Peptides are everywhere: in your favorite serum, on your TikTok FYP, and for many people, injected as part of a “stack” meant to help suppress appetite, stimulate muscle growth, or (purportedly) support longevity, often with code-like names of capital letters and numbers trailing behind. While GLP-1 is definitely the most famous peptide (either you’re on one, or you know someone who is), a new group of peptides may be making their way into our collective consciousness, if health secretary Robert F. Kennedy, Jr. has his way.
As reported by the New York Times, the Food & Drug Administration (FDA) is likely to lift restrictions on a handful of banned peptides, due in part to urging from Kennedy. (A meeting to evaluate seven of these peptides is set for July.) However, this does not mean that the peptides will automatically receive FDA approval. In 2023, the 14 peptides in question were removed from production due to potential safety risks and include several with alleged beauty benefits. But, as the NYT notes, though the 14 peptides were technically restricted by the government (meaning compounding pharmacies were not allowed to produce them), consumers could still purchase them via the online gray market and play doctor from the comfort of their kitchen.
What are peptides anyway?
Let’s back up a bit. The word “peptide” has become a mainstay of skin-care marketing lingo and collagen drink mixes. But what do peptides actually do? “Peptides are best understood as targeted signaling molecules. They tell the body to upregulate processes it already knows how to do, such as repair, regeneration, or metabolic regulation,” explains Amanda Kahn, MD, a board-certified internist in New York City.
“In practice, they can support areas like body composition, recovery, skin quality, hair growth, and inflammation when used appropriately.” (Peptides that you apply topically may have limited penetration into the skin, depending on formulation.)
But what peptides cannot do, she adds, is “act as a replacement for foundational health.” Peptides are not a substitute for things like proper nutrition, sleep, and medical care, Dr. Kahn adds, saying that patients are drawn to the “precision and personalization” of peptides, which allow for a more tailored approach to treatment.
GLP-1s have dominated the peptide game and the cultural conversation for the past few years, but Jeffrey Lee, MD, a board-certified plastic surgeon in Boston, notes that there are many others emerging, and they may have a “wide range” of effects. Some of the restricted peptides may have potential benefits for immune function, healthy aging, healing, and metabolism, he says, and many others are “being explored for similar benefits related to overall tissue health.”
Which peptides are on the banned list?
Included on the banned list is epitalon, which claims to support hair and scalp health; GHK-Cu, which reportedly provides antioxidant and anti-inflammatory benefits; KPV, which may help reduce skin conditions like eczema; and Melanotan II, which has been used to increase tanning abilities. While these claims sound promising (except for the one that makes it easier to tan), the 2023 FDA findings reveal that these peptides may come with significant safety risks. For example, Melanotan II can increase the risk of melanoma. Others, like KPV and GHK-Cu, don’t have adequate safety data in humans.
When we say that peptides are everywhere, we mean it. “Every pharmacy here in Los Angeles…is formulating them and distributing them,” says Ava Shamban, MD, a board-certified dermatologist in California, “and all over the country, for sure, even though they're not approved by the FDA.” Dr. Shamban, who has served as a clinical investigator on many FDA trials, notes that when a product is approved by the agency, it first requires a “fairly expensive” trial process. “The fact that these [peptides] are widely available means there's no one company that started taking the reins and saying, ‘We're going to take this combination, and then we're going to study XYZ,’” she explains. The other issue would involve limiting variables like exercise, nutrition, and sleep, which can also impact improvement, she notes. “That’s what’s really going to prevent them from ever getting the FDA-approved form.”
Peptides and the gray market
We know what you’re wondering: If a product does not have the FDA’s blessing and is not allowed to be sold, how are people getting their hands on it in the first place? Especially when, in some states, you need to show ID to buy something as simple as spray paint. According to Dr. Kahn, peptides that are labeled “for research only” are often sold online through unregulated vendors and can “bypass traditional medical and pharmaceutical oversight,” thus serving as a legal loophole; this is also how these peptides end up in the gray market. “Many of the peptides that have been restricted are still technically available under a ‘for research purposes only’ designation,” says Dr. Lee. “In practice, some consumers purchase them through this loophole and use or distribute them outside of a true research setting,” he explains.
Gray market products exist in an in-between space, since they’re not exactly illegal, but are “obtained through channels that lack proper authorization for personal use,” says Dr. Lee. This also means they’re not subject to safety, quality, and purity testing. You can, at this very moment, purchase many of the peptides on the restricted list online. Some vendors require specific credentials to make the purchase or require you to check a box saying your purchase is for research purposes only and not intended for human and animal use, while others include similar language on each peptide product page.
How are peptides prescribed, compounded, and acquired?
