HHS moves to let pharmacies make unapproved peptides
The health department led by RFK Jr. will let compounding pharmacies make six unapproved peptides, NBC News, the BBC and the Associated Press report. The FDA will not take action against pharmacies that make them. The AP reports most FDA scientific staff opposed the plan.
The US Department of Health and Human Services will let compounding pharmacies make six peptides the Food and Drug Administration has not approved, NBC News, the BBC and the Associated Press report. The notice was posted on Wednesday.
NBC News reports the department will use "enforcement discretion," meaning it will not take legal action against pharmacies that make the drugs. NBC lists the six as BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. Pharmacies must check the identity and purity of the drugs and report side effects.
Peptides are short chains of amino acids. Some, such as insulin, are approved medicines. The six in the plan are sold online for healing, younger skin and building muscle. The BBC reports they have become popular with teens on TikTok. Experts warn there have been no human clinical trials and the long-term effects are unknown.
The BBC notes the plan came from the health secretary's office, not the FDA. The AP, in a story carried by The Guardian, reports that most FDA scientific staff opposed it, citing six people familiar with the process. HHS first wanted the FDA to write a rule declaring the peptides safe. After FDA officials warned that staff would not back that, HHS shifted to telling the FDA not to enforce its rules, the AP reports.
Kennedy has called himself a "big fan" of peptides. An HHS spokesperson, Emily Hilliard, said the department is "confronting the risks of black-market peptides." Peter Lurie, a former FDA official, said the agency was "turning a blind eye."
In July, an FDA advisory panel narrowly voted to loosen limits on the six peptides, NBC News reports. In 2023, the FDA had put BPC-157 and TB-500 on a list of substances that should not be compounded, the AP reports.
What we know: HHS will not act against pharmacies that make six unapproved peptides, with new safety reporting rules.
What we don't: When a formal rule might follow, and how the FDA will track harms.
Where outlets agree NBC News, the BBC and the Associated Press report HHS will let compounding pharmacies make six unapproved peptides without FDA enforcement action.
Where they differ NBC News reports HHS is still working on a formal rule change, while the Associated Press says HHS dropped plans for a rule after FDA staff objected.