Health and Human Services Secretary Robert F. Kennedy Jr. said on Wednesday that he would allow widespread patient access to unapproved peptide injections made popular by internet influencers, sparking serious concern among drug safety experts.
The plan would bypass the most standard Food and Drug Administration safeguards for approving drugs, such as tests to see if the compounds work better than a placebo and whether they might cause cancer or birth defects. To do so, Mr. Kennedy announced “enforcement discretion,” meaning he will tacitly allow companies to produce the unproven injections without going through the usual review process.
Mr. Kennedy, who has said publicly that he has benefited from using peptides, propelled the matter forward, declaring on podcasts early this year that the F.D.A. would lift restrictions to widespread use.
But in a highly unusual turn of events, the document released Wednesday suggested that his action was unilateral and couched the decision as Mr. Kennedy’s alone. F.D.A. scientists previously advised against widespread use of the peptides, and none were present in at least one meeting Tuesday finalizing the policy.
“The secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety,” the document posted on the H.H.S. website said.
Emily Hilliard, a spokeswoman for the Department of Health and Human Services, 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.”
She said the policy was aimed at “confronting the risks of black-market peptides,” adding: “The policy does not grant F.D.A. approval or establish clinical safety and effectiveness.”
Peptides are short chains of amino acids that give the body basic instructions. F.D.A.-approved peptide compounds include insulin to manage diabetes and GLP-1 drugs, a diabetes treatment that is widely used for weight loss.
But there are many other peptide compounds without scientific evidence of efficacy or safety. The six peptides that Mr. Kennedy said on 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. Unlike the GLP-1 drugs, no major pharmaceutical company has performed the costly and regulated studies on those drugs that are required for approval.
Allowing widespread use of the unapproved peptides is consistent with the “medical freedom” movement espoused by Mr. Kennedy’s supporters, which tends to eschew widely studied vaccines and embrace the right to use treatments with little evidence of effectiveness.
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 F.D.A. 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 of them work with telehealth companies that have said they are interested in dispensing the peptides, such as Hims & Hers and Noom.
Dr. Janet Woodcock, who retired in 2024 from the F.D.A. 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 F.D.A.
“It does undermine 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 F.D.A. reviewer.
The new policy states that Mr. 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 U.S. patients.”
To bypass approval, earlier this year the F.D.A. 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, F.D.A. 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 tumor 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 Mr. Kennedy’s department had filled with a majority of people who prescribed peptides or worked in drug compounding, voted in favor of adding the six compounds to the list.
The agency did not take that step, though. Dr. Woodcock said the decision to put so-called enforcement discretion in place “is just a policy of looking the other way.”
Although some panelists 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 F.D.A. and that it’s OK,” said John Hertig, chairman of the Collaborative for Evidence-Based Medicines. “When really there hasn’t been the diligence and the review and the scientific rigor that we deserve as the American public, in terms of what we ingest or inject.”
The peptides that the F.D.A. 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. Critics have raised concerns that people will turn to these unproven therapies instead of medications that are F.D.A.-approved and have a track record of safety and efficacy.
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 on Wednesday 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 supports the claim. TB-500, another peptide, was developed as a veterinary drug to improve greyhound and horse performance in races.
Dana G. Smith contributed to this report.
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