On Friday, an FDA advisory committee voted in favor of two peptides but against a sleep peptide
A Food and Drug Administration advisory committee met Thursday and Friday to decide whether seven peptides should be allowed to be compounded in the U.S.
A group of experts, some of whom work in the peptide industry, said the Food and Drug Administration should allow six peptides to be compounded, in a move that could widen access to the popular wellness products for Americans.
The FDA's advisory committee spent the last two days discussing whether seven peptides - which have become popular in longevity circles - should be legally allowed to be compounded. On Thursday, the advisers largely voted in favor of allowing pharmacies to compound four peptides: BPC-157, KPV, TB-500 and MOTS-C. On Friday, they voted to reclassify a longevity peptide called epitalon and another known as semax.
However, the members voted against emideltide, which is often used to address opioid withdrawal and improve sleep, citing safety and efficacy unknowns. The peptide is also referred to as the delta sleep-inducing peptide.
"I voted 'no' primarily for low-quality evidence around efficacy, the poor characterization of the bulk drug substance, and the fact that there are approved medical therapies for social uses," said Todd Durham, an FDA adviser and executive at the Foundation Fighting Blindness, regarding emideltide.
Epitalon and semax were both discovered and synthesized in Russia. Of the seven peptides reviewed by the FDA advisory committee, semax is the only one that's approved in any country. In Russia, it's used to treat ischemic stroke and optic-nerve conditions.
Peptides are popular in wellness communities, where they are promoted for health conditions. They are recommended by longevity clinics, fitness influencers and telehealth companies. Even Robert F. Kennedy Jr., the Health and Human Services secretary, has said he's used peptides.
A "yes" from the advisory committee that allows a peptide to be compounded is different from an FDA approval. It simply means that compounding pharmacies can legally produce these products if the FDA leadership agrees. Legalizing compounding could make it easier for patients to access these drugs - though doing so has critics, who say the drugs are dangerous or ineffective.
A peptide craze fueled by biohacking
The peptide craze kicked off at the same time that biohacking went mainstream and Americans started turning to compounded versions of GLP-1 medications for weight loss when those drugs were in short supply, or because they are cheaper than the FDA-approved versions. Americans use peptides for a range of reasons, including better sleep, to help with inflammatory conditions like ulcerative colitis or to lose weight.
But in 2023, the FDA decided to restrict production of 14 compounded peptides, which sent some people to gray-market sources to obtain their products. Advocates of reclassifying these peptides argue that people are already using these products, sometimes ordering them from labs in China. They say allowing them to be produced in the U.S. is safer for patients.
"The 2023 restrictions did not raise the standards. They abandoned them," Ricardo Rosselló, the former governor of Puerto Rico, a drug-manufacturing hub, told the committee. "They sent patients to markets where those standards don't exist."
However, the FDA's own scientists have recommended against reclassifying the seven peptides, saying there isn't enough data about their safety risks, clinical benefits or how they are manufactured.
Critics are worried that Americans will mistake compounded peptides for FDA-approved drugs. The FDA approval process is a rigorous review of a drug's safety that requires data from clinical trials. Allowing compounding pharmacies to legally produce peptides isn't a stamp of approval from the FDA about their safety or efficacy.
"Consumers will interpret reclassification as FDA approval," Adriane Fugh-Berman, a critic of the drug industry and director of a watchdog organization that studies pharmaceutical marketing, said Thursday at the meeting. "Most of these peptides will harm patients."
It's a sentiment echoed by Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines.
"The committee's recommendation will inevitably be interpreted by many as an endorsement of broader clinical use. It is not," he said in a statement. "Patients won't read the fine print. They will hear one thing: the FDA said 'yes.'"
The final step in the process requires FDA leadership to issue its determination. The leadership doesn't have to follow the recommendation of the committee but traditionally does so.
On Friday, the advisers discussed three peptides:
The FDA committee voted "no" on emideltide. The peptide has been promoted as a tool to address insomnia, narcolepsy and opioid withdrawal. Unlike the other peptides, there are some studies assessing its clinical effectiveness. However, they were all conducted in the 1980s and '90s, and the FDA described the results as "inconclusive and at best preliminary."
The vote was 6 in favor and 7 against, with one abstention.
Advisers voted "yes" on epitalon. This peptide, which is made up of four amino acids, has a long history. Epitalon is a synthetic version of epithalamin, a drug approved in the Soviet Union in 1990 to treat the symptoms of menopause, certain types of infertility and hormone-dependent tumors. About 15 years ago, a small Australian biotech company started testing it in the U.S. as a treatment for retinitis pigmentosa, a group of rare genetic eye diseases, although that research did not pan out.
Epitalon is now used for insomnia but is best known for its purported longevity benefits.
"We agree with FDA that efficacy data regarding epitalon for longevity are largely mechanistic and preclinical, and that they are drawn from a narrow group of investigators without independent, controlled replication," said David Baker, a physician and executive with Elysium Health, which sells longevity products. "We do not ask the committee to credit the longevity marketing that surrounds this peptide. Our narrow and honest claim is this: Demand for epitalon exists."
The experts voted 7-4 in favor of the peptide. There was one abstention.
Semax also gets the OK: In Russia, this peptide is approved to treat serious issues like stroke or optic-nerve conditions. Online, however, it's promoted as a solution for dozens of neurological conditions. It is dispensed via nasal drops, raising questions for the FDA, which said it doesn't have any information about the containers that would be used by compounding pharmacies to dispense the medication.
The committee voted 8-5 in favor, with one member abstaining.
-Jaimy Lee
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(END) Dow Jones Newswires
July 24, 2026 16:26 ET (20:26 GMT)
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