Hot peptide summer is nigh.
In a two day-long marathon hearing that pitted career regulatory representatives against figures of the peptide industry, the Food and Drug Administration voted on July 23 and 24th to recommend the approval of 6 peptides that had been previously banned for human use under the Biden Administration.
By the end of the day Friday, the FDA’s panel had recommended the approval of six of the seven peptides up for debate. That list included the buzzy “Wolverine Stack” composed of BPC-157 and TB-500, peptides that have been used by biohackers and other pioneers of the gray market for healing skin, ligaments muscle and bone, as well as KPV, said to treat inflammatory skin conditions, MOTS-c, used to treat metabolic conditions, Emideltide, a sleep assistant, and Semax, a supposed form of migraine relief. Only Epitalon, a peptide that has been employed to alleviate insomnia, was rejected by the panel.
These recommendations could open the floodgates for a potential multibillion dollar peptide industry in the US, where peptides are already a buzzword among wellness influencers, Hollywood, and the manosphere. Hims, a telehealth company that sells direct-to-consumer finasteride and GLP-1s, has signaled that it will move to sell the controversial substances should they be approved after acquiring a peptide manufacturing facility in 2025.
The hearing spawned controversy within the FDA well before it began. This past spring, multiple officials inside the agency expressed concern that then FDA head Marty Zakary was stacking the hearing with panelists who had direct connections to the peptide industry, according to reporting from the Washington Post published last week. As this was happening, career FDA scientists quietly argued in posts shared on the FDA website that there had not yet been enough clinical human trials to confirm that the peptides in question are both safe and effective for pharmacies to compound and distribute. Then, in the days leading up to the hearing, controversy surrounding these new industry-connected panelists prompted the FDA to again add 8 new experts to the hearing, bringing the total number of voting individuals to 14.
This tension between established regulatory medicine and the multibillion-dollar wellness industry was on full display throughout the hearings. In the first vote, six peptide suppliers joined with a pharmaceutical executive and a compounding pharmacist to approve the peptide BPC-157 narrowly with an 8-6 vote.
Peptides are chains of amino acids, the building blocks of protein, and serve as messengers to the body’s cells. They play major roles in hormonal regulation, skin health, and your immune system. Already regulated and FDA-approved peptides include Insulin and GLP-1s but the current craze surrounding the medicine extends well beyond these more well-researched examples. BPC-157, for instance, has not yet been the subject of intensive human clinical trials, despite its popularity among tech industry grindsetters, longevity bros, and pilates girlies alike. “This is not the traditional way that the FDA goes about doing stuff, they typically go through phase one trials, phase two trials, phase three trials, and that takes years,” says Dr. Katie Rizzone, a sports medicine specialist at the University of Rochester. “I just don’t see the evidence at this point.”
At least one representative from the telehealth industry agreed that there was scant data to support the claims around BPC-157. “I’m not going to tell you that the evidence for BPC-157 is strong,” Hims chief medical officer Dr. Anant Vinjamoori told the panel during his testimony. “It isn’t, and I won’t overclaim it.” Nevertheless, Hims stock rose 13% after the first day of the panel.