It’s Official: 7 Life-Changing Peptides are BACK.

0:00 So, if you follow the channel, you probably already know, but about a week ago,

0:03 I had the honor of sitting down with Steven

0:04 Barlet for an episode of Diary of a CEO.

0:07 That episode should be out by the time you're watching

0:08 this, and I'll drop the link in the description down below.

0:11 And before I get into anything else today, I just want to say this sincerely,

0:14 Steven and his entire team are an absolute class act.

0:18 I thought I had done media spots before,

0:20 but Diary of a CEO is hands down the most professional

0:22 outlet that I have ever had the pleasure to work with.

0:25 From the first email to the final handshake,

0:27 every single person on that team made me feel welcome,

0:29 respected, and like they actually cared about getting the content right.

0:33 Steven himself was even more thoughtful

0:34 in person than he comes across on camera,

0:36 which is saying something because he comes across pretty thoughtful on camera.

0:39 The prep was meticulous, the questions were sharp, and the studio was gorgeous,

0:43 and the whole experience was genuinely one

0:45 of the highlights of my career so far.

0:47 So to Stephen, Winnie, Zack,

0:48 cause and the rest of the team if you're watching this, which I'm going

0:51 to be realistic and assume you're probably not

0:53 because you have a whole company to run,

0:55 but just in case, thank you from me, from Ronic, and from the whole channel.

0:59 That was an experience of a lifetime.

1:01 And while I'm being sincere, I want to say something to you.

1:04 Yes, you, the person watching this video right now,

1:07 somewhere around the time when this drops,

1:09 we should be crossing the 100,000 subscriber mark on this channel.

1:12 And I don't take that lightly.

1:13 Everything this channel is, everything it's built,

1:16 everything it's going to become.

1:17 The podcast appearance, the AUA talk, the reach, the platform.

1:20 None of this exists without you.

1:22 You are the reason that I get to do this.

1:24 You have trusted me with your time,

1:26 and time is the one thing that none of us gets back.

1:28 And I take that responsibility very seriously.

1:31 Our goal from day one has been to use

1:32 this platform to do real good for real people.

1:35 Evidence-based, honest, occasionally stupid,

1:37 but always pointed at making the information landscape a little

1:40 less terrible for people trying to figure this stuff out.

1:42 and we're just getting started.

1:44 So, thank you for every like, every comment, every share, every DM.

1:48 Every time you passed a video along to a buddy who needed it.

1:51 I see it.

1:52 I appreciate it.

1:53 And I'm going to keep trying to earn it.

1:55 Okay, so here's where the video actually begins.

1:59 So, this video is two things at once.

2:01 First, it is a deep, detailed refresher on the exact legal status of peptides

2:04 in the United States as of right now.

2:06 what they are, how they got regulated,

2:08 how they got deregulated, how they basically got banned,

2:11 and how they're now literally as of a few days ago possibly on the road back.

2:14 It's a messy story.

2:16 It involves a fungal menitis outbreak,

2:18 a Supreme Court decision about breast cancer genes,

2:20 a mysterious FDA website swap, a Joe Rogan appearance,

2:23 a Federal Register notice,

2:25 and a whole lot of biohackers stabbing themselves in the belly

2:27 with vials they bought from websites that accept Dogecoin.

2:29 It is a truly American saga.

2:32 And second, this video is actually a preview

2:34 of a talk that I'm going to give later in May.

2:36 So consider this the public facing version of that lecture.

2:38 Same content, fewer slides, more profanity.

2:40 You've been warned.

2:41 Now, before we dive in, I need to ask you three things real quick.

2:44 And I know every YouTuber says this, but hear me out because

2:47 this video is going to take about 15 minutes of your life.

2:49 And it's genuinely one of the most

2:51 important topics that we've covered on this channel.

2:53 The first is that if you find this sort of content useful,

2:56 smash the like button.

2:57 The algorithm decides whether this video gets shown to 10,000 people or 10.

3:01 And whether or not you click the thumbs up in the first couple of minutes.

3:03 It's free.

3:04 It only takes half a second.

3:05 Do it.

3:06 Two is hit subscribe if you haven't already.

3:08 This channel is where we drop long-

3:10 form evidence-based content on men's health peptides,

3:12 peeds, and the stuff most primary

3:14 care doctors probably aren't comfortable talking about.

3:16 There are a lot of people making videos on peptides right now,

3:19 but most of them are selling peptides.

3:21 I'm not.

3:21 I'm a board-certified urologist with a men's

3:23 health fellowship and a questionable nicotine dependency.

3:26 different vibe.

3:27 And number three, drop a comment down below.

3:29 Specifically, I want to know, have you used peptides?

3:32 Are you using them now?

3:33 Are you thinking about it?

3:34 Or are you watching this video purely

3:35 for entertainment purposes because you heard a urologist

3:38 was about to try and explain

3:38 the administrative procedure act to a fitness audience.

3:42 Whatever your answer, tell me.

3:43 I read every single comment, as does Ronic.

3:45 It tends to fixate on the ones that mention his editing.

3:47 So, if you really want to screw with him, try critiquing his B-roll choices.

3:50 He gets all sassy.

3:51 I'll find her ID.

3:54 All right, let's get into it.

3:56 Okay, quick refresher.

3:57 And if you've watched our peptide deep dives before, I know, I know,

4:00 I keep doing this, but every time I post a peptide video,

4:03 a couple new people wander in from Tik Tok or Reddit or wherever,

4:05 and I just can't assume that everyone's up to speed.

4:07 So, here's the rapidfire version.

4:09 A peptide is a short chain of amino acids linked together by peptide bonds.

4:14 That's it.

4:14 That is the entire definition.

4:16 Amino acids are the building blocks of all proteins in your body.

4:19 So, you can think of peptides as the Lego

4:21 instructions right before you finish the spaceship.

4:23 They're intermediate.

4:24 They're the middle child of the protein world.

4:26 Your body already makes thousands of peptides.

4:28 Insulin is a peptide.

4:29 Oxytocin is a peptide.

4:30 Vasop prein is a peptide.

4:32 Growth hormone releasing hormone or GHR, it's a peptide.

4:35 These aren't all exotic compounds from a lab in Beijing.

4:38 Although, God knows a lot of them are these days.

4:40 At their point of origin,

4:42 these are really molecules your body already uses to help run the show.

4:46 As mentioned, anything 40 amino acids or shorter is classified as a peptide

4:50 and regulated under the standard new drug application pathway, the NDA.

4:54 That's the same pathway as conventional

4:56 small molecule drugs like Lipur or Viagra.

4:58 Anything longer than a 40 amino acids is classified as a protein

5:01 or a biologic and it gets regulated

5:03 under the biologics license application pathway, the BLA.

5:07 That pathway is significantly more expensive and significantly more restrictive.

5:11 So why does this matter?

5:12 Because the FDA has never in the entire history

5:14 of the agency granted a compounding pharmacy a BLA license.

5:18 Not once.

5:19 Same framework as why you can't walk into your local

5:21 compounder anymore and get HCG or FSH like you used to.

5:24 Biologics don't get compounded.

5:25 Period.

5:26 The cost of establishing a BLA capable facility

5:29 is conservatively somewhere between 80 and $150 million.

5:32 So a compounder could apply for a BLA the same

5:34 way that I could win the Arnold Classic next year.

