Key facts
- FDA staff reviewers found limited evidence for the safety and efficacy of seven popular peptides.
- An FDA advisory committee will review the peptides, with seven of its 14 members having financial ties to the peptide industry.
- Robert F. Kennedy Jr. has publicly endorsed peptides, contrasting with FDA staff concerns.
- The FDA recently sent a warning letter to Maximus, a clinic where a panel member is scientific director, over peptide claims.
U.S. FDA staff reviewers have expressed skepticism regarding the limited evidence supporting the use of seven popular peptides, ahead of a crucial advisory committee meeting. These peptides, which have gained widespread popularity driven by wellness influencers and public endorsements, are being considered for use in compounded medications. However, reviewers have flagged inadequate human studies and a lack of demonstrated safety and efficacy, a stance that contrasts with Health Secretary Robert F. Kennedy Jr.'s public support for these compounds.
The Pharmacy Compounding Advisory Committee is set to meet from July 23-24 to deliberate on whether to add these peptides to the agency's list of permissible bulk drug substances. While the committee's recommendations are non-binding, they are expected to heavily influence the FDA's final decision.
Adding to the complexity, seven of the 14 members appointed to the review panel have financial ties to businesses or clinics that offer peptide therapies. These include individuals who own wellness clinics selling peptide injections and growth hormone peptides, and a state senator whose mother, a Congress member, has previously urged the FDA to relax restrictions on peptides. An HHS spokesperson stated that all committee members underwent standard ethics reviews and vetting processes.