FDA committee backs most peptides for compounding pharmacies despite staff opposition

In a highly unusual move, a U.S. Food and Drug Administration committee voted against FDA staff’s own advice on July 23 and 24, recommending that six peptides be added to a list that would allow certain specialty pharmacies to dispense them. The committee voted against adding emideltide, one of the peptides under consideration.

Peptides are short chains of amino acids, and peptide concoctions have grown in popularity in recent years as injectable substances that proponents say can improve energy, sleep, sex drive, and more. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has supported reclassifying peptides to improve access to them, but experts say there is little scientific evidence to support the peptides being considered.

The FDA convened the meeting to debate whether seven popular peptides should be included on the 503A bulks list, which would allow compounding pharmacies to dispense them. Many voting members on the committee consult with or work for companies that could promote or dispense peptides, unlike the academics and researchers who usually serve on FDA panels.

The committee’s recommendation is not binding, and any addition to the list would still have to go through a lengthy public rulemaking process.

Experts said it is unprecedented for drugs to be put on a pathway to widespread adoption in this way instead of through the more arduous FDA drug approval process. Most drugs are not dispensed through compounding pharmacies and are instead approved by the FDA and manufactured under strict supervision.

In 2023, the seven peptides discussed — BPC-157, KPV, TB-500, MOTS-C, emideltide, Epitalon, and Semax — were among more than a dozen that the FDA effectively banned compounding pharmacies from dispensing, saying they "may present significant safety risks." Compounding pharmacies are specialty pharmacies that make drugs with a doctor’s prescription and are largely overseen by state boards of pharmacy rather than the FDA.

Since that ban, consumers have turned to alternative sources, including suppliers in China, which advocates for peptides say puts them in danger. On July 23, Dr. Anant Vinjamoori, chief medical officer at Hims & Hers, said a colleague had recently sent him a photo of a bodega in Queens selling peptides. "This is the real alternative to FDA's permission of legitimate pharmacies to compound peptides in controlled conditions," he said. Hims & Hers and Noom both advocated before the vote for peptides to be allowed to be made at compounding pharmacies.

BPC-157, a synthetic 15-amino acid peptide sometimes used to treat ulcerative colitis, and KPV, which is used for inflammatory conditions, were the first peptides considered on July 23 for addition to the 503A bulks list. Both were approved.

On BPC-157, eight members voted yes, six voted no, and one abstained. The yes votes came largely from committee members who represent or advise telehealth companies that could benefit financially from wider peptide adoption. Several members who voted yes said they wanted compounding pharmacies to dispense peptides because the alternative, patients buying the drugs in the gray market, was worse.

"As a physician, I have to make sure that I'm keeping patients as safe as possible. That's my mandate, right? Do no harm," said Dr. Haleem Mohammed, chief medical officer of Gameday Men’s Health, during the hearing. "So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? And that's why I lose sleep at night."

Mohammed later voted yes on BPC-157 and KPV, saying afterward that he supported BPC-157 in part for "medical freedom." The same term was used by the American Academy of Peptide Medicine, an industry group lobbying for inclusion of peptides on the list; its founder later said the committee "voted to restore medical freedom and medical liberty for all of us."

The committee voted to recommend that all but one of the peptides be included on the list. It voted 6 to 7 against including emideltide, which is used for insomnia and opioid withdrawal, partly because studies on its efficacy are limited and alternative therapies exist.

In preparatory documents, FDA staff said the evaluation criteria "weigh against" placing BPC-157 on the list because evidence of effectiveness is limited and other FDA-approved treatments exist for ulcerative colitis. The only trial staff found involved 46 people and used BPC-157 as an enema rather than an injection.

FDA staff also said the criteria "weigh against" placing KPV on the list. None of the studies staff found in its evaluation were in humans.

The FDA usually relies on clinical trials when considering additions to the 503A bulks list, which determines what ingredients compounding pharmacies can use. There are not yet significant clinical trials for these peptides, but doctors, patients, wellness influencers, and Kennedy have voiced support for opening up the market.

"The substance's supposed benefits are largely based on anecdotal evidence, and the interest in it appears to be driven by those who stand to benefit from increased demand," said Nina Zeldes of Public Citizen's Health Research Group in testimony opposing BPC-157.

The pro-peptide side said popularity is driving the regulatory push. "This is not a question of whether Americans will use peptides. Tens of millions of Americans already are, and millions more are coming, because the interest in taking ownership of your own health is the fastest-growing movement in the entire country. That's what MAHA is," said Gary Brecka, a longevity influencer.

An audible gasp followed the vote tally for BPC-157. Some committee members said they worried about the implications of allowing the FDA to skip over clinical trials when permitting pharmacies to dispense medications.

"As a consumer representative, I worry what placing a bulk substance on the list conveys in terms of FDA approval," said Todd Durham, senior vice president of clinical outcomes and research at the Foundation Fighting Blindness, who voted no.

FDA staff also expressed concern about the committee’s recommended changes on the second day of the meeting. Many members voted to include certain peptides but added that they hoped the FDA would impose guardrails to ensure safety and quality.

"It was shocking to me yesterday—and encouraging, frankly—how many speakers and even members of the committee here noted significant quality problems and asked for a yes vote, but with quality guardrails," said Russell Wesdyk of the FDA’s office of pharmaceutical quality. "But we lack the regulatory authority that put those guardrails in place."

Critics said the vote could create additional safety concerns by allowing consumers to buy non-FDA-approved medications from pharmacies that are not rigorously supervised by the FDA. Shabbir Safdar, executive director of the Partnership for Safe Medicines, said he is concerned about the standards at 503A compounding pharmacies. He pointed to a 2025 paper by Dr. Kenneth McCall finding that compounded GLP-1s were linked to higher rates of adverse effects than non-compounded products between 2018 and 2024, including more abdominal pain, diarrhea, and nausea, along with more prescribing and preparation errors.

Safdar said he knows of several instances in which people had serious health problems after taking compounded medications. He worries that people will assume the peptides have strong clinical evidence if they are added to the list.

"Allowing peptides to be compounded removes incentives to go through FDA's rigorous drug approval process," said Dr. Peter Lurie during the meeting. "Any company that aspires to prove the safety and effectiveness of a peptide will turn away from them, knowing that compounders will simply be able to sell them without ever needing to generate safety and effectiveness evidence."