Episode #135: The REAL Process and DIFFICULTY in Legalizing our favorite Peptides! DO NOT BE MISLED! The TRUE DIFFICULTY REVEALED!

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[00:17]
A
Every movement your body makes depends on energy at the cellular level. Many people think resilience, strength and performance come from discipline or training alone, but that is simply not the case. They rest on a deeper biological foundation, your cellular energy system. The center of that system are your mitochondria, the powerhouse of your cells. Every step you take, every weight you lift and every muscle contraction depends on mitochondrial energy. Muscle cells are especially energy demanding and contain thousands of mitochondria. Without energy, muscle simply cannot perform. And that's why I recommend Timelines Might Appear a supplement containing urolithin A which supports the cellular process mitophagy. Mitophagy helps the body remove damaged mitochondria and support healthier function. Mitopure may support cel muscle strength, recovery and healthy aging, which are the keys to supporting mitochondrial health. Timelines Might Appear is now available at a new lower price of only $79. But you have to visit timeline.combackslash Dylan Gemelli. That's timeline.combackslash Dylan gemelli to save today. So we heard about 12 peptides that were supposedly going to be legalized. We're going to be able to use these. And everybody's up in arms celebrating, talking about how great this is. But are these actually really legal yet? How do we know they're even going to be? Is this some tricky political things going on here like normal or are we actually getting somewhere? Well, I have some information for you that might clear up some of this and give you at least a bit of bit better understanding of what exactly is happening here and what's going on. So the fda, what they did was, and this is all over the place, as many of you know, is they removed 12 peptides like I just brought up from category two. And what is category two? Category two is bulk drug substances that actually raise significant safety risk. So they got removed off of that, but this doesn't change their status. They're not immediately approved for compounding. So what's happening is they're going through this really rigorous evaluation to determine if they can be officially included on the 503A bulk's list. Now the 12 peptides that are up for discussion, BPC 156, TB 500 Epitalon injectable, GHKCU, MOT C Delta sleep induced peptide, Dihexaacetate, Melanitan 2, my favorite, which I'm going to be talking about on another video, kpv, Ibutamorel and Mesalate C Max, another one of my favorites and cathalidisin ll 37. So right now what is happening is the FDA is actually bringing these up before the Pharmacy Compounding Advisory Committee. And what's going to happen is there's going to be an independent science based safety and clinical evaluation going on. So don't necessarily believe everything you hear without fully understanding exactly what is happening or going on. So they have developed what's called a 503, a bulks list. The FDA has what they call this bulk substance list. And that means that these can actually be used to compound different drug products. And this is Section 5 of the FD and C Act. So you have to go through this real rigorous FDA protocol, people meeting committee, whatever you want to call it, that they determine the safety risks. Now I don't like to do this and I'm going to kind of leave it alone, but you're kind of at their mercy when it comes to this. People can come in, plead their case, do whatever. I'm not saying every single person in the FDA everywhere is bad. I'm not a conspiracy theorist, but I think we know how this works. There has to be an exchange of some kind of money somehow, some way where they're winning in one way or another to push things like this through. Because otherwise this creates a massive, massive problems for people in power that are making money. Every now and then something happens where some people in there push the envelope, get something through, or work as hard as they can to bring things to light. That kind of put them in a position where they kind of have to do things. But a lot of times this comes down to money and that's just how life works. I have come to accept that that's how it works, but have also understood that we can have voices and we can do whatever we can to try to speak together to stop some of this and or really push them to have no choice but to accept the facts. There's always going to be pushback and that's just the way it goes. So towards the end of July, what's going to happen there is the committee's going to get together and they're going to discuss a few of the peptides I read off of that list. So they're going to do BPC157 and related bulk drug substances, KPV, TB500, MOT C. These are ones that they're going to be discussing at the next meeting. And they're also going to do DSIP C, Max, Epitalon, these are all fabulous compounds by the way. And they are going to go back and forth rigorously on whether or not these are safe, how they can prove that, the efficacy, all of these things. Now, here's what they're going to tie these two, though. This is their argument. So this is interesting. So with BPC157, they're actually looking at that being used for ulcerative colitis, KPV, they're looking at wound healing and inflammatory conditions. TB 500, also wound healing, MOT C, they're looking at obesity and osteoporosis. Now, this is interesting because most of us know BPC157. It's mainly known for healing injuries. And KPV is well known as something for the gut. Now, inflammatory conditions, we can tie that. We can look at that how we want. Even TB500, yes, they have these benefits that are listed, but that's not what they're mainly used for. So it's interesting, it's the position on how they're going with this. Even MOT C. Now, MOT C, yes, people do use it