FDA Evaluates Unapproved Peptides for Compounded Drugs

The Food and Drug Administration (FDA) is examining seven unapproved peptide substances known for their claimed health benefits. Meetings will occur on July 23 and 24 at the FDA’s White Oak Campus in Silver Spring, Maryland. The FDA’s Pharmacy Compounding Advisory Committee will discuss whether to recommend these peptides for the agency’s 503A Bulks List. If accepted, they can be used in certain compounded prescription drugs.

Peptide Popularity and Concerns

Despite lacking FDA approval, these peptides are available at wellness clinics, through compounders, and online sellers. HHS Secretary Robert F. Kennedy Jr. supports increased access to peptide therapies. However, FDA reviewers question the limited evidence on their safety and effectiveness. Reuters reports that consumer interest remains strong, especially for uses like weight loss, muscle building, performance enhancement, managing chronic diseases, and wound repair.

Peptides Under Review

• BPC-157: Used for ulcerative colitis; available as oral capsules, nasal spray, injections, transdermal cream, and rectal suppository.
• TB-500: Aids wound healing; available as subcutaneous or intramuscular injection.
• KPV: Treats wound healing and inflammatory conditions; available as cream and gel.
• MOTS-c: Addresses obesity and osteoporosis; available as subcutaneous injection.
• Semax: Used for cerebral ischemia, migraine, and trigeminal neuralgia; available as intranasal spray and subcutaneous injection.
• Emideltide: Helps with opioid withdrawal, chronic insomnia, narcolepsy; available as subcutaneous injection.
• Epitalon: Deals with insomnia; available as subcutaneous injection.

Expert Testimony and Performance Potential

Dr. Alex Tatem, a performance medicine expert, will testify at the FDA hearings. In an interview, Tatem highlighted the potential of these products, noting the effectiveness and safety of BPC-157 and TB-500 for healing injuries. He contrasted these with ibuprofen, which, despite being over-the-counter, poses risks like stomach bleeding and kidney damage at high doses.

Millions of BPC-157 doses have been safely administered with few adverse events.

The FDA argues there isn’t sufficient clinical trial evidence to confirm the safety or efficacy of peptides. FDA reviewers also warn that a peptide’s similarity to natural substances doesn’t negate potential risks.

Cautious Approach

Dr. Marc Siegel, Fox News’ senior medical analyst, stresses the need for careful study. He agrees with RFK Jr.’s view that not all peptides are beneficial, and some may require further research. He expressed concern about potential kidney impacts and suggested rigorous trials before any approval.

Proceeding with Caution

Tatem expects intense discussions during the hearings and hopes real-world data, indicating low adverse event rates, will influence decisions. If the committee recommends inclusion, the FDA must finalize its review and rulemaking process before listing any substances on the 503A Bulks List. This list allows state-licensed pharmacies to use certain active ingredients for compounding drugs.

Tatem suggests the FDA might provisionally allow some substances while the rulemaking process progresses, although there’s no official announcement on this. He hopes patients can obtain prescriptions through monitored medical supervision by year-end.

Your voice matters… Tatem encourages public engagement, noting the committee only advises the FDA, leaving ultimate decisions open.

Public action through local representatives can support access to safe, regulated peptides made in the USA.