The committee reviewed BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon and Emideltide (also known as delta sleep-inducing peptide, or DSIP) to determine whether they should be eligible for compounding by 503A pharmacies.
Committee members clash with FDA scientists
Throughout the meeting, FDA scientists generally recommended against adding the peptides to the 503A Bulks List, concluding that the available evidence was insufficient to support their inclusion. Reviewers cited limited clinical data, concerns about safety, efficacy and product quality and, for some peptides, unresolved safety questions.
Committee members frequently questioned whether FDA had applied an overly stringent evidentiary standard for compounded drug substances. Some argued that denying access through licensed compounding pharmacies could drive patients to unregulated online sources, while others cautioned that the committee risked responding to market demand rather than robust scientific evidence.
The committee’s recommendations also drew attention because they diverged from FDA staff recommendations. Additionally, the panel’s composition came under scrutiny after eight voting members were appointed earlier this year under Health Secretary Robert F. Kennedy Jr. Several have backgrounds in regenerative medicine, longevity, hormone optimization and some operate clinics that offer peptide therapies, prompting questions from some observers after the panel repeatedly diverged from FDA staff recommendations. During the meeting, several members questioned whether FDA placed too much emphasis on the lack of randomized clinical trials and too little weight on clinical experience and other available evidence, while members opposing the recommendations argued the committee should rely on stronger scientific evidence rather than growing consumer demand.
Vote breakdown
- BPC-157 — Recommended (8-6, one abstention)
- KPV — Recommended (8-6, one abstention)
- TB-500 — Recommended (8-6, one abstention)
- MOTS-c — Recommended (7-5, two abstentions)
- Semax — Recommended (8-5, one abstention)
- Epitalon — Recommended (7-4, one abstention)
- Emideltide (DSIP) — Not recommended (6-7, one abstention)
The committee’s recommendations are nonbinding. FDA will make the final determination through notice-and-comment rulemaking and is not required to follow the panel’s advice.
The recommendations would not make the peptides FDA-approved drugs. Instead, if FDA adopts the recommendations, eligible 503A pharmacies could compound patient-specific medications using the peptides pursuant to valid prescriptions, consistent with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Implications for dietary supplements
The outcome is being closely watched by the supplement industry as a growing number of companies explore bioactive peptides for applications ranging from healthy aging and metabolic health to sports nutrition, even as the regulatory framework for peptide ingredients remains unclear.
Ahead of the meeting, the Natural Products Association (NPA) submitted comments urging FDA to make clear that decisions regarding the 503A Bulks List should not be interpreted as determining whether naturally occurring peptides could qualify as foods or dietary ingredients under separate provisions of the FD&C Act. The NPA argued that pharmacy compounding and dietary supplements are governed by distinct statutory frameworks, that listing a peptide for compounding should not determine its status as a drug or preclude future consideration under another FDA-regulated pathway where permitted by law, and that scientific advances could ultimately support the evaluation of certain naturally occurring peptides under those separate pathways.
Ahead of the meeting, the Natural Products Association (NPA) submitted comments urging FDA to make clear that decisions regarding the 503A Bulks List should not be interpreted as determining whether naturally occurring peptides could qualify as foods or dietary ingredients under separate provisions of the FD&C Act. The association argued that pharmacy compounding and dietary supplements are governed by distinct statutory frameworks, that listing a peptide for compounding should not determine its status as a drug or preclude future consideration under another FDA-regulated pathway where permitted by law, and that scientific advances could ultimately support the evaluation of certain naturally occurring peptides under those separate pathways. Bob Durkin, a partner and co-chair of the regulatory group at Amin Wasserman Gurnani LLP who previously served on FDA’s Pharmacy Compounding Team, said the committee’s discussions could have implications beyond pharmacy compounding. A registered pharmacist who previously compounded medications, Durkin said the committee’s deliberations expanded the public scientific record on the identity and safety of the peptides. While that information could prove useful for companies interested in developing peptide-based dietary supplements, he cautioned that the committee’s recommendations do not resolve the legal hurdles facing the category.
“From a dietary supplement perspective, the information considered by the PCAC and their discussions show that there is substantive information available about the identity and safety of each of the considered peptides,” Durkin said. “This can certainly add to any effort to distribute the peptides in dietary supplements, but diligent evaluations must still establish that any specific peptide qualifies as a dietary ingredient, is reasonably expected to be safe in oral formulations, and whether it does or does not require an NDIN [New Dietary Ingredient Notification]. And, of course, the drug exclusion clause hasn’t gone away.”
Durkin said the meeting also highlighted a philosophical divide between FDA reviewers and members of the advisory committee. According to Durkin, several committee members appeared to view FDA’s assessment as applying an overly restrictive standard for evaluating compounded peptides, while FDA scientists emphasized the limited clinical evidence supporting many of the substances.
While the committee’s recommendations could expand access to compounded peptides if adopted by FDA, they do not resolve whether any of the substances could ultimately qualify as dietary ingredients. That determination will depend on separate statutory requirements governing dietary supplements, including whether a peptide meets the definition of a dietary ingredient, is reasonably expected to be safe, requires an NDIN and is subject to the FD&C Act’s drug exclusion provision.
