Peptides are gaining traction for widespread acceptance.
An expert panel on Thursday narrowly recommended that the Food and Drug Administration alter the classification of four notable peptides—one of which is endorsed by podcaster Joe Rogan—to allow specific pharmacies to legally dispense them.
In an extensive, at times heated session spanning over 11 hours, an FDA advisory group examined evidence from FDA personnel regarding four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—along with testimonies from medical professionals, patients, pharmacies, and clinics.
The members cast a vote of eight to six, with one abstention, to include three of the four peptides on the agency’s bulks list, permitting compounding pharmacies to utilize them in tailored medicines for patients. (The fourth peptide—MOTs-C—achieved a seven-to-five vote in its favor, with two abstentions.) The panel, which includes members connected to peptide-related enterprises and telehealth clinics, will assess three additional peptides on Friday.
Peptide therapies have become increasingly popular owing to endorsements from podcasters, health influencers, and Health and Human Services Secretary Robert F. Kennedy Jr., who identifies as a “big fan.” Peptides, smaller variants of proteins, are marketed for skin rejuvenation, hair growth, gut health, and recovery from injuries without robust scientific support.
A number of peptides exist in a gray market after the Biden administration restricted compounding pharmacies from manufacturing 20 peptides in 2023 over safety apprehensions. They can be marketed online for “research use only” and “not for human consumption,” though advertising implies otherwise. Major suppliers of peptides include China and India, with some crypto-financed fentanyl laboratories shifting to produce them.
During the meeting, FDA scientists expressed opposition to allowing compounding pharmacies to create any of the seven peptides under review, citing a lack of adequate evidence regarding their safety and efficacy. Advocates claimed that US compounding pharmacies should be allowed to produce them, offering patients safer, regulated alternatives with prescriptions.
“I’m not going to assert that the evidence for BPC-157 is compelling. It isn’t, and I won’t embellish it,” stated Anant Vinjamoori, chief medical officer at telehealth company Hims & Hers. “I would request that you don’t interpret thin as non-existent.” The company is ready to launch peptide treatments if the FDA approves specific peptides.
Among the peptides discussed, two stand out in popularity among podcasters and influencers. BPC-157 and TB-500 are utilized in a “Wolverine stack” to support injury recovery. Committee members assessed BPC-157, thought to assist tissue repair, concerning ulcerative colitis. The World Anti-Doping Agency indicates that BPC-157 presents health risks to athletes due to insufficient human research.
Some healthcare providers reported that their patients turned to the gray market for peptides, discovering products contaminated with illicit substances. While FDA approval could reduce some risks, others argued it might introduce new hazards.
John Hertig, chair of the Collaborative for Evidence-Based Medicines, remarked that allowing compounders to produce these peptides implies FDA endorsement. “That creates significant confusion for patients,” he observed, adding that the existence of a gray market does not justify permitting compounders to manufacture these peptides.
He asserted that a gray market will persist even if the FDA authorizes the compounding of these peptides, highlighting that patients continue to pursue gray market GLP-1 drugs.
