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 .
At meetings scheduled for July 23 and 24 at the FDAs White Oak Campus in Silver Spring, Maryland, the FDAs Pharmacy Compounding Advisory Committee will consider whether to recommend adding seven peptide substances to the agencys 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 , compounding operations and gray-market online sellers.
HHS Secretary 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.
Proposed use: Ulcerative colitis
Proposed forms: Oral capsules, nasal spray, injections, transdermal cream, rectal suppository
Proposed use: Wound healing
Proposed forms: Subcutaneous or intramuscular injection
SECRET TO WEIGHT LOSS MAY BE HIDING IN YOUR GUT, NEW STUDY SUGGESTS
Proposed use: Wound healing and inflammatory condition
Proposed forms: Cream and gel
Proposed use: Obesity and osteoporosis
Proposed forms: Subcutaneous injection
Proposed use: Cerebral ischemia (shortage of blood flow and oxygen to the brain), and trigeminal neuralgia (chronic pain condition in the face)
Proposed form: Intranasal spray, subcutaneous injection
Proposed use: Opioid withdrawal, chronic insomnia, narcolepsy
Proposed form: Subcutaneous injection
Proposed use: Insomnia
Proposed form: Subcutaneous injection
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 â 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 â including stomach bleeding, kidney damage and â especially when used at high doses or for long periods.
Tatem claimed that millions of BPC-157 doses have been administered and that relatively few adverse events have been reported.Â
“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 â it’s because these are natural substances that our bodies make and are familiar with, so that’s what gives them this incredible .”
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 cautione
