The Department of Health and Human Services is allowing compounding pharmacies to prepare six unapproved peptides, BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, despite FDA scientists concluding there is insufficient data to prove their safety and effectiveness. Health and Human Services Secretary Robert F. Kennedy Jr. authorized the move through a draft policy filed Wednesday, stating it will provide patients a more controlled alternative to the unregulated “gray market” where these peptides are currently sold labeled “for research use only.” The FDA will not take legal action against pharmacies compounding the peptides, but will require quality testing, safety reporting, and patient-specific prescriptions. The decision follows a July advisory panel vote narrowly recommending the peptides be added to the list of substances compounding pharmacies are allowed to use, a panel that included members with ties to the peptide industry. The FDA previously required a formal rule-making process, which can take months, before allowing new ingredients for compounding. A CBS News investigation recently found a sample of an experimental peptide weight-loss drug purchased from a Brooklyn bodega did not contain a peptide at all.
The move comes as a growing “gray market” has sprung up around peptides, where retailers sell them labeled “for research use only,” a legal workaround that lets them claim they aren’t meant for humans. Kennedy argued allowing peptides to be compounded would move people away from this gray market and toward safer products. “Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care, and that includes confronting the risks of black-market peptides,” said Emily Hilliard, an HHS spokesperson. Compounding pharmacies must now certify the identity and purity of the compounds and report side effects, which was not previously mandated.
Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest watchdog group, said the FDA was essentially “turning a blind eye” to widen access to drugs that have not been proven to work. The FDA advisory panel’s recommendation in July went against the recommendations of the agency’s own scientists, who said there isn't enough evidence of safety and effectiveness for each of the six peptides. Kennedy cited that panel's recommendation in his decision, saying he had determined the policy “advances patient choice and freedom while appropriately protecting patient safety.”
Our reading is that the Health and Human Services Secretary is prioritizing a policy of expanded access to unproven treatments, even when directly contradicting the advice of his own agency’s scientists. The decision to allow compounding pharmacies to prepare unapproved peptides appears to be driven by a desire to address concerns about an unregulated market, but is simultaneously framed as advancing “patient choice and freedom,” suggesting an ideological component. The composition of the advisory panel and the recent resignation of a top advisor further suggest a pattern of aligning policy with specific advocacy groups and potentially disregarding established scientific consensus.
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