Our View: peptides, regulators, and the trust recession
This is an editorial page. Everything in a green box is sourced fact; everything in an amber box is Panacea Bio Chem's opinion, argued openly. We separate the two because the Myriad story taught us what happens when commercial interest dresses itself as settled fact.
1. The legal status of peptides, as it actually is
- The US drug pathway is IND application → clinical trials → NDA/BLA approval. A handful of peptide medicines (insulin, GLP-1 agonists such as semaglutide) have completed it; the broad universe of "research peptides" has not. FDA drug development & approval.
- DSHEA (1994) defines dietary supplements around dietary ingredients. Synthetic therapeutic peptides generally fall outside that definition, and the drug-exclusion clause bars marketing a substance first investigated as a drug as a supplement. FDA dietary supplements.
- The "research use only / not for human consumption" label is not a legal shelter. FDA has warned companies selling unapproved semaglutide, tirzepatide and retatrutide products carrying exactly those labels. FDA on unapproved GLP-1 drugs.
- On September 29, 2023, FDA placed numerous peptides — BPC-157, ipamorelin, CJC-1295, AOD-9604, thymosin alpha-1, thymosin beta-4 and others — in Category 2 of its bulk-substances list, effectively removing them from lawful pharmacy compounding; in October 2024 several were moved back off Category 2 pending advisory-committee review. FDA Category 2 list.
- In the EU, peptides marketed for human use without authorization are unlicensed medicines under Directive 2001/83/EC, and advertising them is prohibited. EUR-Lex, Directive 2001/83/EC.
The result of this structure is a paradox we live inside: the molecules themselves are unpatentable products of nature — Myriad settled that principle — yet the regulatory pathway to study them in humans is so expensive that almost no one walks it for an unpatentable natural peptide. No patent, no exclusivity; no exclusivity, no trial budget; no trial, no approval. The molecule stays in a grey zone not because the evidence condemned it, but because the economics never let the evidence be gathered. We think that is a market failure, and it is the same failure Myriad made visible from the other direction: ownership games deciding what science gets done.
2. The research-chemical market
A consumer market exists in which peptides are sold as "research chemicals," often with purity claims, outside the medicines framework. FDA's position, quoted from its own page on unapproved GLP-1 products: the agency "has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled 'for research purposes' or 'not for human consumption.'"
We do not sell into that market and we do not bless it. But we refuse the lazy description of everyone in it as a fraudster. A grey market of this size is a demand signal: people are voting with their wallets for access to molecules the official pipeline declined to develop. The honest response is not only enforcement — it is a cheaper, faster route to real human data on unpatentable natural compounds. Open science is that route. It is also, frankly, why we run a research company instead of a patent troll.
3. The trust recession
KFF's Tracking Poll on Health Information and Trust (January 2025) found public trust in the CDC at 61%, down from 66% in June 2023, with trust in the FDA and in state and local public health officials each down by double digits over the same period; KFF's later polling describes CDC trust as remaining at a low point. KFF, January 2025.
Post-COVID distrust of regulators is real, and some of it was earned — shifting guidance, sluggish transparency, and a visible comfort with industry did that. But distrust is not a destination; it is a question. Our answer is the one Harry Ostrer's story models: do not burn the institutions down, and do not worship them either. Sue when the law is wrong. Publish when the data exists. Credit the Court when it gets one right. The Myriad judgment proves the system can correct itself when scientists refuse to leave the room. That, in our view, is the only version of trust worth rebuilding.
Frequently asked questions
Are peptides approved medicines in the US?
A small number of specific peptide drugs are FDA-approved (insulin, GLP-1 agonists). The much larger universe of "research peptides" is not FDA-approved for human use and has not completed the IND-to-NDA pathway.
Can peptides be sold as dietary supplements under DSHEA?
Generally no — synthetic therapeutic peptides typically fail the dietary-ingredient definition, and the drug-exclusion clause bars substances first investigated as drugs.
What did the FDA do to compounded peptides in 2023?
On September 29, 2023 it placed numerous peptides (BPC-157, ipamorelin, CJC-1295, AOD-9604, thymosin beta-4 and others) in Category 2, effectively ending lawful compounding; in October 2024 several were moved back off the list pending advisory review.
Has public trust in US health regulators fallen?
Yes. KFF (January 2025): CDC trust 61%, down from 66% in June 2023; trust in the FDA and in state/local public health officials each down by double digits over the same period.