Effort to loosen rules on unproven peptide drugs, favoured by US Health Secretary Robert F Kennedy Jr, are facing resistance from the majority of Food & Drug Administration (FDA) scientists, reports The Guardian.
Against the advice of the FDA, last week Kennedy said that several unapproved peptide injections promoted by online influencers will become widely available.
Scientific staffers, who had limited input in drafting the document posted by the Department of Health and Human Services (HHS) and which covers several injectable peptides promoted within the wellness industry for building muscle, healing injuries and boosting energy, said the policy could undermine the agency’s longstanding mission of keeping unproven health products off the US market.
The policy directs the FDA not to take action against specialty pharmacies that sell at least six wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not undergone the agency’s rigorous review process for safety and effectiveness.
Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss. But the chemicals subject to the new policy have not been approved as safe and effective by the FDA.
The new document represents a step back from HHS’ original plans, according to two of the people who discussed its development.
HHS officials initially wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies.
But FDA officials warned that the agency’s scientific staffers had major safety concerns and would not support a regulation deeming them safe.
HHS officials then took a different approach that directs the FDA not to enforce its rules against pharmacies that compound the substances.
FDA staffers ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-registered factories.
Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting US consumers from unsafe or poor-quality compounded drugs
The decision has sparked serious concern among pharmaceutical safety experts, who say the plan bypasses standard FDA safeguards for approving drugs, reports The New York Times.
Kennedy had announced “enforcement discretion,” meaning he will tacitly allow the companies to produce the unproven injections without going through the usual review process.
Emily Hilliard, a spokeswoman for HHS, said the new policy requires “patient-specific prescriptions, traceable ingredients, quality testing and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers”.
“It is aimed at confronting the risks of black-market peptides,” she said, adding that it does not “grant FDA approval or establish clinical safety and effectiveness”.
The six peptides which Kennedy said last Wednesday he would now allow to be used include epitalon, marketed for longevity, and BPC-157, marketed as the “wolverine” peptide and purported to help with muscle repair.
The new policy comes with some criteria that are meant to add public protections, such as requiring that peptides be made at an FDA-registered facility, although the step basically only requires a manufacturer to notify the agency of its address. The policy also calls for adverse event reporting to the FDA and product labels that list the active ingredient, strength and a unique identifier for the manufacturing facility.
The compounding pharmacies that will blend the drugs are not household names, but many work with telehealth companies that have said they are interested in dispensing the peptides.
Dr Janet Woodcock, who retired in 2024 from the FDA after 40 years in drug oversight, said that the move harks back to the days of folk medicine endorsed by word of mouth, which caused harm and led to the founding and strengthening of the FDA.
“It undermines the idea that you would test drugs for safety and effectiveness before they were widely made available,” she said.
As unapproved injections, the peptides would not have fundamental agency safeguards in place, such as the type of safety review that flagged thalidomide, a drug that caused devastating birth defects in Europe but was not approved as a morning sickness remedy by a careful FDA reviewer.
The new policy states that Kennedy has “determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients”.
To bypass approval, earlier this year the FDA started a process to add the peptides to a list of products that could be compounded by bespoke pharmacies to meet the needs of individual patients. In July, a compounding committee met to consider adding seven peptides to the list.
During the hearing, FDA officials and patient safety advocates aired concerns about the lack of basic information about the peptides, such as their effect on the immune system or potential to fuel tumour growth. Agency scientists formally advised the committee not to add the peptides to the list.
Other people at the hearings testified about their positive experience using peptides and about the risks inherent in dispensing any drug, approved or otherwise. The committee, which Kennedy’s department had filled with a majority of people who prescribed peptides or worked in drug compounding, voted in favour of adding the six compounds to the list.
Although some panellists at the July meeting aired their concerns about bad actors prescribing unsafe peptides, it is not clear whether the policy change will curtail their operations.
“I think what it translates to for the average consumer and someone looking for these peptides is there’s been a tacit recommendation from the FDA and that it’s OK,” said John Hertig, chairman of the Collaborative for Evidence-Based Medicines. “Really, though, there hasn’t been the diligence and the review and the scientific rigour that we deserve as the American public, in terms of what we ingest or inject.”
The peptides that the FDA panel reviewed this summer are promoted as supporting a wide range of conditions. One of the most popular, BPC-157, is also marketed as helping with joint healing. Another, semax, is purported to treat mental health and neurological conditions like migraine, anxiety and Parkinson’s disease.
There is little research, especially in humans, on these peptides to back up these claims.
Some of the peptides also target fundamental biological processes, which could potentially lead to dangerous side effects. Epitalon is promoted as a longevity peptide for its reported ability to lengthen telomeres – the caps on the end of chromosomes that shorten with age and have been studied in relation to longevity.
But long telomeres have also been linked to cancer, raising concerns that epitalon could potentially be carcinogenic.
Other peptides allowed include KPV, a cream or gel marketed for wound healing and inflammatory skin conditions. Another called MOTS-c is created from mitochondria DNA and is suggested to play a role in cellular metabolism, although no data in humans support the claim. TB-500, another peptide, was developed as a veterinary drug to improve greyhound and horse performance in races.
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