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FDA scientists opposed HHS plan to ease compounding of unproven peptides
Most FDA scientific staff opposed a Health and Human Services plan to ease access to unproven injectable peptides, people familiar with the process told the Associated Press.
Based on reporting by CityNews Toronto
Wire reporting: (AP, via The Seattle Times)
Most Food and Drug Administration scientific staff opposed a Department of Health and Human Services plan to make it easier for Americans to obtain unproven injectable peptides, six people familiar with the policy told the Associated Press (AP, via CityNews Toronto)3.
The draft, which recently went to White House regulatory review, would tell the FDA not to act against specialty pharmacies that sell certain peptides that have not completed the agency’s usual safety and effectiveness review, three of those people said3.
HHS originally sought a regulation adding peptides such as BPC-157 and TB-500 to a list of substances deemed safe for compounding, the people said; FDA officials warned staff would not support that finding, so HHS shifted to an enforcement-discretion approach3.
Health Secretary Robert F. Kennedy Jr. has said he is a fan of peptides and used BPC-157 for a muscle injury; an HHS spokesperson did not immediately comment, AP reported3.
In 2023 the FDA listed more than a dozen peptides, including BPC-157 and TB-500, as substances that should not be compounded, citing risks that include allergic reactions, kidney damage and tumor growth3.
The pending document includes staff-suggested guardrails such as sourcing ingredients from FDA-registered facilities, collecting side-effect reports and verifying chemical identity, two people said3.
Sources
How it’s being reported
2 sourcesFirst reported by 
The Seattle Times
FDA scientists opposed Trump administration’s move to ease peptide access
Gives this outlet’s account of the story.
FDA scientists opposed the Trump administration’s move to ease peptides access
Gives this outlet’s account of the story.
Same copy also at: (AP, via CityNews Toronto)
Where they agree
- FDA scientific staff opposed easier access to unproven peptides; HHS is advancing a policy now at White House review.