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RFK Jr. forces FDA to reconsider 12 unproven peptides after 2023 ban

There doesn’t seem to be new safety or efficacy data, but Kennedy touts them anyway.

Beth Mole | 81
Robert F. Kennedy Jr., US secretary of Health and Human Services (HHS). Credit: Getty | Stefani Reynolds
Robert F. Kennedy Jr., US secretary of Health and Human Services (HHS). Credit: Getty | Stefani Reynolds
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The Food and Drug Administration on Wednesday announced meeting dates for advisors to discuss lifting restrictions on 12 unproven peptides that the agency deemed to pose significant safety risks in 2023. The meetings are scheduled for two days in July, with another in February 2027.

The scheduled meetings do not appear to be accompanied by any significant new safety or efficacy data for FDA advisors to discuss. Rather, the FDA is being pushed to ease restrictions on these peptides at the behest of anti-vaccine Health Secretary Robert F. Kennedy Jr., who has described himself as a “big fan” of the unproven drugs.

Peptide drugs are simply those made of short chains of amino acids linked by peptide bonds. FDA-approved peptide drugs include insulin for diabetes and GLP-1 drugs for obesity. But online, peptides typically refer to unproven drugs, often given by injection, that are peddled without evidence as treating various conditions, reversing aging, and improving appearance. This category has seen a boom in popularity among wellness influencers, including Kennedy and many of his allies.

Peptide proponents

Kennedy, who has no background in science or medicine, has repeatedly championed peptides and touted his use of the unproven drugs, which are currently available on the black and gray markets. In a February appearance on Joe Rogan’s podcast, Kennedy said he used them to treat injuries to “really good effect.” He has also previously vowed to end the FDA’s “war on peptides.”

In a social media post on Wednesday, Kennedy built on that rhetoric, saying that with the agency’s scheduled meetings, “we took long-overdue action to restore science, accountability, and the rule of law.”

He claimed that in the meetings, “independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence.”

But outside experts are highly skeptical of the meetings. Currently, the FDA advisory panel that will review the drugs—the Pharmacy Compounding Advisory Committee (PCAC)—only has three voting members and one industry representative. There are six vacancies, including the chairperson.

Outside experts and watchdogs suspect that before the first meeting in July, Kennedy will work to stack the advisory board with questionably qualified allies who will come with a predetermined decision to ease access to the drugs—no rigorous scientific evaluation needed. A similar scenario has played out at the Centers for Disease Control and Prevention, where Kennedy stacked a key vaccine advisory committee with allies who then rammed through recommendations in line with Kennedy’s anti-vaccine agenda. Those advisors made recommendations that were not supported by scientific evidence and, in some cases, directly conflicted with the data.

Risky peptides

Specifically, the PCAC will consider moving the 12 peptides back onto a list of drugs that compounding pharmacies can make for human use. Compounding pharmacies are those intended to make custom or specialized formulations of medications for patients. In 2023, the FDA removed 19 peptides from that list, finding they posed significant safety risks. The agency explained its concerns for each of the drugs individually.

“There is no credible reason to believe that peptides that were deemed unproven or unsafe in 2023 are miraculously safe and effective in 2026,” Robert Steinbrook, Health Research Group director at consumer watchdog Public Citizen, said in a statement. “These peptides should go through the standard FDA approval process for new drugs, not a more lenient alternate pathway that defeats the reason the agency exists in the first place. If there were convincing safety and effectiveness data, the findings would already be widely known.”

On July 23 and 24, FDA advisors will review seven of the 12 peptides, including BPC-157,KPV, TB-500 (a fragment of thymosin beta-4), MOTs-C, Emideltide (DSIP), Semax (heptapeptide), and Epitalon. In February 2027, the group will review the remaining five: Cathelicidin (LL-37), GHK-Cu, Dihexa-acetate, Melanotan II, and Mechano Growth Factor, Pegylated (PEG-MGF).

These peptides have no proven uses. The FDA lists uses for the first seven, but they don’t necessarily match how people are using them or marketing them online. For instance, BPC-157, which was first isolated from gastric juices, is a popular peptide used to promote tissue repair, particularly for athletic injuries. The FDA lists its use as treating ulcerative colitis.

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Beth Mole Senior Health Reporter
Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.
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