RFK Jr. Proposes FDA Look the Other Way on Peptides
The Food and Drug Administration is moving forward with an interim access policy that would provide enforcement discretion for unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr.'s movement.
Radwan AbdulhadiEditor and technology writer
Interim Access Policy Submitted for Review
Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs. These substances are particularly popular among members of Kennedy's Make America Healthy Again movement, even though FDA staff scientists found that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.
As reported by Ars Technica, the FDA submitted an Interim Access Policy on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. While the posting itself does not provide detailed information on the proposed policy, individuals familiar with the matter told The Associated Press that it would grant the agency enforcement discretion on certain peptide drugs.
This discretionary approach would allow the regulatory agency to choose not to enforce current restrictions on peptides. It would also provide an assurance to specialty compounding pharmacies eager to start making them that they will not be targeted by enforcement actions. The Department of Health and Human Services, which oversees the FDA, did not respond to a request for comment regarding the proposal.
Background on the Re-Review of Compounding List Peptides
The development comes as the FDA is actively re-reviewing a dozen popular, but unproven, injectable peptide drugs. Back in 2023, agency scientists determined that these specific peptides lacked necessary data on safety and efficacy and posed distinct health risks. Consequently, they were stricken from the approved list of formulas that can be manufactured by specialty compounding pharmacies.
Despite these regulatory hurdles, the substances have grown increasingly popular. Sellers frequently claim, without supporting evidence, that the compounds can improve appearance, boost energy, and help heal injuries, among other wellness claims. They hold particular appeal within the MAHA demographic, where numerous prominent figures sell peptide products. Kennedy, a self-proclaimed big fan of peptides, previously vowed to end the agency's restrictions upon taking office.
In response to these developments, the agency announced steps toward reconsidering 12 unproven peptides. This process has faced significant oversight scrutiny and public debate since its inception earlier this year.
Advisory Panel Appointments and Conflict Concerns
In June, Health Secretary Kennedy appointed nine new members to a 13-member FDA advisory panel tasked with reviewing the peptides. Of those newly appointed members, at least six maintain direct ties to peptide-related businesses and clinics, sparking substantial conflict-of-interest concerns across the public health community.
During a subsequent July meeting, the hand-picked committee voted to recommend adding six of the first seven evaluated peptides back to the compounding pharmacy list. These recommendations directly overruled FDA staff scientists, who continued to maintain that the drugs still lack essential safety and efficacy data while carrying potential risks.
Rulemaking Timelines and Advocacy Pushback
It remains unclear if the FDA will ultimately follow through with the advisory panel's recommendations. According to reporting from The Associated Press, formally adding the peptides back to the official compounding list involves a complex federal rulemaking process that could take years and require multiple rounds of public comment.
The newly proposed enforcement discretion policy could potentially ease access in lieu of that lengthy rulemaking procedure or provide immediate access while the formal process unfolds. This possibility has drawn sharp criticism from science-based advocacy organizations.
The Center for Science in the Public Interest (CSPI) is actively pushing back against the administration's support for unproven peptides. The organization sent a formal letter to Acting Food and Drug Administration Commissioner Kyle Diamantas, urging him to disregard the advisory panel's recommendations entirely.
Pete Lurie, president of CSPI and a former associate commissioner at the FDA, emphasized the potential dangers in an official statement. If the committee's recommendations stand, he warned, consumers could face severe health risks from unsupported claims regarding these substances.
Sources
- Ars TechnicaRFK Jr. proposes FDA look the other way on unproven peptides, report says
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