US Food and Drug Administration to convene expert panel on wider access to peptides

Agency moves to review ban on compounding pharmacies producing popular supplements amid political pressure and growing public demand

The US Food and Drug Administration has announced it will convene an advisory panel in July to examine whether licensed compounding pharmacies should be permitted to manufacture more than half a dozen widely used peptides, in a move that signals a potential reversal of restrictions imposed under the Biden administration.

The FDA's decision to seek outside counsel on the matter, disclosed in a federal notice on Wednesday, marks a significant shift in approach toward a category of compounds that has grown rapidly in popularity despite limited clinical evidence of safety or efficacy.

Peptides — short chains of amino acids that perform essential biological functions — were among the products targeted in a 2023 crackdown in which the FDA prohibited compounding pharmacies from manufacturing 14 such compounds, citing concerns over immunogenicity, toxicity and impurity.

The panel, scheduled over two days on July 23 and 24, will consider whether restrictions should be eased for seven peptides. These include BJ BPC-157, used for ulcerative colitis; KPV for wound healing and inflammatory conditions; TB-500 for wound healing; and MOTS-c, which has been linked to obesity and osteoporosis treatment. The following day, the committee will examine emideltide for opioid withdrawal and chronic insomnia, semax for conditions including migraine and chronic pain, and epitalon for insomnia.

The move comes amid growing political pressure from within the Trump administration. Robert F Kennedy Jr, the secretary of health and human services, told podcast host Joe Rogan that he is a "big fan of peptides" and had used them himself with what he described as "really good effect" — remarks that drew considerable attention given his oversight role of the FDA.

Industry figures have welcomed the review but urged caution over implementation. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, warned that regulatory change without adequate supply chain preparation risked creating confusion rather than clarity. "If the agency intends to move forward, it needs to manage the transition deliberately," he said, noting that any liberalisation would first require ensuring the availability of pharmaceutical-grade active ingredients manufactured to FDA standards.

The review reflects broader shifts in public attitudes toward peptides, which have gained significant traction among wellness communities and fitness enthusiasts, in part on the back of the success of peptide-based GLP-1 drugs such as semaglolide and tirzepatide. Influencers across social media platforms have promoted peptides for uses ranging from injury recovery to weight loss, fuelling demand despite federal regulators' longstanding position that most have not been adequately tested in humans.

The outcome of the July proceedings is likely to be closely watched by the pharmaceutical compounding industry, which has lobbied for greater access to peptide compounds, as well as by public health advocates concerned that relaxing restrictions could expose consumers to products with unproven safety profiles.