US FDA panel to review disputed peptides for compounding

A United States Food and Drug Administration review panel is set to consider whether seven peptides should be recommended for compounding, as interest in the substances grows among wellness influencers, celebrities and patients.

Compounding is when pharmacists or outsourcing facilities create custom drugs. The peptides under review include BPC-157, TB-500 and Semax. They were among substances restricted from compounding under Joe Biden's administration, with the source citing a lack of human clinical trial data as one reason for the restrictions.

Supporters promote some synthetic peptides for claimed benefits such as improved skin, sleep, muscle strength, alertness and tissue repair. Medical experts quoted in the report warned that there is not enough evidence to show that the products are safe and effective. Alexander Weber, an orthopedic surgeon and chief of sports medicine at the University of Southern California, said there is not enough clinical data on the peptides, while also saying patients ask him about them every day.

Peptides are short chains of amino acids and occur naturally in the body. Some well-studied medicines, including insulin and GLP-1 drugs such as Ozempic, are peptides. The report distinguishes those treatments from synthetic peptides promoted by influencers and biohackers, often as injections, which have not undergone the kind of large-scale trials the FDA usually requires to assess safety and efficacy.

FDA career scientists have published documents saying evidence remains inadequate to loosen restrictions. A May white paper by the nonprofit ECRI and the Institute for Safe Medication Practices said the commercial market had grown faster than the clinical evidence base and called the lack of adequate evidence for human use an alarming safety concern. ISMP president Rita Jew said there was no new information that would make the group comfortable with authorizing the seven peptides for compounding.

Some advocates say restrictions have pushed the market toward overseas and online suppliers with little oversight. Robert F. Kennedy Jr., President Donald Trump's health chief, said in an interview with podcast host Joe Rogan that gray-market products may be substandard and that consumers cannot know whether they are getting a good product. Medical experts quoted in the report accused Kennedy of filling the FDA advisory panel with people who have strong ties to the peptide industry because of his personal interest in the products.

Ed Lee, an Orlando-based endocrinologist who co-founded the Clinical Peptides Society, supports approval for compounding, especially for BPC-157. He also started a petition called Save Peptides, which has nearly 10,000 signatures and asks federal legislators to loosen restrictions. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, said demand should not replace evidence and described the science as extremely thin. Weber said patient anecdotes about benefits are not enough to guide broader use without deeper research.