for weight loss, but my main thing with MOT C is cellular health, mitochondrial health. So it's interesting. And then as we go down, epitalon makes sense because one of my favorite uses of epitalon too is help with sleep, but also with the heart. So they only list insomnia there and cmax, migraines, neuralgia. They're looking at these in a totally different way than what most of us know them as. So it's interesting and compelling, really, to see what happens. Now, here is something for you. Today's episode is brought to you by my great friends at Ginfinity. One thing that I've learned over the years is that the highest performers do not rely on assumptions, they rely on data. And that's especially true when it comes to nad. Everyone is talking about boosting NAD levels, but very few people actually know where their levels are to begin with, whether their protocol is working or how much they even need. And that's what makes Ginfinity different. Which is why I am thrilled to announce that I have teamed up with genfinity to offer the new Dylan Gemelli NAD Optimization Protocol. Powered by Ginfinity, this protocol provides you the Ginfinity intracellular NAD test and you with the most complete and trusted NAD boosting supplement and protocol in existence, along with proper guidance to ensure that you are optimizing your health, performance and longevity. So check out the link in the show notes and start taking control of your health. Today, the FDA is actually going to have the ability for all of us to link to a live webcast. So be aware of that. And I'll try to keep updating on this and link some things on this. But that's interesting to where we can actually watch this. There are people there that are going to be able to voice a lot of our concerns. But it looks to me, from what I read, that there's a place where you can make electronic submissions and you can send it in writing to and present data arguments to help or any of the areas that you're concerned. They actually have a website if you. It's on FDA.gov that you can use and you can send in electronic submissions. There's also ways that you can actually write in. I don't know how many people actually send written letters anymore, but you certainly can. And it's. It's pretty. It's one of those things that if you don't know which it's not easy to know, unless you're looking for things like this, then you would never have any clue that you have these capabilities. There's a lot of things out there. We have capabilities and a voice to have, but it takes people to spread that word and to really dig in and know. I find it strange that they're not looking at all of the benefits that we all know, but I'm thankful that they're looking at anything at all. And it's great that there's at least some people that are working for us or at least are trying to make it appear like they work for us. I'm always a little skeptical, but I like to give people the benefit of the doubt as well. I've just seen too much and gone through too much over the years and seeing how this works. But let's keep our hopes up. I will continue to provide information on how this works and what's actually happening. But be aware because people post a lot of things. They get your hopes up, they say things that aren't exactly accurate. And I want to make sure that we're getting all of the right information. There is an opportunity coming soon and it's very soon. So stay tuned there end of July for that committee meeting and take a look and see if there's a way for you to present some facts, write some things in, have a voice, help. Because let's put it this way, we are in a time right now more than I've ever seen, where there's a lot of people that are really bringing to light different types of medicine, naturopathic, functional medicine. And I will always be of the ilk that it's your body and your choice on what you get treated with. There is far too much of this telling people that this is it, this is how it is and this is the end all, be all. And that is not true. And when there is a problem with you asking a question, wanting to know answers, and that seems to be an issue where angers people or whatever kind of reaction you get, that's not an answer that tells you all you need to know. It's far past insane on what happens anymore and how people are brainwashed or forced into things that they don't want to do and don't think they need to do. It's your body, it's your choice. Now you have to deal with the consequences if you make a bad one. But there should be different options for everybody. And there's a lot of data that gets skewed, a lot of data that gets manipulated and then gets put out and put in front of the crowds, the masses. And it's not always true. Sometimes it's great and sometimes it's not. These are simple facts. I'm just telling you what I see and what I know. And I will always, always, always advocate for you being able to make your own choice. And just remember something, we are told that things are conventional. Conventional medicine. Is it really conventional though? Is taking something natural and chopping it up and doing a bunch of different things to it and making it into something else conventional? Or is taking the pure form of it what's actually conventional and has been deemed non conventional? Think about that. Think about how we're told things are the opposite of what they actually are. It's something to think about, let that resonate. And remember, peptides are an alternative medication and treatment for you. And it's up to you to do your due diligence and research on these, but also on what gets prescribed to you. Because oftentimes you're getting something that you don't need and it's causing an adverse effect. Just do your homework, take care of yourself. Because aside from God, nobody else is going to take care of you but you. It's your responsibility. That being said, stay tuned for plenty more to come. Dylan Gemelli, signing.

