FDA panel recommends easing restrictions on several peptides, including BPC-157
A narrow panel vote could let compounders make the peptides after FDA reviewers warned the evidence on safety and benefits remains limited.
- On Thursday, FDA advisers narrowly recommended adding four unapproved peptides—BPC-157, KPV, TB-500, and MOTS-C—to the "503A Bulks List," endorsing lifting restrictions that prevented compounding pharmacies from using them.
- Safety concerns led the FDA to ban these substances three years ago, but they have since surged in popularity among supporters of the "MAHA" agenda, with Health Secretary Robert F. Kennedy Jr. personally advocating for wider access.
- "There's stuff happening out there that we need to try and control," said panelist Haleem Mohammed, Chief Medical Officer of Gameday Men, as dissenters raised concerns about unknown risks and potential conflicts of interest.
- Agency reviewers previously advised against broader use, citing scant evidence regarding safety and efficacy, though the FDA usually follows advisory committee recommendations despite this narrow, divided vote.
- The panel debates three additional peptides—Emideltide, Semax, and Epitalon—on Friday, testing the agency's willingness to expand the "503A Bulks List" despite reviewers' warnings about unknown safety profiles.
40 Articles
40 Articles
A panel of experts recommended flexible access to promoted compounds to gain muscle, accelerate recovery and promote longevity, although experts from the agency itself warned that there are few studies that demonstrate their safety and benefits
LIVE NOW: FDA Advisory Committee Meets on Compounded Drug Substances (DAY 2)
The FDA’s Pharmacy Compounding Advisory Committee meets at 8 a.m. ET on July 24 to discuss several bulk drug substances being considered for inclusion on the 503A bulks list, including BPC-157, KPV, TB-500, and MOTs-C. The committee will also hear presentations from nominators supporting the proposed substances. ...
FDA Panel Makes 'Alarming' Move on Peptides
A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals haven't been shown to be safe or effective. In a series of votes, outside experts advised the Food and Drug Administration...
U.S. panel says to loosen restrictions on popular peptide despite safety concerns
A U.S. review panel on Thursday recommended loosening restrictions on the much hyped peptide BPC-157, voting that specialized pharmacies be allowed to produce it despite alarm bells from medical experts over safety concerns.
Coverage Details
Bias Distribution
- 44% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
