On Wednesday, the Food and Drug Administration (FDA) said it plans to hold a meeting in July to review whether to loosen regulations on several unapproved peptide injections that have gained popularity among wellness influencers and celebrities.
The FDA has scheduled meetings on July 23 and 24 for its Pharmacy Compounding Advisory Committee to evaluate seven peptide compounds, including BPC-157, for possible inclusion on the list of substances pharmacies can legally produce.
Political And Regulatory Context
The development follows public statements from Health Secretary Robert F. Kennedy Jr., who has supported broader access to peptide therapies. Kennedy oversees the Department of Health and Human Services, which includes the FDA.
The review marks a shift from earlier FDA action in 2023, when the agency restricted nearly 20 peptides from compounding pharmacies due to safety concerns, including potential risks to major organs. At the time, an FDA advisory panel largely supported those restrictions, citing limited human testing data.
Markets reacted to the broader regulatory discussion around peptides, with Hims & Hers Health Inc. (NASDAQ:HIMS) rising 9% in premarket trading on Thursday, after the company expressed support for the FDA’s plan to clarify the regulatory status of peptide therapies and expand potential access through compounding pharmacies.
Scientific And Regulatory Uncertainty
Most of the peptides under review have not completed large-scale human clinical trials. Some are widely discussed in wellness and longevity circles, but remain outside the standard FDA drug approval pathway.
Some critics, including former pharmaceutical executive Martin Shkreli, argue that many peptide therapies lack sufficient clinical validation and question whether they meet the standards of established drug development.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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