USFDA to Review Peptide Compounding Ban, Advisory Panel Meet Set for July
Bengaluru: The U.S. Food and Drug Administration will convene a panel of outside advisers in July to consider whether licensed compounding pharmacies should be allowed to manufacture more than half a dozen popular peptides, according to a federal notice on Wednesday.
Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body.
The peptides under review were among the 14 products the FDA, under the Biden administration, barred compounding pharmacies from manufacturing in 2023, citing risks related to the peptides' immunogenicity, toxicity and impurity.
Federal regulators have said most of these peptides have not been adequately tested in humans and could pose safety risks.
"If the agency intends to move forward, it needs to manage the transition deliberately. This is, at its core, a supply chain issue," said Scott Brunner, CEO of Alliance for Pharmacy Compounding in a LinkedIn post.
Flipping a regulatory switch without first ensuring the availability of pharmaceutical-grade active ingredients made under FDA manufacturing standards will create confusion, not clarity, Brunner added.
Despite limited data on their safety and effectiveness, peptides have gained immense popularity among wellness influencers online, who often promote them for injury recovery, inflammation and weight loss.
More recently, peptides have also become popular among the fitness community, driven in part by the success of peptide-based GLP-1 weight-loss drugs such as semaglutide and tirzepatide.
The FDA's move also follows public support from Health Secretary Robert F. Kennedy Jr., who recently told the Joe Rogan podcast that he is a "big fan of peptides" and has used them himself with "really good effect."
On July 23, the committee will discuss whether compoundersshould be allowed to manufacture the peptides BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis.
The following day, the panel will discuss emideltide for opioid withdrawal and chronic insomnia, semax for cerebral ischemia, migraine, and a type of chronic pain and epitalon for insomnia.
