I’m a bit slow when it comes to learning about popular culture and ‘wellness’ fads. But a drive-time piece from NPR this week about this peptide wellness fad captured my attention.
Does the science of peptides live up to the hype?
In the piece I learned FDA was having advisory committee hearings this week to recommend whether the FDA should legitimize the current ‘gray market’ for untested & unlicensed peptides by officially putting the drugs on the loophole list – called the Section 503A Bulks List.
Adding the untested drugs to that list makes it clear compounding pharmacies can legitimately supply them to med spas and other ‘wellness’ clinics. Right now, they’re doing it in a regulatory gray area.
A quick google search revealed that there are tons of these ‘wellness clinics’ all over Arizona making bold (and unsubstantiated) claims about how awesome and curative these peptides are.
I saw all kinds of claims that peptide injections and nasal sprays accelerate injury recovery, reduce inflammation, improve sleep, sharpen thinking and slow aging. Clinics across metro Phoenix and Tucson advertise products including BPC-157, TB-500, Semax and Epitalon. More on these later.
So… I wanted to dig a little deeper and look at the actual evidence and also see how it is that these unapproved drugs are actually available even though they’re not assessed for safety and effectiveness nor licensed by the FDA.
What are Peptides?
You probably learned what peptides were in high school biology class. They’re short chains of amino acids that help regulate many biological functions. Insulin is a peptide, as are several proven and FDA-approved medications, including the new GLP-1 weight loss drugs (which are approved and licensed).
But those aren’t the peptides being promoted by the wellness med-spas and the like. The unlicensed drugs they’re claiming are so curative are called BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon.
They’re being marketed for broad ‘wellness’ purposes without the clinical evidence normally needed for a new drug.
Not surprisingly, Kennedy is an enthusiastic advocate of these untested and unlicensed peptide drugs & makes frequent public statements about how he wants to make them more available by clearly giving them an exemption in compounding pharmacies.
Demand is also being driven by a podcaster called Joe Rogan, who repeatedly praises BPC-157 and TB-500 for injury recovery, calling the combination the “Wolverine stack.” Literally.
Med-spas and other wellness clinics use his name in their marketing. People hear that Rogan thinks they’re good, so they search for the product and arrive at a med spa to buy it.
FDA Advisory Committee Recommends Broadening Access Despite the Lack of Approval
This week (Thursday and Friday) an FDA advisory committee (which was recently stacked with new Kennedy appointees) recommended allowing the compounding of the peptides despite objections from the agency’s career scientific staff.
Advisers to the FDA will vote to ease regulation of popular peptides : NPR
The FDA advisory committee recommended that the untested peptides be officially placed on something called the Section 503A Bulks List, which makes it clear that state-licensed compounding pharmacies can make them available (with prescriptions) even though the products haven’t been FDA-approved.
I know that’s already happening – but right now it’s in a gray market. If FDA puts these them on the official Bulks List it’ll be clear they can fill the prescriptions even though the drugs aren’t tested or licensed.
What Does the Evidence Show?
Not much.
FDA staff reviewers (who supplied the evidence base with the advisory committee) found no human data for KPV, MOTS-c or TB-500 (Joe Rogan’s “Wolverine Stack”). In other words, they found no data at all to show that those peptides are either safe or effective.
They presented evidence that BPC-157 has a tiny (and inadequate) human evidence base that it may be effective (no safety data), despite widespread wellness industry claims that they heal muscles and tendons.
They also presented evidence to the advisory committee that Semax, Epitalon and emideltide had even limited animal testing which was poorly documented. No human data.
FDA’s career scientists recommended against allowing the compounding of all seven.
Naturally, a majority of the committee (recently overhauled with new members by Kennedy) disagreed with FDA professional staff and recommended 8-6 that all the peptides be given an exemption – to let compounding pharmacies fill prescriptions for them anyway.
If They’re Not Approved, How Come They’re Available?
A doctor or other clinician who can prescribe meds can conduct a consultation and send a patient-specific prescription to a compounding pharmacy, even if the drug isn’t licensed by the FDA. That’s the loophole.
Compounded drugs aren’t FDA-approved and aren’t reviewed beforehand for safety, effectiveness or even manufacturing quality.
Compounding can be important when a patient needs an approved medication in a dosage that the manufacturer doesn’t provide. But in the case of peptides, wellness spas & woo-woo clinics drive a truck through that loophole.
The FDA’s advisory committee is nonbinding, so nothing immediately changes on the ground until (when) the FDA formally accepts the recommendations and updates its compounding policy, which is sure to happen given Kennedy’s zeal for the untested drugs.
When FDA adds the peptides to the bulk list, Arizona med spas, wellness stores etc. will have a much clearer legal supply route through compounding pharmacies and access (along with the unsubstantiated claims of safety and effectiveness) would likely expand.
BUT — but the decision still doesn’t establish that the peptide is safe, effective, or even clean.
Caveat Emptor, I guess.
Note: These peptide ‘treatments’ are almost entirely cash pay. Regular Medicare and most Medicare Advantage plans don’t cover bulk powders used as active ingredients in compounded drugs. Likewise, AHCCCS coverage is wired to evidence-based medicines, which these unapproved wellness peptides aren’t.
Private commercial insurance policies vary, so I can’t say that every plan excludes these peptides. But it’s safe to say that they’re unlikely to be covered.
So, for the most part, these drugs will be sold to people with enough disposable income to pay hundreds or thousands of dollars out of pocket. That means the people most likely to be ripped off (or potentially harmed) will tend to be higher-income people who can afford to experiment on themselves.







