A US Food and Drug Administration (FDA) advisory committee voted to recommend relaxing restrictions on a handful of controversial peptides that have become popular online despite limited evidence to support their safety or efficacy in humans.
The panel narrowly voted yes to allowing specialised compounding pharmacies to make peptides, including BPC-157, TB-500 and KPV, under prescription. The recommendation is a major regulatory milestone, but the FDA is not bound to follow the panel's advice -- though it often considers advisory committee recommendations as it makes its final decision.
Peptides are short chains of amino acids that are found naturally in the body and used in some approved medicines to treat conditions including diabetes. However, the peptides discussed here are different from approved peptide-based drugs because the FDA has not approved them for use in humans.
The popularity of injectable peptides has exploded across online wellness communities, particularly since GLP-1 weight-loss medications became widely used. Influencers have been pushing a combo of peptides, called “stacks”, and claim they help with recovery, skin, muscle growth and overall appearance. The evidence for many of these claims is not particularly strong in clinical terms.
Health experts continue to caution against using these products outside of clinical research, citing the absence of well-designed human trials and uncertainty about potential long-term health risks.
BPC-157, a peptide popular in the wellness community, is a fragment of a protein found in the stomach. It is sold online as a way to promote tissue repair, reduce inflammation and improve gut health. Some animal studies have investigated its effects on healing, but there is little good-quality evidence to demonstrate its safety or effectiveness in people.
The US Anti-Doping Agency states that BPC-157 has not been studied enough in humans to establish a safe dose or proven medical use. The World Anti-Doping Agency bans the substance in sport.
KPV has also been promoted online for gut health, skin repair and immune regulation, but again there is not enough clinical evidence to support these claims.
Currently peptides like BPC-157 and KPV are in a regulatory grey area. They can be easily bought online and are legal to own in the United States, but they lack FDA approval for human use and do not meet the same manufacturing and quality standards as approved pharmaceuticals.
Panel member Elizabeth Rebello, an anaesthesiologist and chemist, also voted against recommending BPC-157 during the advisory meeting, citing a lack of evidence of effectiveness and unresolved safety issues, Reuters also reported.
Supporters of lifting restrictions say that giving more options to patients through compounding pharmacies would increase their choices and medical freedom.
In all, the committee is considering seven peptides for possible removal of existing restrictions. Some members of the advisory panel reportedly have ties to clinics or businesses that offer peptide therapies, which could bring more public attention.
During the Biden administration, the FDA cracked down after its officials found many compounded peptides didn’t meet the agency’s safety standards. Health Secretary Robert F. Kennedy Jr., who has previously supported increased access to peptides, promised to revisit those policies.