And where do doctors factor into all this? “If you’re able to purchase a peptide online without seeing a doctor, without a prescription, and without any credentialing, that should absolutely raise red flags,” says Dr. Shamban. “Legitimate peptide therapies [like a GLP-1], intended for human use, require medical oversight, and must be dispensed through licensed pharmacies. When none of those safeguards are in place, you’re operating completely outside the medical system.”
When prescribed by a doctor, peptides “must be sourced from approved bulk substances or supported by a clear clinical justification,” adds Dr. Shamban. “These pharmacies operate under FDA oversight and can only dispense to licensed providers; these are not products available directly to consumers.”
Some peptides are not on the FDA-banned list, some have FDA approval, while others exist outside the sphere of approvals; you can acquire them, but they don’t come with the safety assurances an approved product does. “Not all peptides are FDA approved, but when prescribed by a licensed physician and dispensed through a regulated US-based compounding pharmacy—503A or 503B—they are used in clinical practice under medical supervision,” explains Dr. Kahn. “Many peptides used in medicine are compounded formulations, meaning they are customized rather than commercially approved drugs.”
While semaglutide is FDA-approved, not all peptides produced at compounding pharmacies are. “Most of these compounds still lack robust clinical data proving their safety and long-term efficacy,” says Dr. Lee. “At this stage, much of what’s circulating is anecdotal: people reporting personal use without clear, evidence-based conclusions about risks or side effects.”
“Legitimate compounding pharmacies operate under a strict regulatory framework and work only with licensed prescribers,” explains Dr. Shamban. These facilities cannot legally compound or dispense restricted or banned peptides for safety reasons. That hasn’t stopped some compounding pharmacies: One peptide on the restricted list that Dr. Shamban often sees in Los Angeles is BPC-157 (aka Body Protection Compound), which is derived from gastric juices and typically used for workout recovery; you can easily buy it online for about $120. “While these products may be easy to find online, that convenience often comes at the expense of safety,” she explains. “Easy access does not mean safe or appropriate for human use.”
The legality of it all
So, how are pharmacies legally selling and distributing peptides on the restricted list? Well, they shouldn’t be. “Peptides on the FDA’s restricted list are not allowed to be compounded. Period!” says George Hajduczok, a medical device and pharmaceutical product liability and regulatory affairs attorney in Buffalo, New York. “When the FDA places a peptide in a restricted or high-risk category [known as Category 2], it is explicitly signaling that it has identified safety concerns and that enforcement discretion does not apply.” But, as Hajduczok notes, just because something is “not FDA-approved” doesn’t mean it’s “illegal to compound,” but the restricted peptides should not be compounded.
Take, for example, BPC-157, the “recovery” peptide on the restricted list. David J. Holt, attorney and owner of Holt Law, a health-care business law firm in Minnesota and California, points out that it was moved to Category 2 in 2023, so “legally, compounding pharmacies cannot distribute it for human use.” But they’re using that “for research purposes” loophole to distribute it. “They claim the product is for research or not for human consumption to dodge FDA jurisdiction,” Holt says. “The FDA looks to intent, not simply what you say, as an alleged legal loophole. Selling a research peptide to a patient for a workout injury is misbranding and distributing an unapproved new drug. It is illegal. Enforcement is currently a game of Whack-A-Mole. The patient demand greatly outweighs the federal government's appetite to enforce, so we are in a unique legal environment.”
But again, Holt says, “simply because a peptide is not banned does not make it legal.” A pharmacy can compound a bulk substance if it meets one of three criteria: It has a USP monograph (official, written quality standards for a substance that is approved by the FDA), it is a component of an FDA-approved drug, or it’s on the FDA 503A Positive List. “If a peptide doesn't hit one of those buckets, it is an unapproved new drug,” he says.
It's confusing, we know, and doctors recognize that too. “This space can feel like a gray area,” says Dr. Shamban. “Some peptides are increasingly being prescribed by physicians, even though they’re often labeled as ‘research compounds’ in other contexts. Generally, when formulations are based on FDA-approved bulk substances or compliant ingredient components, they can fall within regulatory guidelines when prescribed and dispensed appropriately.”
Dr. Kahn also calls the peptide category a “bit of a gray zone,” given its uncertain regulatory status, but says she wants to emphasize that patients cannot simply buy peptides from compounding pharmacies. “All pharmacies, whether a well-known compounding facility or a CVS, need a prescription to fulfill the order."
There are “real risks” from unregulated sources, adds Dr. Shamban, including testing that verifies what is actually in the vial that shows up at your door. “Products may contain impurities, synthesis byproducts, or fillers that can lead to allergic reactions or toxicity,” she says. “Many are manufactured overseas, outside of FDA jurisdiction, which increases the risk of contamination or counterfeit ingredients.”