5:37 Not technically impossible,

5:38 but essentially a guaranteed dumpster fire for everyone involved.

5:41 Become Mr.

5:41 Olympia.

5:42 I could be the best bodybuilder in the world.

5:43 I could go to the moon if I wanted to and then I'm going to get rich.

5:46 And here's another key conceptual point that I

5:48 want every single person watching this to internalize.

5:50 Peptides are defined by their structure, not by their therapeutic effect.

5:54 This is totally different from how we usually think about drug classes.

5:57 Statins are defined by what they do.

5:59 Beta blockers are defined by what they do.

6:01 ACE inhibitors, again, defined by what they do.

6:04 Peptides are defined by what they're made of.

6:06 The metaphor that I used with Steven Bartlett,

6:08 and which I think actually landed pretty well,

6:10 is that peptides aren't a drug class.

6:12 Think of them more like a platform.

6:14 They're like apps on your phone that are

6:15 all running on the same operating system, which just happens to be your body.

6:19 Insulin and oxytocin are both peptides, but they do wildly different things.

6:23 They just happen to be written in the same biological language.

6:26 Think of it like using the same programming language.

6:28 But that biological language is going to matter a lot when we

6:31 get to why a lot of these things are so hard to commercialize.

6:35 And I want to kill one specific myth right at the top.

6:38 Peptides are not new.

6:39 They are not some fancy biohacker invention from the last 10 years.

6:42 We've been making, injecting,

6:44 and saving lives with peptides for over a hundred years.

6:46 Quick timeline.

6:47 1921 to 1922.

6:49 Banting and best isolate insulin at the University of Toronto.

6:52 Insulin is a peptide.

6:54 It's 51 amino acids,

6:55 which you'd think means it's technically a biologic here

6:57 in the good old US of A, but it actually got grandfathered in as a peptide since

7:01 it was discovered before the FDA created that rule.

7:03 This was the first therapeutic peptide and it

7:05 fundamentally changed the trajectory of human medicine.

7:08 Type 1 diabetes went from a dissence

7:09 to a manageable chronic condition essentially overnight.

7:12 It's impossible to overstate what a big deal this was.

7:16 1954 Vincent Duvenyad synthesizes oxytocin in a lab at Cornell.

7:20 This was the first time a biologically

7:22 active peptide had been synthesized from scratch.

7:24 He got the Nobel Prize for it the following year,

7:26 which is how you know it's kind of a big deal.

7:28 And here I am, Ronic.

7:29 I just want my 100K subscriber plaque.

7:31 Oxytocin, for those of you who don't know,

7:33 is the molecule that makes you feel warm

7:34 and fuzzy when you hug someone you love.

7:36 It's also the molecule that causes uterine contractions during childirth.

7:39 Biology is not always subtle.

7:40 1982, recombinant human insulin made by Genentech and Eli

7:44 Liy just down the street, hit the market.

7:46 It was the first recominant drug ever approved.

7:49 We could now manufacture peptides at industrial scale

7:52 instead of harvesting them from pig and cow pancreases,

7:55 which yeah, that's exactly how we used to do it.

7:57 1985 to 1989 lupide and gazerellin

8:00 are approved for prostate cancer and endometriosis.

8:03 Lupralide is a peptide, a synthetic nonopeptide to be specific.

8:06 Namino acids, hence the nana.

8:08 It is a G&R agonist and by continuously stimulating the pituitary,

8:12 it paradoxically downregulates G&R receptors, suppresses luteinizing hormone,

8:17 and drops testosterone to castrate levels.

8:19 This is now a foundational tool in urology.

8:22 Every urologist in America has put a patient on Lupron at some point.

8:25 This is our poster child and we're going to come back to it later.

8:28 Poster child of course because I'm a urologist I'm biased that way.

8:30 And then we have 2005 to the present day.

8:33 GLP-1 agonist emerge lagglutide simaglutide trespatide.

8:37 These are also peptides.

8:39 The whole ozimpic wgoi mjaro zeppbound revolution is a peptide revolution.

8:43 The reason your aunt lost 40 lbs

8:45 before your cousin's wedding is peptide pharmacology.

8:48 As of today there are roughly a 100

8:49 peptide drugs approved globally with many more in development.

8:52 This is a mature, wellestablished, clinically validated class of molecules.

8:55 We know how to make them.

8:56 We know how to test them.

8:57 We know how to dose them.

8:58 We've been doing this for over a century.

9:00 So, anyone who tries to tell you that peptides are some cutting edge,

9:02 untested, unproven, probably dangerous new thing,

9:05 they're either lying to you or more likely,

9:07 they just don't know what they're talking about.

9:08 Peptides as a category are extremely legitimate.

9:11 What's new is which peptides we're talking about, how they're being sold,

9:15 and the regulatory environment that they have to move through.

9:18 Which brings us to the 19 peptides that have set the internet ablaze.

9:22 Between about 2014 and 2023,

9:24 compoundingarmacies in the United States could legally

9:27 prepare a specific list of peptides for patients.

9:29 The list wasn't infinite.

9:30 They had to go through a nomination process, which we'll get to.

9:33 But during that window, there were roughly 19 peptides that drove

9:36 the bulk of modern clinical and biohacking interest.

9:39 Let me group them for you because 19 peptides

9:40 is a lot to throw at you all at once.

9:42 Group one is what we're going to call

9:44 the growth hormone and IGF-1 access peptides.

9:46 These are the anti-aging and potentially muscle-building darlings.

9:50 CGC-1295, which is a GHR analog.

9:53 Ipamorin, a selective growth hormone secret.

9:56 Abutamorin, which is also known as MK677,

9:58 which is also not technically a peptide because it's

10:00 an oral ghrelin agonist and it's a small molecule,

10:02 but it got selected in the band anyways.

10:04 Then we've got CAX, which is sometimes pitched for lipolysis,

10:07 but really it's more of a neotropic.

10:09 And then PEG MGF, which is pitched as a post-injury muscle repair compound.

10:12 These are the peptides the anti-aging clinics and teleahalth

10:15 bros have been shouting about for over a decade.

10:17 Group two is tissue repair and regeneration peptides.

10:20 BPC57, which we've covered extensively on this channel.

10:23 TB500, the other half of the Wolverine stack.

10:26 KPV, which we're about to record a video on and we'll be dropping soon.

10:30 And then LL37, which is actually an antimicrobial peptide.

10:33 And then we've got GHKQ,

10:34 the copper peptide that dermatologists and biohackers fight over.

10:37 Group three is going to be longevity, sleep, and neuotropic peptides.

10:41 Epalon pitch for tomeres activation and longevity which

10:44 is the kind of claim that makes me

10:46 want to take a long sip of my energy drink and sigh audibly can't keep doing

10:54 to be fair epalon has shown the potential

10:56 to actually regenerate the pineal gland which would

10:59 really help with regulating your circadian rhythm which

11:01 Ronic gave up on his 20 years ago.

11:03 So I am actually interested in it.

11:04 We just need more data.

11:07 Stephen is overated at Yeah.

11:09 Yeah.

11:09 as your continued existence proves.

11:12 Well, people have a view video preferably this week.

11:18 Everyone's gonna be like sleep next video.

11:21 And then we've got Matsi pitched as an exercise mimedic.

