RFK Jr. takes shortcut to make some peptides more widely available

Key Points:

• The Department of Health and Human Services (HHS) announced it will temporarily allow compounding pharmacies to produce six unapproved peptides—BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500—by exercising enforcement discretion while formal rule changes are in progress.
• These peptides, promoted online for various unproven health benefits, are not FDA-approved, and the agency’s scientists have found insufficient evidence of their safety and efficacy; however, pharmacies must certify their identity and purity and report any side effects.
• The move aims to reduce the gray market of peptides sold as "for research use only," which Health Secretary Robert F. Kennedy Jr. argues is less safe, but critics like Dr. Peter Lurie and Shabbir Safdar warn that allowing untested compounds could risk public safety.
• The FDA advisory panel recently voted narrowly to add these peptides to the official bulk drug substances list, a necessary step for formal approval, despite concerns about potential impacts on regulatory standards and industry ties among panel members.
• Upcoming FDA meetings with outside groups, including compounding pharmacies, signal ongoing efforts to formalize the rule change, though some experts fear this could lead to broader access to unproven and potentially dangerous drugs.