In addition, Dr. Kahn says, there are risks to creating your own peptide protocol without a doctor’s help. “A lot of issues are unrelated to the safety of the peptides themselves [and related to] how they are used.” This includes stacking multiple peptides, incorrect dosing, and the lack of appropriate monitoring, like bloodwork or imaging done under a doctor’s supervision.
What happens if the ban is removed?
If the ban is removed, those peptides would likely make their way from the gray market to “more regulated channels,” Dr. Lee says, citing medspas, local clinics, and telehealth providers as potential sources. “The most probable scenario is that compounding pharmacies would be permitted to produce certain peptides under FDA oversight, allowing licensed health-care professionals to prescribe them.”
This would be similar to what happened with semaglutide, the active ingredient in GLP-1 medications like Ozempic, he says. Compounding pharmacies helped meet the demand, which made the product more widely and easily available to consumers. “If peptides follow a similar trajectory, increased access would likely depend on regulatory guidance and consumer demand, with distribution expanding through these same medical and wellness channels,” Dr. Lee says. (FDA oversight is basically an established safety standard regarding how a product is manufactured in a compounding pharmacy facility, less so about its performance or safety.)
“A reversal would not automatically open the floodgates, but it would be a significant change,” notes Hajduczok. “If the peptide restrictions are reversed through formal FDA rulemaking, compounding pharmacies would be legally allowed to prepare those peptides, but only as traditional, patient-specific compounded drugs, not as mass-market or FDA-approved therapies.” If the peptides are formally added to the 503A bulk list, he says, pharmacies would have to follow the traditional 503A compounding rules. “This means individual patient-specific prescriptions, limited quantities, no mass production, and full responsibility for quality and sourcing,” he explains. “The drugs would still not be FDA-approved, and the FDA would still not vouch for their safety or effectiveness.”
Koehl Robinson, founder and CEO of CeliaRX, a telehealth company that sells injectable and topical peptides compounded by a 503A pharmacy partner (not the ones on the FDA’s potential unbanned list), says that if the peptides are reclassified, it would likely open up new possibilities for her customers, as well as lead to more clarity and less confusion. “Now we're understanding these effects: What are these results and how can we compliantly sell these products? Let's drive the information, education, and oversight with a compounding pharmacy that manufactures compliantly anywhere."
How to navigate this uncertain terrain
Dr. Shamban cautions that if your peptides aren’t formulated in a sterile setting, like a pharmaceutical lab, you may be exposed to bacteria and fungi. “Sterility is a major concern—without proper cleanroom standards, bacterial contamination and endotoxins are very real possibilities," she says. “You want to make sure the compounding pharmacy has a good reputation…not just a pharmacy that sells aspirin and Lipitor,” she says. “There are pharmacies that really are expert compounders.” She says that many women buy compounded hormone creams from these pharmacies. The FDA says it “lacks sufficient information to know whether the drug would cause harm when administered to humans.”
Both Dr. Lee and Dr. Shamban agree that if you’re interested in any kind of peptide, the safest approach is to work with a doctor, not an unverified online vendor—and especially not the gray market. “Purchasing peptides online from unverified sources carries significant risk, with little to no accountability,” says Dr. Lee. “Licensed health-care professionals are far more likely to prescribe responsibly, as both their reputation and medical license depend on patient safety.” Dr. Shamban likens buying peptides on the gray market or from an unverified source to “playing blackjack with your health…the odds are really not very good.”
Even if some of the 14 peptides were to be reclassified, Dr. Kahn says she would remain skeptical. “I only incorporate therapies that are supported by clinical rationale, safety data, and appropriate sourcing through regulated pharmacies,” she says. “The question is less about availability and more about whether a given peptide is appropriate, safe, and necessary for a specific patient. I would not prescribe something simply because it becomes accessible. It must fit within a thoughtful, individualized treatment plan.”
The future of peptides
But get used to seeing the word “peptides,” because they’re not going away. “Obviously, the world's going into a whole evolution of tech and AI, but I think the same thing is happening on the medical and biological side,” says Robinson. “We have to evolve as everything else evolves, and I think peptides are the thing. The innovation for what is possible in creating new peptides is also going to become a huge area of focus."
Dr. Kahn agrees that peptides will likely have a place in medical care. “We are moving toward a more personalized, preventative model of medicine, and peptides fit into that framework well, when used appropriately,” she says. “The most important takeaway is that peptides should not be approached casually. While there is a lot of excitement around stacks and optimization, injecting any compound carries risk if not done properly.”
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