The Trump administration is crafting plans that would allow the temporary sale of certain previously restricted peptides as federal health officials hammer out new regulations around the controversial products, according to two people familiar with the matter who spoke on the condition of anonymity to share private details.
Such a move would allow some compounding pharmacies to dispense certain peptides marketed as new medical treatments and wellness products even as the claims for what they treat have not been fully safety tested. The plan has not yet been announced and timing was unclear, meaning it could still change.
Health Secretary Robert F. Kennedy Jr. has made no secret about his affinity for peptides, which have been booming in popularity. He’s a self-professed “big fan” of the products and has said he wants to make them more broadly available.
But Food and Drug Administration scientists and some medical experts have raised alarms about increasing access to certain peptides. That’s because many of the products’ claims haven’t gone through the rigorous clinicals trials that FDA-approved drugs undergo to assess safety and efficacy.
Federal officials are seeking guardrails around the peptide policy, two people said.
The Department of Health and Human Services did not comment.
Peptides are short chains of amino acids and in some cases have turned into approved drugs to treat diabetes. GLP-1 medications are peptides.
But untested and unapproved wellness peptides that influencers and others have claimed boost longevity or improve physical health have been proliferating in gray and black markets.
The FDA has struggled to keep up with the proliferation of the products, as pharmacy, medical and nursing boards lack the authority and resources to oversee the growing industry, a Washington Post investigation found. This includes schemes such as peptides being made within people’s homes and labels claiming to come from manufacturing facilities that turn out to be empty office space, leaving consumers vulnerable to potentially tainted products.
Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding, said his trade group has been seeking for the FDA to use what’s known as interim enforcement discretion — where the agency essentially acknowledges it will focus its enforcement resources on other matters — to pave the way to let state-licensed compounding pharmacies prepare the drugs for patients with a prescription. He said he’s met twice with the FDA to lay out the approach his group would like to see federal regulators take, with certain conditions, including enhanced disclosures to patients, serious adverse event reporting and data collection on peptide use.
“That’s a much better approach than what we’re seeing in the illicit markets,” Brunner said.
It was not immediately clear which peptides the administration is aiming to make temporarily available, but the FDA has been weighing whether to allow compounding pharmacies to produce seven peptide treatments for conditions such as insomnia, obesity and wound healing.
In late June, FDA career scientists said there isn’t enough evidence on the effectiveness and safety of the peptides to allow their production by compounding pharmacies, which make specialized versions of medications. But an FDA advisory committee — which included multiple people who promote peptides or work for companies that sell peptides — voted to recommend six of the peptides. The panel voted against loosening regulations on one peptide, emideltide, which was proposed to treat opioid withdrawal and insomnia.
Agency officials had expressed potential conflict-of-interest concerns as the Department of Health and Human Services was assembling the panel. The concerns were around selecting those with ties to peptide businesses and clinics, The Post previously reported. FDA staff typically choose their own advisers.
In a statement, an FDA spokesman previously defended the members, saying they underwent the same ethics and vetting process required of all FDA advisory committee members.
It’s not clear when formal rulemaking will be released. The FDA isn’t required to take the panel’s advice. During the sessions, the agency’s scientists urged the panel to vote against the peptides because they haven’t undergone robust clinical trials.
Some medical experts said they would not support efforts to increase access to certain peptides.
“I think it just puts people at more risk,” said Paul Knoepfler, a professor at the University of California at Davis School of Medicine who has been tracking unproven peptide use in parallel to marketing of stem cells by clinics.
Ilisa Bernstein, a former deputy director of the FDA’s drug compliance office, said she has some overall concerns due to the lack of safety and use data presented by the agency at the advisory panel meeting.
“But it seems inevitable that the floodgates will open, and having appropriate guardrails with the enforcement discretion could help identify safety concerns,” she wrote in a message.
As the debate over the wellness products wages on, the American Academy of Peptide Medicine sought polling on the issue this summer. It tapped a firm run by Trump’s pollster, Tony Fabrizio, which has clout within the Republican Party and among Trump officials. A polling memo viewed by The Post says there’s a “political upside” to boosting access to peptides to allow for access at “regulated U.S. pharmacies.”
“We would encourage the HHS to use temporary enforcement discretion to allow access to these as soon as possible to help eliminate the gray and black market that currently exists,” said Lee Rosebush, the chairman of American Academy of Peptide Medicine.
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