FDA moves on peptides put consumers in harm's way

If the Food and Drug Administration follows the advice of a recent advisory committee, it will not only expose the public to the dangers of unproven peptides but also threaten the integrity of the advisory committee system and the FDA's drug approval process itself, according to a Viewpoint published today in the Journal of the American Medical Association by three authors from the Center for Science in the Public Interest. The issues raised in the Viewpoint are all the more urgent, as FDA has recently forwarded to the Office of Management and Budget a proposal that could allow the compounding of certain peptides and would apparently lead to non-enforcement of many FDA regulations as they apply to these peptides.

The FDA's Pharmacy Compounding Advisory Committee met on July 23-24, 2026, to discuss whether to add seven specific peptides to the 503A Bulks List, which would allow licensed pharmacists to provide them to individual patients with a prescription.

The seven peptides proposed for inclusion were BPC-157, KPV, TB-500, MOTs-C, emideltide, semax, and epitalon, which proponents variously claim will help with muscle and joint healing, reducing inflammation, improving metabolic health, and promoting longevity. In fact, authorizing these peptides would create a huge, largely unregulated market that will be characterized by misleading claims, needless risk, and widespread grift, according to CSPI.

Currently, peptides are sold over the Internet for research use only, although there is little evidence that meaningful research is being generated. In September 2023, the FDA restricted the compounding of these same seven peptides due to "significant safety risks." Subsequently, the Health and Human Services Secretary, Robert F. Kennedy Jr., declared that peptides had "really good effect" based on his own experience and that he wanted to make peptides "more accessible."

In March 2026, only four members of the PCAC remained, due to infrequent meetings and term limits. In April and May 2026, eight new permanent members were appointed by the HHS, even with FDA officials expressing concerns about possible member conflicts of interest as most new members were tied to peptide-related businesses and clinics. For example, one of the recently appointed permanent members is a scientific director at a clinic that offers peptides and has developed a peptide optimization Substack called "The Syringe Runneth Over."

At the meeting, at which Dr. Peter Lurie, one of the coauthors and a former FDA associate commissioner testified, FDA staff presented detailed briefs on all seven peptides. These concluded that none of them could be sufficiently characterized, and many lacked thorough data supporting their safety and efficacy. The committee voted to include six out of seven peptides on the 503A Bulks List, with every favorable vote coming from the newly appointed permanent members. (After the eight new permanent members were appointed, the FDA appointed eight additional temporary members, but most were restricted to voting on one or two peptides, giving the Kennedy-appointed members a numerical advantage.)

CSPI's authors highlight the many concerning implications for the future of the FDA's drug approval process with this meeting as a precedent.

First, proponents for including peptides on the 503A Bulks List argue that the genie was out of the bottle and the size of the current market mandated listing. If the FDA allows peptides to be compounded based on market demand, this would open the doors for the agency to greenlight other unapproved products, such as kratom and cannabidiol, whose illegal sales reached a certain level. This would create an incentive for illegal sales.

Second, if peptides can be compounded and sold through this 503A pathway without providing the robust safety and effectiveness evidence required by the standard approval process, pharmaceutical companies, knowing that they will be undercut by compounders, would have less incentive to conduct clinical trials to demonstrate safety and effectiveness of their peptide drug candidates, thus undermining the drug approval process.

Third, the integrity of advisory committees themselves would be put into question if members have financial conflicts of interest and vote in lockstep, according to the authors.

"When votes are, in effect, predetermined by selective appointments, the role of advisory committees as a mechanism to solicit independent expertise and adjudicate scientific uncertainty is fundamentally undermined," according to the Viewpoint.

Finally, HHS is poised to expand peptides in other settings, as a March 2026 FDA meeting considered whether peptides could be considered dietary ingredients and included in supplements. If the agency adopts this policy, peptide products would be as accessible as any supplement in pharmacies or supermarkets, provided an oral preparation can be developed, as is the case for BPC-157.

"If the FDA continues to indulge RFK Jr.'s enthusiasm for peptides, we can expect cases of injury to consumers to continue to mount," said CSPI President Dr. Peter G. Lurie. "But if one of these peptides were to show promise, the FDA's actions make it much less likely that it would be developed into a safe and useful drug. Why would a reputable pharmaceutical company bother to conduct extensive clinical trials when consumers can just go to compounding pharmacies, or worse, find one of these peptides in a dietary supplement on a supermarket shelf?"

Besides Lurie, the Viewpoint authors included CSPI Policy Associate Isabella Xu and former intern Sophia Samantaroy.

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