FDA Reviews Peptides Amid Safety and Efficacy Concerns

Health advisers are meeting to assess more than six peptides, substances gaining popularity in wellness trends despite insufficient evidence of their safety or effectiveness. The Food and Drug Administration (FDA) is hosting this two-day event with backing from Health Secretary Robert F. Kennedy Jr., who supports peptides and opposes industry restrictions by President Joe Biden.

Peptide advocates, like podcaster Joe Rogan and wellness influencer Gary Brecka, promote peptides for muscle building, injury recovery, and anti-aging effects. Social media is filled with claims supporting these benefits. However, FDA scientists express concerns, emphasizing the lack of substantial data for widespread availability, especially through compounding pharmacies, which create customized medicines unavailable from regular producers.

Many medical experts have shared similar doubts before the meeting. Rita Jew, president of the Institute for Safe Medication Practices, highlighted the lack of clinical evidence for substances being widely used. Nevertheless, the advisory panel includes several doctors and pharmacists with financial ties to the peptide industry, leading to potential conflicts of interest.

The FDA has added more experts to the panel, including academics with no industry connections. Discussions will consider whether seven peptides should be deemed safe for compounding. The votes are advisory, and the FDA may not follow them.

Peptides are essential components of proteins, influencing bodily hormones related to growth, metabolism, and healing. Pharmaceutical companies have developed peptide-based drugs for conditions like diabetes and weight loss. Peptide proponents requested FDA consideration for peptides to treat ulcerative colitis, migraines, and opioid addiction.

The FDA has warned about peptides like BPC-157 and TB-500, considered doping substances by sports authorities. FDA scientists remain skeptical about their safety and benefits, highlighting the lack of human trials and emphasizing contamination risks, allergic reactions, and quality issues. For all peptides under review, staff suggests against their compounding availability.

The meeting includes over 18 hours of presentations and public input opportunities, with over 1,900 comments submitted. The American Academy of Peptide Medicine, advocating for peptides, emphasizes safe and legal access through regulated pharmacies.

Following the meeting, the FDA will evaluate votes, discussions, and public comments before deciding on peptide access. Observers speculate a provisional policy may reassure pharmacies about compounding peptides under review. Formally adding them to the list of safe drugs for compounding requires new regulations, a lengthy process.

Health and Science content by the Associated Press, supported by the Howard Hughes Medical Institute and the Robert Wood Johnson Foundation.