Bonjour,

Waiting for l’addition at the cafe, missing the speed and unchecked capitalism of the good ole US of A.

ily,

Writer: Natasha
Editor: Miranda

CALLING CREATOOOOOOORS

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Yesterday was a big day for dudes on TikTok who've been taking something called The Wolverine Stack.

Over the past two days, the FDA's Pharmacy Compounding Advisory Committee, a mix of doctors, pharmacists, industry experts, and consumer representatives, met to decide whether seven peptides (BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon) should be added to the list that lets compounding pharmacies legally make them, instead of leaving people to source them gray market style through wellness clinics, med spas, and "know a guy" telegram groups.

Here's what's been going on. There's a whole bunch of peptides that in 2023 were banned from compounding pharmacies and put on the FDA's Category 2 classification, meaning the Food & Drug Administration considered them too risky to compound.

Compounding pharmacies mix custom medications for patients with a prescription, instead of you getting a prepackaged drug. Think ordering custom versus getting a Harvest Bowl at Sweetgreen. The 2023 ban made it basically impossible to legally get compounded peptides, creating the gray market we talked about here:

In February, good old RFK Jr. (who has become the main character of this newsletter, mea culpa) said, wait, I take some of these peptides and I love them, so let's definitely move them out of Category 2, which the FDA did in April. But in order for these peptides to be legally compounded again, they need to be added back onto something called the 503A Bulks List.

The April reclassification kicked off that process and a hearing was set for July. That hearing started yesterday, will continue today and has been a study in the market will regulate itself.

Meaning, consumers, or more accurately the companies that sell to consumers, forced the regulatory hand here.

TLDR, FDA scientists did not support easing restrictions and said, look, (1) the clinical trial evidence just isn't there, not enough studies on actual humans, (2) the standardization of what's in the vials is all over the place, and (3) the unknown effects on one's immune system were specifically flagged.

While counterarguments from other experts leaned on the idea that lack of proof does not equal harm, that the alternative (unregulated gray market sources) is worse, and that a legal pathway gives doctors another option for patient care rather than leaving oversight up to individual pharmacies.

The panel voted YES on BPC-157, KPV, and TB-500, 8 members said LFG, 6 said nope, and 1 was like I'll sit this one out (MOTS-c also passed but with 2 abstentions). A yes vote still doesn't give the green light, it's more like a jury giving its recommendation to a judge. Over the next few months, the FDA will go through formal rulemaking, and given this recommendation, there's a real chance these peptides get cleared for legal compounding.

I'm a proponent of people doing whatever they want with their body, as long as it doesn't harm anyone else, and I'm generally glad this passed. But we need to look at who benefits here. This article does a great job of saying, uh hold up.

Let me shoot you straight, this committee is living by the code no conflict, no interest. Here are the names, titles, and potential incentives for an enthusiastic yes on 3 of the 4 peptides voted on yesterday.

A caveat is, of course you want medical experts on peptides sitting on a committee making decisions about peptides. I’m just here to make sure you have all the available information.