FDA panel supports broadening access to peptides popular on the gray market
6 hours ago
- An FDA advisory panel recommended reclassifying six popular peptide therapies to allow U.S. compounding pharmacies to produce them, expanding access beyond the current gray market.
- The panel endorsed BPC-157, MOTS-c, KPV, TB-500, Epitalon, and Semax, but voted against Emideltide, an insomnia compound.
- Proponents argue reclassification would shift patients from unregulated online sources to safer, FDA-overseen production, while critics cite lack of rigorous human trials and safety concerns like cancer risk.
- The recommendation aligns with Health Secretary Robert F. Kennedy Jr.'s support for peptides and could benefit the wellness industry, but final FDA action may take years or be expedited via special authority.