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Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

Summary

Health Secretary Robert F. Kennedy Jr. issued a policy directing HHS not to enforce restrictions on compounding pharmacies that make six specific peptides. The policy does not change the peptides’ regulatory status, and FDA scientists have said evidence of their safety and effectiveness is insufficient.

Key Facts

  • The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
  • In 2023, the FDA removed the peptides from a list of substances that compounding pharmacies could use because of safety concerns.
  • The new policy says HHS will not take enforcement action against certain pharmacies for making the peptides.
  • The policy was posted on the Federal Register on Wednesday, with final publication scheduled for October 30.
  • An FDA advisory panel voted in July to add the six peptides back to the list of substances pharmacies could compound.
  • Kennedy added eight members to the panel before the vote; at least six had ties to peptide-related businesses or clinics, according to the article.
  • HHS says allowing compounded versions could steer people away from products sold on gray or black markets.
  • Peptide sellers and advocates publicly praised the policy.
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