GOP lawmakers ask RFK Jr. to make FDA unleash risky peptides like BPC-157

RFK Jr. posted last year about wanting to weaken FDA oversight of both stem cells and peptides. What we mean by peptides here is a class of unproven and non-FDA-approved drugs sold by wellness influencers. Compounding pharmacies have made such wellness peptides available in the past before the FDA rightly became more restrictive about their use. The unfortunate irony here is that these “wellness peptides” risk making people unwell.

Now, a GOP congresswoman, who also runs a compounding pharmacy, has asked Kennedy to have the FDA weaken peptide oversight by compounders. She proposed the idea of using a specific FDA regulatory mechanism to do this. Earlier a U.S. Senator had made essentially the same ask of Kennedy.

With all of this in mind, Kennedy is likely to unleash risky peptides soon. If he does, public health will suffer even as compounders and wellness influencers stand to benefit. Maybe he already made the change and we don’t know it?

Diana Harshbarger, a GOP representative and pharmacist, asked RFK Jr. to weaken FDA oversight on peptides.

GOP Rep asks RFK Jr. to stop oversight on 6 sketchy peptides

It was Tennessee Rep. Diana Harshbarger who wrote Kennedy last month asking him to ease up on peptides. She referenced some of the most popular peptides among health influencers. These substances are all unproven to be safe and there’s no good evidence that they are beneficial to people for specific health conditions or general wellness. Most studies have been on animals or dishes of cells in the lab. From her letter, we see the six peptides that she wants unleashed and her claims about them:

• “BPC-157: Promotes wound healing, musculoskeletal recovery, and gastrointestinal protection, with anti-inflammatory and angiogenic properties.
• CJC-1295: A growth hormone–releasing hormone analog with sustained biologic activity for muscle wasting, metabolic dysfunction, and age-related decline.
• Ipamorelin: A selective ghrelin receptor agonist that safely stimulates growth hormone release without elevating cortisol or prolactin.
• Thymosin alpha-1: Immune-modulating peptide with evidence of benefit in infectious disease and oncology, though no FDA-approved formulation exists.
• Thymosin beta-4 fragments (e.g., TB500): Studied for wound healing, tissue repair, and anti-inflammatory properties.
• GHK-Cu: Demonstrates wound healing and regenerative potential, with both topical and injectable uses of interest to prescribers”

Letter on peptides ignores lack of data and peptide risks

I believe the claims are mostly aspirational. For example, there’s an absence of strong clinical trial data on BPC-157.

Yet she wants Kennedy to have the FDA exercise what’s called enforcement discretion on these peptides. That would mean that despite the agency having found reasons for concerns about risks,  and limited evidence for any benefit, the FDA would turn a blind eye to the compounding of these peptides and their use by the public moving forward.

Five out of six of these peptides (all but GHK-Cu) are currently in something called Category 2, which means compounding is not allowed for them due to risks or limited data. I am also not convinced that GHK-Cu is safe, especially when injected.

Harshbarger argued in the letter that the FDA has been too strict, which has led peptide users to sketchier sources:

“Yet FDA policy significantly restricts compounding of these peptides — even where no FDA approved alternative exists — leaving patients without safe, regulated access. This has driven patients to seek unregulated gray-market sources, exposing them to preventable risks.”

It is true that Americans have been buying risky, research-grade peptides, including from China, that could contain toxins and poor quality peptide fragments.

Still, this is not a good argument for the FDA to let unapproved peptide drugs be made widely available in the U.S. from compounders, even if the peptides are higher quality from pharmacies than random sources.  It’s akin to saying something like “let vendors that produce high-quality but unapproved and scientifically unproven pharmaceuticals sell them without formal FDA approval because otherwise people will use risky counterfeits.” It makes no sense.

What will Kennedy do on the peptide front?

I hadn’t realized until I saw Harshbarger’s letter that U.S. Senator Tommy Tuberville had also written Kennedy this summer asking for enforcement discretion on many substances including a bunch of unproven wellness peptides.

With pressure from the GOP, what happens next could? If Kennedy wants to weaken things here, having the FDA exercise enforcement discretion on peptides would be much simpler than the agency trying to change the rules or laws that pertain to peptides.

We’ve talked about enforcement discretion from the FDA before here on The Niche. It’s a terrible idea in this case. Peptides need more FDA oversight, not less. Same for the types of stem cells sold by unproven clinics.

Despite that reality, Kennedy is reasonably likely to force the FDA to do what Harshbarger and Tuperville have asked or something very similar. I think this will happen perhaps as soon as within 1-2 months. I bet it was already part of his agenda even before he got this letter. Why is Kennedy so interested in peptides? Is part of the motivation coming from his own personal experience? Kennedy disclosed getting unproven stem cells.

Keep in mind, it’s possible enforcement discretion on these peptides is already underway and we just don’t know it yet. I still would think Kennedy would have made a big deal out of it via an announcement from HHS or the FDA.

Any pushback?

It’d be interesting if Makary pushed back on this peptide deregulatory effort, but that seems relatively unlikely. What about Vinay Prasad of CBER? Remember that peptides are regulated by CDER (Tracy Hoeg in charge there now) as much as we biologists think of peptides as biologics.

Would Hoeg stand up to Kennedy? I doubt it. Hoeg also at some point listed unproven stem cells as available for patients at a clinic here in California. So maybe she’ll feel flexible on peptides too?

Peptide risks

As a reminder, synthetic peptides can have powerful activities in the body. But those activities can be good or bad. Some peptides probably do nothing at all.

As I’ve written before, many of the most remarkable drugs like insulin are peptides. GLP-1’s are peptides. The thing is that you’ve got to prove their safety and efficacy in clinical trials before widespread marketing and use. For example, you need to produce data on dosage, route of administration, and more. The wrong dose of a peptide could easily be fatal. There is remarkably little good trial data on wellness peptides.

If peptides are soon unleashed by the FDA via Kennedy, it’ll just translate to bigger profits for the compounding and wellness industry going along with increased risks to public health.

This is not just a theoretical issue. Already some people have been hurt by peptide injections. We’ll just see more of that if the FDA decides to turn a blind eye to compounding and marketing of these peptides.

---

As a side note, I’m not sure what to call these particular peptides. They are not really wellness peptides. Hyped peptides? Any other ideas? Many of the health influencers just call them “peptides” and people seem to get the picture, but peptides is a very broad name.