11:24 DIP, Delta sleep inducing peptide.

11:26 CMAC shows up here too because it's also pitched a stroke recovery agent.

11:29 And then we've got Selen, which is a non-sedating anzolytic.

11:32 and dhexa which is a potent synaptogenic compound that like

11:35 MK677 isn't technically a peptide but it got canned anyways.

11:39 Group four includes immune genital urinary and alpha MSH peptides.

11:43 This is the group probably most relevant to my fellow

11:45 penis surgeon audience and it starts out with something called

11:48 thyosin alpha 1 which is actually approved in other countries

11:51 for the treatment of both hepatitis B and hepatitis C.

11:54 We've also got kissepin 10 which triggers G&RH release and is a research tool

11:57 of genuine GU interest and melanotan 2

12:00 which activates melanocorton receptors MC1, MC3 and MC4.

12:03 Melanitin 2 is also the one that gets marketed as an injectable tan and also

12:07 incidentally gives you raging erections that might just get you put on a list.

12:10 I live near a school.

12:11 I have to consider these things.

12:12 But yeah, it is a wild compound.

12:14 So those are the 19.

12:15 Well 17 technically if you don't count MK677 and DHEXA 19 if you do.

12:19 And then the FDA itself sometimes counts different numbers

12:22 depending on how they're batching the CJC1295 salt forms.

12:26 But you're going to hear everything from 14

12:28 to 19 depending on which news article you read.

12:30 And they're all talking about basically the same list of molecules.

12:32 So don't let the numbers confuse you.

12:34 But what matters is that from 2014 to 2023,

12:37 these compounds were the engine of the modern peptide wellness market.

12:40 Anti-aging clinics, longevity docs, functional medicine practices,

12:44 sports recovery clinics, men's health clinics right here.

12:47 Even some legitimate urology and dermatology

12:49 practices use these peptides and a lot of people were using these compounds

12:52 on a lot of patients and getting good results.

12:55 And then on a random Friday in September of 2023, that all changed.

12:59 But before we can talk about that fateful day and what

13:02 it happened and why it was such a big deal,

13:04 we actually have to rewind the clock even more and go back to 2012.

13:08 In the fall of 2012, a compounding pharmacy in Framingham, Massachusetts,

13:12 called the New England Compounding Center shipped

13:14 contaminated steroid injections to clinics in 20 states.

13:17 Don't get excited.

13:18 They weren't those steroids.

13:19 We're talking about injectable methyl predniscolone acetate,

13:22 the type of steroid your Mima needs for her rheumatism.

13:25 But this particular batch of steroids was actually

13:27 being used for epidural injections for back pain.

13:30 And yeah, they were contaminated with a black mold called exosereroym rostratum.

13:35 If that sounds like something out of a horror novel,

13:37 that's because it basically was.

13:39 We're talking upside down place level bad.

13:42 751 patients got sick and 64 people died because of this.

13:47 This is one of the worst pharmaceutical disasters in modern American history.

13:51 And almost nobody talks about it anymore

13:53 because it's been overshadowed by the opioid epidemic,

13:55 COVID, and every other horrible thing we've been subjected to.

13:58 But it fundamentally changed how compounding is regulated in this country.

14:03 When investigators went into the NECC facility,

14:06 they found visible mold growth, bacterial contamination in the clean rooms,

14:10 and what the prosecutor later described as quote,

14:12 "a fungal zoo." The owner eventually plead guilty to manslaughter, 64 counts.

14:18 So, Congress had to act.

14:19 You know, back when they actually did things.

14:21 In November of 2013, they passed the Drug Quality and Security Act, the DQSA.

14:26 And the DQSA did something really important.

14:28 It created a two-tier system for compoundingies in the United States.

14:33 Tier one is 503A.

14:35 These are traditional pharmacy compounders.

14:37 They fill patient specific prescriptions.

14:39 Your local compounding pharmacy, if your physician,

14:41 writes you a prescription for a custom strength testosterone

14:43 cream or a weird dose of liothyine or whatever,

14:47 that pharmacy is operating under 503A.

14:50 They're regulated mostly by state boards of pharmacy,

14:52 but with the FDA as backs stop authority.

14:55 Tier two is 503b and they're way up here.

14:58 These are actually called outsourcing facilities.

15:00 They operate more like pharmaceutical manufacturers.

15:03 They can compound very specific drugs in larger

15:05 quantities without individual prescriptions for sale to hospitals,

15:08 clinics, and surgery centers.

15:10 They have to comply with current good manufacturing

15:12 practices which are super super strict and they're

15:15 the same standards that pharmaceutical manufacturers operate under

15:18 CGMP and they are directly regulated by the FDA.

15:22 I've had the privilege to tour empoweries 503b

15:25 manufacturing facility and I will tell you it

15:28 is the most impressive industrialcale manufacturing facility I've

15:32 ever seen and I live in Lily's backyard.

15:35 Now here's where peptides enter the picture.

15:37 Under 503A, a compounding pharmacy can only prepare a bulk

15:40 drug substance if one of three conditions is met.

15:43 Number one, the substance has a USP or NF monograph.

15:47 Number two, the substance is a component of an FDA approved drug.

15:51 Or number three, the substance appears on what's

15:53 called the 503A bulks list for peptides at that time back in 2013 and 2014

15:59 that were not already FDA approved and didn't have monographs.

16:02 The bulk list was the only path.

16:04 And so the FDA opened the nomination process in 2013.

16:07 Industry submitted over 2,000 nominations.

16:10 The FDA refined that down to about 740

16:13 substances and then categorized each one into separate buckets.

16:17 Category 1 included substances that were

16:19 still considered to be under evaluation, but they appear to be safe enough

16:22 that the FDA was going to exercise enforcement discretion.

16:26 In plain English, category means we're still looking

16:28 at this, but you can compound it in the meantime.

16:30 Category two are substances that the FDA

16:33 has determined present significant safety risk.

16:35 Compounding these is prohibited.

16:37 Full stop.

16:38 And then we have category three, which are substances that the FDA

16:41 just didn't have enough information to evaluate.

16:43 These are in regulatory purgatory and they're basically stuck there.

16:46 For nearly a decade, from around 2014 to 2023,

16:49 most of the popular peptides that we

16:50 just went through were sitting in category 1, enforcement discretion,

16:53 available at your friendly neighborhood

16:55 compounding pharmacy with a doctor's prescription.

16:57 I personally came into this space in 2018,

16:59 which was right in the middle of what many described as the peptide golden era.

17:02 And look, there was a lot of good that came out of that era.

17:05 Patients with legitimate issues got access to novel therapies

17:08 that the traditional pharma pipeline was just never going to develop.

17:12 I've treated patients whose lives were immeasurably

17:14 improved because of access to these compounded peptides.

17:16 My life personally was changed in part due to MK677.

17:20 Again, not technically a peptide, but that's not the point.

17:22 So, this really isn't a story with villains and heroes.

17:24 Maybe.

17:25 There's actually a pretty good argument to be

17:26 made that there may have been a pharma

17:28 lobbying boogeyman or boogie woman behind the regulatory

17:30 snafu that you're about to hear about.

17:32 But what we do know for certain is

17:34 that this is a story about a regulatory framework trying

17:37 to do its best with a category of molecules

17:39 that simply don't fit neatly into any of the existing boxes.

