To make it easier for people to get [00:02:00] Right.
yeah. I think one of the things that I always go back to is like, whenever some of these large announcements come back, it's like, okay, well wait, hold on. I'm really confused then.
Right. So,
yeah.
I'm like, wait, BPC 1 57 is just now something that is eligible for, being compounded. Then how are all these people getting their hands on it? Like, you can go on freaking Amazon and get your hands on, you know, a quote unquote peptide these days.
And so I dug in because I had a lot of unanswered questions and. The first thing that I realized is that, peptides technically there's a good subset of them that can be prescribed by a provider. So that's one way to get your hands on.
Mm-hmm.
some, quote unquote approved, treatments or, peptide.
That doesn't change the fact though, that the regulations still are saying that they should not be produced at these compounding pharmacies for human use. So even though it's like a weird [00:03:00] loophole that still isn't technically allowed.
Oh no, and going back to the categories, right?
You're talking about compounding so forth and so on, right? because I didn't know, but now I do. So really the category one, like substances, right? Compounders are able to compound it, Because technically it's a very low risk, right? And compound two substances the compounding pharmacies are restricted from doing it.
So really in essence, changing it from a two to a one, you're increasing the availability, right? You're increasing the combating pharmacy's ability to produce this and sell it. Right. And that's just basically what RFK did, right? Well,
exactly.
typically it's not in though, right?
He announced it, he will do it. But
yeah, I mean, I think what their, just, signaling is like, look, if you want to figure out a way to like. Produce, sell, get a prescription for these, like we're able to approve these now. Yeah. Right now
From my perspective, there were some other ways that people, of course are doing anything in the research space. I don't wanna call [00:04:00] 'em workarounds, but some of the interesting things were you know, having IRB approval. So basically having that like research classification saying like, we're using these to research, we're tracking.
We have a principal investigator that's a physician who's tracking outcomes and blah, blah, blah, blah. Right? That's one interesting, kind of like angle that some companies did, because again, then it is, it's defensible. It's a little bit more on the flip side, there is also like the black market of peptides, which, is the interesting, not for human use kind of disclaimers on websites.
Yeah. And. it's really interesting to me. 'cause again, just like you have compounding pharmacies, that are, potentially doing some formulations that might not be, 100% up to snuff. And then you have kind of like these other kinds of, like, companies that are selling these, like research grade peptides.
And it's funny, some of these companies too is just looking at it up, advertising on social media. Hey, heads up when you're talking about [00:05:00] our product. Make sure you mention that you're not taking the product, but you're actually helping the research out. Right. Little, little shady practices there.
And in terms of the animal products or not for human use? Actually, I've talked to doctors that have been approached by some companies or, some people that wanted to start companies. But we're actually dealing with drugs that were not for human use. And I don't know, to me, it's just something I don't want to touch.
But it's funny how, heads up, doctors are being approached for this and you gotta do your due diligence and ask, Hey, where is this coming from? You know what specific drugs are being used.
Yeah. I mean, I think that this is where, to me, I go back to the what is the purpose of a regulator, right?
So we have the FDA who comes in and goes, look, we tested these products. it went through rigorous reviews. We are quote unquote guaranteeing whether or not they do [00:06:00] this. we are going to guarantee that this is safe for, people and humans and again, we're not putting profit over people.
And so when you have people skirt some of these rules, especially when you factor in like the cost savings, right? Like we are talking right now about, potentially, peptides that people are looking at on Instagram or Googling or hearing about from their friend.
They're going to, these companies to get these not for human use. Peptides, little do you know, those are made in India and, there's a whole gang of, you know, potential things that you're injecting into your body. So there's a lot of like, reasons as to why these like rules exist and to, really.
Be cautious and cognizant when you are thinking about either offering these services, wanting to, try these services yourself. it still leaves a little bit of a pit in my stomach.
Yeah. And As it should. Right. You know,
And to your point, just because it's out there doesn't mean it's [00:07:00] necessarily right. Or even safe or even that compliant, right. what are they being used for sure, and how do they approach it?
Yeah. Well, like it just goes back to kind of like my similar conversation as before, right?
At the end of the day, we live in a world where, and I'm not trying to like get all up on my little soapbox, but we live in a world where like we're aging, we're more connected than we ever can be. And access to, different providers and access to different services is no longer like
You don't have to go to your PCP, you don't have to go through your insurance. part of my issue with it is, again, as we just wanna feel better. We don't feel, potentially heard from our, you know, providers maybe. And we're turning to this industry that you have wellness influencers and you have all these people telling you do these things.
