What Are Peptides? A Doctor's 20-Year Perspective on How They Work & FDA Restrictions

Dr. Aaron Hartman, a clinical researcher with 20 years of peptide experience, explains what peptides are and why the FDA reclassified 19 of them from safe to restricted in September 2023, including BPC-157 and TB-500. He describes the shift to unregulated markets and notes that VIP peptide remains approved due to his group's safety data.
Chapters
Welcome back once again. I'm super excited to dive in this topic today of peptides. As you may know, GLP-1s and a whole host of other peptides are super popular, and I've been working with these since 2006. So at this stage, about 20 years, so I have a unique perspective on it as a clinical researcher as well. I've done some pharmaceutical-based studies with these. So I'm going to start with the GLP-1s, which are everybody's favorite right now. Um, but just a little bit of basic business. If this, this podcast is useful to you, please follow us, like below. That's how we get more good information out there. It also helps us know who's watching and just helps us do this better, get better guests, et cetera. So please follow us below. Now to GLP-1s. I'm gonna start with the most famous of all the peptides, which are your GLP-1s, your semaglutide, your Ozempic, your Byetta, your Victoza. I first started using these in 2006, so that's, you know, 20 years ago and I've been using them for a long time. Some of you may or may not remember, that's back when Byetta was a twice a day shot. And then it was a big deal when Victoza came out and was a once-a-week shot. We have now gone to the point now that we've got a whole host of different peptides. We've got GLP-1s, GIP-1s, glucagon, which is some of the newest ones coming out. But what are peptides first? Because people don't quite understand what they are, and so it's really kind of hard to understand how they work, don't work, advantages, disadvantages, et cetera. First, you have to think about what, what are peptides? Well, peptides are made of amino acids. Now many of you are familiar with collagen peptides. You get your collagen peptides or other bone broth or bovine cow peptides, and they're made of amino acids. Now the definition of peptide is a very arbitrary thing. The FDA, the government, said anything more than 50 amino acids put together is a biologic. Anything less than that is— becomes a peptide. To put things in perspective, glutathione, which many of you may know, is 3 amino acids. It's a tripeptide. BPC-157, which is very popular right now, is a penta-decapeptide. It's 15 amino acids. Cerebrolysin, which is something that's great for, um, concussions, head injuries, is over that 50 amino acid number. So that's the reason that why that disappeared about 2 to 3 years ago, because the FDA said this is a biologic and just totally got it off board. So ultimately these peptide things are just amino acids put side by side. Together and based— and your body makes these naturally. You know, we look at whether it's growth hormone-like peptides, whether it's the GLP-1s, whether it's BPC, thymosin alpha 1, whatever your favorite peptide is. These are things your body naturally makes or things that have been reproduced in the chemistry biological lab that look like things your body makes to help, um, imitate that action. That's what peptides are. And they act, they act as single molecule messengers. So when your body is doing stuff, right, let's say, um, you have an injury, you need to heal that injury. Your DNA will make RNA that then make proteins that'll help heal, activate your immune system. But in between that time of RNA making proteins, they'll make these things called peptides. And the interesting thing about peptides as well, they're in the foods we make. There are micro RNAs, micro peptides in green leafy vegetables, for example. When you eat meat, we eat protein, it actually has peptides in it. So even the foods we eat, have these little— these messaging molecules in them that actually help educate, help change our gene expression, help change— literally make you who you are. Which is one of the reasons why eating real food, not microwaving your food, which is a totally different topic, not overheating, not burning— all these things actually change how your food works in your body through these, these messenger molecules, whether they're microRNA or actually peptides themselves. And also finally, you know, it's also how like fermenting some foods actually increases the nutrient ability or health benefits of certain foods is because they're making these messenger molecules. So peptides are really, really cool. They do a lot of cool things. You got to think of them as messengers of— and that's when you start getting things like microRNA, RNA, and a bunch of different things. But that's kind of just about peptides per se. So where they come from, where do peptides come from? You know, they can be isolated from within an animal. You can actually take thyroid extract and that's where you get some of your thyroid, your TB4, thymosin alpha-1. You can actually take your stomach, take animal stomachs, grind them up. You know, for you, all the— some of you who like ferment know what rennin is. That's actually a gut, a cow gut or sheep gut extract that's used to ferment, make cheeses, right? But where most, 99.999% of all peptides are coming from now are actually being synthesized in China through chemical reactions using different solvents. And the result is you make the peptides, but they come with a lot of other chemicals. And adulterants and things that need to be purified out. And that's where some of the difficulty in peptides come is not making them is pretty easy. It's the purification process that make it goes from a cheap one, you know, research grade to an expensive one, a pharmaceutical grade. So BPC-157 was originally isolated from gastric juice. Thymosin alpha 1, we already mentioned in the 1970s was isolated. So these things have been around for, you know, thymosin alpha 1 for, you know, 50 years. It's actually a drug in certain countries overseas and you can actually get it from when you're traveling around as a drug. GLP-1s are actually produced naturally by your gut L-cells after every single solitary meal. And there's actually certain bacteria that are in fermented foods and even butyrate. Your body makes butyrate in the bacteria in your gut. These things act kind of sort of like GLP-1s in our body naturally. So our body's kind of made to be exposed to these and use these things. But the point is like the, the, the point is these peptides are not exotic. Things we're making in test tubes that are unknown to our body. They're actually things our body actually naturally makes. So we look at the categories of peptides, you know, you have Category 1, Category 2, and Category 3. Category 1 are the ones that are considered safe for compounding pharmacies to use. And for those of you