17:42 And then the framework broke in the sketchiest way possible.

17:45 On Friday, September 29th, 2023, the FDA did something that, in my opinion,

17:49 will go down as one of the strangest regulatory actions of the decade.

17:53 They quietly swapped out a PDF on their website.

17:56 That's it.

17:57 That was the whole regulatory action.

17:59 They updated the category 1 list.

18:01 And when the updated list came out,

18:03 19 of the peptides that have been sitting in category

18:05 1 for years had been moved without any public hearing,

18:07 without any press release, without any prior notice to category 2.

18:11 Overnight, these compounds went from legal to compound to prohibited.

18:15 With a stroke of a PDF upload,

18:16 an entire sector of the wellness economy was made illegal.

18:20 The justification the FDA provided was

18:22 that these substances presented significant safety risks.

18:25 But what they didn't provide was actual compound specific justifications.

18:28 They didn't even site specific adverse event reports and they

18:32 didn't publish the data they are basing this on.

18:34 They did not go through the administrative

18:36 procedure acts notice and comment rulemaking process which

18:39 is the legal mechanism by which these kinds

18:41 of substantiative decisions are supposed to happen.

18:44 They just arbitrarily change the list.

18:46 Now I want to be careful here.

18:48 I'm not going to sit here and tell you

18:50 I know exactly why this happened because I don't.

18:52 Nobody outside the FDA that was there at that time actually does.

18:56 Now, there are theories and some people

18:58 think it could have been genuine safety concern.

19:00 But some people like this guy think it was

19:02 pressure from pharmaceutical lobbyists who are watching their patent protected

19:06 GLP-1 molecules get slowly chipped away at by compounding

19:10 competitors and wanted to them over any way they could.

19:13 Some people think that it was a career regulator making a unilateral call.

19:16 And some people think it was all three.

19:18 I genuinely don't know.

19:19 But what I do know is that these compounds worked.

19:22 I prescribed most of them and patients have been using them safely for years.

19:26 So when the FDA flipped that switch in September 2023,

19:29 they didn't make the peptides go away.

19:31 They couldn't make the peptides go away.

19:33 These are chemically simple molecules that could

19:35 be synthesized at any reasonably equipped lab

19:37 in any reasonably developed country and in some

19:40 maybe not so reasonably developed countries.

19:42 What they did instead is create the largest

19:44 black market in modern America since prohibition.

19:47 Sorry, gray market to all my lab rat legion out there.

19:49 But here's the thing about prohibition.

19:51 It's never actually worked.

19:53 Not with alcohol in the 20s.

19:54 Not with cannabis starting in the 70s.

19:56 Not with MDMA or psilocybin or any of the other

19:59 compounds we've tried to make disappear with a political decree.

20:03 And guess what?

20:03 It hasn't worked with peptides either.

20:05 What happened after September 2023 was extremely predictable.

20:09 The demand didn't evaporate.

20:10 It just went underground.

20:12 Within weeks, a whole new crop of websites

20:14 popped up selling these exact compounds as research chemicals,

20:17 not for human consumption.

20:18 Totally for your lab rat.

20:19 Again, shout out to my elaborate legion.

20:21 I love you guys.

20:22 And these sites shipped from China, Turkey, India, Muldova.

20:25 They accepted cryptocurrency.

20:27 They had names like research peptides.biz and peptide bros.io.

20:31 They were not FDA regulated, not USP tested,

20:33 and not sterility verified, and honestly not really accountable to anyone.

20:37 And patients who had just lost access to pharmagra licensed

20:41 pharmacy prepared peptides started ordering

20:43 them because the alternative was nothing.

20:46 And simultaneously, the GLP-1 revolution kicked into overdrive.

20:50 Simaglutide and Trespatide went from niche diabetes drugs to cultural phenomena.

20:55 Everyone on the planet had an opinion on osimpic by early 2024.

20:58 And because of the way these drugs work and the fact that they're peptides,

21:01 the word peptide became a household term in the way it never had been before.

21:05 People who had never heard of a peptide

21:07 in their lives were now asking their doctors about peptides.

21:10 And when their doctor said, "I'm sorry,

21:12 we can't prescribe most of these anymore." They went online and Tik Tok

21:16 of course had already figured out how to monetize every piece of it.

21:19 Influencers were pitching VPC57 to rehab from injuries.

21:22 Creators were walking viewers through their first self- injection.

21:25 We had before and after photos of GOP1 weight loss,

21:28 pages upon pages upon pages of content promoting compounds

21:31 that were at that point federally illegal to compound.

21:34 And that gray market that the FDA created,

21:37 it's now estimated to be worth billions of dollars.

21:39 Kennedy has cited this number himself in interviews.

21:42 billions of gray market peptide money flowing to labs nobody can regulate

21:46 for products nobody can quality control being

21:48 injected by patients who nobody is supervising.

21:51 If you wanted to design a policy to make peptide use more dangerous,

21:54 less supervised, and less evidence-based, this would be that exact policy.

21:57 So, the obvious question and one that gets asked in pretty

22:00 much every comment section of every peptide video I've ever made is,

22:02 if these compounds work,

22:04 why doesn't some pharmaceutical company just run the trials,

22:06 get them FDA approved, and then sell them like regular drugs?

22:09 Great question and there are two reasons

22:11 and we've got to walk through both of them.

22:13 Reason one is the patent problem.

22:15 In June of 2013, the Supreme Court decided

22:17 a case called Association for Molecular Pathology versus Myriad Genetics.

22:22 Myriad was a biotech company that held patents on the BRCA1 and BRCA2 genes.

22:27 And these are genes that when mutated dramatically

22:29 increase a woman's risk of breast and ovarian cancer.

22:32 They also happen to increase a man's chance of developing prostate cancer.

22:35 And Myriad's patents gave them an effective monopoly on BRCA testing,

22:39 and they enforced that monopoly very aggressively.

22:42 They sent ceased and desist letters.

22:43 They sued competitors.

22:45 They charged over $3,000 per test.

22:48 The Supreme Court's ruling was unanimous, 90,

22:50 and it was written by Justice Clarence Thomas.

22:53 And the core holding was this.

22:54 A naturally occurring DNA segment is a product of nature,

22:58 and it is not patent eligible merely because it's just been isolated.

23:02 In other words, if it exists in nature, you can't patent it.

23:05 You can only patent something that you actually invented.

23:08 Now, pause for a second and think about why this is relevant to peptides.

23:12 BPC157 is a partial sequence derived

23:15 from a protein naturally found in human gastric juice.

23:18 TB500 is a synthetic fragment of thymus and beta 4,

23:21 which is a naturally occurring human peptide.

23:24 GHKCU is a naturally occurring copper binding

23:27 peptide that circulates in your bloodstream while

23:29 KPV is a three amino acid fragment of alpha MSH which your body already makes.

23:34 Every single one of these is at its core a naturally occurring human molecule

23:39 which means under myriad genetics none of them

23:41 are patentable as composition of matter claims.

23:44 And without patent protection there's no commercial pathway

23:47 because here's the brutal economics of drug development.

23:50 Getting molecule through phase 1, phase 2,

23:52 and phase three clinical trials to FDA approval

23:55 costs somewhere between$1 and2 billion dollar with a B.

23:59 Nobody spends $2 billion on a trial program if the day the drug is approved,

24:03 anyone in the world can legally copy it and sell it cheaper.