It's hip, it's trendy, it's great. Is it, I don't know. I don't know that answer. And again, the interesting thing is as I talk to more and more physicians also don't really understand peptides and how [00:08:00] peptides work. really takes like that extra kind of like training and kinda like diving into it a little bit, which is kind of interesting,
right?
it is interesting, right? 'cause a lot of the physicians, again, are being approached, Hey, especially in the telemedicine space. Especially the ones with multi licenses, from companies that wanna start, this national company providing that. And it's, talking to these providers, these doctors, there's a common theme.
It's like, hey, there is a role, I think there is a role in doing this. You know, there is some data that says, Hey, this can help people. But I think the problem is. A lot of the companies that come in and approach, you don't know exactly where that role fits in or how to appropriately do it.
Right. Some companies are just like, Hey, we want somebody just to sign their name. Here's a protocol, right? and just do it sometimes asynchronously even too, right? And talking to a lot of different doctors that are in the wellness space and actually [00:09:00] practicing. And prescribing peptides within telemedicine.
They, common theme is there's a process behind it where they look extensively in the medical history. these appointments take 30, 40 minutes because they go delve deep. They also, get your labs. they try to rule out any other organic issues.
Instead of jumping straight to the peptides and saying, Hey, we could fix your fatigue, or we could help you gain muscle mass without looking into other different valid, organic reasons of doing so. And, I remember having this conversation with one provider. They actually offered him a pretty decent deal in becoming their medical director and, you know, being that person to sign off.
But after talking it over and looking into the protocols more, It was suspect. Right. and yeah. they kind of just shied away from that opportunity,
yeah. Well I think that there's a few things that are a little bit, I guess what I would consider, interesting factors.
I too, I was [00:10:00] approached by a person who was starting like a peptide clinic. They were looking for a medical director, kind of the whole thing. And when I started to ask questions was actually when they terminated my contract was,
well, where do you seriously get
peptides? like, again, like for each scope of service that you're trying to do, you always wanna ask different kinds of questions.
So in the peptide industry, I'm always like, where are you procuring your peptides? Like, what pharmacy,
did they answer you?
They didn't and yeah, and then like later on I found, this person on, social media pretending almost, selling peptides and talking about peptides
from the same company,
I don't know.
that's interesting. So they didn't want to answer your question, you're asking valid questions, obviously, right? Hey, what's the source? Were you getting this? Is this for human consumption, so forth and so on. And they're like, peace out.
Yeah. So again, it's a little interesting 'cause I think there's a good subset of [00:11:00] people that are like, no, I wanna take my peptides.
I wanna do this thing. And I do believe that there are many amazing uses for peptides. GMPs are a peptide, right? Like,
yeah.
I totally think that there's like a lot of goodness. But I just also think that there's a lot of potential for patient harm if again, you don't know where the peptides are coming from, how they're being, kind of like compounded and made and really just, double checking that what you're putting in your body is not something toxic.
And just getting sold something. Right.
Yeah.
Yeah. No, what a funny story. What happened to that company? Are they still going Now?
I do not know. So I mean, I didn't stay you know, working with, them for very long.
but again, I did think it was kinda like an interesting experience, you know, jumping into it. And then especially as it is heating up. So I think an interesting thing to kind of just like, come back to what is happening. This is something that is like being [00:12:00] enforced more and more and more.
So, in 2024 and 2025, there were a lot of different like enforcement letters that were kind of going out to, a lot of like 5 0 3 A compounding pharmacies. Basically that they're distributing unapproved drugs, right? Yeah. So you haveAgain, very, very large companies.
The FDA is significantly cracking down, not just on peptides, but just in general on compounding. So those companies that are like, oh, not for human consumption. We could have a website, we could market, we could do all that like they are.
Investigating, shutting you down. So there's been many big names in the peptide industry that's websites went down overnight, and this idea that they just shut their doors because they're good Samaritans is, come on, people. It is, you know, these are all due to some pretty significant fines and penalties.
On the flip side, [00:13:00] there's just more and more companies that are getting in trouble for this, and so. Yeah, as I've spoken to many clients who wanna offer peptides, right? They believe in it. They believe in the science they have they have, let's say for example, the IRB process, it still is a slippery slope with you marketing these services.
You have to be very clear in your marketing that these are for research only. especially if you have,the IRB, you don't wanna put like a bullseye on your company by, doing some heavy, heavy marketing to kind of drive, especially when. This is a little bit gray now with the changes that, were made, over the past couple weeks in this space.
