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Non-FDA Approved Peptides
The truth about peptides, Big Pharma, and FDA approval
Most of you guys who follow me know how it works regarding peptides and the FDA.
You know that most peptides available today have not undergone the FDA approval process.
You also know why this is the case—and why it has nothing to do with safety or efficacy.
But I realize some people haven’t gotten the memo yet.
Some people are just starting their peptide journey and don’t know “how the game is played.”
And because they don’t know how the game is played, they send me questions like “Are non-FDA approved safe?”.
It makes sense…
After all, if you’ve spent your life being told by the health “experts” know what’s best for you, you could be forgiven for being a little skeptical.
Here’s the answer I always give:
Yes - (MOST) non-FDA-approved peptides are perfectly safe and effective.
So…why aren’t they approved?
Let me ask you this…
Do you know how long it takes a drug to make it through the approval process laid out by the Food and Drug Administration?
10-15 years 😳
That’s right - from the basic research to the clinical trials to finally getting the almighty stamp of approval, it typically takes a decade to a decade and a half.
Want to know how much it costs?
Millions or even BILLIONS of dollars.
A New Drug Application alone is a couple of million bucks.
The average cost of just the Phase 3 Clinical Trial is around $20 million.
That’s not counting all the money that needs to be sunk into preliminary research and development.
And who do you think has that kind of money?
That’s right - Big Pharma.
And if we know anything about pharmaceutical companies, they DESPISE most peptides.
Why?
First, they’re incredibly hard to patent (which is where pharma makes most of their cash).
Secondly, peptides do what many drugs don’t - they get to the root cause of a health issue.
Compare that to most of what’s on offer today, which exists to cover up symptoms, and it’s pretty easy to see which is more profitable (the one you have to continue taking into perpetuity).
That’s why these companies are so resistant to bringing new peptides to market (and are determined to squash out their use).
And because massive pharma conglomerates are typically the only folks with the cash necessary to run through the gauntlet set up by the FDA, most peptides don’t make it through the process.
But does that mean they’re “dangerous”?
Generally, NO!
Most peptides are inherently health-promoting.
They’re agents that occur naturally within the body.
They come with few (if any) side effects.
I’d go as far as to say that they’re safer even than some of the things you can pick up on iHerb or Amazon.
Now, before I close out, I will say this…
I’ve noticed a phenomenon where people can swing in the OPPOSITE direction as they begin their optimization journey.
They assume that just because something’s been produced by Big Pharma, it’s inherently unsafe - including brand name GLP-1s like Ozempic (semaglutide) and Mounjaro (tirzepatide).
I even had one guy ask me recently if generic peptides are safer than brand-name.
My answer to that is also (generally) NO.
What can I say? A broken clock is right twice a day.
Semaglutide, tirzepatide, and several other peptides like Melanotan 1 and PT-141 have cleared the regulatory gauntlet and are being sold by these companies.
And at the end of the day, it doesn’t matter which version you pick up…
At least from a safety perspective.
From a price perspective, you’re MUCH better off going with a generic formulation from a trusted vendor like my company BioLongevity Labs (side note: we’re currently moving our warehouse and out of stock on all peptides, but we’ll be back up and rolling soon).
If you want to learn more about the ins and outs of self-peptide use, check out our flagship course, Peptides Demystified.
It’s got everything you could ever want on how to procure, prepare, and administer these wonder agents on your own.
Best,
Hunter Williams