Summary5 min read

The Dylan Gemelli Podcast

Date: June 18, 2026
Host: Dylan Gemelli

Episode Overview

This episode dives deep into the real legal, political, and scientific hurdles involved in legalizing popular peptides for therapeutic use in the United States. Dylan Gemelli cuts through widespread misinformation and hype, providing listeners with a detailed, fact-based breakdown of the FDA’s process and where things actually stand with peptide legalization. The main takeaway is to temper excitement, stay vigilant about the truth, and understand your rights and options as a consumer interested in alternative therapies.

Key Discussion Points

1. The Current Status of Peptide Legalization

Hype vs. Reality:
- Many in the health and fitness community are celebrating the “legalization” of 12 peptides, but Dylan urges caution:
  
  “Are these actually really legal yet? How do we know they're even going to be? Is this some tricky political things going on here like normal or are we actually getting somewhere?” (03:01)
FDA Process Explained:
- The FDA has removed 12 peptides from "Category 2" (bulk drug substances considered to raise significant safety risk) but this does NOT mean they are FDA approved for compounding or legal use yet (04:10).
- These peptides now move to a rigorous evaluation to possibly be included on the 503A bulks list, which would allow their compounding under certain conditions.

2. The Peptides In Question

List of 12 Peptides:
- BPC 157, TB 500, Epitalon (injectable), GHK-Cu, MOTS-c, Delta Sleep-Inducing Peptide (DSIP), Dihexa acetate, Melanotan II, KPV, Ibutamoren, C-Max, and Cathelicidin LL-37 (06:00).
What’s Next:
- These are under review by the Pharmacy Compounding Advisory Committee for independent, science-based safety and clinical evaluation (07:09).

3. How the Review Process Works

Section 503A of FD&C Act:
- Peptides must pass stringent FDA committee reviews before being added to the bulk substances list for compounding pharmacies—essentially, approval is NOT guaranteed or imminent (08:15).
- The process is lengthy, political, and may involve behind-the-scenes maneuvering:
  
  “You’re kind of at their mercy when it comes to this…there has to be an exchange of some kind of money, somehow, some way, where they're winning in one way or another to push things like this through.” (09:00)

4. Upcoming Public Committee Meetings

Late July Meeting:
- The FDA committee will specifically review several peptides (e.g., BPC 157, KPV, TB 500, MOTS-c, DSIP, C-Max, Epitalon) at a public session (11:24).
FDA's Focus:
- Noted by Dylan: the official medical indications under review don’t always align with what the peptide community knows or uses these compounds for. For example:
  - BPC 157: Ulcerative colitis (official), used for injury healing (community)
  - KPV: Wound healing/inflammatory cond. (official), mostly regarded for gut health (community)
  - MOTS-c: Obesity/osteoporosis (official), cellular and mitochondrial health (community)
- “They are looking at these in a totally different way than what most of us know them as. So it’s interesting and compelling, really, to see what happens.” (14:06)

5. Get Involved: Community Advocacy

Public Participation:
- The FDA offers a live webcast of the meeting.
- Opportunity: There’s a public call for electronic submissions and written letters to share data, personal testimony, and arguments (17:45).
  
