Peptides: Drugs On Demand Whether Effective, Safe, Or Neither
By
Leonard Zwelling
https://www.nytimes.com/2026/07/25/opinion/peptides-fda-health-supplements.html
https://www.nytimes.com/2026/07/24/us/politics/fda-panel-vote-peptides.html?searchResultPosition=2
Anyone interested in regulatory affairs associated with the drug industry and the current mindset of the FDA, has probably become aware of the growing market in peptides. Peptides are just strings of amino acids. Insulin and Ozempic are both peptides. It is reasonable to conclude then, that peptides can be drugs given the wide use of insulin and GLP-1 compounds as drugs for diabetes and weight loss.
Many people on the internet are demanding access to peptides for therapeutic purposes. If you alter your skin, muscles, or brain with an external substance, you do so with a drug, by definition. Since people are using peptides to make those alterations, peptides need to be considered drugs. A external substance that is administered or taken to alter the structure or function of the body is a drug. Period.
As this op-ed from The New York Times on July 25 relates, the vitamin industry has avoided federal regulation for decades and now the peptide makers–they could be off-shore, they could be compounding pharmacies–want what the vitamin makers have. Essentially, they see the multi-billion- dollar unregulated vitamin industry as one to be emulated regardless of whether or not their products help anyone, let alone whether they could harm anyone.
The second article from The Times on July 26 by Jewett and Smith detail what happened when the FDA reviewed whether or not to allow some peptides to be compounded. Of course, this occurred after Secretary of HHS Kennedy packed the review panel with people whose companies market these products. Can you say “conflict of interest?”
This mindset is all part of the Trump Administration’s ignorance of modern science and medicine and HHS Secretary Kennedy’s bizarre belief system that would give free rein to these peptide makers, but deny many children access to proven vaccines.
As a physician and investigator and former Vice President of Research Administration at MD Anderson who had to deal with the FDA on a regular basis, I understand why many people would like to avoid government regulation of peptides. But if that occurs, who then will guarantee their safety, efficacy, and purity? Answer: no one.
As someone who also took Zepbound for weight loss (yes, it really works!) ordered by my physician through a compounding pharmacy and who later took brand name Zepbound sourced from ro.co, Serena Williams is the spokesperson, I will willingly testify that the Lilly brand Zepbound I got from ro.co was far more potent than the stuff from the compound pharmacy. They both worked, but I had to take far less of the Lilly branded drug than of the compounded version.
I get the notion that Americans should be “free to choose” and have a “right to try” any substance they wish to for any purpose, therapeutic or not. I understand it, but I don’t agree with it. I have seen enough damage done by drugs that have gone through the FDA regulatory process successfully, to think that eliminating the process is a good idea. People will be harmed and people will be taken for a ride by unscrupulous scammers who make outrageous claims for their usually costly peptides without any real evidence of either efficacy or safety.
I know it’s a real pain to deal with the FDA from personal experience as well as the experience of the many MD Anderson faculty members whose Investigational New Drug applications I had to sign during my years overseeing clinical research. I am also not so naïve as to roll out the old saw of Thalidomide and how the FDA saved many women from having deformed children. The FDA also allowed Vioxx to be marketed and that proved to be a dangerous drug.
If a facilitated approval process can be developed for peptides, and for that matter, vitamins, I’m all for it. But someone with the proper expertise, experience, and judgment needs to review real data on any substance Americans will use as they would a traditionally-approved drug. Real data should mean a real clinical trial. For vitamins, and as being proposed for peptides, this is not the case currently.
If the FDA backs away from regulating peptides, damage is inevitable and so is people wasting their money on useless or even harmful products. Excluding peptides from being regulated as drugs is a terrible idea.
