More red flags on peptides even as softening of FDA oversight could happen soon under RFK Jr.

Last year, HHS Secretary RFK Jr. claimed in a post that the FDA was suppressing things like peptides and stem cells. I started hearing about “peptides” earlier, about 2-3 years ago. Some were saying that specific peptides were even better than stem cells, which is a big red flag.

The term “peptides” in this context means substances that health influencers claim can do all kinds of good stuff to your health. These are largely evidence-free claims and there are big risks here.

RFK & peptides | What are peptides? | List of hot peptides | A peptide scam? | Peptide risks | Compounding & the FDA | FDA & peptides | References

For those reasons, I believe the FDA needs to oversee this space far more carefully. However, there’s reason to think that soon the agency will do the opposite.

I believe it may open the door to even more risky peptide use under Kennedy’s HHS leadership. Today’s MAHA summit agenda suggests peptides are likely to come up during that meeting.

RFK Jr. & peptides

What’s Kennedy’s interest here?

He’s very into alternative approaches to health. For instance, we’ve seen that he disclosed getting unproven stem cells.

Has he also used unproven peptides? I haven’t seen him say that so far, but he seems linked to at least one peptide enthusiast. More broadly, there are signs that the marketing and use of unproven peptides has exploded in the U.S.

A few years ago, in a wise move, the FDA restricted compounding (the usual route of peptide production for unapproved use) of various substances and peptides.

Remarkably, some with ties to firms that have marketed peptides are speaking at today’s MAHA summit. Also, if you just search the web for RFK peptides, you can start seeing the scope of the wild world of peptides. It’s another red flag that versions of the word “miracle” come up here too.

The public and the stem cell research arena need to be aware of this trend.

What are these “peptides” really?

Let’s start by talking about peptides more generally.

Earlier in my career, synthetic peptides were an important part of some of my research. Further, as a molecular and cell biologist, I’m very familiar with peptide synthesis.

A peptide is just a short polypeptide chain. In other words, a small string of amino acids or a tiny protein. How big does a peptide have to be to qualify as a protein?

The cutoff between a peptide and a protein isn’t well-defined in research. I tend to think of something under 50 or 100 residues as a peptide, but that’s arbitrary.

The FDA defines things more strictly based on the law. The agency sees a peptide as a molecule of 40 amino acids or less, while anything bigger is a protein. The difference is important in this context. Proteins fall into the biologics class, while peptides are generally drugs. They can be regulated somewhat differently, but both are typically drugs.

The bottom line on the oversight side is that nearly all peptides and proteins are drugs requiring FDA approval before use or marketing. That approval is just not happening in most cases for the peptides touted by health influencers. I’ve included a list below of the “hottest” peptides. Hottest does not mean best here and these peptides definitely have risks. I wouldn’t use them unless a good clinical trial proved they were safe and effective for a specific condition.

List of popular peptides pitched by alternative health influencers

• BPC-157
• GHK-Cu
• TB-500 or Thymosin Beta-4
• CJC-1295
• Ipamorelin
• Sermorelin

Those selling regenerative and other unproven peptides today have no FDA drug approvals and nearly zero even semi-solid science behind what they are doing and claiming with these peptides. For more detail on BPC-157 specifically, check out my background post on BPC-157 & RFK Jr.

Are influencer-touted peptides largely a scam?

What are the claims?

Many of the claims related to peptides relate to supposed regenerative powers. It’s very reminiscent of the claims about unproven stem cells.

Beyond anti-aging assertions, a more specific common assertion is that peptides will help you build muscle and/or lose fat. There are claims about blood sugar too, and many other outcomes.

I’ve been blogging here on The Niche for 15 years. During this time I’ve generally avoided using the word “scam”. However, I believe that much of what is going on now with supposed regenerative and similar peptides touted by influencers might be in that realm.

It’s definitely a big money grab.

Peptide risks

To be clear, in general peptides often can have powerful activities in the body. This is in part why they should be regulated as drugs. An example of an approved peptide drug is insulin. GLP-1s are also peptide drugs.

Insulin is also a good example of how an amazing, useful peptide drug can still easily be deadly if misused.

Some of the unproven peptides out there like BPC-157 and GHK-Cu likely do things to the human body too after injection, but at best it’s likely a mix of potentially helpful and dangerous things. They have not been sufficiently studied for specific claims or safety.

This recent ProPublica piece A Las Vegas Festival Promised Ways to Cheat Death. Two Attendees Left Fighting for Their Lives is a good read. It illustrates the risks of popular peptides. At this time it appears the specific peptides that made these people so sick are not yet identified.

More broadly, attendees at various health meetings and festivals may be getting unproven drugs like peptides (and see this on getting exosomes at a meeting booth) more often. The risks go up in a non-medical setting.

Compounding and FDA regulation of peptides

Getting back to peptides, certain compounding pharmacies play some role in this whole mess. They have provided peptide products for clinical use that are likely non-compliant, unapproved drugs. What makes this more complicated though is that compounding (whether of peptides or other substances) is regulated in arcane ways. There has been more of a loose system there.

As a biologist I tend to think of small peptides as biologics and that brings to mind the CBER branch of the FDA, but again it seems they generally aren’t regulated that way. For instance, it appears it is often CDER and not CBER that oversees peptides at the FDA.

Since peptides can also be compounded in some instances, other arcane things like 503A/B compounding lists and related compounding Category 1,2, and 3 lists, etc. can apply. I’m not an expert on those so I’m not going to dive into those here. One other thing that struck me though is that the FDA hasn’t seemed to have updated the 503A/B compounding lists in quite a long time.

Possible changes at the FDA on peptides

Several peptides that are favorites of influencers like BPC-157 are in something called Category 2 (simply put, not deemed safe and not allowed for compounding), which means they cannot be used in compounding.

Since RFK Jr. seems to like peptides based on his tweet, will some popular peptides be “freed” from being blocked from compounding?

It’s possible but not so simple given existing laws and regulations. Still, the FDA could say it’s going to exercise enforcement discretion on those without changing regulations, changes in laws, etc.

In other words, it might announce it’s not going to block compounders from using such substances anymore.

My sense is that something is going to change soon that benefits those selling peptides yet in my view puts the public at risk.

References and notes

• FDA page defining a protein as 41aa or longer.
• Federal register on peptide definition.
• Note that there are likely millions of kinds of peptides produced and active in our bodies, but any given peptide sold on the web is synthetic. Synthetic peptides may not act the same as naturally occurring ones. Synthetics, which are often produced and labeled as “not for human use” or “research use only”, can also have toxic or unpredictable contaminants.
• The USADA or anti-doping agency statement on BPC-157
• FDA bulletin, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
• This is not medical advice. Talk to your physician before taking peptides or other biologics like PRP, stem cells, etc.