  “There’s a lot of things out there. We have capabilities and a voice…but it takes people to spread that word and to really dig in and know.” (19:00)
Details:
- Links and instructions are available at FDA.gov; Dylan intends to provide updates and additional resources.

6. Skepticism, Personal Responsibility, and Medical Freedom

Mistrust of Institutions:
- Dylan maintains a measured skepticism regarding regulatory bodies and “conventional” medicine:
  
  “Is taking something natural and chopping it up and doing a bunch of different things to it and making it into something else conventional?…Think about how we're told things are the opposite of what they actually are.” (23:36)
Advocacy for Informed Choice:
- Encourages listeners to:
  - Research any medication, peptide, or treatment.
  - Question data presented by authorities and the mainstream.
  - Assert their autonomy in health decisions:
    
    “It's your body, it's your choice. Now you have to deal with the consequences if you make a bad one. But there should be different options for everybody.” (21:06)
  - Remain vigilant about misleading or incomplete information spreading online.

Notable Quotes & Memorable Moments

On the FDA process and politics:

“A lot of times this comes down to money and that’s just how life works. I have come to accept that that’s how it works, but have also understood that we can have voices and we can do whatever we can to try to speak together.” (10:10)
On public participation:

“It’s one of those things that if you don’t know—which it’s not easy to know unless you’re looking for things like this—then you would never have any clue that you have these capabilities.” (18:35)
On the mismatch between medical labels and peptide community knowledge:

“They are looking at these in a totally different way than what most of us know them as. So it’s interesting and compelling, really, to see what happens.” (14:06)
On medical autonomy and skepticism:

“I'll always, always, always advocate for you being able to make your own choice.” (23:50)

Important Timestamps

FDA removes peptides from “Category 2”: 04:10
List of 12 peptides under review: 06:00
Explanation of 503A Bulk Drug Substances List: 08:10
Discussion of late July FDA public review meeting: 11:24
Analysis of official medical indications versus community use: 13:35–16:50
Public submission opportunities and advocacy: 17:45–19:30
Dylan’s thoughts on medical freedom and skepticism: 21:00–24:00

Summary Takeaways

The removal of certain peptides from the “danger” list does not immediately legalize them—they are now under formal review by the FDA.
Approval for compounding still requires extensive public, scientific, and committee-based evaluation.
There is a critical opportunity for community participation: submit comments, share experiences, and advocate for peptide access.
Stay critical: Much misinformation is circulating, and the FDA’s criteria often don’t align with the practical, community-proven uses of many peptides.
Ultimate message: Stay informed, speak up, and remember—when it comes to your health, it’s your body and your choice.

