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The Food and Drug Administration is taking a closer look this week at seven unapproved peptide substances that have surged in popularity for their purported health benefits.
At meetings scheduled for July 23 and 24 at the FDA’s White Oak Campus in Silver Spring, Maryland, the FDA’s Pharmacy Compounding Advisory Committee will consider whether to recommend adding seven peptide substances to the agency’s 503A Bulks List, which would allow them to be used in certain compounded prescription drugs.
Although these peptides are not FDA-approved, they are widely available through wellness clinics, compounding operations and gray-market online sellers.
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HHS Secretary Robert F. Kennedy Jr. has voiced support for expanding access to certain peptide therapies, while FDA reviewers have raised concerns about the limited evidence supporting the safety and effectiveness of the seven substances under consideration.
According to Reuters, consumer demand is likely to “remain strong” despite the outcome, as peptides have surged in popularity for weight loss, muscle building, performance enhancement, chronic disease management and even wound repair.
FDA documents show that the following seven peptides are under review.
No. 1: BPC-157
Proposed use: Ulcerative colitis
Proposed forms: Oral capsules, nasal spray, injections, transdermal cream, rectal suppository
No. 2: TB-500
Proposed use: Wound healing
Proposed forms: Subcutaneous or intramuscular injection
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No. 3: KPV
Proposed use: Wound healing and inflammatory condition
Proposed forms: Cream and gel
No. 4: MOTS-c
Proposed use: Obesity and osteoporosis
Proposed forms: Subcutaneous injection
No. 5: Semax
Proposed use: Cerebral ischemia (shortage of blood flow and oxygen to the brain), migraine and trigeminal neuralgia (chronic pain condition in the face)
Proposed form: Intranasal spray, subcutaneous injection
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No. 6: Emideltide
Proposed use: Opioid withdrawal, chronic insomnia, narcolepsy
Proposed form: Subcutaneous injection
No. 7: Epitalon
Proposed use: Insomnia
Proposed form: Subcutaneous injection
Performance potential
Performance medicine and peptide expert Dr. Alex Tatem, a board-certified urologist and member of Rugiet’s Medical Advisory Board, will testify at this week’s FDA hearings.
In an interview with Fox News Digital, Indiana-based Tatem said that every product up for review is “exciting,” as each targets a different problem faced by patients.
“BPC-157 or TB-500 are compounds that can help facilitate healing after injury and have been shown in multiple studies to be incredibly safe when administered — which is interesting when you compare that to the over-the-counter options that we use now for aches and pains, like ibuprofen,” he said.
Although ibuprofen is available over the counter, the FDA warns that it can cause serious side effects — including stomach bleeding, kidney damage and cardiovascular complications — especially when used at high doses or for long periods.
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Tatem claimed that millions of BPC-157 doses have been administered and that relatively few adverse events have been reported.
“There is no other drug on the market that had that sort of safety record,” Tatem said. “And it’s not because of any magic — it’s because these are natural substances that our bodies make and are familiar with, so that’s what gives them this incredible safety profile.”
The FDA, however, has publicly stated that there is not enough evidence from human clinical trials on the safety or efficacy of these drugs. FDA reviewers have also cautioned that a peptide’s similarity to a naturally occurring substance does not eliminate potential risks.
Fox News senior medical analyst Dr. Marc Siegel cautioned that these substances “need careful study.”
“I am not convinced the data is fully there yet.”
According to the doctor, RFK Jr. told Siegel in their latest interview that he believes “not all peptides are created equal, whereas some are helpful, others may not be and need further study.”
“I agree with that,” Siegel told Fox News Digital. “I’m concerned about the impact some may have on the kidneys. I would like to see rigorous clinical trials before approval. I am not convinced the data is fully there yet.”
Next steps
Tatem said he expects the hearings to be a “hard-fought battle,” but hopes committee members will consider what he described as real-world data from tens of millions of doses administered between 2014 and 2023. The data showed adverse event rates of “well under 0.1%,” he added.
If the committee recommends inclusion, the FDA would still need to complete its review and rulemaking process before formally adding any of the substances to the 503A Bulks List.
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That list includes active ingredients that state-licensed pharmacies are legally permitted to use for compounding prescription drugs, Tatem said.
He also suggested that the FDA could place some substances under a more permissive enforcement category temporarily while the rulemaking process continues. (The agency has not announced that it intends to do so.)
“Ultimately, what we would hope is, before the end of the year, patients would be able to go to their doctor, work through maybe a telehealth provider, and then be able to get a prescription for this under monitored medical supervision,” he said.
“The most important thing to take away is that your voice matters.”
“The most important thing to take away is that your voice matters, because this committee is just issuing a recommendation to the FDA. The FDA can take it or leave it,” Tatem noted. “Everything that happens afterward is still anyone’s guess.”
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Tatem encourages people to reach out to their local representatives to request access to “safe, regulated peptides made here in the United States of America.”
Fox News Digital reached out to the FDA and ibuprofen product manufacturer Haleon for comment.
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