A fortune favors bold peptide policymaking

The peptide business is already roughly as big as legal weed. Just saying.

(Nataliya Vaitkevich on Pexels)

The power of Federalism always has been about different parts of the country experimenting with ways of running their hunk of freedom-loving land.

The FDA recently sent letters¹ out to multiple providers of peptides in the U.S. warning them that further action could be taken if they don’t quit offering what they call ““new drugs””² in every letter. Three things jump out at me about all of these:

1. All the letters focus strictly on peptides that exist in the regulated market (knock-offs of Ozempic and Zepbound) or are on the way (retatrutide).

2. All the letters invoke interstate commerce, as in the interstate commerce clause, the tiny little passage of the Constitution from which nearly all federal domestic power derives.

The peptide business is very big. Based on estimates, it is already around the size that video games reached in 2018 and 2019, when journalists noticed that games had gotten to be bigger than movies.

• Background: Peptides are short chains of amino acids. Amino acids are the building blocks of proteins. Proteins and peptides work as chemical signals to other parts of your body. Some folks who want more of one kind of signal or another have been using synthetic peptides with strong results.

• Editorialization: Peptides also generate more demand via lifestyle enhancement rather than curing diagnosed medical conditions — and this seems to make many people uneasy.

OK, but chill out

These letters from the FDA to compounding pharmacies might indicate a limited campaign.

On the surface, it looks reasonable that the FDA has taken these actions at the behest of the pharmaceutical industry, which wants to protect its intellectual property.

Getting a pharmaceutical approved for sale in the United States is a lengthy and massively expensive process (the The Clinical Trials Abundance blog has started making the case for reigning this in, but for now this is real life). It’s understandable that Big Pharma would want to undermine companies popping up that eat into their market share.

Is it weird that the FDA has a side hustle as an IP enforcement agency for the industry? Seems weird to me.

But there is (arguably) a public health justification here. Patients can feel confident that name-brand Ozempic and Zepbound have been made in regulated labs, have the kind of dose they expect and won’t have garbage in the vial.

(but there is always some kind of justification)

But it remains to be seen whether or not the FDA starts going after other peptides. All the signs suggest that they will not, but we’re still waiting for that big announcement about the recategorization of some of podcast-nation’s favorite “peppers.”

The Wolverine Stack debate misses the point (and needles)

BacteriostaticWTF

But the Feds also seem to be cracking down on the peptide scene indirectly, which could indicate that more moves are afoot.

For the uninitiated: Grey market peptides require more work than getting stuff through a pharmacy, and more ways to go wrong. If you played around with a chemistry set as a kid, though, you’re going to be good to go.

The key point here, though, is most of the time people get peptides in a powder form and they need to add bacteriostatic water in order to make it injectable.

• Does this sound daunting to you? Me too! I haven’t done it.

Bacteriostatic water is sterilized water that has an additive that will keep it sterile for longer after the seal has been broken on a bottle.

Bacteriostatic water is the bandwidth of the peptide business. It’s like: No fiber internet = no Netflix, just as no bacteriostatic water = no home peptide business.

Getting this crucial ingredient has been tougher lately. The FDA has been cracking down on it (several of the letters this week mention it), or providers are getting nervous.

And Amazon has also moved to sell a little less of everything. Earlier this year, the company said it needed to see third-party current good manufacturing practices certification for providers of supplements. I don’t know if that’s the cause of the crackdown or not, but it might be.

If folks can’t get bacteriostatic water, they can’t safely use peptides. If the Feds make that difficult or impossible, it’s very much like saying: “You can sell cars but you can’t sell them with tires.”

Pair of dimes

I think I have a unique perspective on this peptide story. I’m confident that I’m the only veteran cryptocurrency reporter who has gotten interested in covering peptides. It’s too early to say for sure, but it looks to me like some very similar forces are in play in peptides.

I have some guesses about how this story is going to play out that might not look obvious to new arrivals or to journalists coming at the story from a purely healthcare oriented framework.

Obviously, peptides are about as analog as it gets, and crypto has always been about hopping on a blockchain Kawasaki, popping the throttle and gunning it straight into Lawnmower Man.

But here’s how it’s similar: There’s just a massive gap between those who get it and don’t get it.

• For those who don’t get it, the ones who “get it” are suckers.

• For the ones that “get it,” the ones who don’t have blinders on.

You can make a strong case for either side, but which one is right, I submit, doesn’t actually matter.

If crypto is peptides’ prologue, then more and more people are going to start putting the weight of their disposable income into this controversial intervention, and entrepreneurs will find ever more creative ways to get them to them and to assure them that what they are getting is safe.

For example, I have one source now who has explained to me how peptide users are already entering into informal testing cooperatives. It’s not at all hard to see how someone turns that into a startup.

If more and more people use them because they feel convinced that they are doing some good, it’s going to be harder for politicians to justify regulatory blockages. Some official will come to power by promising to provide a legal pathway for these products.

• The Amazon Basics peptide collection is just a matter of time.

By then, one or two companies will have arisen that will be de facto unicorns of the peptide space (the Coinbase, Uniswap and Tether of short amino acid chains). And it won’t be bro-science anymore. It will be on NASDAQ.

I might be wrong! (But I’m not wrong.)

Dr. Governator

If I were an ambitious governor of a state, I might give a long look at throwing down with the Feds over peptides, like Wyoming semi-threw down over cryptocurrency.

The peptide gambit could go a lot farther.

Texas is already looking at funding and running clinical trials into the psychedelic, ibogaine, for mental conditions.

• Texas or another state could put its foot down and do something similar on peptides, particularly because pharmaceutical companies are not.

A state could offer its own lab certifications for compounding pharmacies focused on peptides.

It could even go further and try to contend that while it’s a grey area nationally, in its state the legality could be made clear.

• If states can pull this off with marijuana (roughly) why couldn’t they with peptides? It already looks like the peptide industry might already be on par with legal weed, or close enough.

If history comes down on the side of peptide treatment, this could be a win for the state. That’s a big ‘if,’ but the road is made by walking.

Remember, it is no accident that the various parts of the USA are called “states” and not “provinces.” The core idea embedded in the Constitution, much muddled and muddied since as it may have been, was that these regions would be largely self governing, an amalgamation of real-life laboratories in running the nation, with programs and priorities that reflected their populations.

• There’s a reason, after all, that every single state operates its own pharmacy board.

What we know is that clinical trials and regulatory approval under the existing regime will take a very long time, and no one has even started.

A state that might like to make some money might decide it doesn’t want to wait quite so long.

1. The letters can be found here. I’m putting this in a footnote so I can add this caveat: the letters in question were posted on April 7, 2026, but there’s some letters posted on that date that aren’t germane to this post. But there’s less than 10 letters, total.

2. Yes, I’m putting the FDA’s quotation marks in quotation marks.