RFK Jr allows access to six unapproved peptide drugs
Summarised from 5 outlets · Updated 29 Oct, 00:51 · Archive
US Health Secretary Robert F Kennedy Jr has announced a policy allowing access to six unapproved peptide drugs despite FDA scientists opposing the move.
US Health Secretary Robert F Kennedy Jr announced on Wednesday that his Department of Health and Human Services will no longer take enforcement action against specialty pharmacies selling six specific unapproved peptide compounds. The peptides affected are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. These injectable peptides are promoted within the wellness industry for building muscle, healing injuries and boosting energy, though they have not undergone FDA testing for safety and effectiveness.
The policy uses what Kennedy calls 'enforcement discretion', which means the regulatory status of the peptides does not formally change but the agency will not pursue them for sale. Under normal FDA rules, these chemicals would be classified as illegal drugs because they have not gone through the agency's rigorous review process. The document, published on the Federal Register on Wednesday with final publication set for 30 October, states that HHS will instead give specialty compounding pharmacies a 'green light' to freely produce and sell them.
FDA scientists overwhelmingly opposed the policy. According to six people familiar with its development, the effort was driven almost entirely by HHS, and FDA drug staffers had limited input in drafting it. They warned that easing access to these peptides could undermine the agency's longstanding mission of keeping unproven health products off the US market. FDA scientists continue to say there is insufficient evidence to show whether the peptides are effective and that they are potentially dangerous.
The policy sidesteps FDA tests for whether drugs work better than placebos or if they cause cancer or birth defects. In 2023, the FDA had removed the six peptides from a list of drugs that compounding pharmacies could manufacture, citing safety concerns. Kennedy's new rule effectively reverses that decision without formally undoing it.
Kennedy has personally advocated for peptide access. He has called himself a 'big fan' of peptides and told podcaster Joe Rogan that he used BPC-157 to treat a muscle injury with 'really good effect'. Several prominent figures in Kennedy's Make America Healthy Again movement sell peptide injections and supplements.
HHS justified the policy as confronting 'the risks of black-market peptides' by giving people 'a more controlled alternative'. A department document stated that Kennedy has 'determined that the policy advances patient choice and freedom while appropriately protecting patient safety', though it also acknowledged that these drugs can 'pose risks to patients'. Former FDA official Dr Peter Lurie, now at the nonprofit Center for Science in the Public Interest, noted that there are already FDA-approved and tested medications for the conditions peptides are purported to help.
How it is being reported
- RFK Jr says he will allow widespread unapproved injections despite his FDA advising people not to use themAs peptide compounds like GLP-1 drugs become more popular, the Trump administration is easing accessIndependent World · 29 Oct, 00:39
- Dr. Jon LaPook explains why peptide sales are controversialHealth Secretary Robert F. Kennedy Jr. took steps on Wednesday that could expand access to some unapproved drugs called peptides, which are being promoted for wellness. But there's not much evidence that they are safe and effective. Dr. Jon LaPook breaks it down.CBS News · 28 Oct, 23:45
- RFK Jr. to allow use of unapproved peptide injections, bypassing FDA rulesU.S. Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday that he will allow access to unapproved peptide injections.UPI · 28 Oct, 22:41
- Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDASix unproven peptides popular with MAHA now under "enforcement discretion policy."Ars Technica · 28 Oct, 22:17
- FDA scientists opposed Trump administration’s move to ease peptide accessEffort to loosen rules on unproven peptide drugs, favored by RFK Jr, faced fierce pushback from agency scientists A plan to give people in the United States easier access to unproven peptide drugs favored by the US health secretary, Robert F Kennedy Jr , was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with its development. The document posted online on Wednesday by Kennedy’s Department of Health and Human Services (HHS) covers a handful of injectable peptides promoted within the wellness…Guardian World · 28 Oct, 18:35
In this story: Robert F Kennedy Jr · Food and Drug Administration · Department of Health and Human Services · United States
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