In this image taken from video, an intravenous infusion is administered at Pure Alchemy Wellness in Chula Vista, California, in November 2025. Javier Árciga/AP hide title toggle title Javier Árciga/AP Stay up to date with our Top First newsletter, sent every business day in the morning. It’s a big week for the peptide industry and
In this image taken from video, an intravenous infusion is administered at Pure Alchemy Wellness in Chula Vista, California, in November 2025.
Javier Árciga/AP
hide title
toggle title
Javier Árciga/AP
Stay up to date with our Top First newsletter, sent every business day in the morning.
It’s a big week for the peptide industry and for the growing number of Americans who have embraced therapies touted for wellness and longevity.
The Food and Drug Administration will convene a panel of outside experts for a two-day meeting starting Thursday to make recommendations on whether compounding pharmacies should be allowed to produce some of the most popular injectable peptides.
The Pharmaceutical Preparations Advisory Committee meeting is scheduled to begin early Thursday morning and run through Friday afternoon.
The group will review the evidence for seven compounds, including some of the most sought-after injectables: TB-500, BPC-157 and MOTs-C.
None of them have undergone the type of large-scale trials to establish safety and effectiveness that are required for drug approval by the FDA.
“I see it as very risky,” says Paul Knoepfler, a cellular and molecular biologist at the University of California, Davis, who has followed the rise in demand for these peptides. “These are medications and have not been scientifically tested.“
The adoption of peptides has not waited for science
And yet, the therapies have attracted enormous attention in the wellness space, where they are promoted for injury recovery, muscle growth and fat loss, skin health, metabolism, and more.
Leading direct-to-consumer telehealth companies, medical spas, and high-end longevity medical practices are marketing peptides and their potential.
Proponents argue that current Biden-era restrictions on substance mixing (due to safety concerns and lack of data) have fueled a gray market of foreign suppliers, raising safety concerns as Americans inject unauthorized substances.
It’s a message that industry groups are pushing hard ahead of this week’s meeting.
“When peptides were removed from regulated compounding pharmacies, demand did not disappear. It went underground,” Gary Brecka, a popular podcaster and wellness influencer whose company markets peptides, told reporters during a briefing held by the American Academy of Peptide Medicine, a professional society that formed earlier this year that advocates for regulatory changes.
“It’s not a question of whether Americans will use peptides,” he added.
Peptides are chains of amino acids (smaller than a protein) that often act as signaling molecules in our body and carry out many critical functions. They can be synthesized and administered as drugs. Some of them, like insulin, are found naturally in the body. Others are modified versions, as are many of the successful GLP-1 weight loss drugs.
For example, BPC-157 is based on a peptide found in human stomach juices, while TB-500 is related to a molecule found in many types of cells, called thymosin beta-4.
An influential peptide advocate at the top
The upcoming meeting represents another point of tension between Health Secretary Robert F. Kennedy Jr.’s Making America Healthy Again agenda and the traditional medical and scientific establishment.
Kennedy has publicly advocated lifting restrictions on peptides and has spoken of their benefits.
In June, the FDA reviewed the advisory committee’s list. Many of the new members have ties to the peptide industry. Some work for compounding pharmacies or clinics that offer them.
On Tuesday, the agency made more additions, adding a handful of temporary voting members, mostly from academic institutions who were appointed for having expertise in specific peptides.
FDA officials did not immediately respond to NPR’s question about why it had made the changes.
Meanwhile, the FDA’s own career scientists recommend against giving compounding pharmacies the green light to produce any of the seven peptides under consideration.
Little clinical evidence versus real-world experience
In a review of the evidence published before the meeting, they repeatedly point out that the data comes mainly from preclinical work with animals, and is quite limited for humans.
For example, no human clinical studies were identified for TB-500. In the case of another compound, Semax, the available evidence “does not establish efficacy,” the document states.
Medical providers need to be honest about the “relatively scant clinical evidence for these peptides,” says Dr. Anant Vinjamoori, chief medical officer of Hims & Hers, which plans to offer the peptides if the FDA reclassifies them.
“At this point, we have experience accumulated over almost a decade (thousands of doctors, nearly millions of patients) that seems to indicate that these peptides may be beneficial in promoting health,” he adds.
The FDA committee is tasked with reviewing data supporting the use of these peptides for specific conditions, including migraines, ulcerative colitis, opioid withdrawal, and wound healing. However, if the FDA eventually reclassifies them, doctors would have discretion to write prescriptions outside of those strict indications.
While compounding pharmacies can “undoubtedly produce better versions of these peptides,” says UC Davis’ Knoepfler, that doesn’t resolve concerns that the peptides, especially if taken at the wrong dosage, could inadvertently promote cancer growth or trigger a dangerous immune response.
But he’s also concerned about the possibility of FDA leadership going against the advice of its own internal scientists.
“I think that’s not good for the FDA,” he says. “I think that undermines their authority and coherence.”
{For more tech updates, stay tuned to our blog.|Keep following us for the latest insights.|Check back often for more exciting news!}
