FDA panel to consider loosening regulations for some peptides

A U.S. Food and Drug Administration advisory panel is set to deliberate on the use of unapproved peptides by compounding pharmacies. The meeting comes as interest surges in these therapies, which are often marketed online with claims of slowing aging or enhancing muscle growth, despite lacking robust clinical data.

Peptides, short chains of amino acids, are naturally produced by the body, and over 80 are already FDA-approved for various uses, including insulin and GLP-1 medications. However, a growing number of unapproved peptides are being sold, typically labeled for "research use only."

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At this point, we all need to be wary about putting an injection in your body without actually knowing the product. I mean, they could have arsenic in it

Health and Human Services Secretary Robert F. Kennedy Jr. has expressed support for these unapproved therapies, citing personal use for injury recovery. The panel will review seven specific peptides, including BPC-157, known for its purported healing properties. Dr. Rachel Pessah-Pollack of NYU Langone noted that BPC-157 has only been tested on about 30 humans, a stark contrast to the extensive testing of approved GLP-1s.

Dr. Jessica Duncan, chief medical officer for IVIM Health, argues that the FDA should facilitate regulated access to these sought-after therapies. "People want them. They have proven to us that they are going to seek them out," Duncan stated, advocating for proper medical guidance. Concerns remain about the "gray market" where many peptides are sold, with potential risks of contamination and impurities, as highlighted by Dr. Pessah-Pollack's warning about unknown substances like arsenic.

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People want them. They have proven to us that they are going to seek them out. What I'm asking and advocating for is that the conversation with them, the education that's provided, is in the exam room.