The Food and Drug Administration (FDA) is hosting a meeting over two days to assess the safety and efficacy of over half a dozen peptides, which have surged as a popular wellness trend despite minimal evidence supporting their safety and effectiveness. This event has attracted attention from Health Secretary Robert F. Kennedy Jr., who is a strong advocate for peptides and seeks to remove industry restrictions instituted during President Joe Biden’s tenure.

Well-known personalities, such as podcaster Joe Rogan and wellness influencers like Gary Brecka, have endorsed peptides. Brecka is a proponent of Kennedy’s “Make America Healthy Again” initiative and sells peptide vials online. Social media is filled with accounts from individuals claiming peptides have helped them enhance muscle, heal faster from injuries, and appear younger.

This meeting is set to highlight disagreements concerning these compounds. FDA career scientists have expressed the view that current data does not justify making peptides more readily accessible, notably from compounding pharmacies that create specialized medications unavailable through conventional drug manufacturers. This standpoint is supported by many medical and scientific experts.

This is really alarming, said Rita Jew, a pharmacist and president of the Institute for Safe Medication Practices. There aren’t that many other substances people are injecting into themselves where you see that the clinical evidence is so lacking.

Interestingly, the panel includes several doctors and pharmacists with financial interests in the peptide industry, like owners of wellness clinics selling peptides, pharmacies producing these compounds, and online consulting businesses promoting them. Critics have previously pointed out conflicts of interest regarding other panels appointed under Kennedy.

Recently, the FDA supplemented the panel with academic members who have no connections to the industry amidst ongoing skepticism about peptide safety. The panel will vote on whether the FDA should add seven prominent peptides to a list allowing compounding by pharmacies. These votes aren’t binding, and the FDA has a history of defying external expert advice.

Peptides serve as the foundational elements of more complex proteins, activating essential hormones for growth, metabolism, and healing. Some medications with peptides exist, including treatments for diabetes and weight loss. Supporters are urging the FDA to consider these peptides for various conditions, such as ulcerative colitis, migraines, and opioid addiction.

The FDA has previously cautioned the public regarding the dangers associated with peptides like BPC-157 and TB-500, which are reviewed at the meeting. Marketed online for injury recovery and inflammation reduction, they are also flagged as doping agents internationally. FDA reviews reveal concerns about the lack of human-based data, contamination risks, allergic reactions, and quality control issues.

The two-day event will feature presentations and allow public input, including comments from doctors and patients who have benefited from peptides. The American Academy of Peptide Medicine advocates for making peptides safely accessible from regulated pharmacies.

For many people, this is about a therapy that is helping them, and whether they can get it safely and legally from a regulated pharmacy instead of taking their chances in the gray market, states the Academy.

The FDA will evaluate discussions, votes, and public opinions to decide on peptide access. Observers suggest the FDA might temporarily reassure pharmacies they aren’t at risk for compounding the peptides in question. Adding peptides to the list of drugs safe for compounding would require new regulations, which could take a long time to finalize.

We’re still going through this process, but I think it’s more than likely that the process will end up at the result that Secretary Kennedy wants, commented Nathan Beaver, an attorney specializing in FDA issues.

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