October 16, 2026

Doctors for America Urges White House to Reject FDA's "Interim Access Policy" for Unapproved Peptides

WASHINGTON, D.C. – Doctors for America (DFA) calls on the Office of Management and Budget to return FDA's "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94), which OIRA received for review on October 14, 2026. The policy would let compounding pharmacies sell injectable peptides that have never been shown to be safe, effective, or even reliably identified, before FDA completes the notice-and-comment rulemaking the law requires.

The peptides at issue include BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax. In July, FDA's own scientists recommended that none of the seven peptides reviewed be added to the compounding list. Doctors who treat patients every day see three reasons this policy is dangerous.

1. No one can say for certain what is in the vial

An approved drug has a defined identity, a validated purity specification, and controls on every impurity. These peptides have none of that. None is an FDA-approved drug, so there is no approved reference product to measure a batch against.

This matters because impurities in peptides are not inert. FDA scientists have warned that peptide-related impurities can raise the risk of immune reactions and are hard to detect, analyze, and control. For approved generic peptides, FDA expects every peptide-related impurity at or above 0.10% to be identified, and new impurities above 0.5% to be justified. When FDA moved most of these peptides into Category 2 in 2023, it cited immunogenicity, peptide-related impurities, and limited safety information.

The current market shows what happens without those controls. Independent testing of direct-to-consumer peptides has found wide variability in purity and in how much active ingredient a vial actually contains. A compounding pharmacy that buys bulk powder from the same overseas supply chain does not fix this. Pharmacy compounding can make an uncharacterized substance sterile; it cannot make it known.

2. There is no human evidence of safety or benefit

FDA reviewers told the advisory committee that the available studies were short and underpowered, and recommended against every peptide on the agenda. The committee overrode them on narrow 8–6 votes.

The published literature bears FDA out. BPC-157 is the most studied of the group. A 2025 systematic review in HSS Journal screened three decades of research and found 35 animal studies and a single small retrospective human report: 12 patients with knee pain, 7 of whom reported relief. Its authors noted the risks from unregulated production and the lack of clinical safety data. A separate systematic review presented at AAOS 2025 concluded that human safety remains unknown and cautioned clinicians and athletes against using it. A 2026 critical review of the preclinical literature called BPC-157 a hypothesis-generating candidate, not an established therapy.

Without human pharmacokinetic studies, there is no evidence-based dose. Patients would be injecting substances at doses extrapolated from rats, for conditions no trial has tested. An "interim" policy removes the one step designed to catch the harms we cannot yet predict.

3. Patients bear the risk; sellers collect the revenue

The market for these products is large and growing. One obesity-medicine physician cites projections of $50 billion to $75 billion by 2028 for gray-market and direct-to-consumer peptides. Observers expect telehealth companies to ramp up marketing for wellness and cosmetic uses if FDA follows the committee's advice.

The process that produced this policy raises conflict-of-interest concerns. HHS appointed physicians with financial stakes in the peptide industry to the advisory committee before the July votes. One new member runs an anti-aging clinic that sells a BPC-157 product for $149. HHS says every member met FDA ethics requirements, but patients deserve decisions free of even the appearance that sellers wrote the rules.

The central appeal of the interim policy to sellers is that it skips the usual proof. As one industry advocate told the committee, bulk compounding carries no requirement to prove safety or efficacy. That shifts the cost of the unknowns onto patients: out-of-pocket spending on unproven injections, adverse events with no reporting system built to catch them, and delayed care for conditions that have proven treatments.

What Doctors for America is asking for:

• OMB should return RIN 0910-ZD94 to FDA and decline to clear any enforcement-discretion policy that reaches substances FDA has not placed in Category 1.
• Anyone seeking to market these peptides for medical use should go through the drug approval pathway. That means FDA review: an investigational new drug application showing a fully characterized drug substance,and adequate and well-controlled clinical trials showing safety and efficacy.  
• FDA should follow the law's process. Any Bulks List addition should proceed through a proposed rule, public comment, and a final rule, with the full scientific record published.
• FDA should release its evidence reviews for each peptide, including identity, impurity, and immunogenicity assessments, so clinicians and patients can judge the risks.
• If any peptide is ever made available, require safeguards first: a defined quality specification, mandatory serious adverse event reporting, and clear patient disclosure that the product is unapproved and unproven.
• HHS should disclose the financial interests of advisory committee members who voted on these substances.

‍

###

‍

About Doctors for America:

Doctors for America (DFA) is a national nonprofit that mobilizes over 40,000 physicians and medical trainees to advocate for policies that improve the health of patients and communities. Through advocacy training and action at the state and federal levels, DFA works to expand access to affordable care, strengthen community health and prevention, and advance health justice and equity. We do not accept funding from pharmaceutical, insurance, or for-profit health care entities, ensuring our work remains fiercely independent and patient-centered. DFA puts patients over politics–and over profits. Find out more at doctorsforamerica.org and on X @drsforamerica or Bluesky drsforamerica.bsky.social.

‍