FDA Advisory Panel Recommends Easing Restrictions on Unapproved Peptides Despite Agency Scientists' Concerns

An FDA advisory panel voted to recommend easing compounding restrictions on six unapproved peptides, including BPC-157 and Semax, while rejecting emideltide. The decision, which reverses Biden-era restrictions, represents a major victory for Health Secretary Robert F. Kennedy Jr. and the wellness industry. However, the vote drew sharp criticism from FDA staff scientists who warned of a lack of clinical safety data, amid concerns over the panel's newly appointed members who have extensive ties to the peptide industry.

FDA advisory panel peptide recommendations

• ▪The Food and Drug Administration Pharmacy Compounding Advisory Committee voted to recommend that compounding pharmacies be allowed to manufacture six out of seven unapproved peptides under review.
• ▪The Food and Drug Administration Pharmacy Compounding Advisory Committee recommendations are non-binding, and the Food and Drug Administration will make the final decision through a formal rulemaking process.
• ▪The Food and Drug Administration Pharmacy Compounding Advisory Committee voted to recommend compounding for BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax, while voting against emideltide.

Insufficient clinical trial evidence

• ▪Dr. Rachel Pessah-Pollack stated that the peptide BPC-157 has only been tested in approximately 30 humans, compared to the hundreds of thousands of patients involved in GLP-1 clinical trials.
• ▪Food and Drug Administration official Russell Wesdyk stated that the chemical composition of peptides labeled with the same name varies considerably, presenting a foundational challenge for establishing quality standards.
• ▪Food and Drug Administration staff scientists opposed loosening restrictions, stating there is a lack of clinical trial data to establish the safety and effectiveness of the reviewed peptides.

Panel members' industry connections

• ▪Health and Human Services Secretary Robert F. Kennedy Jr., who has publicly supported peptide therapies, appointed the new panel members who voted to ease the peptide compounding restrictions.
• ▪Committee member Tennessee State Senator Bobby Harshbarger is the son of Representative Diana Harshbarger, who previously requested that compounding pharmacies be allowed to manufacture certain peptides.
• ▪Prior to the meeting, the Department of Health and Human Services appointed eight new members to the 14-member advisory committee, most of whom have ties to the peptide industry.

Compounding pharmacy regulatory pathway

• ▪During the Biden administration, the Food and Drug Administration added nearly 20 peptides to a federal list of substances barred from legal compounding due to safety risks.
• ▪If the Food and Drug Administration approves the compounding of the six peptides, patients will require a doctor's prescription to obtain the therapies from specialized compounding pharmacies.

Unregulated online peptide sales

• ▪Medical experts warn that gray market peptides purchased online carry significant risks of contamination, impurities, infections, or allergic reactions.
• ▪Unapproved peptides are widely sold online in a 'gray market' under labels such as 'for research use only' and 'not for human consumption' to bypass federal drug regulations.