Robert F Kennedy Jr is sitting stiffly in Joe Rogan’s podcast studio, inside the influencer’s enormous Texas mansion. Atypically for Rogan’s guests, Kennedy still cloaks himself in the trappings of authority; in a blue suit and pink novelty tie featuring kayakers paddling upstream, he is a stark contrast from Rogan, who sports a biceps-hugging T-shirt depicting a cowboy and an outline of Texas, from the “regenerative wellness” brand Ways2Well.

This was in February, when Kennedy, amid his nationwide Take Back Your Health tour, was pushing his new red-meat-heavy food pyramid on to Americans. For an hour and a half, the two chatted casually about everything from soda pop to medical scams that supposedly fund Boko Haram.

But the interview was building to something. Rogan is a lover of peptides, the cure du jour of the “biohacking” and wellness worlds, capable of fixing everything from poor sleep and bad skin to an inability to get the perfect tan, should you believe the podcasters and influencers who push them. Rogan is especially boosterish about the peptides BPC-157 and TB-500, together known as the “Wolverine stack” – a reference to the Marvel character who can quickly regenerate lost limbs and heal wounds. The month before Kennedy’s interview, Rogan bragged to his guests Matt Damon and Ben Affleck that a professional footballer once told Rogan that he “shot that shit into [his] hamstring” and “was right back on the field” after a severe injury.

Finally, Rogan got to the question: “Where are we at right now on peptides?” “I’m a big fan of peptides,” Kennedy assured him. “I’ve used them myself.” But for years, he explains, lots of peptide devotees have been getting the injectable vials from a legally gray marketplace that sells peptides for “lab use only”. Kennedy blamed this lack of availability on an “illegal” action by the Biden-era FDA. (In reality, Biden’s FDA had declared the medications unproven and potentially dangerous, and put a halt on production of many peptides until more research was complete.)

But, Kennedy teased in the February podcast, things may be changing. Soon, he said, he hoped to make several of the most hyped peptides – including Rogan’s beloved Wolverine stack – easier to get a hold of. He said he was “very anxious” to do so.

That interview kickstarted a series of announcements that finally came to fruition last week, when a panel within Kennedy’s Food and Drug Administration met to advise on whether or not several of the most popular, if unproven, peptides should be made legally available to consumers. The committee – whose members include many people with financial ties to the burgeoning peptide industry – recommended, by thin margins, that six of the seven peptides in question be made legally available, and not just for “lab use”.

But this committee didn’t recommend that access be increased by putting the peptides through testing, proving their safety and effectiveness, and subsequently making them available to patients. Instead, they recommended using an in-the-weeds “reclassification” method that would allow the peptides to be legally sold, even before the FDA has proven their safety or benefit. To do this, the panel will leverage a little-known corner of the pharmaceutical world that, thanks to a regulatory loophole, is a haven from the strictest federal oversight: compounding pharmacies.

These less-regulated pharmacies have long been a vital part of patient care, known previously for formulating bespoke drugs for patients with allergies or special medication needs. But they historically have had a reputation for sometimes deadly errors. Today, compounding pharmacies can take the shape of small neighborhood drugstores – or for-profit telehealth corporations like Hims & Hers with in-house compounding divisions. In recent years, as rhetoric around alternative and minimally tested treatments has been supercharged, the once staid and unobserved world of compounding pharmacies have become enormously profitable. And now, on the eve of a potential peptide explosion, some of these pharmacy companies stand to make further billions by selling unproven drugs.

Compounding pharmacies should be boring. They make the personalized or less-common drug compounds that some patients require, but which leading drug manufacturers don’t make: allergen-free formulations, liquid versions of pill medications for patients who have a hard time swallowing, or unusual dosages of existing medications. “If you think back to 150 years ago, pretty much everything that somebody would take as a medication was compounded in some form – kind of mixed up with a mortar and pestle by a pharmacist,” says physician and toxicologist Dr James Watson. In these pharmacies of old, he said, pharmacists combined different drugs into a bespoke formulation for each individual patient.

But in the first half of the 20th century, the role of the pharmacy changed dramatically. New manufacturing technology allowed common drugs to be produced in bulk. As mass-produced drugs became the norm, local pharmacies mostly shifted from making drugs to holding stockpiles of medications, and were tasked with dispensing the correct dosage and giving guidance to patients. On rare occasions when needed, they still created individualized concoctions – but the number of prescriptions that required some kind of compounding dropped from 75% in the 1930s to less than 5% by 1960.

Legally and sensically, drug manufacturers and small local pharmacies became regarded as separate entities. These two businesses had different enforcement regimes: bulk drug manufacturers received the attention and scrutiny of the FDA’s foundational 1938 Federal Food, Drug, and Cosmetic Act. Pharmacies, on the other hand, were grandfathered into an older regulatory scheme, with oversight from state boards. “Compounding pharmacies were specifically excluded from FDA oversight,” Watson says. At a time when huge volumes of drugs were being created in bulk and dispensed across the country, “compounding for a single person from a single prescription in the back of your corner drugstore didn’t seem relevant” to federal enforcers, he says.

