Happy Thursday!
The FDA classified BPC-157 as a Category 2 bulk drug substance in 2023.
Their reasoning? Insufficient evidence on whether it causes harm to humans.
Meanwhile, hundreds of thousands of people have used BPC-157, including many of you reading this right now. And most of you walked away with zero adverse events and a healed injury.
But as of now, we have no documented way to verify the safety and efficacy of some of the most common and effective peptides.
Well, hopefully that’s about to change.
The Project
I've been working on something behind the scenes with a team of heavy hitters that I'm finally ready to share with you.
It's called the Peptide Safety Initiative.
The FDA says there isn't enough human safety data on BPC-157 to justify allowing compounding pharmacies to produce it. The published clinical data are razor-thin. One small pilot study. A couple of retrospective case reviews. No large-scale human trials.
But what does the FDA not have access to?
Your experience.
The real-world experience of the thousands of people who have used BPC-157 for gut healing, tendon repair, joint recovery, post-surgical rehab, and everything in between.
That gap between what regulators see on paper and what our community has experienced firsthand is the entire problem.
So we built a tool to close that gap.
The Peptide Safety Initiative
We created a structured reporting platform where you can document your personal experience with BPC-157. The data gets aggregated and de-identified. Then it goes directly to the doctors and researchers working with the FDA on peptide reclassification.
This is a real-world evidence collection effort modeled after the kind of data regulatory bodies actually take seriously.
There is a commission currently reviewing the Category 2 designation for several peptides.
The doctors on that commission need volume.
They need to show the FDA that real humans have used this compound, here's what happened, and here's the safety profile across a large population.
Good, bad, or neutral. All of it matters.
What You'll Be Asked
The form takes a few minutes. There are two tracks.
If you're a clinician or prescriber, you'll document your professional experience with BPC-157 across your patient population.
Clinical indications you treated. Objective outcomes you observed. Routes of administration, dosing protocols, duration of use, and sourcing.
There's a dedicated adverse event reporting section covering injection site reactions, fluid retention, hypoglycemia symptoms, cardiac changes, neuropsychiatric effects, GI issues, and blood pressure fluctuations.
You'll also rate the overall safety profile on a 0 to 10 scale based on your clinical judgment.
If you're an individual user, you'll share basic demographics (age, sex, height, weight, ethnicity), what your goal was for using BPC-157, what results you experienced, your dosing details, and where you sourced it.
You'll go through the same adverse event checklist covering injection site reactions, swelling, hypoglycemia symptoms, heart rate changes, mood effects, GI distress, and blood pressure changes. You'll rate overall safety on the same 0 to 10 scale.
Both tracks ask whether you discontinued use due to side effects. And both give you space to share additional details like lab values, imaging findings, or recovery stories.
Everything is voluntary. Everything is anonymous.
Why This Matters
The regulatory landscape around peptides is shifting fast. There are people inside the system right now who are willing to fight for reclassification. But they need ammunition.
Anecdotes in a Reddit thread don't move regulatory bodies, but structured, aggregated real-world evidence from hundreds or thousands of people does.
Think about what we're up against.
The FDA's position is that there's not enough human data. That's technically true when you look at published clinical trials. But it completely ignores the massive real-world evidence base sitting inside this community.
We can change that. But only if enough people participate.
What Happens With Your Data
Your submissions are aggregated into a de-identified dataset.
No personal information gets shared with anyone.
The compiled data is presented to the physicians and researchers on the FDA advisory commission reviewing peptide classifications.
That's it. No middlemen. No commercial interests. No product to sell you. Just community data going where it needs to go.
Final Thoughts
The biggest threat to peptide access is the absence of organized data from the people who actually use these compounds.
We have the community. We have the experience. We've just never had a system to capture it in a way that regulators take seriously.
Now we do.
If BPC-157 helped you heal a torn tendon, recover from gut issues, bounce back from surgery, or anything else, your experience is valuable evidence. Don't let it sit in your memory. Put it on record.
If you're a clinician who has prescribed or administered BPC-157, your data carries even more weight. The form has a dedicated track for you. Please take five minutes and fill it out.
We're starting with BPC-157 because it's the most widely used and the most immediately relevant to reclassification efforts. Other peptides will follow.
Share this with anyone you know who has used BPC-157. Patients, providers, training partners, anyone. The more data points we collect, the stronger the case becomes.
Thanks for being part of this!
Best,
Hunter Williams
P.S. If you had a negative experience with BPC-157, that data is just as important. We are not cherry picking! Honesty is what gives this data credibility with regulators. If we only show them the wins, they'll dismiss the whole thing. We need the full picture.