FDA panel eases restrictions on popular peptides

An FDA Pharmacy Compounding Advisory Committee voted 8‑6 to recommend adding several unapproved peptides—including BPC‑157, KPV, TB‑500, MOTS‑c, Semax and Epitalon—to the Section 503A Bulk Drug Substances List, a step that would allow specialized pharmacies to compound them for patients. The vote split along lines of safety concerns raised by agency scientists, who warned that the compounds lack robust human clinical data, and arguments from panel members citing “medical freedom” and the perceived public benefit. Health Secretary Robert F. Kennedy Jr., a vocal supporter of the substances, has promoted the market and helped shape the advisory panel, which includes members with ties to the peptide industry. The non‑binding recommendation could legitimize a gray‑market industry worth an estimated $2‑3 billion, while raising questions about quality control, adverse‑event reporting, and the precedent of allowing untested compounds into the regulated pharmacy supply chain. The FDA will decide whether to adopt the panel’s advice, which could significantly expand consumer access to these controversial wellness products.