The Food and Drug Administration (FDA) is closely reviewing seven unapproved peptide substances this week to evaluate their health benefits. The FDA’s Pharmacy Compounding Advisory Committee will meet on July 23 and 24 at the White Oak Campus in Silver Spring, Maryland. Their discussions will focus on whether to add these peptides to the 503A Bulks List, which would enable their use in compounded prescription drugs.
Despite their lack of FDA approval, these peptides are commonly available through wellness clinics, compounding facilities, and online sellers. Peptide therapies have gained popularity for various purported benefits, including weight loss, muscle building, performance enhancement, chronic disease management, and wound repair.
HHS Secretary Robert F. Kennedy Jr. supports expanding access to peptide therapies, although FDA reviewers express concerns about the limited evidence for their safety and efficacy. Consumer demand is expected to remain strong, with peptides drawing interest for diverse health applications.
The FDA is evaluating the following seven peptides:
- BPC-157: Proposed for ulcerative colitis, available as oral capsules, nasal spray, injections, transdermal cream, and rectal suppository.
- TB-500: Proposed for wound healing, available as subcutaneous or intramuscular injection.
- KPV: Proposed for wound healing and inflammatory conditions, available as cream and gel.
- MOTS-c: Proposed for obesity and osteoporosis, available as subcutaneous injection.
- Semax: Proposed for cerebral ischemia, migraine, and trigeminal neuralgia, available as intranasal spray and subcutaneous injection.
- Emideltide: Proposed for opioid withdrawal, chronic insomnia, narcolepsy, available as subcutaneous injection.
- Epitalon: Proposed for insomnia, available as subcutaneous injection.
Dr. Alex Tatem, a urologist and performance medicine expert, will testify at the FDA hearings. Tatem highlights the safety of these compounds compared to over-the-counter options like ibuprofen, which carry risks of stomach bleeding, kidney damage, and cardiovascular issues.
Despite concerns from FDA reviewers, Tatem cites the low adverse event rate of “well under 0.1%” from millions of BPC-157 doses administered between 2014 and 2023. The FDA acknowledges the lack of sufficient human clinical trials to establish the safety and efficacy of these peptides.
Other medical experts, like Dr. Marc Siegel, emphasize the need for comprehensive studies before peptide approval. Siegel agrees that some peptides may require further investigation while others show promise.
If the advisory committee supports inclusion, the FDA will proceed with its review and rulemaking. This process must be completed before formally adding any substances to the 503A Bulks List, which includes approved ingredients for compounding prescription drugs.
Tatem suggests temporarily categorizing some peptides for permissive enforcement while rulemaking continues. Ultimately, patients could eventually obtain prescriptions under medical supervision following FDA approval.
Tatem encourages public involvement, advocating for access to safe, regulated peptides through local representatives. The FDA’s final decision will reflect these recommendations, though outcomes remain uncertain.