FDA scientists push back on easier access to seven peptides
Health Secretary Robert F. Kennedy Jr. has moved to loosen access, but agency scientists found too little human evidence to support compounding seven peptides.
By Priya Raghavan · Science Reporter
3 min read
Food and Drug Administration scientists say seven peptides should not be made easier to obtain through compounding pharmacies, putting agency staff at odds with Health Secretary Robert F. Kennedy Jr.’s push to loosen restrictions. The dispute matters because the FDA is preparing to ask an advisory committee whether pharmacies should be allowed to make the substances despite limited human data.
According to NBC News, Kennedy has supported deregulating several peptides and in April reclassified 12 of them as Category 1 substances, an initial step toward placing them on a list of substances that compounding pharmacies may produce. Kennedy told a House hearing that month that the Biden administration had wrongly treated the peptides as safety risks, NBC News reported.
Peptides are chains of amino acids, the building blocks of proteins, and many occur naturally in the body, according to NBC News. Synthetic versions have gained attention from wellness influencers and podcasters who promote them for weight loss, injuries, joint pain and other uses, while Kennedy has said he used peptides on injuries with what he described as good results.
The FDA’s Pharmacy Compounding Advisory Committee is scheduled to meet July 23 and 24 to review BPC-157, emideltide, epitalon, KPV, MOTS-c, semax and TB-500, according to FDA meeting materials cited by NBC News. The FDA has final authority, though the agency often follows recommendations from its advisory committees.
In briefing documents released before the meeting, FDA scientists said none of the seven peptides had enough evidence to support adding them to the compounding list, NBC News reported. The scientists also said they could not rule out safety concerns and, in some cases, could not determine exactly which form of a peptide they were being asked to assess.
Some peptides have little or no human research behind them, according to the FDA scientists. For TB-500 and KPV, which nominators described as possible wound-healing treatments, the scientists said they found no studies in which the substances were given to people. They also found no published human studies evaluating MOTS-c, which had been nominated for obesity and osteoporosis.
The FDA scientists also found too little evidence to support BPC-157 for tendonitis, Crohn’s disease or celiac disease, NBC News reported. For ulcerative colitis, they found a small trial described only in a meeting abstract, which they said did not provide enough detail to support its use.
For semax, nominated for migraines, facial nerve pain and cerebral ischemia, the FDA scientists found insufficient evidence, according to NBC News. They also did not find enough evidence to recommend epitalon for insomnia or emideltide for chronic insomnia, narcolepsy and opioid withdrawal.
Dr. Anita Gupta, an anesthesiologist and former member of the compounding advisory committee, told NBC News that the panel previously rejected some peptides after FDA staff presented adverse-event data showing possible immune reactions. Gupta, an adjunct assistant professor at the Johns Hopkins University School of Medicine, also cited concerns about contamination and labeling problems in some products sold through compounding pharmacies.
The FDA on Monday listed nine new members appointed to four-year terms on the advisory committee, according to NBC News. Some of those members own or work at wellness centers that promote or sell peptides, raising the possibility that they could benefit if the products become available through compounding pharmacies, NBC News reported.
The seven peptides were initially nominated by LDT Health Solutions, representing the International Peptide Society, and Wells Pharmacy Network, which operates compounding pharmacies nationwide, according to NBC News. Both groups later withdrew their nominations, but the FDA continued its review.
C. Michael White, head of pharmacy practice at the University of Connecticut, told NBC News it would be significant if the advisory committee rejects the conclusions of FDA scientists. The FDA, the Department of Health and Human Services, LDT Health Solutions and Wells Pharmacy Network did not respond to NBC News requests for comment.
This story draws on original reporting from NBC News.