The Trump administration on Wednesday released its plans for the temporary sale of six unapproved and controversial peptides that have been marketed but untested to treat maladies including osteoporosis, insomnia and migraines.
The changes, when in effect, would give compounding pharmacies the ability to dispense certain peptides sold as new medical treatments and wellness products that had been previously restricted by federal regulators.
The plan is a draft policy, and the public can submit comments for two weeks after it’s officially published in the Federal Register later this week.
The six peptides that would be available for temporary sale were backed by the controversial Pharmacy Compounding Advisory Committee but raised concerns among career FDA scientists:
- BPC-157, proposed to treat ulcerative colitis.
- Epitalon, proposed to treat insomnia.
- KPV, proposed to help promote wound healing and treat inflammation.
- MOTS-c, proposed to treat several conditions including obesity and osteoporosis.
- Semax, proposed to treat migraines, cerebral ischemia (a condition where the brain receives inadequate blood flow) and trigeminal neuralgia, a chronic pain disorder.
- TB-500, proposed to promote wound healing.
The policy came from Health Secretary Robert F. Kennedy Jr.’s office rather than the Food and Drug Administration. Kennedy is a self-professed “big fan” of the products, which he has described using for some of his own injuries. He’s pushed to make them more broadly available and pledged to end the FDA’s “aggressive suppression” of peptides, along with other substances.
“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care — and that includes confronting the risks of black-market peptides,” Emily Hilliard, a spokeswoman for the Department of Health and Human Services, said in a statement. She added: “The policy does not grant FDA approval or establish clinical safety and effectiveness. It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”
Ilisa Bernstein, a former deputy director of the FDA’s drug compliance office, said it was “unusual” for the policy to come from Kennedy’s office instead of the FDA.
The department is seeking to make the change by using its enforcement discretion, where the agency essentially acknowledges it will focus its enforcement resources on other matters. The move essentially means HHS would allow state-licensed pharmacies, federal facilities and licensed physicians to compound those peptides, according to a notice in the Federal Register, which added the interim policy will be revisited if there are safety issues.
The notion of boosting access to certain peptides has raised alarm among some medical experts, as well as career scientists at the FDA. Many of the products haven’t gone through the robust clinical trials that FDA-approved drugs undergo to test for safety and effectiveness.
Such products have been proliferating in gray and black markets, and the FDA has struggled to keep up, leaving Americans vulnerable to potentially tainted and dangerous products.
Some peptides, which are short chains of amino acids, have been turned into approved drugs, such as GLP-1 medications used to treat diabetes and obesity. But many social media influencers are hyping unapproved peptides, claiming they can boost longevity and physical health.
Ahead of the midterm elections, Joe Rogan, the popular podcast host, recently criticized the Trump administration for not making headway on various issues, specifically calling out peptides as “supposed to be done two years ago.”
Some groups, such as the Alliance for Pharmacy Compounding, had been seeking for the FDA to pave the way to let state-licensed compounding pharmacies prepare the drugs with patients for a prescription. Scott Brunner, the group’s chief executive, had earlier met with the FDA to lay out the approach they wanted to see the agency take, which included enhanced disclosures to patients, serious adverse event reporting and data collection on peptide use.
The policy was announced Wednesday as federal officials continue to hammer out permanent rules for the products. HHS said it believes the policy will discourage the use of “peptides supplied by foreign manufacturers that pose a safety risk to U.S. patients.” The health department issued various guardrails around compounding the peptides, such as the reporting of adverse events, product labeling and the facility where a substance was obtained.
The American Academy of Peptide Medicine praised the move as a “forward-thinking, evidence-based approach.”
“Crucially, it represents a vital step toward eliminating the unsafe gray and black markets, restoring safe patient access through legitimate, physician-supervised care,” Lee Rosebush, the group’s chair, said in a statement.
Peter Lurie, president of the nonprofit Center for Science in the Public Interest, said he believes the guardrails amount to “window dressing,” adding that the FDA does not have the resources to enforce the measures.
Paul Knoepfler, a professor at the University of California at Davis School of Medicine, said widening access is “inappropriate” given that the peptides are “unproven and unapproved” and have “clear potential risks and little if any proven upside.”
“Kennedy’s action on peptides undermines the FDA’s independence and interferes with its mission,” Knoepfler, who has been tracking unproved peptide use in parallel to marketing of stem cells by clinics, wrote in an email.
FDA career scientists this summer said there isn’t enough evidence on the effectiveness and safety of seven 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.
FDA officials had expressed potential conflict-of-interest concerns as Kennedy’s health department was assembling the panel. The concerns focused on selecting those with ties to peptide businesses and clinics, The Post previously reported.
An FDA spokesman previously said the members went through the same ethics and vetting process required of all FDA advisory committee members.
Daniel Wu contributed to this report.
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