In the second half of the last century, though, new lifesaving treatments were being developed. Many required new drugs, from intravenous chemotherapy to medications that would temporarily stop the heart so surgery could be conducted. Since these weren’t produced in bulk immediately, small, often hospital-based pharmacies filled the gap, creating small runs of medication for a specific hospital or region. By the 1990s, more commercial compounding pharmacies sprang up to combine and sell new drug compounds.

In many ways, these compounding pharmacies were great for patients. They made advanced procedures accessible. Some treatments that would eventually become widely embraced, such as hormone replacement therapy for menopause, started in the backwater of compounding pharmacies.

But these new compounders weren’t just mixing up a bespoke medication for an individual upon receiving a prescription; instead, they were often making them for small groups of people, in bulk and ahead of time. And it was at this time, says Watson, that “we start to see this blurring, this muddying of the waters” between pharmacists and drug manufacturers. Some compounders were scaling up and industrializing – operating more like small drug production companies. But the regulations didn’t change with them, and compounding pharmacies remained beyond the FDA’s reach. The state pharmacy boards that were supposed to oversee them, meanwhile, had varied track records. When they did conduct inspections, it wasn’t uncommon that pharmacies were found to have bad ventilation, improper temperature control and even rodents and bugs.

Sometimes those problems turned deadly. In 2012, the New England Compounding Center in Framingham, Massachusetts, created a run of injectable steroids for patients across the US. But they didn’t store the medication properly, and mold was visible in some of the vials. The pharmacy sent out the drugs anyway, and soon patients in multiple states began falling ill with fungal meningitis. Sixty-four people died and more than 750 got sick, some of whom had lasting ailments. The FDA couldn’t take action, as compounding pharmacies weren’t subject to their scrutiny. (Many of the company’s leaders were later charged with crimes beyond the FDA purview, including involuntary manslaughter and racketeering.)

After that incident, the FDA finally took action. They announced that they would make two different classifications for compounding pharmacies: “outsourcing facilities”, which made drugs in bulk, could now be inspected by the FDA. Smaller, “traditional” compounding pharmacies remained unregulated at the federal level.

Safety has improved since the FDA got oversight over bulk compounders. But these large compounding pharmacies still don’t need to be inspected by the FDA before they start selling drugs. Instead, they pay a fee and get started. And while the legal change allowed the FDA to regularly inspect these larger pharmacies, that doesn’t mean it always does. As of last July, the public health group Partnership for Safe Medicines reported that there were 93 bulk compounding facilities registered with the FDA, more than half of which came online in just the last six years; as of last year, 81% of the new compounders had not yet been inspected by FDA staff.

While some workaday compounding pharmacies have strong track records, research suggests that errors remain more common at compounding pharmacies than at large drug manufacturers. Sometimes, Watson says, compounders use the wrong active ingredient or misread a decimal placement. “ We’ve seen cases of young children who are supposed to get a low dose of a sedative every day … accidentally being given a tenfold dosing error by their parents not realizing it, because they just are giving what was dispensed by the pharmacy,” he says. “ An error like this happening at the level of a pharmaceutical manufacturer is unheard of.”

For years, compounding pharmacies remained under the radar, save for a few major errors and corresponding headlines. But that changed during the Covid-19 pandemic, when Trump and conservative media pundits pushed the antimalaria drug hydroxychloroquine and antiparasitic drug ivermectin, without backing, as a cure for Covid-19. (To date, neither has been shown to have meaningful benefit for treating Covid.) Many adherents got these drugs from compounding pharmacies. In a local news report from 2021, one compounding pharmacist in Austin, Texas, reported filling about 300 prescriptions for ivermectin every day.

Since then, observers like Christina Madison, a pharmacist and former pharmacy school instructor in Las Vegas, have watched an alliance grow between some compounding pharmacists and leaders of the “medical freedom”, wellness and Maha movements. “ It’s the peptides, it’s the bioidentical hormones, it’s the biohacking, it’s all of that,” Madison says. “ It doesn’t start off as being a conversation around compounding pharmacies … it’s like, ‘These are the things I’m trying to get. Where do I get those products from?’”

Commenters in online forums repeatedly say they’re drawn to peptide treatments specifically because the FDA has not necessarily approved them. Some compounders are cashing in on that skepticism: Last year on Rogan’s show, right-leaning wellness personality Brigham Buhler, who runs a compounding pharmacy called ReviveRx, said: “If you go to your doctor and they will not prescribe you a medication, you have to understand … that is not your doctor’s decision,” he said. “So when your doctor says ‘I’m not going to let you go to a compounding pharmacy,’ you need to fire that fucking doctor.” (Buhler also runs the wellness company Ways2Well, whose shirt Rogan wore in his February interview with Kennedy.)

But while many compounding pharmacies are indeed less regulated than drug manufacturers, Madison says they are not as much of a free-for-all as some in the Maha world have come to believe. “As much as it seems like a great marriage,” she says, compounding pharmacies “still have regulatory and legal guidelines that they have to follow”. For example, though compounding pharmacies can sell drugs that haven’t been approved by the FDA, they cannot make and sell compounds that have been deemed potentially dangerous.

