FDA Panel Reviewing Some Peptides for Regulation Changes
Wertynews.com – A Food and Drug Administration advisory panel is currently reviewing some peptides to potentially loosen regulations for unapproved therapies. During a two-day meeting, the FDA panel reviewing some peptides voted to broaden access to at least one peptide, allowing compounding pharmacies to fill prescriptions for certain unapproved options. This decision comes amid growing public interest in these alternative treatments.
Peptides are short chains of amino acids—the building blocks of proteins—connected by chemical bonds. While the human body naturally produces some peptides, more than 80 have already received FDA approval for medical use. These approved peptides appear in insulin, skincare products, and GLP-1 medications.
What the FDA Panel Is Reviewing
The FDA panel reviewing some peptides is currently examining seven specific peptides to determine whether they should join a list of substances that compounding pharmacies can safely produce. Compounding pharmacies mix medications that aren’t available from standard drug manufacturers. Patients would need a doctor’s prescription and must take the therapy for a specific medical condition. Importantly, this decision does not constitute full FDA approval.
During the first session on Thursday, the panel focused on BPC-157, one of the most popular peptides among longevity and wellness influencers. Marketed as a treatment that can heal injuries and reduce inflammation, BPC-157 drew mixed reactions from the 24 speakers who commented on it. Four scientists argued against making the drug more accessible, while the remaining 20—doctors, chemists, and peptide business owners—supported expanded access using personal and patient anecdotes.
“Anecdotes are not evidence,” said Dr. Rachel Pessah-Pollack of NYU Langone, who told CBS Mornings that BPC-157 has only been tested in about 30 humans, compared to the hundreds of thousands of patients GLP-1 medications were tested on.
The panel ultimately voted 8-6 on Thursday afternoon to broaden access to BPC-157. Dr. Jessica Duncan, chief medical officer for IVIM Health, emphasized that the FDA should work to ensure unapproved therapies can be provided by doctors. “People want them. They have proven to us that they are going to seek them out,” Duncan told CBS News. “What I’m asking and advocating for is that the conversation with them, the education that’s provided, is in the exam room.”
Many peptides can be purchased online through what practitioners call the “gray market”—a space considered risky due to potential contamination or impurities. “At this point, we all need to be wary about putting an injection in your body without actually knowing the product,” Pessah-Pollack warned. “They could have arsenic in it, they could have lead. So we all need to pause. We all need to speak to our doctors.”
During the Biden administration, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies. Regulators stated at the time that these peptides “present significant safety risks” due to insufficient testing. However, many of the FDA advisers and internal staff who made that decision no longer work for the agency.
According to the Associated Press, more than half a dozen people with connections to the peptide industry were added to the panel before the discussion, including doctors, pharmacists, and consultants. All of these new experts voted to allow pharmacies to produce their own formulations of BPC-157.
Former FDA official Dr. Peter Lurie, who now leads the Center for Science in the Public Interest, expressed skepticism about the process. In April, he told CBS News that Secretary Kennedy’s statements made it unlikely that unapproved peptides would receive real scrutiny. “Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”
