FDA Panel Narrowly Backs Reclassification of Controversial Peptides

An FDA advisory committee has narrowly voted to recommend that the Food and Drug Administration reclassify four popular peptides—BPC-157, KPV, TB-500, and MOTs-C—allowing compounding pharmacies to legally dispense them. The panel voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulk list, while MOTs-C received a seven-to-five vote in favour, with two abstentions. The recommendation follows testimony from proponents, including influencers and telehealth providers, who argue that legal compounding would provide safer, regulated alternatives to the current unregulated gray market. However, FDA scientists and several committee members opposed the move, citing a lack of scientific evidence regarding safety and efficacy, and warning that legalisation could confuse patients and fail to eliminate illicit supply chains. The panel’s recommendations are not final, and a formal FDA decision is expected in several months.

The advisory committee, which included members tied to peptide-related businesses and telehealth clinics, held an emotionally charged meeting lasting more than 11 hours. During the session, the panel heard data presentations from FDA staff and testimony from health care practitioners, patients, and clinics. The panel will consider three more peptides on Friday. Peptide therapies have gained significant traction through endorsements by wellness influencers, podcasters, and Health and Human Services Secretary Robert F. Kennedy Jr., who has described himself as a “big fan” of the compounds.

Peptides are essentially smaller versions of proteins and are being touted for a wide range of applications, including skin rejuvenation, hair growth, gut health, and injury recovery. Despite their growing popularity, there is a lack of scientific evidence to back up many of these claims. Many peptides currently exist in an unregulated gray market after the Biden administration banned compounding pharmacies from producing 20 peptides out of safety concerns in 2023. They are often legally sold online for “research use only” and “not for human consumption,” yet their marketing heavily implies otherwise.

China and India are major suppliers of peptides, with some reports indicating that crypto-funded fentanyl labs have pivoted to producing these compounds. During the meeting, the FDA’s own scientists recommended against allowing compounding pharmacies to produce any of the seven peptides being considered due to a lack of evidence showing they are safe and effective. Peptide proponents, however, testified that US compounding pharmacies should be able to produce them so that patients can access safer, regulated options with a prescription.

Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers, testified that while evidence for BPC-157 is not strong, it is not non-existent. Hims & Hers is actively preparing to launch peptide treatments in anticipation of FDA approval. Among the peptides approved, two are particularly popular with podcasters and influencers. BPC-157 and TB-500 are paired as part of a “Wolverine stack” touted by influencers for injury recovery. The World Anti-Doping Agency states that BPC-157 poses a risk to athlete health due to a lack of extensive human studies.

Critics, including John Hertig of the Collaborative for Evidence-Based Medicines and Adriane Fugh-Berman of Georgetown University, argued that legalisation could confuse patients and would not eliminate the gray market. Hertig noted that allowing compounders to make these peptides sends a message that the FDA is approving them, which is confusing for patients. Fugh-Berman challenged the idea that allowing legal versions would eliminate the gray market, asking if the government would endorse companies manufacturing heroin because it would be cleaner than what is sold on the street. She argued that just because the market is large, it does not mean it should be legalized, but rather that a product should be studied.

Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, voted against the move, citing safety unknowns and warning of entering a “Pandora’s box.” She was one of the committee members who voted against allowing the four peptides to be compounded, citing unknowns around safety and confusion for the public. For now, the panel’s recommendations are just that. A formal FDA decision will likely not come for several months.