FDA scientists question peptides backed by Kennedy

Food and Drug Administration scientists say there is not enough evidence to support wider access to seven popular peptide therapies, setting up a potentially significant test for Health Secretary Robert F. Kennedy Jr., who has pushed to loosen restrictions on the substances.

The FDA’s Pharmacy Compounding Advisory Committee is scheduled to meet July 23 and 24 to review whether compounding pharmacies should be allowed to make BPC-157, emideltide, epitalon, KPV, MOTS-c, semax and TB-500. The FDA has the final say, but it typically follows recommendations from its advisory committees.

Peptides are chains of amino acids, the building blocks of proteins. Thousands occur naturally in the body, and some can be made synthetically. The GLP-1 weight-loss drugs are examples of synthetic peptides, NPR reported. But many peptide products promoted online for wellness, longevity, weight loss, injury recovery, joint pain, muscle recovery and metabolism have not undergone large, rigorous human trials.

Kennedy has said he has used peptides on injuries with “really good effect” and wants the FDA, which is overseen by the Department of Health and Human Services, to allow compounding pharmacies to offer them. In April, he reclassified 12 peptides as Category 1 substances, a step toward adding them to a list of bulk drug substances that compounding pharmacies may use. At a House hearing that month, he said the Biden administration had incorrectly flagged the peptides as safety risks.

The Biden administration restricted these and other peptides in 2023, effectively barring compounding pharmacies from making them. Since then, users have often turned to a gray market, including online sellers and overseas suppliers. Some vendors label products “For research use only,” which allows them to sell peptides while saying they are not intended for human use.

Some experts, as well as Kennedy, argue that allowing licensed compounding pharmacies to make the products could reduce underground sales and steer consumers toward safer sources. But FDA scientists, in briefing documents released before the meeting, concluded that none of the seven peptides had sufficient evidence to support compounding and said they could not rule out safety problems.

The scientists noted that some peptides had not been studied in humans at all. For TB-500 and KPV, which nominators said could help with wound healing, they found no human studies. MOTS-c, nominated for obesity and osteoporosis, had not been evaluated in published human studies. For BPC-157, which Kennedy and podcaster Joe Rogan have said can help heal tendon injuries, FDA scientists said they lacked enough data to assess its use for tendonitis, Crohn’s disease or Celiac disease. They found only a small ulcerative colitis trial described in a meeting abstract and concluded evidence was lacking.

The FDA scientists also found insufficient evidence to recommend semax for migraines, facial nerve pain or cerebral ischemia; epitalon for insomnia; and emideltide for chronic insomnia, narcolepsy and opioid withdrawal.

Dr. Anita Gupta, an anesthesiologist who served on the FDA committee from 2020 to 2025, said the panel previously voted against making certain peptides available through compounding pharmacies. “At the time, the FDA presented a lot of adverse event data that showed there was a risk of immunogenicity — immune reactions — and that raised some red flags for the committee,” said Gupta, an adjunct assistant professor at the Johns Hopkins University School of Medicine.

She also cited concerns about contamination. “Studies have begun to show that there are significant issues with some of these products. Some of them have heavy metals. Some have microbial contamination. Some are mislabeled,” Gupta said.

The FDA on Monday listed nine new advisory committee members appointed to four-year terms. NBC News reported that some own or work at wellness centers that promote or sell peptides, suggesting they could benefit if the products become available through compounding pharmacies. NPR reported the panel includes members with ties to the peptide industry, including some who work for companies offering injectable peptides.

Dr. Alexander Weber, an orthopedic surgeon and chief of sports medicine at the University of Southern California, told NPR patients ask him about peptides frequently. “My stock answer is that we just don’t have enough data to support their use,” he said.