It does, open it up a little bit more to the compounding side and kind of like the legal side, but how that'll shake out when it's finally like implemented, will be seen.
Yeah. Yeah. And still, it's gonna be [00:14:00] interesting how that definitely changes the market. 'cause you're right, looking back at even the recent actions, you know, one of the big peptide compounding pharmacies shut down peptide sciences.
Right. Because they knew that the FDA or, That the compliance folks were gonna knock on their door, right? they just put this big target on themselves. You know, we'll see if this reclassification actually kicks in that was promised by the HHS director, right?
and to see how that shakes out. You know, I expect, more of these companies just booming, right? Because now you Kinda have better access to it and almost like an open door to say, Hey, here you go. Now it's accepted.
Yeah, I mean, it's pretty interesting. I will say like the, big pharma does own some of the formulations for how you compound some of these LPs.
So it is to me, especially with everything going on in the world, it is a little bit interesting to think about. Peptide sciences get shut down, [00:15:00] right? There's a few others that just get that shut their doors, right? And then all of a sudden it's no, no, no compounding is okay for these drugs.
So to me it's this very interesting like song and dance of are we going to start seeing maybe. State or federal, programs in the peptide space because now we're incentivized and, I don't know. I will say that opening it up, allowing, you know, compounding pharmacies versus the research only companies does.
Make my heart feel a little bit better from a consumer perspective. But, like I said, we'll see how it shakes out. I am so interested in kind of seeing how this, evolves over the next year
and, going back to the telemedicine telehealth provider specifically.
So why is this specifically important? You know, you were talking about these legal kind of actions, just late last year, right? The tele there were warning letters from the FDA, right? Was the FDA? Yeah. [00:16:00] specifically targeting specific telehealth providers. usually it's these big companies now, the individuals are being targeted, right?
And you're always mentioning, but hey, enforcement is cracking down. this is the future. This is another sign that, hey, the wild, wild west of telehealth is no longer right. people or the regulators states the federal agencies are cracking down and you gotta make sure that you are in the up and up.
Yeah. Right. Well,
It's no longer in the best interest of the federal government for compounding to continue. So today actually, you know, Eli Lilly released big warning to basically every compounding pharmacy in every telemedicine practice out there saying that if you are adding vitamin B12 to your formulations.
We are coming after and we know [00:17:00] who you are. that was released today.
Seriously. that's a big thing.
Yeah.
Just reading that, oh, I wonder how that's gonna change A lot of The telehealth companies, that's how they get around.
Right? you know, you add B12,
That's always my question. you wanna use a compounding pharmacy? Fine. How do you actually personalize it at scale? And the answer's always been, I'm gonna add some B12. And it's like, great. I have been saying ever since this changed that.
Great. That's not personalized. how do you verify, did you update your screen or tool? I mean, I go through all the questions that I have, but.
you know, they did that today over the past couple weeks.
It was, I think March 6th, where, the FDA released 30 warning letters to all these companies, basically saying you are doing, deceptive marketing. I am not going to be shocked when those same 30 companies are the ones that are gonna be mentioned in Eli Lilly's lawsuit.
Oh, yeah. the [00:18:00] compounding, because that's exactly what they're saying. We have the same ingredients. we personalize, we just add vitamin D like It's like clockwork. And interestingly enough, I think like a lot of these companies use the same clinical team. So it's this very interesting thing where it's like these marketing companies that are doing it, but ultimately it's the same providers that are kind of like behind the scenes.
Yeah. And it's all over too. The whole Eli Lilly warning letter, right? I'm reading it now. the warning that, hey. Mixing tirzepatide with B12 may result in, impurities or, yeah, the impurities in the B12 tirzepatide, mixture may cause, adverse reactions.
That's big news. because that's what happened first. Right? Eli Lilly was like, Hey stop compounding, stop using compounded versions of our drugs. When was that? That was like last year, right?
I think about two years ago.
Yeah. But you have to understand like the whole point of it is, and like [00:19:00] whether or not I agree with it is beyond the point. It's that there are rules and regulations that say that, you know, you have A specific drug that's been approved by the FDA and that's how it has to be prescribed. And you've had a bunch of people who had the flexibility around the shortage to go, okay, amazing, we're gonna go compound, we're gonna fill these gaps, make a bunch of money, and then give the middle finger to the government and to these companies.
