FDA Panel Backs 6 Peptides for Compounding as Black-Market Demand Outruns Safety Data
Updated
Updated · Los Angeles Times · Aug 6
FDA Panel Backs 6 Peptides for Compounding as Black-Market Demand Outruns Safety Data
3 articles · Updated · Los Angeles Times · Aug 6
Summary
Six peptides — BPC-157, TB-500, KPV, epitalon, Semax and MOTS-c — won an FDA committee recommendation for compounding-pharmacy production; emideltide was rejected.
The vote responds to booming online use of experimental peptides pushed by wellness influencers and telehealth firms, even though products like MOTS-c lack the clinical evidence, dosing standards and interaction data required for approved drugs.
Compounding would shift supply from largely unregulated online sellers to state-regulated pharmacies, but FDA staff told the two-day meeting there was not enough safety data to support the move.
Pinchas Cohen, whose lab discovered MOTS-c, backed supervised compounding as the safer option because he says tens of thousands are already injecting black-market versions of unknown purity and sterility.
The recommendation is nonbinding, leaving the FDA to decide whether to follow the panel as a broader fight grows over consumer-driven peptide use and the traditional drug-approval system.