RFK Jr. wants to make it easier to get peptides. FDA scientists disagree.

Health Secretary Robert F. Kennedy Jr. has advocated for deregulating a number of peptides, but scientists at the Food and Drug Administration say there’s insufficient evidence to recommend their use.

The FDA scientists are set to present their conclusions next month at an FDA advisory committee meeting that will assess whether to allow compounding pharmacies to produce seven different peptides.

Peptides are molecules made up of chains of amino acids, the building blocks of proteins. Thousands are found naturally in the body but they can also be made synthetically in a lab. They’ve seen a recent surge in popularity as wellness influencers and popular podcasters have touted them for weight loss and as remedies for injuries, joint pain and myriad other issues. Kennedy has said he’s used peptides on injuries with “really good effect.”

But they exist largely in a “gray market:” They’re not FDA-approved drugs, but can be found online from unregulated suppliers. In April, Kennedy reclassified 12 peptides as Category 1 substances, the first step toward adding them to a list of substances that compounding pharmacies can make. (Compounding pharmacies make customized versions of medications that aren’t available at standard pharmacies.) Kennedy said at a House hearing that month that the Biden administration had incorrectly flagged the peptides as posing safety risks.

Most peptides have not been studied outside of animals, meaning there’s little data to demonstrate their safety or effectiveness in humans. However, many are sold online under the label “For research use only,” giving vendors a legal workaround to sell peptides they claim aren’t meant for humans. Some experts — and Kennedy — argue that offering peptides through licensed compounding pharmacies would shrink this underground market and direct people toward safer products.

The FDA’s Pharmacy Compounding Advisory Committee will meet on July 23 and 24 to review the evidence behind seven peptides: BPC-157, emideltide, epitalon, KPV, MOTS-c, semax and TB-500. Like other FDA advisory committees, the panel is supposed to consist of independent experts who make recommendations to the agency. The FDA has the final say on whether to allow the peptides, but the agency usually follows the advice of its advisory committees.

Dr. Anita Gupta, an anesthesiologist who served on the committee from 2020 to 2025, said the panel previously voted against making certain peptides available through compounding pharmacies.

“At the time, the FDA presented a lot of adverse event data that showed there was a risk of immunogenicity — immune reactions — and that raised some red flags for the committee,” said Gupta, an adjunct assistant professor of anesthesiology at the Johns Hopkins University School of Medicine.

She added that there were concerns about contamination of the products sold through compounding pharmacies.

“Studies have begun to show that there are significant issues with some of these products. Some of them have heavy metals. Some have microbial contamination. Some are mislabeled,” Gupta said.

The FDA on Monday published the names of nine new members appointed to four-year terms on the advisory committee. Some own or work at wellness centers that promote or sell peptides, suggesting they could benefit from the products becoming available through compounding pharmacies. Previous panelists included university experts in dermatology, anesthesiology, pediatrics and pharmacy compounding.

The FDA and the Department of Health and Human Services did not respond to requests for comment.

The seven peptides that will be scrutinized during the meeting were originally nominated by LDT Health Solutions, Inc, a consulting firm representing the International Peptide Society, and the Wells Pharmacy Network, which operates compounding pharmacies nationwide. Both groups subsequently withdrew their nominations, but the FDA elected to evaluate the substances anyway.

LDT Health Solutions and the Wells Pharmacy Network did not respond to requests for comment.

In briefing documents released ahead of the meeting, FDA scientists concluded that none of the seven peptides had sufficient evidence to support adding them to a list of substances that pharmacies can compound and they couldn’t rule out safety issues. Some of the peptides, they wrote, had not been studied in humans at all. The scientists also said it was unclear what version of the substances they were being asked to evaluate (peptides can come in a pure form or a salt form, which can have different properties).

“It’s a really big deal if the advisory committee ends up striking out on its own,” going against the conclusions of FDA scientists, said C. Michael White, head of the department of pharmacy practice at the University of Connecticut.

In the briefing documents, FDA scientists underscored the lack of human data for many of the peptides being considered by the advisory committee. For TB-500 and KPV — peptides the nominating groups said could help with wound healing — the scientists said they could not find any studies in which the substances were administered to humans. Another peptide that was nominated as a way to treat obesity and osteoporosis, MOTS-c, had not been evaluated in any published human studies either, the scientists found.

In several cases, the scientists noted that effective FDA therapies already exist for many of the conditions in question, like insomnia, psoriasis or eczema.

For the popular peptide BPC-157, which both Kennedy and podcaster Joe Rogan say can heal tendon injuries, the FDA scientists did not find enough data to evaluate its use for tendonitis, nor could they analyze its use for Crohn’s or Celiac disease. The scientists found a small trial that looked at BPC-157 as a treatment for ulcerative colitis — a serious gut condition — but the results were reported in a meeting abstract, which meant they were short on details. The scientists ultimately concluded that there was a lack of evidence to support BPC-157 as an ulcerative colitis treatment.

In the case of semax, a peptide that the nominators said could treat migraines, nerve pain in the face and a serious condition called cerebral ischemia, where there is not enough blood flow to the brain, the FDA scientists found “insufficient evidence” to recommend it. They also did not find enough evidence to recommend the peptide epitalon for insomnia, or the peptide emideltide for chronic insomnia, narcolepsy and opioid withdrawal.

White said he worries about a double standard with federal health officials’ approach to vaccines versus peptides.

“It looks like, at the end of the day, the same health leadership in the administration that would expect to see extremely large, multiyear randomized controlled trials to look at a vaccine would be perfectly happy to have a product that was only studied in rats and small animals being used in people if it’s promising six-pack abs and less muscle injury,” he said.

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