The Department of Health and Human Services has announced it will allow compounding pharmacies to produce six peptides that have not received formal approval from federal regulators, a decision that raises significant questions about drug safety and the federal approval process.
In a notice filed Wednesday, the agency stated it would exercise “enforcement discretion” against compounding pharmacies that manufacture these six unapproved peptides. The agency will not pursue legal action while it works through the formal rule-making process required to add these substances to the approved list.
The six peptides in question are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. These substances have been promoted through various channels as treatments for a range of conditions, from accelerated healing to anti-aging benefits and extended lifespan. However, the Food and Drug Administration’s own scientists have concluded there is insufficient data to prove these peptides are either safe or effective for human use.
The decision represents a departure from standard regulatory procedures. Compounding pharmacies typically may use only ingredients the FDA has added to an official list known as the bulk drugs substances list. Adding an ingredient requires the FDA to propose a rule, accept public comment, and issue a final rule, a process that ordinarily takes several months.
Health Secretary Robert F. Kennedy Jr. has argued that permitting peptides to be compounded would redirect consumers away from an unregulated gray market where retailers sell these substances labeled “for research use only,” a legal workaround that allows them to avoid claiming the products are intended for human consumption.
“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,” stated Emily Hilliard, an HHS spokesperson.
The agency has imposed certain requirements on compounding pharmacies that choose to produce these peptides. They must certify the identity and purity of the compounds and report any side effects, a requirement that was not previously mandated.
Critics have expressed concern about the decision. Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest, characterized the FDA’s action as “turning a blind eye” to expand access to drugs that have not been proven to work.
The matter came before an FDA advisory panel in July, which narrowly voted in favor of adding the six peptides to the bulk list. That panel included six new appointees with connections to the peptide industry and another member who is the son of a United States representative who has advocated for Kennedy to make peptides more readily available. During that meeting, some committee members voiced concerns that the recommendation could establish a precedent making it more difficult for the FDA to deny other unapproved drugs in the future.
The decision comes at a time when a growing gray market has emerged around these peptides, with various retailers taking advantage of regulatory loopholes to market these unproven substances. Whether this new approach will indeed move consumers toward safer products or simply legitimize access to substances of questionable safety and efficacy remains to be seen.
And that is the way it is.
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