24:06 You don't get a return on your investment.

24:08 You go bankrupt.

24:09 This is not a hypothetical.

24:11 This is exactly why there is no commercial BPC157.

24:14 Nobody's going to fund a $2 billion trial for a compound they can't protect.

24:18 Now the GLP-1 drugs sidestep this by being modified novel forms.

24:23 Simaglutide is not endogenous GLP-1.

24:26 Native GLP-1 has a halflife of about 2 minutes

24:28 which makes it useless as a once weekly injection.

24:31 Simaglutide has been engineered with specific amino acid substitutions

24:35 and a fatty acid side chain to extend its halfife.

24:38 Trazepide is a dual GIP and GOP1 agonist that doesn't exist in nature at all.

24:41 And these are patentable and that's why Nova

24:43 Nordisk and Eli Liy can afford to sell them.

24:46 So, in theory, Pharma could do the same thing with BPC157 or TB500.

24:50 Make a modified version, patent it, run the trials.

24:52 But here's the catch.

24:53 Unlike native GLP1, which has a 2-minute half-life problem,

24:56 these native forms seem to work just fine as is.

24:59 So, why spend $2 billion developing a modified version

25:03 of BPC57 when the plain jane vanilla version already does

25:06 what it needs to, and anyone with an internet

25:08 connection can already buy it from a gray market supplier.

25:10 The economic incentive isn't there.

25:12 Reason two is the disease state problem.

25:14 FDA approval requires a drug to target a specific disease state.

25:18 That's how the regulatory framework is structured.

25:20 You have to say this drug for this condition

25:23 in this patient population at this dose.

25:25 You have to run a phase three trial showing that your drug

25:28 treats that specific condition better than placebo or standard of care.

25:32 And that whole paradigm is part of the reason why American

25:34 healthcare is really more sick care than focusing on health and wellness,

25:38 which is a whole other rant that I'm not going to get into right now.

25:41 And so many of the peptides that we've been talking

25:43 about are marketed for things that aren't formal disease states.

25:46 Tissue repair in an aging athlete, longevity,

25:48 general wellness, cognitive enhancement, vague functional improvements.

25:52 These aren't ICD10 codes.

25:54 The FDA doesn't have an approval pathway for making you feel better.

25:57 And if that isn't a big glaring banner for how healthcare in the US,

26:00 again, is totally screwed.

26:02 I don't know what is.

26:03 Which means even if the patent problem got solved,

26:05 you'd still run into the indication problem.

26:07 What disease are you treating with GHKCU?

26:10 inflammate aging.

26:11 It's not a real disease.

26:12 Although I feel like it is every time I wake up and look in the mirror.

26:15 It's a concept.

26:16 And you can't run a phase three trial on a concept.

26:19 Put those two problems together and you get exactly what we have now.

26:22 Strong therapeutic interest with limited commercial pathway and then

26:25 a massive gray market that is formed to fill the vacuum.

26:28 The system isn't broken because the FDA is evil.

26:30 The system is broken because our drug

26:32 approval framework was built for our pharmaceutical

26:34 industry that made money by patenting

26:36 novel molecules to treat discrete diseases.

26:39 and peptides just don't fit that mold.

26:41 Okay, that brings us to now.

26:43 Through 2024 and even into 2026,

26:45 the peptide reclassification issue just simmered.

26:48 The FDA did remove a handful of substances from category

26:50 2 in September 2024 after the nominators withdrew their nominations.

26:54 CJC1295, Iporan, AOD9604, thymus alpha 1, and Selen.

26:59 These got bumped out,

27:00 but they didn't go into category one where they could be made again.

27:03 it just went into a sort of regulatory limbo

27:05 while PCAC meetings happened in October and December of 2024.

27:09 And at those meetings,

27:10 the committee mostly voted against recommending these substances

27:12 for inclusion into the 503A bulks list, which again, as we talked about,

27:16 is where they have to be if they're going to be manufactured.

27:18 So, nothing really changed.

27:20 The gray market kept growing.

27:21 Biohackers kept injecting.

27:22 And then came February 27th, 2026.

27:25 On that day, Health and Human Services Secretary Robert F.

27:28 Kennedy Jr.

27:29 appeared on the Joe Rogan Experience episode 2461.

27:33 and he made a pretty big announcement.

27:34 He said on Joe's podcast that the FDA was going to move

27:37 approximately 14 of the 19 category 2 peptides back to category 1.

27:42 Now, this was not a regulatory action.

27:44 This was a policy announcement made

27:45 in a three-hour interview with an MMA announcer/podcaster/ comedian.

27:50 Nothing actually had happened yet.

27:51 Kennedy just signaled intent and that's all.

27:53 For the next six weeks, everyone in the compounding space, the peptide industry,

27:57 the biohacker community, the regulatory law firms,

28:00 everyone was just holding their breath,

28:01 waiting to see if the FDA was actually going to follow through on this or if it

28:05 was just going to evaporate the way a lot

28:07 of politician statements have evaporated in the past.

28:09 Well, it definitely didn't evaporate.

28:12 On April 15, 2026, the FDA issued a federal register notice,

28:16 docket number FDA 2025N6895.

28:20 That notice announced the formal referral of seven

28:23 peptides to the pharmacy compounding advisory committee,

28:25 as I mentioned, the PCAC,

28:27 for review at a meeting scheduled for July 23rd and 24th, 2026.

28:31 Simultaneously, the FDA administratively removed 12 peptides from category 2,

28:35 effective 7 days from publication.

28:37 And that was the regulatory action everyone was looking for.

28:40 It wasn't the podcast.

28:41 It was the Federal Register noticed published April 16th, effective April 23rd.

28:46 Coincidentally, I learned about it while on the airplane

28:48 going to go interview with Steven Bartlett.

28:50 No pressure.

28:51 Future Alex popping in here with some rumors that, if true,

28:54 could radically change GOP1 peptide access in America, potentially forever.

28:59 Yeah, I know.

28:59 We just finished this whole video.

29:01 We wrapped.

29:01 Ronic started the edit.

29:02 I came home, unpacked, slept in my own bed for the first time in days,

29:05 hugged my kids, drank a victory white monster, and I thought I was done.

29:09 And then then the internet did what the internet always does,

29:12 which is wait exactly long enough for me to feel accomplished.

29:15 and then drop a bomb in my lap, which in this case was Friday.

29:18 So yeah, I'm recording this addendum in a different hoodie.

29:21 Ronic is probably have got to figure out

29:22 where to put this in in the original video.

29:24 Sorry, Ronic.

29:24 I owe you a free vow of testosterone.

29:28 I'm kidding.

29:29 Please don't report me to the medical board.

29:30 Let's get into it.

29:31 Okay, so here's what happened.

29:32 On April 16th, a tweet dropped from an account

29:35 claiming to have spoken to an HHS insider.

29:37 The allegations were wild.

29:39 Eli Lily is actively aggressively pushing the FDA

29:42 and the HHS to reclassify GLP-1 peptides, simaglutide, trespide,

29:47 and in particular their next generation

29:49 compound reatride as biologics rather than drugs.

29:53 That single post caught fire.

29:55 Within 72 hours, it had been amplified by a halfozen

29:58 other accounts with serious reach in the compounding and biohacking space.

