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.
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FDA panel backs wider access to six peptide pherapies: Cites 'grey...
A Food and Drug Administration (FDA) advisory panel has voted to recommend expanding legal access to six popular peptide compounds. Supporters say could pull patients out of the unregulated grey market that has flourished under years of federal inaction. The FDA's Pharmacy Compounding Advisory Committee reviewed seven peptides during a two-day hearing in Maryland last week, weighing whether each should be added to the agency's Section 503A Bulks…
FDA Panel Backs Wider Access to Six Peptide Therapies, Citing Grey Market Concerns › American Greatness
A Food and Drug Administration (FDA) advisory panel has voted to recommend expanding legal access to six popular peptide compounds. Supporters say could pull patients […] Source
Health advisors met on Thursday to review more than half a dozen unproven peptides, substances that have become a growing trend of well-being, despite little evidence that they are safe or effective.
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