Peptides are all anyone wants to talk about right now, and the conversation is about to get louder with HHS Secretary Robert F. Kennedy Jr’s push to make more of them available from specialized pharmacies. On April 15, the FDA announced that an expert panel will meet in July to evaluate seven peptides for inclusion on the agency’s list of substances that can be dispensed by compounding pharmacies. The panel will evaluate another five peptides in 2027. What does that really mean?
Peptides are short strands of amino acids that help cells communicate with each other. Some can be taken as drugs. Among the most famous are GLP-1s like Ozempic. But what’s gettingthe spotlight right now are more than a dozenunapprovedpeptide drugs that, back in September 2023, the FDA added to its Category 2 Bulk Substances list—that’s alist of substances that the FDA says pose “significant safety risks” and are not eligible for compounding without further research.
Historically, compounding pharmacies have created tailor-made medications for patients under numerous circumstances. A patient who can’t swallow a capsule, for example, may require a liquid version of a drug. These pharmacies can also supply essentially a copy of [ST1] an FDA-approved drug when there’s a shortage. The particular peptides that now reside on the FDA’s Category 2 Bulk Substances list never met the criteria for compounding, yet some pharmacies had been supplying them anyway to patients with a physician’s prescription.
Now, RFK wants to reverse course and create a legal pathway for compounding pharmacies to dispense some peptides that have not passed through the series of studies required for FDA approval. Kennedy and other advocates say that, anecdotally, individual patients have benefited greatly from these experimental substances, and if people are going to use them, then it’s safest to get them from a licensed pharmacy that sources its ingredients from FDA-registered manufacturers and wholesalers. Currently, many people purchase their peptides on the gray market, where quality can vary widely.
Whether people will actually ditch the gray market in favor of pricier compounded drugs remains an open question (more on that below). But meanwhile, many physicians and researchers are raising concerns. This potential new setup offers greater safety in terms of quality control, says Christopher Mendias, PhD, a rehabilitation clinician-scientist at Performance Medicine Institute in Phoenix, Arizona. But even a pure form of a drug that hasn’t been through rigorous testing isn’t necessarily a safe one. Mendias stresses that when it comes to unapproved peptides, “there’s still a lot where we don’t understand the safety profile.”
What’s Behind the Proposed Change
OVER THE YEARS, the gray market for experimental peptides has ballooned, driven initially by bodybuilders looking for a competitive edge and then later by biohackers and people with unmet medical needs. Today, many individuals purchase the substances directly from manufacturers in China, or from companies in the US and the UK which import the substances and then may—or may not—do third-party testing for purity. (Companies that do third-party testing often post the results on their website or provide the results upon request.)
Kennedy, along with some physicians and pharmacists, have argued that it would be safer to create a legal pathway for unapproved peptides. In this scenario, compounding pharmacies, which are overseen at the state and federal level, would obtain active ingredients from FDA-registered manufacturers. “Then we know patients are actually getting what the vial purports itself to be,” said Tenille Davis, a pharmacist and chief advocacy officer for the trade group Alliance for Pharmacy Compounding. “It’s actually sterile; it has the right concentration.”
Abe Malkin, MD, founder and CEO of ConciergeMD, a national concierge practice, holds that this shift is better for patients and their doctors. Malkin said he started prescribing experimental peptides about six years ago when his patients, who include biohackers, expressed interest. “They would often come to me and say, ‘Hey, I heard about this thing called sermorelin or BPC-157,” he recalled. “We would go do our research on them, and you find out there’s a ton of amazing anecdotal evidence on it.”
Physicians themselves have flexibility in what they prescribe, he explained. “As a physician, you can prescribe experimental drugs to your patients, if you think that they’re helpful for your patients and there’s clinical need.” The important point, he continued, is that physicians can’t claim the substances treat a particular disease. “I can’t say, ‘this will cure your diabetes,’” he explained. Instead, he can say that a peptide “has been shown to have benefits in terms of anti-inflammation” or pain relief.
Malkin said that before prescribing a peptide, providers at his clinic screen patients to be sure they have a medical need and don’t have any contraindications.
He suspects that once more licensed pharmacies are allowed to compound, that will drive prices down. Clinical-grade peptides that currently sell for $299 or $399 per one-month supply might come down to $199 or $159 per month, once large companies start to sell them.
Why All Peptides Might Not Be as Safe as They Sound
TO DATE, THE FDA has approved more than 100 peptides for use as drugs. To receive approval, a drug must pass through a series of studies testing its use in humans. These studies help researchers pinpoint a safe dose. And unlike individual anecdotes, the studies are designed to ensure that any observed benefits are due to the treatment itself and not to the placebo effect.
Human trials also help identify side effects. There are reasons to be cautious about injecting substances that haven’t been approved by the FDA, said Denise Belsham, PhD, a peptide researcher at the University of Toronto. She pointed to kisspeptin-10, an experimental peptide that she studies in her lab. Kisspeptin is a promising therapy, she said, in that can increase libido in both men and women by binding to a particular receptor that sits on the surface of brain cells. But those same receptors exist elsewhere in body, including the liver and the pancreas. It’s not yet clear what effect kisspeptin-10 might have on those organ systems when it’s administered as an injectable drug, said Belsham.
Optimal dosing is also an open question. “Any peptide can cause detrimental effects if it’s used at too high a level,” she explained. “Peptides are amazing biological molecules that our bodies have used in a precisely regulated manner for millennia,” she wrote in a follow-up email. “Just like anything, too much of a good thing can cause major problems, and this includes effects on our normal physiology. Buyer beware.”
Without rigorous human-based research, Belsham worries, the United States may be setting itself up for what she described as a “tobacco moment for peptides,” meaning harmful effects are linked to the product, but only after many people have been exposed to it.
The Gray Market May Stay Hot
EVEN IF THESE peptides are taken off the do-not-compound list, the move may have only a limited effect when it comes to moving people from the grey market to regulated vendors.
Luke Turnock, PhD, a criminologist at the University of Lincoln in the UK who studies enhancement drugs, said he suspects some patients will be happy to pay a premium for experimental peptides that come from a licensed compounding pharmacy. However, he said, price will be a significant consideration. Turnock noted that he knows people in the UK who buy retatrutide—a GLP-1 that hasn’t yet been approved—on the gray market because it costs a fraction of any approved GLP-1 they could get with a prescription.
This was echoed on Reddit threads, where numerous users said they plan to continue buying their peptides on the gray market.
One 71-year-old man with a background in computer science who asked to remain anonymous told us he currently uses about 14 different peptides for wellness purposes to improve how his body functions as he ages. Initially, he said, he sourced his peptides from a compounding pharmacy, but then he switched to a less-expensive gray market company based in the US. Eventually he started buying directly from even less-expensive Chinese vendors that are only able to operate by accepting cryptocurrency.
It wasn’t just about price, he added. Perhaps paradoxically, he came to trust his Chinese vendors more than the compounding pharmacy, which bombarded him with emails promoting their products. “I found that much more sketchy than sending crypto to China,” he said.
Regulatory Implications
FOR HIS PART, Mendias said that his clinic will continue to practice evidence-based medicine. When patients ask about peptides, he says, “we talk about ‘here’s what the claims are for this peptide. Here’s what the safety risks are potentially with it, and here’s what we could do that’s probably going to do the same thing, if not better, but in a safer way, with more predictable outcomes.’” To help other health care providers navigate these conversations, he wrote a review of unapproved peptides for musculoskeletal performance and athletic performance, which was published online earlier this month in the journal Sports Medicine.
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