The Food and Drug Administration (FDA) is scrutinizing seven unapproved peptide substances that have gained popularity for their supposed health benefits. Scheduled meetings on July 23 and 24 at the FDA’s White Oak Campus in Silver Spring, Maryland, will see the FDA’s Pharmacy Compounding Advisory Committee consider whether to recommend these peptides for addition to the agency’s 503A Bulks List. If included, these substances could be used in certain compounded prescription drugs.
Despite not being FDA-approved, these peptides are widely accessible through wellness clinics, compounding outlets, and online sellers operating in the gray market. Robert F. Kennedy Jr., Secretary of Health and Human Services (HHS), has supported expanding access to some peptide therapies. Meanwhile, FDA reviewers express concerns about the scant evidence validating the safety and effectiveness of the seven peptides under evaluation.
A report from Reuters suggests that demand is expected to stay strong regardless of the committee’s decision, driven by the peptides’ popularity for weight loss, muscle growth, performance enhancement, chronic disease management, and wound repair. FDA documents list seven peptides currently under review:
- BPC-157
Proposed use: Ulcerative colitis
Proposed forms: Oral capsules, nasal spray, injections, transdermal cream, rectal suppository - TB-500
Proposed use: Wound healing
Proposed forms: Subcutaneous or intramuscular injection - KPV
Proposed use: Wound healing and inflammatory conditions
Proposed forms: Cream and gel - MOTS-c
Proposed use: Obesity and osteoporosis
Proposed forms: Subcutaneous injection - Semax
Proposed use: Cerebral ischemia, migraines, trigeminal neuralgia
Proposed forms: Intranasal spray, subcutaneous injection - Emideltide
Proposed use: Opioid withdrawal, chronic insomnia, narcolepsy
Proposed form: Subcutaneous injection - Epitalon
Proposed use: Insomnia
Proposed form: Subcutaneous injection
Peptide expert Dr. Alex Tatem, a board-certified urologist and member of Rugiet’s Medical Advisory Board, is set to testify at the FDA hearings. Tatem emphasizes the potential of each peptide to address different patient issues, praising compounds like BPC-157 and TB-500 for healing after injury. Unlike over-the-counter choices like ibuprofen, shown to cause serious side effects when misused, these peptides provide a safer alternative.
Tatem highlights the safety record of BPC-157, with millions of doses administered and few adverse events reported. This might partly be due to their composition as natural substances familiar to the human body. Nonetheless, the FDA insists there’s insufficient human clinical trial data regarding peptide safety or efficacy. Despite their likeness to natural substances, potential dangers are not entirely eliminated.
Fox News medical analyst Dr. Marc Siegel stresses the importance of thorough studies. RFK Jr. concurs some peptides might be beneficial, while others require deeper investigation. Siegel, however, is cautious about potential renal effects, calling for comprehensive trials before the FDA’s approval.
As Tatem anticipates a challenging hearing, he hopes real-world data from doses given between 2014 and 2023 will sway committee members. These figures reportedly show adverse event rates below 0.1%. Should the committee suggest inclusion, the FDA would proceed with its review and rulemaking process before any substances join the 503A Bulks List.
The list permits state-licensed pharmacies to use specific active ingredients for compounding prescription drugs. Tatem suggests that the FDA might temporarily relax enforcement for certain substances while rulemaking continues, although this is not confirmed.
Tatem remains optimistic that by year’s end, patients might consult doctors or telehealth providers to obtain a prescription for monitored medical use. He encourages individuals to voice their opinions as the committee’s recommendation to the FDA is non-binding. Tatem urges reaching out to local representatives for access to regulated, U.S.-produced peptides.