FDA advisory panel votes to expand use of four untested peptides despite safety concerns
An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The recommendation came despite limited evidence of the peptides' safety or efficacy.
The four peptides under review were KPV and TB-500 for wound healing, BP-157 for ulcerative colitis, and MOTs-C for weight loss. All had been prohibited three years ago after the FDA raised safety concerns, but they have gained popularity in wellness circles and on the grey market.
The panel's endorsement could pave the way for a formal regulatory change, although the FDA does not always follow its advisory committees. Critics note the lack of rigorous testing and warn that broader availability may expose patients to unproven treatments.
This writeup was produced by pharmadog from original reporting by BioPharma Dive.
Original headline: “FDA panel endorses broader use of certain peptides”
read at BioPharma Dive ↗
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