Loading summary

Transcript1 lines

[00:17]
A
Every movement your body makes depends on energy at the cellular level. Many people think resilience, strength and performance come from discipline or training alone, but that is simply not the case. They rest on a deeper biological foundation, your cellular energy system. The center of that system are your mitochondria, the powerhouse of your cells. Every step you take, every weight you lift and every muscle contraction depends on mitochondrial energy. Muscle cells are especially energy demanding and contain thousands of mitochondria. Without energy, muscle simply cannot perform. And that's why I recommend Timelines Might Appear a supplement containing urolithin A which supports the cellular process mitophagy. Mitophagy helps the body remove damaged mitochondria and support healthier function. Mitopure may support cel muscle strength, recovery and healthy aging, which are the keys to supporting mitochondrial health. Timelines Might Appear is now available at a new lower price of only $79. But you have to visit timeline.combackslash Dylan Gemelli. That's timeline.combackslash Dylan gemelli to save today. So we heard about 12 peptides that were supposedly going to be legalized. We're going to be able to use these. And everybody's up in arms celebrating, talking about how great this is. But are these actually really legal yet? How do we know they're even going to be? Is this some tricky political things going on here like normal or are we actually getting somewhere? Well, I have some information for you that might clear up some of this and give you at least a bit of bit better understanding of what exactly is happening here and what's going on. So the fda, what they did was, and this is all over the place, as many of you know, is they removed 12 peptides like I just brought up from category two. And what is category two? Category two is bulk drug substances that actually raise significant safety risk. So they got removed off of that, but this doesn't change their status. They're not immediately approved for compounding. So what's happening is they're going through this really rigorous evaluation to determine if they can be officially included on the 503A bulk's list. Now the 12 peptides that are up for discussion, BPC 156, TB 500 Epitalon injectable, GHKCU, MOT C Delta sleep induced peptide, Dihexaacetate, Melanitan 2, my favorite, which I'm going to be talking about on another video, kpv, Ibutamorel and Mesalate C Max, another one of my favorites and cathalidisin ll 37. So right now what is happening is the FDA is actually bringing these up before the Pharmacy Compounding Advisory Committee. And what's going to happen is there's going to be an independent science based safety and clinical evaluation going on. So don't necessarily believe everything you hear without fully understanding exactly what is happening or going on. So they have developed what's called a 503, a bulks list. The FDA has what they call this bulk substance list. And that means that these can actually be used to compound different drug products. And this is Section 5 of the FD and C Act. So you have to go through this real rigorous FDA protocol, people meeting committee, whatever you want to call it, that they determine the safety risks. Now I don't like to do this and I'm going to kind of leave it alone, but you're kind of at their mercy when it comes to this. People can come in, plead their case, do whatever. I'm not saying every single person in the FDA everywhere is bad. I'm not a conspiracy theorist, but I think we know how this works. There has to be an exchange of some kind of money somehow, some way where they're winning in one way or another to push things like this through. Because otherwise this creates a massive, massive problems for people in power that are making money. Every now and then something happens where some people in there push the envelope, get something through, or work as hard as they can to bring things to light. That kind of put them in a position where they kind of have to do things. But a lot of times this comes down to money and that's just how life works. I have come to accept that that's how it works, but have also understood that we can have voices and we can do whatever we can to try to speak together to stop some of this and or really push them to have no choice but to accept the facts. There's always going to be pushback and that's just the way it goes. So towards the end of July, what's going to happen there is the committee's going to get together and they're going to discuss a few of the peptides I read off of that list. So they're going to do BPC157 and related bulk drug substances, KPV, TB500, MOT C. These are ones that they're going to be discussing at the next meeting. And they're also going to do DSIP C, Max, Epitalon, these are all fabulous compounds by the way. And they are going to go back and forth rigorously on whether or not these are safe, how they can prove that, the efficacy, all of these things. Now, here's what they're going to tie these two, though. This is their argument. So this is interesting. So with BPC157, they're actually looking at that being used for ulcerative colitis, KPV, they're looking at wound healing and inflammatory conditions. TB 500, also wound healing, MOT C, they're looking at obesity and osteoporosis. Now, this is interesting because most of us know BPC157. It's mainly known for healing injuries. And KPV is well known as something for the gut. Now, inflammatory conditions, we can tie that. We can look at that how we want. Even TB500, yes, they have these benefits that are listed, but that's not what they're mainly used for. So it's interesting, it's the position on how they're going with this. Even MOT C. Now, MOT C, yes, people do use it for weight loss, but my main thing with MOT C is cellular health, mitochondrial