The promotion of various peptide injections by some health and fitness influencers, celebrities, and people in the Make America Healthy Again movement – compounds that haven’t been approved as safe and effective – raises important questions about how drugs are tested, marketed, and used in today’s social media-fueled society, says medical toxicologist Matthew Zuckerman, MD, of the University of Colorado Anschutz Department of Emergency Medicine.
At the urging of U.S. Health and Human Services Secretary Robert F. Kennedy Jr. – a leader of the MAHA movement, and himself a peptide user and enthusiast – the U.S. Food and Drug Administration, which Kennedy oversees, has been moving toward making it easier for people to obtain peptide injectables. These are substances that the FDA itself has said present potential safety risks because of a lack of study of their effects on humans.
People who take drugs for purposes that haven’t been fully studied and tested are experimenting on themselves, Zuckerman says. “Just ask yourself: Do you want to be the research subject?”
Zuckerman is an associate professor in the department’s Medical Toxicology and Pharmacology section. He is board certified in emergency medicine and medical toxicology.
A peptide is a short chain of amino acids, the building blocks of proteins. They either occur naturally or are created in the lab. Some peptides are in FDA-approved drugs, including insulin (for diabetes) and GLP-1 drugs such as Ozempic, Wegovy, and Zepbound (for diabetes and obesity).
But various other, unapproved peptides have been touted on TikTok, in podcasts, and by health-tech startups as ways to reverse signs of aging, repair tissue, relieve pain, and improve cognitive performance, among other claims. That’s despite the lack of rigorous scientific study and the three phases of human clinical trials that precede FDA approval of new drugs.
Among these widely promoted peptides is BPC-157, which popular podcaster Joe Rogan has frequently endorsed as a way to heal soft tissue injuries and joint issues.
An FDA advisory committee has scheduled a meeting for late July to discuss whether compounding pharmacies should be allowed to prepare several unapproved peptides for sale to people with a prescription, including BPC-157. Those prescriptions could come from a telehealth doctor without an in-person physical exam.
Unlike a traditional pharmacy, which dispenses FDA-approved drugs produced by pharmaceutical companies in defined doses, a compounding pharmacy mixes raw pharmaceutical ingredients to create custom medications. Compounded drugs are not FDA-approved.
During the Biden administration, the FDA restricted compounding pharmacies from making these and other peptides, citing safety concerns. But advocates are now pushing to have those limitations reversed in some cases.
Many users of peptide injectables currently get them through an underground “gray market” that includes online “research chemical” sites, spas, and overseas factories.
There’s a misconception hovering over this potential change in compounding rules, Zuckerman says.
“In the United States, where we assume that we have a fairly well-regulated drug market, when something is legally available on a shelf, people often think that means that the FDA has tested it and it’s safe and effective. That’s true for classically regulated drugs and medications, where the FDA has approved the drug, the manufacturing methods, and even the labeling on the bottle and the box. But it’s not true for everything.”
Zuckerman says that “the rise of telemedicine and direct-to-consumer marketing, and a greater focus on lifestyle medications, has led to an increased interest” in unapproved drugs such as peptide injectables. Some see relaxing restrictions on production of peptides by compound pharmacies as the answer to meeting demand and steering consumers away from the gray market.
In years past, Zuckerman says, compound pharmacies worked like “custom tailors,” making medications in forms or dosages that weren’t available from traditional pharmacies for patients who needed them, or helping to fill gaps when an approved drug was in short supply. Now, he says, the interest in peptides “puts compounding pharmacies in an area where they start to act like mass drug producers.”
He says compounding pharmacies “have been inspected and regulated by states more than the FDA, and in some cases there have been outcomes where there’s been bacterial contamination and issues with quality control and dosing that would typically be caught in a larger manufacturing process but are missed.”
There isn’t enough efficacy and safety data to approve these peptide injectables as traditional drugs, but Zuckerman says that the FDA is facing the reality that “a lot of Americans are interested in drugs that they feel probably work and are probably safe. They think the FDA is just too slow in evaluating them, so they want to have them today versus five years or 10 years from now. There’s a perception that if a drug isn't approved, that just means it’s not approved yet. There’s a sense that if they’re not killing people, we should have them available.”
There have always been complaints that the FDA is too slow, Zuckerman says, but “historically, one of the reasons why lots of countries look to our drug regulatory system and our safety data to say if a drug is safe is because our system works really well. There was a period in American history where we didn’t have an FDA, and there were accidental deaths and a lot of harm.”
Zuckerman notes that the FDA often is able to move quickly on approving drugs during medical emergencies, such as the process that led to effective vaccines during the COVID-19 pandemic. “But when you're talking about a treatment that promises to make you smarter or help you look better, rather than protecting you in a global pandemic, the public health justification for short-circuiting becomes less obvious to many people,” he says.
If compounding pharmacies are given the green light to produce peptide injectables, he says, “it’s more challenging to get these approved through traditional routes, because there’s no longer any financial incentives. You could already sell them and make money off them. I mean, why have a drug regulatory system when you’re going to constantly come up with exceptions?”
Zuckerman notes that some peptides, like the GLP-1 drugs, have been approved by the FDA.
“Honestly, if the demand is there and the efficacy is there, then traditional drug development – which does take time and money – should be able to bring these peptides to market.”
He adds: “At the end of the day, we’re seeing that people have an unmet need. They’re concerned about longevity, about energy, about their body. They should be having conversations about that with the same physicians they typically see. They should ask them what they think and be astute consumers. Be careful.”