An FDA advisory panel has recommended making six unapproved peptides more accessible through compounding pharmacies — but scientists warn that easier access does not mean these experimental products have been proven safe or effective.
When you purchase through links on our site, we may earn an affiliate commission. Here’s how it works.
Controversial wellness products called peptides are rising in popularity as they're touted by leaders like Health and Human Services Secretary Robert F. Kennedy Jr.
While some peptides — including drugs like Ozempic — have been rigorously tested and approved by the Food and Drug Administration (FDA), many peptides are untested and unregulated. These untested peptides are often accessible online for anyone to purchase from loosely regulated manufacturers. There's now a multibillion-dollar gray market for these products, in which many peptides are sold without human-safe manufacturing processes or human testing to demonstrate their effectiveness, scientists say.
Recently, an FDA advisory panel voted to increase consumers' access to several peptides, saying the products — marketed for sleep issues, wound healing, cognitive disorders and more — should be available through compounding pharmacies with a prescription. These pharmacies, which offer customized medications, are subject to less oversight than traditional pharmacies and can distribute drugs that have not been FDA approved. Opponents of the advisory panel's decision argue that these peptides have not gone through rigorous clinical testing and could pose risks to consumers.
So what does this advisory panel decision mean for peptide regulation, and how might it affect consumers? And at the end of the day, are the peptides safe? Here's what you need to know.
Broadly speaking, peptides are short chains of amino acids, the same building blocks that make up proteins. Peptides are smaller than proteins, and their structures are less complex.
Body-made peptides can act as messengers throughout the body, telling cells what to do. Some are considered hormones and some are not. There are about 7,000 known peptides that help organs communicate with each other and direct various bodily functions and behaviors, including blood sugar control and mood. Insulin, oxytocin, vasopressin and endorphins are examples.
The first synthetically manufactured peptide was insulin, which is normally produced by the pancreas to regulate blood sugar levels but is lacking in people with diabetes. Recently, peptides called GLP-1 agonists — the class of drugs that includes Ozempic and Wegovy — have become incredibly popular. Naturally expressed in the gut, the GLP-1 hormone functions, in part, by telling the brain that you've had enough to eat.
Only a few peptides are actually FDA approved meaning they are safe and efficacious for certain diseases. Many other peptides are still not FDA approved and should be considered experimental.
While these peptides are usually injectable medicines, others are taken orally or inhaled via nasal sprays. Peptides that are intended to treat or prevent disease, or to affect the structure or function of the body, are legally considered drugs and should be regulated and approved for safety and effectiveness by the FDA. (However, that doesn't always happen, as we'll explain in the following section.)
Plant- or food-derived peptides, such as collagen peptides, are considered supplements. Supplements are less strictly regulated than drugs are, which results in their potency and purity being more variable than that of approved drugs.
Peptides like insulin and GLP-1 agonists have been extensively studied for years through rigorous trials to determine whether they are safe and effective for human use and to treat specific ailments. This is what is required to obtain FDA approval. The FDA has approved the use of about 100 peptides for therapeutic use against specific conditions, such as diabetes and multiple sclerosis.
GLP-1 agonists, used for blood sugar control and weight loss, are an example of approved peptide-based drugs.
That said, there are also peptides that have become popular for general wellness and even "biohacking," a form of self-experimentation to optimize physical and mental performance. These unapproved peptides are sold online, often with the label "research use only." The label acts as a loophole to legally bypass the regulatory oversight that would usually be applied to approved drugs. That said, the FDA has come after companies that explicitly advertised and sold these products for human use, despite that research-only label.