out there have noticed, this thing is changing all the time. One of my big frustrations in the last, you know, I don't know, last year to 2 years has been once I— every time I find a compounding pharmacy that I can source peptides from, they change the rules, the federal government changes the rules, or I'm in Virginia, the state of Virginia changes the rules. So just in the last 3 months, I've had to resource all my GLP-1s, for example, all over again. It's, it's kind of arbitrary, but again, this is the system we're in. We have to figure out how to navigate it. And part of a lot of my time recently has been devoted to just making sure when I have to resource peptides, the price point doesn't escalate at the same time I'm getting clean things, which require me getting certificate analysis. So Category 2 is ones the FDA say are too risky and their compounding is blocked. The interesting thing about a lot of these ones, actually, they're medications in other countries or in the research line to become medications in the United States. The question is, is it really they're risky or is it just they're getting ready to become drugs and they're interested to play? And that's the Suboxone story, that's the thymosin-alpha-1 story, that's the BPC-157 story. So And then category 3 is when they say there's not enough evidence or data to release the peptides and use them for general consumption. The problem here is that there's over 7,000 of these compounds. We've known about them for decades. The very first peptide actually is insulin. We've been using that extracted from pigs, right? Since the 1950s. Thyroid extracts from pigs since the, you know, before that. So again, the idea of safety typically means are there randomized double-blinded placebo-controlled trials that have gone through phase, you know, 1, 2, 3, all the way to be released. And then are the post-release studies. And that's typically what the FDA means when they say it's too risky. And the functional medicine world, things like BPC-157, thymosin alpha-1 have been used for decades that are pretty, pretty safe. But that's the environment we're in. So back in September 2023, again, a little history here, the FDA added 19 peptides to this category too. Which effectively banned them. And this list was BPC-157, thymosin alpha-1, TB-500, which is another version of TB-4, basically, uh, CJC, which is a growth hormone, Epirelin, Epitalon, C-Lanc, MOTC. I mean, a whole bunch of these. The gist is, is that the government said, we're going to change categories from 1, safe, to 2. And a lot of these things were pretty arbitrary. It was basically administrators, special interest groups, however you want to get into it, But basically someone somewhere said these things are no longer considered safe, even though we have decades of experience with them. Um, I'm not quite, you know, one interesting one that's not been removed is VIP, which in the mold chronic inflammatory response world we use all the time for like resetting people's brain after injuries from mold or biotoxin exposure. It's also used for traumatic brain injuries. It's also used for immune modulation. It's used for a lot of interesting things. One of the reasons this one has not been pulled is because Dr. Heyman and Shoemaker and their group of practitioners, of which I am one, have been using this for years in a very, very controlled environment. We've collected data and actually taken it to the FDA. There's been at this stage probably over 10,000 patient encounters watched for safety. So when all this kind of crazy peptide stuff started for VIP in our world, we had the ability to protect it and keep it protected, which is one of the things that some of the groups I'm involved with are talking about. How can we get more research and study, take it to the FDA? But to put things in perspective, just to show up in front of the FDA cost anywhere from $100,000 to $250,000. And these are things that are pretty inexpensive to get compounded. So it's kind of interesting. Um, one interesting thing of note I actually put down here is the same month, um, that this crackdown happened, the FDA approved, um, tirzepatide for weight loss. So that's kind of interesting that the same time that tirzepatide was approved for weight loss, 17 others were banned. You know, you can draw your own conclusions on that one. So between 2000, 2024 and 2026, there's going to shift back to actually trying to get peptides more available. And that gets into the politics and Make America Healthy Again with Senator, with RFK, actually, stuff he's been doing, whether you like the guy or not, he is trying to get peptides more available. And I think it's important to make things available because what the result with a lot of these limitations is people are going to the Wild West, getting stuff online. I have a patient currently who is in California and it's really interesting. In California, you can buy stuff on the streets there. It's really, it's kind of like most vape shops, but at the same time, I can't send stuff to the state of California. I have multiple pharmacies around the country I use and none of them ship to California. And so you have to wonder if people are getting stuff in the state of California and I can't ship stuff from Texas, I can't ship it from Nevada, I can't ship it from Florida, I can't ship it from Indiana, I can't ship it from Virginia or Alabama, which are the, where some of the compounding pharmacies I work with. What's actually getting in the state. And that's where you really have to know the sourcing, be able to track it. It's really, really is truly the, um, the Wild West. So that's a lot of introduction to peptides. I'm gonna stop this episode here, try to keep these about 10 minutes. And next I want to talk about the GLP-1s because those are the ones I've worked with for about 20 years. And I think those are the ones that get the most, um, most, most PR right now. So hopefully this information will help you, this little backdrop into peptides, and then Next, next episode, we're gonna talk about GL-1 specific and their uses. And I think it'll be interesting to find out all the things they've been actually studied for. It actually blows your mind, um, how versatile this group of peptides is. And all of them are like this, so you gotta keep that in mind as well. Take care, we'll talk to you soon.
More from Aaron

Too Many Gut Fixes Can Undo Your Healing. What Helps It Last | Dr. Sabine Hazan

Women’s Heart Attack Symptoms Differ From Men’s 95% of the Time — Only 30% Have Chest Pain #shorts

Heart Disease Kills More Women Than All Cancers Combined — 80% of Cardiac Research Is on Men #shorts

Women’s Physiology Was Systematically Ignored in Drug Research — The Consequences Are Still #shorts

It Took the FDA 20 Years to Realize Women Need Half the Dose of Ambien #shorts

Until 1993, Women Were Banned From Clinical Drug Trials — Then Those Drugs Were Prescribed t #shorts




