FDA’s Review Of Peptides Signals A Growing Public Health Challenge— Separating Science From Hype

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The U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee will meet July 23-24 to review whether seven peptides should be eligible for compounding under Section 503A of the Federal Food, Drug and Cosmetic Act. The committee will evaluate whether sufficient evidence exists to allow these peptides to be legally compounded by pharmacies throughout the U.S.

What Are Peptides?

Peptides are short chains of amino acids, which form the building blocks of proteins. Some peptides are naturally produced in the body, such as insulin; which is a hormone secreted by the pancreas that decreases blood sugar levels. In addition, some medications, like GLP-1 drugs for obesity, are peptides. These drugs, like semaglutide and tirzepatide, have been rigorously tested over years of clinical human trials and have been FDA approved to treat obesity.

However, the seven peptides that will be under review occupy a different category. The seven peptides include BPC-157, TB-500, KPV, MOT-s, Semax, Epitalon and Emideltide. These substances have gained wide popularity on social media and have been touted by a number of influencers with claims of promoting longevity, skin rejuvenation, metabolism and enhanced cognition. Despite their popularity, there remains a paucity of human clinical evidence to support their safety and efficacy.

BPC-157

Body Protection Compound-157 is a peptide that naturally occurs in human gastric juice. It has been marketed as a recovery peptide capable of healing injured muscles, tendons and ligaments. Although several laboratory and animal studies suggest potential regenerative effects, there are scant high-quality randomized controlled human trials demonstrating its safety or efficacy. Without human trials, clinicians cannot reliably determine appropriate dosing, long-term risks or whether benefits outweigh risks.

TB-500

TB-500 has been promoted for tissue repair and faster athletic recovery. It promotes the growth of new blood vessels and modulates inflammation to allow for repairing muscles and healing wounds. Despite claims on social media of its efficacy, no human trial to date has shown it to be effective at repairing muscle or improving performance in healthy individuals.

Semax

Semax, which was developed decades ago in Russia, has been investigated for cognitive disorders and stroke recovery. While some studies have shown potential benefits positively affecting some brain functions, much of the evidence comes from small studies or animal studies. Rigorous human clinical trials are lacking for this specific peptide in documenting safety and efficacy.

Concerns For FDA Review

After reviewing the evidence surrounding peptides, the FDA’s own scientists recommended against changing the status of any of the seven peptides that will be reviewed later this week. In addition to scientific concerns, some concerns on the integrity of the meeting itself are also present. Many of the members of the FDA’s Pharmacy Compounding Advisory Committee have ties to the peptide industry according to reports from NPR, raising concerns of bias in the evaluation of the evidence for or against the use of peptides in compounding pharmacies.

Public Health Implications

The FDA review presents a challenging dilemma for public health in the United States. Americans are increasingly seeking innovative therapies for aging, chronic pain and longevity; often faster than science can provide definitive answers. When demand exceeds evidence, an unregulated marketplace frequently fills the gap.

This grey market where these peptides are being sold creates enormous risk for Americans. Products sold online as “research use only” have the possibility of containing contaminants, impurities or incorrect doses. These products have not received the safety and quality review of the FDA, and have not adequately been tested on humans like other more rigorously tested products like GLP-1 drugs.

The FDA’s upcoming review serves as an important reminder than popularity is not the same as evidence. Science starts with curiosity and posing a question that is then tested through acquiring data and then analyzing the accuracy of that data. Without robust evidence, Americans remain vulnerable when purchasing products that have not undergone regulatory oversight.

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