- Injectable “wellness” peptides have gained significant popularity among health and wellness enthusiasts, despite a lack of convincing evidence regarding their safety and efficacy.
- Social media influencers and biohackers have promoted these peptides as a “fountain of youth” for achieving longevity benefits and improving physical fitness.
- Experts in the medical community have expressed concern regarding the safety of compounded peptides marketed for wellness, calling for federal regulation of these products, which are increasingly sold online.
In the 1980s, anabolic steroids moved beyond elite athletic circles and became popular among fitness enthusiasts and gym-goers.
The medical community soon questioned their safety. Researchers and sports organizations have highlighted health risks associated with the recreational use of anabolic steroids, such as heart disease. By 1991, these substances were banned for non-medical use under the Anabolic Steroid Control Act.
However, the quest for quick, unproven methods to achieve peak physical condition is far from over.
Currently, influencers and biohackers promote peptide injections as a “fountain of youth”—an all-in-one solution for muscle growth, longevity, and other benefits.
In the past, so-called “wellness” peptides have become widespread despite the absence of reliable evidence. To date, no study has demonstrated their safety for human use.
A recent position paper by the Institute for Safe Medication Practices (ISMP) on the safety and efficacy of wellness peptides highlights “troubling safety concerns” regarding their widespread use. Unlike commercially studied peptide drugs (such as insulin and GLP-1 agonists), compounded peptide products marketed for “wellness” are not regulated by the Food and Drug Administration (FDA).
While no state has outright banned peptides not approved by the FDA, some have reinforced public health messaging to curb online sales. For example, Alabama’s medical regulatory body recently issued a warning against the use of research-grade peptides not approved by the FDA, citing health and safety risks.
The FDA is expected to decide in July whether certain compounded wellness peptides should be officially authorized for use.
Experts are concerned that Secretary of Health and Human Services Robert F. Kennedy Jr.—a staunch advocate of FDA-regulated peptides—might ease some regulatory hurdles. “This has nothing to do with wellness,” says Dr. Bert Mandelbaum, a sports medicine specialist, orthopedic surgeon, and co-director of the Center for Regenerative Orthobiologics at Cedars-Sinai Orthopaedics in Los Angeles.
“I would say it’s more of a trend that’s flying under the radar. It’s worse than that: it’s criminal. Influencers, including RFK Jr., are taking advantage of the system and ignoring the science,” he told Healthline.
Healthline spoke with Mandelbaum to learn more about the dangers of unregulated peptides and the reasons why most people should steer clear of them.
What are wellness peptides?
Mandelbaum: Peptides are a group of compounds that combine to perform various functions in our body.
Among the peptides is leucine, an excellent amino acid for building muscle that has been widely studied. Since peptides are derived from proteins, they are widely promoted on social media.
The peptides BPC-157, TB-500 and CJC-1295 are being marketed by *influencers* for all kinds of purposes: from improving physical performance and healing joints to losing fat and combating aging. They are simply peptides whose use has been distorted. There is no research, no proper labeling, and no clear information on the associated side effects.
Fortunately, our real athletes have not fallen into this trap. The good news is that we have biological drugs that can achieve many of the effects attributed to peptides.
If you are a bodybuilder looking to gain muscle mass, you might think peptides will help you achieve that. In the past, the topic revolved around anabolic steroids and their combinations, but we have proven that they are not safe.
Are compound peptides illegal?
Mandelbaum: As for the legality of these self-injections, this is all a farce.
From a regulatory perspective, they are not FDA-approved. They are barred by the World Anti-Doping Agency (WADA), the Department of Defense (DoD) and the Department of Justice (DoJ).
BPC-157 (a 15-amino acid pentadecapeptide) is a synthetic derivative of human gastric juice; It is touted online for its incredible healing properties and benefits for performance and longevity, although such effects have never been demonstrated in subjects other than mice.
It’s like a bunch of gym freaks got together and said, “Let’s see how many we can sell.” It is a market completely unregulated.
What are the risks of wellness peptide injections?
Mandelbaum: There are risks, some of which we are unaware of; for example, the risk of developing tumors.
Infections and negative effects on the heart or immune system, as well as risks to bones or tissues, may occur; These are aspects about which we have limited or no information. These products need to be investigated.
We don’t know its safety profile yet, but I have seen patients injecting this substance into their knees, and there have been cases of contamination.
The supposed effectiveness of BP-157 is a myth. There is no clinical evidence supporting its use, and its safety raises serious questions. Currently, some influencers market it and take advantage of the reach of social networks to encourage people to inject this substance into their knees.
In addition to the safety risks, these products are very expensive.
Are there safer, proven alternatives to wellness peptides?
Mandelbaum: In sports and performance medicine, we aim to foster recovery, build muscle, and optimize performance; we call this preservation.
There is an entire family of orthobiologic compounds whose safety and efficacy in promoting recovery have been demonstrated with a very high level of evidence.
Whether we are talking about longevity, health, or an athlete’s playing time, maintaining performance over the long term involves more than just a single factor.
Physical condition, VO₂ max, and workload all play a role. Nutritional aspects—such as recovery, sleep, and injury prevention—are also fundamental. Creatine, for example, can help build muscle mass.
Currently, we limit ourselves to what are known as “autologous products,” including platelet-rich plasma (PRP), bone marrow aspirate concentrate, and adipose tissue; all are FDA-approved, and none are banned.
Orthobiologics play an important role, but together with these elements, they make up the full picture.
Each of these factors can influence an athlete’s performance, so every variable matters. Understanding the role of free radicals and inflammation in the body is crucial.
Should the FDA propose a ban on peptides?
Mandelbaum: That is precisely what we expect from the FDA.
I hope the government’s initial response takes into account the immense interest surrounding this topic.
We need more research and more evidence of efficacy; the process of gaining FDA approval for a biological procedure involves overcoming incredibly complex hurdles.
As physicians and scientists, we must ask and answer certain questions: Is it effective for that specific use? Is it safe? Is it safe for animals? Is it safe for humans? The only way to know is through research. Peptide promoters have entered the scene through the back door. Until we have more evidence and that information available, the responsibility falls on the government to bridge the gap between expectations and actual knowledge.
Public health authorities have a responsibility. Let us study the matter; let us sponsor a 5- to 10-year research protocol to analyze it, and let the FDA evaluate the data once the study is complete. Take the case of PRP, for example. In 2007, we noted that further research was needed to determine its safety and efficacy for healing muscles, tendons, and joints. We have had to undergo this scrutiny over the last 19 years—simply by using PRP—to understand how it can help athletes.
Responding at the government level without conducting proper research will seriously harm our population.