30:01 By the weekend, it was everywhere on my feed.

30:03 People were asking me about it in the comments and my inbox was full of it,

30:06 which is different than how my wife says that I'm full of it.

30:09 Now, let me give you the fair assessment.

30:10 The specific claim that there is an HHS insider

30:13 feeding information about active lobbying pressure is single source,

30:16 one tweet, not independently corroborated.

30:19 And I can't tell you whether that specific allegation is true or not.

30:21 And I'm not going to pretend like I can.

30:24 But here is what is absolutely verifiably on the record true.

30:28 And this is the part that matters.

30:30 Eli Liy, the guys just down the street from where I'm recording this, is suing

30:33 the FDA to have Redat True Tide classified as a biologic rather than a drug.

30:38 That isn't a rumor.

30:39 That isn't a tweet.

30:40 That is a federal lawsuit filed in the Southern

30:42 District of Indiana on September 3rd, 2024.

30:45 Eli Lily and Company versus Bera, case number 124 CV01503.

30:51 You can look it up.

30:52 And here's the dispute.

30:53 Redat True Tide, which is Lily's NextG triple agonist

30:56 and one that we've talked about a lot in this channel.

30:58 Check the video up above.

30:59 Hits GLP-1, GIP, and glucagon receptors.

31:02 And it does this with a main backbone of 39 alpha amino acids.

31:06 Under current FDA interpretation,

31:08 you need more than 40 alpha amino acids to qualify as a biologic.

31:11 39 is a drug, 41 is a biologic.

31:14 That one amino acid is the difference between

31:16 two of the biggest regulatory universes in modern pharmaceuticals.

31:19 And so Lily is arguing that reatrite actually has 41 amino acids if

31:24 you count a second small side chain

31:26 attached by what's called an isopeptide bond.

31:28 Two non-alpha amino acids hanging off the main structure.

31:31 Count those and reatride crosses the threshold.

31:34 The FDA said no alpha amino acids only.

31:36 Retatruide is a drug.

31:38 And then Lily sued.

31:39 And on September 30th, 2025, a federal district court judge in Indiana,

31:43 my own backyard, sided with Lily partially.

31:46 The court vacated the FDA's classification of reatride as a drug.

31:50 The agency now has to go back and reconsider

31:52 and the case is now on appeal to the seventh circuit.

31:55 In other words, this fight is live and going on right now.

31:58 The rumor about Lily pushing hard on this probably isn't even news.

32:01 They've been pushing hard on this in federal court for 19 months.

32:04 Whether there is also an HHS side

32:06 push happening behind closed doors, I can't verify.

32:09 But the broader strategy, the intent, and the legal architecture,

32:12 all of that is public record and undeniable.

32:14 So why does Lily care?

32:16 Why is Eli Liy, one of the largest pharmaceutical companies on the planet,

32:20 spending who knows how many millions of dollars

32:22 in legal fees to argue about two amino acids?

32:25 And why should you care about it?

32:27 Because of how much money is on the line.

32:30 And I'm going to walk you through the math because once you understand it,

32:33 you're going to understand everything.

32:34 When a pharmaceutical company gets a new

32:36 drug approved under the standard small molecule pathway,

32:38 which is the one we talked about in the main video,

32:40 they get 5 years of exclusivity under the Hatch Waxman Act.

32:44 5 years.

32:44 Now, there's some nuance and exceptions there,

32:46 but that's what we're looking at in general.

32:48 So, after that, generic manufacturers can file

32:50 an abbreviated application and start making cheaper copies.

32:53 And once those generics hit the market,

32:55 prices typically drop by 80 to 90% within 12 months,

32:58 which is the entire reason why Viagra,

33:00 which used to cost north of $70 a pill, is now basically free.

33:03 Selenil went generic in 2017.

33:05 Seals went generic in 2018.

33:06 The patents expired, the generics flooded in, and prices collapsed.

33:09 So, American men with erect function could finally afford to have sex again.

33:13 Free market capitalism kind of beautiful when it works.

33:15 But biologics get a completely different deal.

33:18 Under the Biologics Price Competition and Innovation Act of 2009,

33:22 the BPCIA, Biologics get 12 years of exclusivity.

33:26 12, not five.

33:27 And even after those 12 years,

33:29 biosimilars, which are biologic versions of generics,

33:31 do not collapse prices the way traditional generics do.

33:34 The median time to actual biosimilar competition in the US is over 20 years.

33:38 20.

33:39 And here's the kicker and the one that really matters for this conversation.

33:43 Compoundingarmacies cannot compound biologics.

33:46 Full stop.

33:47 They need a biologics license application, a BLA,

33:50 which again we covered in the main

33:52 video costs somewhere between 80 and $150 million

33:55 to establish and has never in the history

33:58 of the FDA been granted to a compounding pharmacy.

34:00 So the moment a molecule gets classified as a biologic,

34:03 the 503A and 503b compounding pathways are closed to it forever.

34:07 End of discussion.

34:09 So just think about what happens if Lily wins this fight.

34:11 Retatrutide and potentially simaglutide and even trespatide by extension

34:15 would get 12 years of exclusivity instead of five.

34:18 Biosimilars would be delayed for decades.

34:20 Compoundingarmacies would be permanently locked out.

34:23 Medicare negotiation leverage would be diminished and the price

34:25 of GLP once which is already destroying

34:27 household budgets and insurance formulators across the country

34:30 would stay at pharmaceutical company pricing levels essentially forever.

34:34 This isn't speculation.

34:35 This is the basic architecture of US drug regulation applied

34:39 to a very specific chemistry argument about whether a couple of side

34:42 chain amino acids get to count two amino acids billions of dollars

34:46 maybe hundreds of billions over the lifetime of the GLP-1 category.

34:50 And here is why I am taking this seriously and why you should too.

34:54 Because we have seen this exact same playbook run before in urology

34:58 in the male fertility space on a hormone

35:00 my patients have depended on for decades.

35:03 And that hormone, that glyoprotein is hCG, human corionic anatropen.

35:08 HCG has been around since the 1930s as a purified hormone.

35:12 And since the 1950s as an FDA

35:14 approved injectable for literally almost a century,

35:17 hCG has been a workhorse medication in men's health.

35:20 In urology specifically,

35:22 we use it for low testosterone, for fertility preservation,

35:25 for testicular atrophy during testosterone replacement,

35:27 for delayed puberty, for undecided testicles and boys.

35:30 It is a mainstay.

35:32 Every urologist, every endocrinologist,

35:34 every men's health doc in America has written dozens,

35:36 hundreds, thousands of prescriptions for hCG.

35:39 Or at least they did up until March 23rd, 2020.

35:42 Before that time, hCG was classified as a drug.

35:45 It could be compounded by 503A and 503barmacies.

35:48 A 10,000 unit vial of compounded HCG cost

35:51 somewhere in the range of 50 to 80 bucks.

35:53 It was available, it was affordable, and it was everywhere.

35:56 But then on March 23rd, 2020,

35:59 a provision of the Biologics Price Competition and Innovation Act of 2009,

36:03 the same BPCIA we just talked about

36:05 took effect after a 10-year transition period.

36:07 That provision transitioned hCG along with FSH LH and a handful

36:11 of other hormones from drug status to biologic status overnight.

36:15 So what happened?

