The Best FDA Decision On Peptide Authorization Isn’t Yes Or No

The FDA Debate: To Authorize Or Not

Last month, the Food and Drug Administration’s Pharmacy Compounding Advisory Committee narrowly recommended adding six of seven experimental peptides to the Section 503A Bulks List, which identifies ingredients that pharmacies can use to prepare compounded medications. Those substances include BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax.

The committee’s recommendation also drew scrutiny for two reasons. First, FDA staff cited insufficient evidence about the safety and effectiveness of the six peptides. Second, as the Washington Post reported, at least six newly added members had ties to peptide-related businesses or medical practices, which prompted FDA officials to raise concerns about potential conflicts of interest during the selection process.

The FDA said all members underwent its standard ethics review. Supporters argue that clinicians and pharmacists with direct peptide experience bring valuable expertise to the discussion.

No decision date is set. It could be days or months before a final ruling.

However, even if FDA leaders accept the committee’s recommendation, the compounded medications would not be FDA-approved. Still, access through physicians and licensed pharmacies could make them seem more fully vetted than they are.

Why ‘Yes’ Or ‘No’ Isn’t The Right Answer

The central problem is that either FDA decision would leave major questions unanswered. Americans still would not know whether these peptides are effective or safe. Scientific research is needed to answer both questions.

If the peptides improve health, more patients would benefit from using them. If they are ineffective or dangerous, people need to be warned.

Neither the previous administration nor the current one has created a credible way to generate those answers. Under the Biden administration, regulators effectively barred these peptides from being sold in the United States after raising concerns about potential safety risks and gaps in human evidence.

The policy, along with stepped-up enforcement against suppliers and pharmacies that might be providing them, did not eliminate demand. Large numbers of Americans continued obtaining the peptides online from gray-market and overseas sources.

The Trump administration, with HHS Secretary Robert F. Kennedy Jr. among the most prominent supporters of peptides, appears poised to move in the opposite direction by permitting broader access through licensed compounding pharmacies.

But the same fundamental problem remains: we still don’t know whether these peptides should be used more widely or restricted far more aggressively.

What The Six Peptides Do (And Don’t Do)

There are thousands of natural and synthetic peptides. Many occur naturally in the body and act as chemical messengers, influencing metabolism, inflammation, reproduction and other physiological processes.

More than 100 peptide drugs are currently FDA-approved in the U.S., and many are lifesaving medications.

Insulin revolutionized diabetes treatment while GLP-1 drugs have helped people with obesity and diabetes lose substantial weight and improve their health. But just because two substances belong to the same chemical family does not mean they are equally safe or effective. Peer-reviewed scientific studies are needed to establish both.

For the six peptides now under final consideration by FDA leadership, public enthusiasm has advanced much faster than the science:

1. BPC-157 is promoted for gastrointestinal conditions, injury recovery and tissue repair.
2. KPV is marketed for inflammation, wound healing and skin conditions.
3. TB-500 is promoted for healing muscle and tendon injuries.
4. MOTS-c is marketed for metabolic health, weight loss, exercise performance and healthy aging.
5. Epitalon is promoted for sleep and longevity, including claims that it lengthens telomeres.
6. Semax is promoted for migraines, cognition and neurological conditions.

Across all six, high-quality human evidence remains limited. Much of the available research consists of animal studies and small human trials without control groups. All suffer from insufficient data to establish either effectiveness or long-term safety. The lack of evidence does not prove these peptides are dangerous. It means researchers cannot yet say with scientific confidence whether their claimed benefits outweigh their risks.

A Better Federal Strategy

Supporters of broader peptide access make a reasonable argument: Americans are already using these substances, and obtaining them through physicians and regulated U.S. compounding pharmacies would be safer than relying on gray-market suppliers.

Critics make an equally valid point: expanded access would encourage far more Americans to use products, despite lingering uncertainty about their benefits and long-term risks.

The FDA won’t resolve these competing concerns with a simple yes-or-no choice. If it authorizes these substances for use in qualifying compounding pharmacies, it should pair that decision with a federally coordinated research program.

The National Institutes of Health could lead a one-year research effort, with the FDA and Centers for Disease Control and Prevention contributing regulatory and safety-surveillance expertise.

• People already using the peptides could continue receiving them if they agreed to submit data on their health and any adverse events.
• New patients could gain access under a scientific double-blind research protocol. Researchers would conduct controlled clinical trials of individual peptides for specific medical uses (with appropriate comparison) groups to evaluate efficacy and short-term safety.
• At the end of one year, the FDA could review the findings and decide whether to continue, expand or restrict access while longer-term, follow-up research continues. Although a one-year program would not answer every question, particularly about rare or long-term risks, it would generate far more evidence than the current process and give regulators a stronger basis for deciding what should happen next.

This type of approach has precedent. The federal government has previously linked access or coverage for certain treatments to participation in research when important questions remained unanswered. Medicare, for example, used “coverage with evidence development” for certain Alzheimer’s treatments, requiring qualifying patients to participate in approved studies.

Companies that stand to profit from expanded peptide access should help finance the research. That principle also has precedent: pharmaceutical and medical-device companies already pay FDA user fees that support product review and certain post-market safety activities.

Both Democrats and Republicans have failed to resolve basic questions about peptides. The Biden administration’s absolute restriction on peptides resulted in Americans turning to the gray market without being properly educated. If the FDA, under the Trump administration, authorizes the sale of peptides through compounding pharmacies without requiring additional research, we’ll likely never find out whether these substances are safe or effective.

The best path is to pair regulated access with scientific research.