health. So it's interesting. And then as we go down, epitalon makes sense because one of my favorite uses of epitalon too is help with sleep, but also with the heart. So they only list insomnia there and cmax, migraines, neuralgia. They're looking at these in a totally different way than what most of us know them as. So it's interesting and compelling, really, to see what happens. Now, here is something for you. Today's episode is brought to you by my great friends at Ginfinity. One thing that I've learned over the years is that the highest performers do not rely on assumptions, they rely on data. And that's especially true when it comes to nad. Everyone is talking about boosting NAD levels, but very few people actually know where their levels are to begin with, whether their protocol is working or how much they even need. And that's what makes Ginfinity different. Which is why I am thrilled to announce that I have teamed up with genfinity to offer the new Dylan Gemelli NAD Optimization Protocol. Powered by Ginfinity, this protocol provides you the Ginfinity intracellular NAD test and you with the most complete and trusted NAD boosting supplement and protocol in existence, along with proper guidance to ensure that you are optimizing your health, performance and longevity. So check out the link in the show notes and start taking control of your health. Today, the FDA is actually going to have the ability for all of us to link to a live webcast. So be aware of that. And I'll try to keep updating on this and link some things on this. But that's interesting to where we can actually watch this. There are people there that are going to be able to voice a lot of our concerns. But it looks to me, from what I read, that there's a place where you can make electronic submissions and you can send it in writing to and present data arguments to help or any of the areas that you're concerned. They actually have a website if you. It's on FDA.gov that you can use and you can send in electronic submissions. There's also ways that you can actually write in. I don't know how many people actually send written letters anymore, but you certainly can. And it's. It's pretty. It's one of those things that if you don't know which it's not easy to know, unless you're looking for things like this, then you would never have any clue that you have these capabilities. There's a lot of things out there. We have capabilities and a voice to have, but it takes people to spread that word and to really dig in and know. I find it strange that they're not looking at all of the benefits that we all know, but I'm thankful that they're looking at anything at all. And it's great that there's at least some people that are working for us or at least are trying to make it appear like they work for us. I'm always a little skeptical, but I like to give people the benefit of the doubt as well. I've just seen too much and gone through too much over the years and seeing how this works. But let's keep our hopes up. I will continue to provide information on how this works and what's actually happening. But be aware because people post a lot of things. They get your hopes up, they say things that aren't exactly accurate. And I want to make sure that we're getting all of the right information. There is an opportunity coming soon and it's very soon. So stay tuned there end of July for that committee meeting and take a look and see if there's a way for you to present some facts, write some things in, have a voice, help. Because let's put it this way, we are in a time right now more than I've ever seen, where there's a lot of people that are really bringing to light different types of medicine, naturopathic, functional medicine. And I will always be of the ilk that it's your body and your choice on what you get treated with. There is far too much of this telling people that this is it, this is how it is and this is the end all, be all. And that is not true. And when there is a problem with you asking a question, wanting to know answers, and that seems to be an issue where angers people or whatever kind of reaction you get, that's not an answer that tells you all you need to know. It's far past insane on what happens anymore and how people are brainwashed or forced into things that they don't want to do and don't think they need to do. It's your body, it's your choice. Now you have to deal with the consequences if you make a bad one. But there should be different options for everybody. And there's a lot of data that gets skewed, a lot of data that gets manipulated and then gets put out and put in front of the crowds, the masses. And it's not always true. Sometimes it's great and sometimes it's not. These are simple facts. I'm just telling you what I see and what I know. And I will always, always, always advocate for you being able to make your own choice. And just remember something, we are told that things are conventional. Conventional medicine. Is it really conventional though? Is taking something natural and chopping it up and doing a bunch of different things to it and making it into something else conventional? Or is taking the pure form of it what's actually conventional and has been deemed non conventional? Think about that. Think about how we're told things are the opposite of what they actually are. It's something to think about, let that resonate. And remember, peptides are an alternative medication and treatment for you. And it's up to you to do your due diligence and research on these, but also on what gets prescribed to you. Because oftentimes you're getting something that you don't need and it's causing an adverse effect. Just do your homework, take care of yourself. Because aside from God, nobody else is going to take care of you but you. It's your responsibility. That being said, stay tuned for plenty more to come. Dylan Gemelli, signing.