Peptide Injections Touted as ‘Fountain of Youth’ and claim amazing benefits without any clinical studies

During the 1980s, anabolic steroids emerged out of elite athletic circles and rose to popularity among fitness and gym enthusiasts. It didn’t take long for the medical community to question their safety. Researchers and athletic organizations raised concerns over the health risks associated with recreational anabolic steroid use, such as cardiovascular disease. By 1991, the substances were banned for non-medical use under the U.S. Anabolic Steroids Control Act.

But the quest for fast-tracked, unproven methods to achieve peak fitness is far from over.

Today, influencers and biohackers tout peptide injections as a “fountain of youth,” a one-stop shop to achieve muscle gain, longevity, and more. Echoing the past, so-called “wellness” peptides have become ubiquitous despite lacking any credible evidence. No studies to date have verified their safety for use in humans.

A recent position paper by the Institute for Safe Medication Practices on the safety and efficacy of wellness peptides highlights an “alarming safety concern” about their widespread use.

Unlike well-studied commercial peptide drugs (i.e., insulin and GLP-1s), compounded peptide products marketed for “wellness” are unregulated by the U.S. Food and Drug Administration (FDA).

While no states have outright banned non-FDA-approved peptides, some have stepped up public health messaging, aiming to crack down on online sales. For instance, Alabama’s medical regulator recently issued a warning against the use of non-FDA-approved research-grade peptides due to health and safety risks. In the Commonwealth of Kentucky, the use of peptides is regulated by the Kentucky Board of Pharmacy. Their mission statement says, “The Kentucky Board of Pharmacy serves the Commonwealth to promote, preserve, and protect the public health, safety, and welfare through effective regulation of the practice of Pharmacy.​”

The FDA is expected to decide in July whether certain compounded wellness peptides should be officially authorized for use. Experts are concerned that U.S. Health and Human Services Secretary Robert F. Kennedy Jr., an avid supporter of peptides and the FDA’s overseer, could ease some of the red tape.

“This has nothing to do with wellness,” said Bert Mandelbaum, MD, sports medicine specialist, orthopedic surgeon, and co-director of the Regenerative Orthobiologic Center at Cedars-Sinai Orthopedics in Los Angeles. “I would call it more of an uninformed fad. It’s worse than that — it’s criminal. The influencers, including RFK Jr., are abusing the system and failing to follow the science. I would call it more of an uninformed fad. It’s worse than that — it’s criminal. The influencers, including RFK Jr., are abusing the system and not following the science,” he stated.

What are wellness peptides?

Peptides are a group of compounds that come together to have a wide variety of functions in our body.

Peptides are leucine, the amino acid that’s fantastic for building muscle, and it’s been well studied. Since peptides are protein derivatives, they’ve been exploited on social media.

The peptides BPC-157, TB-500, and CJC-1295 have been marketed by influencers for anything from performance to joint healing to fat loss and anti-aging. They’re just peptides that are being abused. There’s no research, there’s no label, there’s no associated effects.

Are compounded peptides illegal?

In the sense of the legality of these self-injections, this whole thing is a farce. From a regulatory perspective, they’re not FDA-approved. They’re banned by the World Anti-Doping Administration (WADA), the Department of Defense (DoD), and the Department of Justice (DoJ).

BP-157 (15-amino acid pentadecapeptide) is a synthetic derivative of human gastric juice, and it’s promoted online as having incredible healing capabilities and also for performance and longevity, none of which have ever been substantiated in anything other than rodents.

What are the risks of wellness peptide injections?

There are risks, some of which we don’t know, like tumor risk, for example. There’ve been infections; there may be negative impacts on the heart or the immune system, or risks to bone or tissue, none of which we know or don’t know. These things have to be investigated.

Should the FDA or the states ban peptides?

A ban would be ideal. We hope that our government’s first response would be that there’s a tremendous amount of appeal to do so. We need more research, more efficacy — the number of steps we have to go through to get a biological process approved by the FDA is extremely challenging.

As certified or licensed health coaches, APRNs, PA-Cs, physicians, and scientists, we have to ask ourselves and answer the questions:

1. Is it effective for that specific use?
2. Is it safe?
3. Is it safe in animals?
4. Is it safe in humans?

The only way we learn this is to study it. Peptide influencers have gone through the back door.

Until we have more evidence, until it’s been well studied, until we have that information, the onus is on our government to close the gap between hope and knowledge. Public health officials have a responsibility. Let’s study it; let’s sponsor a 5- to 10-year research protocol to examine it, and let the FDA evaluate that data when it’s complete.

Take PRP, for instance. In 2007, we said we needed more research to determine its safety and to ensure its efficacy for muscle, tendon, and joint healing. We had to go through this vigilance over the last 19 years, just with PRP, to understand how it could help athletes.

Responding at the governmental level without due diligence would seriously harm our population.