HHS Halts Enforcement Against Six Compounded Peptides, Overruling FDA
HHS will stop enforcing restrictions on compounding pharmacies making six peptides FDA scientists say lack efficacy evidence and may be risky, Ars Technica reports.
The story in focus
Ars Technica reports HHS Secretary Robert F. Kennedy Jr. issued a final rule, published October 30, under which HHS will stop enforcing restrictions on compounding pharmacies making six peptides FDA scientists say lack efficacy evidence and carry potential risk. The policy does not change the peptides' regulatory status.
- HHS will cease enforcement action against compounding pharmacies producing BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
- The rule leaves the peptides' regulatory status unchanged; it only sets enforcement discretion.
- FDA scientists maintain there is insufficient evidence of efficacy and potential danger.
- HHS cites a July FDA advisory panel vote that followed Kennedy adding eight members to the 12-member committee.
- CSPI and ASEM warn of untested products, safety risks and misleading claims.
What the rule does
Ars Technica reports that the rule, titled Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, was made available Wednesday on the Federal Register with final publication set for October 30. It states HHS will no longer take enforcement action against compounding pharmacies for making the six peptides, which Ars Technica lists as BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
The rule does not alter the peptides' regulatory status. Ars Technica reports it sidesteps the need to formally undo a 2023 FDA decision that removed the six peptides from the list of drugs compounding pharmacies may produce. Kennedy had proposed the policy earlier this month, according to the report.
Rationale and criticism
Ars Technica reports HHS cited a July FDA advisory panel vote to add the peptides back to the compounding list. Before that vote, Kennedy added eight new members to the 12-member committee, and at least six of his additions have ties to peptide-related businesses and clinics, the report says.
HHS also argues safety concerns are mainly hypothetical because few human studies exist showing benefits or harms, and that compounding access will discourage gray- and black-market purchases of research-use-only peptides from foreign manufacturers. Critics disagree: CSPI said harm reports will continue to mount, and ASEM said the rule does not resolve problems with untested products, safety risks, questionable ingredients or misleading claims. Ars Technica reports peptide sellers celebrated the news.
Does the new HHS rule change the legal regulatory status of the six peptides?
Ars Technica reports it does not. The rule only states HHS will stop taking enforcement action against compounding pharmacies that make the six peptides; it leaves their existing regulatory status unchanged.
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