36:16 80% of the compoundingies that have been making hCG had to stop overnight.

36:21 Patients who had been paying $50 for a vial suddenly had to pay five

36:24 to seven times more than that for the brandame

36:26 versions including pregnant Novaril or Avadril.

36:29 Some of those brands went into shortage almost immediately because they just

36:32 couldn't scale to replace the compounded

36:34 supply and critically for men's health specifically.

36:37 And this is the part that makes me really mad.

36:39 There is no FDA approved hCG indication

36:41 for adult men with hypogadatism or male fertility issues.

36:45 So now we're using a branded biologic five times

36:48 more expensive product off label and dosages that don't

36:50 make sense for an indication the FDA has

36:53 never even considered because we have no other option.

36:55 The population that got hurt, young men trying to build their families.

36:59 Hypoconatal men trying to preserve fertility.

37:01 Men on TRT trying to keep their testicles somewhat functional.

37:04 Boys with unescended testicles whose families are now paying

37:06 a fortune for something that used to cost basically nothing.

37:09 Men whose marriages depend on being able to have a child.

37:12 that population, my patients, hurt by a regulatory reclassification that no

37:17 patient ever asked for and provides no

37:19 meaningful safety benefit because hCG is one

37:22 of the most well-characterized hormones in medicine.

37:24 The excuse that hCG is a biologic because

37:27 it's a complex glyoprotein derived from a biological source.

37:30 Sure, fine.

37:31 But guess what?

37:31 We've been safely compounding it for decades.

37:34 The reclassification didn't make hcg safer

37:36 and made it more expensive and less accessible.

37:39 So guess what?

37:40 That's the playbook.

37:41 That's the template.

37:42 And it is exactly what Lily is trying to do with reatride

37:45 and by extension potentially simaglutide and trespathide

37:48 if the door opens wide enough.

37:50 So I encourage you if you care about this and by this I

37:53 mean whether or not GLP-1 medications will stay at their current price

37:56 point whether biosimilar competition will ever

37:59 meaningfully arrive or whether compoundingies will

38:01 even have the option to make these drugs during the next shortage cycle.

38:05 You can actually do something.

38:06 Call your senators.

38:07 Call your congressional representative.

38:09 Tell them that you're a constituent and tell them

38:11 that you're paying attention to the retatride classification fight.

38:14 Tell them that you oppose the quiet expansion of biologic

38:17 status to compounds that have historically been regulated as drugs.

38:21 Tell them that reclassifying small molecule scale peptides as biologics simply

38:25 because a pharmaceutical company wants longer exclusivity is bad public policy.

38:30 You don't have to be a pharmacist or a doctor to make that call.

38:33 You don't have to explain what an isopeptide bond is.

38:35 You just have to say this.

38:36 I'm a constituent.

38:37 I care about GLP-1 drug pricing and I oppose reclassifying GLP1s as biologics.

38:43 So that's it.

38:44 That's the ask.

38:45 Five minutes of your time.

38:46 Five minutes that actually matters because this kind of technical

38:49 regulatory fight almost always gets decided by whoever is paying attention.

38:53 And right now the only people that are

38:54 paying attention are the pharmaceutical companies and their lobbyists.

38:57 All right, there you go.

38:58 That's the addendum, the rumor, the lawsuit,

39:01 the hCG parallel, and that's the ask.

39:04 So, is Eli Liy actively lobbying HHS behind

39:07 closed doors the way the April 16th tweet claimed?

39:10 I don't know.

39:10 I can't verify it.

39:12 If someone shows me independent corroboration,

39:14 I will totally update this in another video.

39:16 But the broader strategy that the tweet described, that's absolutely happening.

39:20 It's in federal court in the public with real legal filings and real stakes.

39:25 If Lily wins this fight, GOPs stay expensive forever.

39:29 Compounders stay locked out.

39:30 Biosimilars are delayed by decades.

39:32 And the hCG disaster gets replayed at a scale about a hundred times bigger.

39:37 And ultimately, we're the ones that end up paying the price.

39:40 Now, back to our regularly scheduled programming.

39:42 And Ronic, sorry again for the different hoodie.

39:44 I owe you two free vials of testosterone.

39:47 Kidding.

39:48 Catch you in the main video.

39:49 The seven peptides going before the PCAC

39:52 on July 23rd and 24th break down like this.

39:55 On day one, July 23rd, we've got BPC-157, KPV, TV500, and MOS C.

40:00 And then on day two, July 24th,

40:02 we got emadelide aka delta sleepinducing peptider, dip, cmax, and epitalon.

40:08 And a second group of compounds is expected to follow in later PCAC meetings.

40:12 GHKCU, dhexa, ibutamor, melanotan 2, ll37.

40:15 These haven't been formally scheduled yet, but they're in the pipeline.

40:18 Now, I have a theory, and I want to be clear about this.

40:21 This is just speculation on my part.

40:22 Nobody at the HHS has told me this.

40:24 This is just what it looks like

40:25 from an outsider who pays attention to this space.

40:27 Throughout 2025 and into 2026, the FDA under Dr.

40:31 Marty McCary has led a genuinely brutal enforcement

40:34 crackdown on compoundingies that have been making GLP-1 products.

40:37 Now, compounded semiglutide and compounded trespide

40:40 had exploded in popularity during the shortage

40:42 periods because the commercial guys just couldn't keep up with the demand.

40:46 And so, compounders were making money that Lily

40:48 and Novon Nordis believed belonged to them.

40:50 So, the FDA under pressure from lobbyists, I believe, shut that down hard.

40:54 We're talking warning letters,

40:55 enforcement actions, subpoenas, constant inspections.

40:58 It was not subtle.

40:59 It was mob enforcer level.

41:00 So why does this matter?

41:02 Because it was likely the quidd proquo promised by the Trump

41:05 administration to get his Trump RX initiative off the ground,

41:08 which is positioned to sell brandame GLP1s directly to consumers at a discount,

41:12 cutting out compounders entirely.

41:14 And from that angle,

41:15 restoring access to peptides is a lot like extending an olive branch.

41:18 Hey compounders, we took your GLP-1 business,

41:20 but here's your BPC157 business back.

41:22 Now, please shut up.

41:23 go home and stop lobbying Congress.

41:25 You're welcome.

41:26 Is this exactly what happened?

41:28 I don't know.

41:28 I can't prove it.

41:29 I'm not in those meetings.

41:30 But the timing is suggestive and the regulatory analysts in the compounding

41:34 space have been saying more or less the same thing.

41:36 Okay.

41:37 So, here's the part where I need to temper

41:38 expectations because there is a tremendous amount of misinformation

41:42 on social media right now suggesting that BPC 157

41:45 is going to be on pharmacy shelves in August.

41:47 And it's not.

41:48 And here's why.

41:49 The PCAC meeting in July is an advisory committee meeting.

41:53 The PCAC's job is to review the data, hear from nominators,

41:57 listen to public comment, and then vote on a recommendation.

42:00 That recommendation is not binding.

42:02 The FDA can follow it or not follow it.

42:04 Historically, the FDA follows the PCAC recommendations

42:08 most of the time, but not always.

42:10 And even if the PCAC votes favorably on every single peptide,

42:14 the FDA accepts every single recommendation,

42:16 there's still a legal process that has

42:18 to happen before anything can really change.

