The FDA & compounding pharmacy telehealth connections on pop peptides

One of the questions I get asked most often about pop peptides is why they are so popular. What puts the “pop” in pop peptides?

Peptide mania

After all, these peptides like Ipamorelin, BPC-157, and so on don’t have clinical trial data to support the uses for which they are being marketed.

That makes them potentially unsafe and a waste of money.

Yet RFK Jr. is intent on making the FDA unleash peptides on the public. Just next month the peptide compounding committee (with largely still unknown membership at this time) will meet for the first of several times to likely OK peptide compounding.

I believe the peptides are so popular for two reasons.

First, wellness influencers and telehealth firms have been intensely promoting them. Sometimes the influencers directly or indirectly are involved in marketing and profiting from specific unproven peptides.

Second, the excitement over approved peptide drugs, namely GLP-1’s, has spilled over the in public consciousness to view “peptides” more generally as positive.

One of the only arguably semi-reasonable explanations for this upcoming “un-ban” is that compounding pharmacies can make better, safer versions of these peptides than what is available on the gray market. However, as I’ve written before, that does not address the inherent safety issues related to these peptide drugs.

Compounding pharmacies, telehealth firms, and peptides

Compounding pharmacies and associated firms provided the peptides to the public (indirectly or directly) for years up until the FDA crackdown in September 2023.

The pharmacies seemed to have profited in a big way from such peptides. This in part explains their eagerness to have Kennedy help them make these substances available again.

Where things get murky sometimes is trying to find bright lines between certain compounders and telehealth-type firms.

The model for years was that an excited public could get access to peptides initially through the telehealth firms, which could connect potential customers with a physician. The doctor would then write a prescription after some kind of online video visit. Sometimes it lasted just a few minutes. Based on that, the telehealth firm would contact the compounding pharmacy, which would then supply the peptide. It appears that all of those parties would profit from this pipeline.

in some cases, the telehealth/online wellness  firms and pharmacies were owned by the same people even if technically different entities. I’m also hearing that in some cases the compounders would label the peptide vials with the brand name/logo of the telehealth firm, rather than their own pharmacy label. It just seems like there were and still are many ties between these firms.

So, if the telehealth firms (and health influencers) generally did the marketing for these peptides, did any compounders arguably do peptide marketing too? In my view, while most compounders didn’t directly do marketing, some did.

FDA warnings back in the golden age of peptides: including on compounding marketing?

In what some are calling the “golden age of peptides”, meaning pre-the FDA September 2023 “crackdown”, perhaps hundreds of millions of dollars in revenue flowed into this system. Could it have even been a billion in total?

Still, during this “gray” (gray-gold?) period of enforcement discretion, the FDA did take some actions on peptides like BPC-157. Two FDA warning letters to compounders from this time particularly struck me:

• Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine (2021)
• Tailor Made Compounding LLC (2020)

Both letters name some of the most hyped pop peptides and also mention marketing issues in much the same language from the FDA. For example, from the Tailor Made Compounding warning letter (emphasis mine):

“Unapproved New Drug Products

You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.³ Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.“

Is the FDA saying here that marketing occurred and was a violation? That’s my reading. Most of the specific substances noted in this FDA letter are peptides.

These letters suggest to me that the FDA was concerned about peptide marketing by compounding pharmacies.

Looking ahead, a big FDA U-turn

Of course, now it’s a totally different world under Kennedy. In coming months we are likely to see the feds allow broad pop peptide compounding again. We’ll see a surge in pop peptide marketing too.

The connections between telehealth firms and compounders are more firmly established as well so there may be blurred lines between who is actually doing the marketing moving forward.

More practically, in this scenario, will these US firms be able to compete with the big, cheap gray market for peptides? Perhaps somewhat, especially if the FDA launches a high-profile crackdown on the gray market.