HHS is opening a path to peptide access. ANH welcomes the move but wants to expand it to include other important peptides. Action Alert!
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THE TOPLINE
- HHS has proposed expanding access to six compounded peptides while FDA completes formal rulemaking.
- ANH welcomes the move but urges HHS to explain why other peptides remain excluded, particularly thymosin alpha-1.
- Restricting supervised access can push patients toward unregulated online sellers. We must call for a transparent, consistent process to reconsider excluded peptides and protect informed patient choice.
RFK Jr.’s Health and Human Services (HHS) Department continues to shift policy on compounded peptides in a positive direction. A new HHS draft policy sets out enforcement discretion for compounding six peptides, BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500, while FDA works through its formal rulemaking process. It is a welcome recognition that restricting access does not eliminate demand—or protect the people seeking these treatments.
But the announcement also leaves an important question unanswered: what is the scientific, medical or legal basis of the decision that greenlighted six peptides, while maintaining a red light for others, such as thymosin alpha-1 (Ta1)?
A Welcome Step Toward Access
As we’ve explained previously, peptide bioregulators are an exciting frontier in medicine. They are critical signaling compounds for gene expression, helping cells in specific tissues to ‘know what to do and when to do it,’ supporting repair, regeneration, and healthy function in organs such as the brain, heart, immune system and endocrine glands. Such peptides show promise for a wide range of uses including tissue repair, immune modulation, and healthy aging.
As most of these injectable peptides are not FDA approved drugs, they are made to pharmaceutical GMP standards at compounding pharmacies after a doctor prescribes them. To be legally compounded, peptide bioregulators need to be added to the FDA’s Bulk Drugs List. For several years now, the FDA has been evaluating nominations to that list through its Pharmacy Compounding Advisory Committee (PCAC).Unfortunately, yet predictably, PCAC had been voting to reject all the peptides it considered, including Ta1, kisspeptin, and several others. After a shakeup at the committee in which several peptide supporters were added to PCAC, the committee voted to approve BPC-157, epitalon, and four other peptides.
Under the new policy’s conditions, access would involve patient-specific prescriptions, traceable ingredient manufacturers, testing for identity and contaminants, and reporting of serious adverse events and product quality problems. Coverage is limited to specified forms and routes of administration.
ANH thanks Secretary Kennedy for advancing this approach. Giving patients and doctors a supervised route to treatment preserves patient autonomy and choice.
Why Have Some Peptides Been Left Out in the Cold?
By way of example, Ta1 is absent from the policy, as are kisspeptin-10 and ipamorelin.
HHS does provide reasons for including the six selected peptides. Its appendix cites updated ingredient testing, documented use, and safeguards intended to address identified concerns. Yet this still begs the question: why could a comparable approach not be considered for these other peptides, such as Ta1?
The FDA’s own review presented at a PCAC meeting couldn’t help but show that Ta1 has a strong safety profile, with 40 plus years of safe use. The FDA stated: “In most clinical studies, Ta1 has not been associated with significant adverse events attributable to Ta1 when administered in doses in the range of 1-16mg via the subcutaneous route of administration for up to 12 months.”
Given this safety record, why would HHS exclude Ta1 from its enforcement discretion policy? HHS should publish a clear comparison of the standards applied to included and excluded peptides. Kisspeptin-10 and ipamorelin also deserve explanations.
When he came into office, RFK promised transparency. Patients and providers deserve some of that transparency when some peptides are given leniency while others are not.
Safety Requires More Than Alarming Comparisons
It’s notable that the media coverage of this topic has emphasized Kennedy’s disagreement with FDA scientists and the absence of FDA approval. Some coverage has invoked comparisons with thalidomide, the drug associated with devastating birth defects in the 1960s that triggered substantially more rigorous pre-market safety testing for drugs in both the US and Europe.
This is a wild comparison to make given the totality of evidence available on the safety profile of peptide bioregulators. It’s like filling the blank spaces on a map with shipwrecks: gaps in knowledge become pictures of catastrophe.
The media narrative paints RFK Jr. as a cowboy unleashing dangerous, untested medicines onto an unwitting public. Conversely, the FDA is painted as completely neutral and trustworthy, simply looking out for consumer safety. This conveniently ignores the paternalism and bias of the FDA—a bias that has been present for decades, not just against peptides, but against all compounded medicines, including compounded bioidentical hormones.
For example, the FDA repeats the same mantra when it seeks bans on compounded natural medicines: “there aren’t clinical trials that prove the safety or efficacy of [insert natural medicine or peptide].” Clinical trials are the standard to approve new drugs. But here’s the key point: legally compounded drugs are exempted from new drug approval requirements. What the agency appears to be saying is that it does not want compounded drugs to exist, period, because the agency doesn’t control them and they compete with Big Pharma’s drugs.
The Gray Market Belongs in the Safety Equation
Consumers are already encountering peptide promotions online. Some purchase products outside the care of a physician.
Consider the practical difference. A person buying a vial online from a little known, say Chinese, supplier may have little assurance about its contents and no clinician evaluating whether the treatment is appropriate. A physician working with a qualified pharmacy can provide meaningful oversight of the peptide’s use and respond to any issues.
ANH supports Secretary Kennedy’s move toward supervised peptide access. Now HHS should build on it: explain the exclusions, reconsider Ta1 and other peptides through a consistent and transparent process, and make patient safety and informed choice the standards that guide the next decision.
Action Alert! Post a comment on the official docket of the HHS policy and tell them that Ta1 and other excluded peptides should be included in the enforcement discretion policy.