42:20 And that process is called notice and comment rulemaking.

42:23 It's governed by the Administrative Procedure Act.

42:25 It requires the FDA to publish a proposed rule in the Federal Register,

42:29 open a public comment period that typically lasts 30 to 60 days,

42:32 review and to respond to those comments, and then issue a final rule.

42:36 All of that takes time and so in the best case we're looking at maybe

42:39 12 months if we go on precedent alone from PCAC vote to final rule.

42:43 Now again this FDA has moved lightning fast to other approvals.

42:46 So maybe we'll be surprised in the more realistic

42:49 or worst case scenario maybe 18 to 24 months.

42:52 So even with a maximally favorable PCAC

42:54 outcome in July 2026 compounders likely won't

42:57 get full legal access to these peptides

42:59 until late 2026 if things move lightning fast.

43:02 But honestly, it could be early 20s 27 or later.

43:05 July 2026 is a milestone, but it isn't the finish line.

43:08 And on top of all that, let me underline

43:10 one more time what category 1 reclassification actually means.

43:14 It means that these peptides can be legally compounded by licensedarmacies

43:18 with a physician's prescription under enforcement

43:21 discretion while they remain under FDA evaluation.

43:25 Which means no, these things are not FDA approved.

43:28 It does not mean proven safe and effective in phase three trials.

43:31 It doesn't mean standardized dosing.

43:33 And it certainly doesn't mean insurance coverage.

43:35 It means compounding eligibility,

43:37 which is real and valuable and a meaningful step

43:39 towards patient safety over the current gray market nightmare.

43:42 But it isn't the same as approval.

43:44 And I want that to be clear because I have watched people

43:46 online get this wrong for months if not years at this point.

43:49 And it's driving me crazy.

43:51 So what do we do with all of this?

43:52 If you're a clinician watching this, here's what I'm

43:55 going to be telling the room at AUA in May.

43:57 And here's what I'm going to tell you.

43:58 I've got four things.

44:00 One is educate yourself now.

44:02 The regulatory landscape is shifting underneath us.

44:04 PCAC review begins in July.

44:06 If reclassification proceeds,

44:07 a lot of patients are going to walk into your clinic

44:09 in late 2026 or 2027 asking about peptides if they aren't already.

44:14 You don't have to become an expert,

44:15 but you should at least know what these compounds are,

44:17 what the evidence does and does not show, and where the risks actually lie.

44:21 You should also know what your patients are already doing because I

44:25 promise you a non-trivial fraction of them are already using these things,

44:29 including a lot of the people watching this channel.

44:31 Number two is providers need to counsel patients on gray market dangers.

44:35 Patients sourcing so-called research chemicals face adulteration,

44:38 endotoxin contamination, unsterile manufacturing, and zero quality control.

44:42 Again, it's like gas station sushi.

44:44 You can get lucky and it could be fine, or it could be terrible.

44:46 If a patient tells you that they're using a compound, don't shame them.

44:49 Don't reflexively just tell them to stop.

44:51 Instead, ask them where they're getting it.

44:54 Talk about the real risks.

44:55 Redirect them towards legitimate channels when those channels become available.

44:58 Meet them where they are.

45:00 Three, advocate for rigorous human trials.

45:03 Some of these compounds have genuine therapeutic promise.

45:05 Thyosin alpha 1 has enough data to justify fast-tracked phase 3 trials.

45:09 AOD9604 is a plausible obesity adjunct and these are molecules that deserve

45:14 real clinical investigation and the compounding

45:16 framework isn't a substitute for that.

45:18 Reclassification is a pressure valve.

45:20 It's not a substitute for evidence.

45:22 And finally, we've got number four.

45:24 Prescribe judiciously when legal.

45:26 If and when these pep guides return to category 1,

45:28 you'll be in a good position to prescribe them.

45:30 And that's a privilege and a responsibility.

45:32 Don't be the guy writing random scripts for anyone who just walks in the door.

45:35 But also, don't be the guy who reflexively refuses because these compounds

45:39 don't fit neatly into your traditional pharma box and, you know,

45:42 because no one brought you free lunch to talk about them.

45:44 Use your clinical judgment.

45:45 Apply the evidence you have.

45:47 counsel honestly and monitor carefully.

45:49 And if you're a patient watching this, my advice hasn't changed.

45:52 Talk to your doctor.

45:53 If you're already using these compounds, just be honest about it.

45:56 And if you're thinking about using them, understand that as of today,

45:59 literally today, we are still in the category 2 era for most of them.

46:03 That will likely change, but it hasn't changed just yet.

46:06 I believe in bodily autonomy.

46:07 I believe adults have the right

46:09 to make informed decisions about their own health.

46:11 What I care about is that those decisions are informed

46:14 and that the information you're using to make them is accurate.

46:17 That's the whole mission of this channel and that's the whole reason

46:20 that I went on Diary of a CEO and it's the whole reason

46:22 that I'm about to stand up at AUA and try to explain

46:25 this to a room full of urologists

46:26 who understandably probably already think I'm crazy.

46:29 But if this video helped you understand

46:31 the situation better than you did 15 minutes ago, then I've done my job.

46:34 And if Ronic actually managed to edit this video down to 15 minutes,

46:37 then he's done his job.

46:39 All right, we made it.

46:40 15,000word Federal Register notices summarized into one YouTube video.

46:43 You're welcome.

46:44 If this video helped you, do me a favor.

46:46 Smash that like button.

46:48 Seriously, I know every YouTuber says it,

46:49 but the algorithm genuinely runs on it.

46:51 And this is a niche topic that most channels just are too scared to cover.

46:55 Your like is how this video finds the next person who needs it.

46:58 Subscribe if you haven't.

46:59 This channel is where I drop long form content on peptides, PEDs,

47:02 men's health, and all the stuff

47:04 that your doctor probably isn't comfortable talking about.

47:06 It's evidence-based, honest, and occasionally profane,

47:09 but it's always coming from a place of genuine care about getting it right.

47:12 So, drop a comment.

47:13 Tell me, were you using any of these peptides before September 2023?

47:17 And are you using them now?

47:18 Are you waiting for them to come back?

47:20 What's your situation?

47:21 I want real stories.

47:22 I want to know what the last two

47:23 and a half years have looked like from your side.

47:26 If you want to watch the Diary of a CEO interview,

47:28 the link is in the description.

47:29 Stephen and his team did an incredible job.

47:31 If you want to see me try to explain all

47:32 of this to a room full of urologists live and in person,

47:35 I'll be at the AUA annual meeting in Washington DC come this May.

47:38 Come find me, say hi, tell me you watch the channel.

47:41 I'll be the guy sipping an energy drink,

47:43 popping a zeni in a poor fitting blazer.

47:45 And to all of you, seriously,

47:46 from the bottom of my heart, thank you for watching.

47:49 Thank you for subscribing.

47:50 Thank you for the comments and the DMs and the stories.

47:53 This channel exists because you exist.

47:55 And I don't take that for granted.

47:56 To Stephen and the whole Diary of a CEO team, thank you again.

48:00 It was an experience of a lifetime and I owe you one.

48:02 And to my three urology buddies who actually watch these videos, hi guys.

48:06 I'll see you in May.

48:07 I'm Dr.

48:07 Alex.

48:08 Stay curious, stay skeptical, and as always, proceed accordingly.