Peptides work closer to the mainstream.
On Thursday, a panel of experts strongly recommended that the Food and Drug Administration reclassify four common peptides – including one approved by podcaster Joe Rogan – to allow some pharmacies to legally dispense them.
During a sometimes tense meeting that lasted more than 11 hours, FDA advisory committee members heard presentations of FDA staff data on four unapproved peptides – BPC-157, KPV, TB-500 and MOT-C – as well as testimony from healthcare professionals, patients, pharmacies and clinics.
Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s omnibus list, meaning compounding pharmacies will be able to operate them to create custom medicines for patients. (The fourth peptide – MOTs-C – received seven to five votes in favor, with two abstentions). The advisory panel, which includes several members associated with peptide companies and telehealth clinics, will consider three more peptides on Friday.
Peptide therapies are gaining popularity thanks to endorsements from podcasters, wellness influencers and Secretary of Health and Human Services Robert F. Kennedy Jr., who has said he is a “huge fan.” Essentially, smaller versions of proteins and peptides are touted for everything from skin rejuvenation and hair growth to gut health and injury recovery, despite a lack of scientific evidence to support these claims.
Many peptides currently exist in an unregulated gray zone after the Biden administration banned pharmacies from making 20 peptides for safety reasons in 2023. They can be legally sold online for “research purposes only” and “not for human consumption,” but their marketing largely suggests otherwise. China and India are major suppliers of peptides, and some cryptocurrency-funded fentanyl labs are changing how they are produced.
During the meeting, FDA scientists advised against allowing pharmacies to produce any of the seven peptides under consideration due to a lack of evidence showing they are unthreatening and effective. Meanwhile, peptide advocates testified that U.S. pharmacies should be able to produce them so that patients have access to safer, regulated prescription options.
“I won’t say that the evidence for BPC-157 is strong. It’s not, and I won’t overstate it,” said Anant Vinjamoori, chief medical officer of telehealth company Hims & Hers. “Please don’t read thin How non-existent” The company is actively preparing to introduce peptide therapies while awaiting FDA green light for certain peptides.
Of the approved peptides, two are particularly popular among podcasters and influencers. BPC-157 and TB-500 are combined as part of what is called the “Wolverine stack” to help enhance recovery from injuries. Committee members were asked to evaluate BPC-157, which is believed to promote tissue repair, for ulcerative colitis. The World Anti-Doping Agency says BPC-157 poses a threat to the athlete’s health because it has not been extensively studied in humans.
Some healthcare workers testified that their patients turned to the gray market to purchase peptides and ended up receiving products containing illegal substances. While FDA approval may help reduce some of these risks, other commentators say they may create new ones.
John Hertig, president of the Collaborative for Evidence-Based Medicines, said allowing manufacturers to make these peptides sends a signal that the FDA is approving them. “It becomes very confusing for our patients,” he said, adding that the existence of a gray market is not a reason to allow compounders to produce these peptides.
He argued that there will still be a gray area even if the FDA allows these peptides to be combined, citing that patients continue to seek gray-market GLP-1 drugs despite several FDA-approved drugs on the market.