And again, it goes back to like. sure they can absolutely continue to compound and absolutely continue to try to find these, you know, little workarounds. Does it benefit the consumer? I've heard from my perspective, just even from talking to physicians, right? What's the difference between compounding and branded?
And they're like, well, like branded. You actually see results. Compounding is kind of hit or miss, like there's a lot of variation. It's a little bit harder to manage. [00:20:00] I mean to me, even talking to the doctors that are talking to patient after patient, I'm like, it's very evident that like the Wegovy stick, ozempic.
Seems like a better option than getting a syringe and a little vial and titrating it myself.
is a little funny, right? You know, the way it's packaged, it comes in with this little vial and a syringe. You are like, here you go Here's your little thing . Don't forget to draw it up.
Yeah.
I'm like, okay, all right. you know, and then. it goes back to like how it's marketed and how they are doing it. That's what's kind of getting them in trouble. But again, how do you get patients if you don't market it? So it's this interesting, double-edged sword.
Yeah.
Yeah. and I'm reading up on the headlines too, with this new fight and this new claim that, you know, these B12 additives are, dangerous. you're gonna see a lot more of these deals that the big telehealth companies that were previously using, compounded drugs with [00:21:00] additives, you know, with, the pharmacy companies you know, like HIMSS and Novo, right.
They just partnered to do that. Oh, that's gonna be interesting to see how it shape with the market.
Oh no, absolutely. I mean, again, you have to understand
it no longer interests the government, so like, in most instances, the government's going to ignore certain things. But in this, there's a partnership, right? There's a partnership between Eli Lilly and the government.
They're getting some solid discounts to, American citizens through some coupons. To me it isn't the government's best interest to, make sure people are taking the branded drugs. Whether that's like the clinically correct thing or the thing that just is, I'm enforcing the rules like
That is, I think, what is going to start happening. And I think, Leo, I've said this many times, right?
You always gotta just, follow the dollar, I guess.
Right. And that's the end all be all.
Yeah. So yeah. So that's kind of where we're [00:22:00] standing lots of movement in the glp in the compounding space, which I think I was able to,
I guess last year when I was doing my guesses on things that were gonna happen in the regulatory space, and so it's kind of coming to fruition a
little bit. Yeah. You called it, you definitely did. we should look back and see what episode that is, but you definitely called it. I remember talking about it.
Yeah, everything takes a little bit of time. Regulators take time. it's like you got three years, you have three years to go and operate in a space where maybe it's a little bit gray, but then after three years you really, they're gonna come after you. And so again, I think we're hitting that mark of like the post boom and we're starting to see some of the ramifications.
Yeah. Yeah. again, we're trying to bring more people on the show. Yeah. Tell us what you think. Come on the show. Tell us, your experience with it and what your thoughts are and if you're a provider practicing on these platforms, and I know a lot of us are you know, it'd be awesome to have a conversation on.
how [00:23:00] this is gonna affect what your practice is
I think that if you are a provider that is doing peptides, is using compounding pharmacies is, you know, kind of marketing some of this stuff, I would definitely take a look at the FDA website and look at some of the warning letters.
From some of the other companies that received it. Yeah. Also definitely look at the Eli Lilly warning letter to make sure that you are not going to put yourself in harm's way. Yeah. And then lastly is, look, there are options that you can do this in a compliant way, so try to build in a compliant infrastructure.
I will say, I do think this is gonna be something that is going to be a. Very hot topic of regulating anybody who's doing things in any way that is, quote unquote non-compliant. So I would just, really start to get your ducks in a row because big small private practice franchise, [00:24:00] you name it they're really starting to crack down.
Yeah. No it's definitely a hot topic like you're saying, and it's on, the regulator's radar. being a provider or doing a lot of telemedicine it makes me a little nervous when I don't understand, or, don't have a good grasp . So it is great having these conversations.
'cause then, it helps me, go out and go forth and know that, hey, I'm not doing anything wrong. I'm protected. 'cause Yeah, once your night license gets nicked, it just kind of all goes tumbling down. So. Cool . Thanks Phoebe. Well, hey, thank you all for listening.
sorry to scare everybody and like be such a thorn in the side next week I'll be more fun. I don't know. We'll come up with an idea.
Yeah, This is great. I think, this is something that we need to always think about, right? you know, we all go when there's a lot of opportunities out there and we need to know what we're stepping on or, what we shouldn't step on.
This is definitely helpful for my end knowing that hey, I could go out and practice.
Yeah. Yeah.
Alright, well, hey thank you [00:25:00] all for listening and we'll
check you next time.
all right y'all. Thanks for listening.