Peptides, the short chains of amino acids that help regulate biological functions, have become the latest obsession in health, fitness, and longevity.

Online clinics and wellness influencers promote them as ways to heal injuries, reduce inflammation, improve metabolism, sharpen thinking, and slow aging.

Today, these substances are part of a growing gray market. A recent Forbes report estimates millions of Americans are injecting unapproved peptides, often purchased from suppliers in China whose manufacturing quality, purity, and contents are difficult to verify.

Federal regulators now face a milestone decision: whether six popular — but experimental — peptides should be made available through licensed compounding pharmacies, which customize medications for patients based on physicians’ prescriptions.

The financial stakes of this decision are substantial. If the FDA authorizes them, analysts at Leerink Partners estimate that telehealth sales of these peptides could approach $2.2 billion in 2027.

The FDA debate: To authorize or not

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

The committee’s recommendation drew scrutiny for two reasons. First, FDA staff cited insufficient evidence about the safety and effectiveness of the six peptides. Second, 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.

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

Why ‘yes’ or ‘no’ isn’t the right answer

The central problem is that whether the FDA approves or rejects the advisory committee recommendations, Americans won’t 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. That policy, along with stepped-up enforcement against suppliers and pharmacies, 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 to the opposite extreme by permitting broad access through licensed compounding pharmacies.

Either way, doctors won’t have sufficient research data to determine whether to recommend these peptides or limit their use.

What the six peptides do (and don’t do)

There are thousands of biological 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., including insulin and GLP-1 drugs for diabetes and obesity.

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 limited human trials without control groups. As a result, patients can’t determine whether their benefits will outweigh their risks.

A better federal strategy

Supporters of FDA authorization point out that Americans already use these substances. Acquiring them through physicians and regulated U.S. compounding pharmacies would be safer than relying on gray-market suppliers.

Critics argue that expanded access would encourage far more Americans to use products, despite 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, the best path would be to pair that decision with a federally coordinated research program.

The NIH could lead a one-year research effort, with FDA and CDC contributing regulatory and safety-surveillance expertise.

— People already using the peptides would continue receiving them if they agreed to submit data on their health and any adverse events.

— New patients would 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 the research expectations and expand or restrict access based on the data.

Although a one-year program would not answer every question, particularly about rare or long-term risks, it would generate far more evidence than exists today.

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 access to peptides 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 Democratic and Republican administrations have failed to resolve basic questions about the safety and efficacy of the six peptides. The best path now is to pair regulated access with scientific research.

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Robert Pearl, the author of “ChatGPT, MD,” teaches at both the Stanford University School of Medicine and the Stanford Graduate School of Business. He is a former CEO of The Permanente Medical Group.

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