This distinction lies at the heart of last week’s reclassification recommendation. Kennedy’s pharmacy compounding advisory committee, which passes along official recommendation to the broader FDA for approval, suggested that several peptides be moved out of the “significant safety risk” category, and into one that would allow compounding companies to legally make injectable peptides – without backing, and sometimes even without an inspection.

Some of those who stand to profit are close to Kennedy. Many members of the compounding pharmacy advisory committee, for example, run clinics that offer peptide treatments. (A few other, less-invested experts from the FDA were added to the panel after pushback prior to last week’s meeting. When voting on these peptides, the committee was starkly divided along lines of affiliation; most of these career scientists recommended against reclassification of the peptides in question, but were outnumbered by members of the peptide-invested camp.)

But even before that, the economic ties had been brewing between the peptide industry and Kennedy; last year, Mark Mikhail, CEO of one of two main compounding pharmacies, was appointed to the pro-Kennedy Maha Pac, where he has advocated to lift the regulations that have kept pharmacies from producing unproven peptides. “Follow the money,” says Madison. “You’re definitely seeing these strategic alliances.”

The FDA told the Guardian that they are considering the pharmacy compounding advisory committee’s recommendations and will make a final decision about peptides reclassification after consulting with the United States Pharmacopeia, “along with other information available to the agency”.

Maha moneymakers and biohacking influencers aren’t the only ones who are hopeful about peptides. Doctors in the evidence-based medicine world have been researching them for decades, and are optimistic about their ability to act as what are known as “signaling molecules”, encouraging the body to do things such as regulate blood sugar to help patients with diabetes. Some peptides, like insulin and GLP-1s (literally “glucagon-like peptide”), have been proven safe and extremely effective.

The FDA, too, has spent years getting serious about the treatments’ potential benefits, as well as their risks. In 2023, as GLP-1s were becoming increasingly used for weight loss, the FDA turned their attention to several other less-common peptides. Without much research behind them, and with concerns over safety, the agency moved just shy of 20 specific peptides into what’s known as “category two” for compounded drug ingredients. The category allows the FDA to keep studying the drug in question, but generally prohibits compounders from selling it to the public until doctors have more proof of its safety and efficacy.

This move, which Kennedy referred to as “illegal” in his February appearance with Rogan, is what his committee has just recommended reversing, at an FDA pharmacy compounding advisory committee meeting last week. Here, the committee officially recommended placing six of the seven peptides up for consideration in “category one”. While the move still needs the final stamp of approval from the FDA, placing these peptides in that less restricted category will allow compounders to create and sell these medications before their safety and effectiveness has been proven.

Kennedy’s proposal has some scientists sounding the alarm. Reclassification is not “supposed to be a route for unapproved drugs to get into the market”, Janet Woodcock, a former FDA chief deputy commissioner who helped oversee the 2023 assignment of the peptides to category two due to safety concerns, told ProPublica before the meeting. “It would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the US.”

But the concerns of Woodcock and other medical professionals are not stopping large compounders from preparing to make a fortune. During the GLP-1 boom, corporations such as Hims & Hers and Noom started buying up compounding pharmacies, and bringing production in-house. Now, they are ready to strike gold. Since Kennedy announced his intention to increase access to peptides, Hims & Hers’ stock prices have skyrocketed by more than 125%. In the hours immediately after the committee announced their recommendation to make several popular peptides legal to compound, their stock prices climbed again. Investment firms predict the peptide market will balloon to several billions of dollars annually, should the FDA formalize the change – and companies like Hims & Hers stand to take a large cut.

At Hims & Hers (and other telehealth companies with their own compounding divisions), patients are sent drugs with a stamp of approval from a Hims & Hers-affiliated doctor – who will order the prescription through the Hims & Hers compounding pharmacy. (Patients, though, will probably pay out of pocket, as the medications won’t be FDA-approved and are unlikely to be covered by insurance.) This vertically integrated, frictionless, moneymaking process is a far cry from the backroom of a 20th-century drugstore, where a pharmacist mixed up bespoke concoctions for patients in need. But Hims & Hers, and other companies like them, have already announced plans to hit the ground running on peptide sales, at least initially through their compounding division. In a statement to the Guardian, a spokesperson for Hims & Hers said that their “senior medical advisers see meaningful potential in several peptide therapies, and we welcome the FDA’s move to evaluate regulated access to certain peptides for compounding”, adding that they manufacture all peptides in-house, ensuring direct control over safety and quality control.

Some companies, though, didn’t even wait for last week’s meeting. This April – long before the formal review meeting that recommended these several influencer-favorite peptides be placed in the more lenient category one – Kennedy made a sweeping, unilateral decision: while he couldn’t personally place these drugs in category one, he did remove them from the FDA’s category two, rendering them legally homeless. While many large companies are playing it safe, some smaller compounders have already been producing these freshly undesignated peptides. Even if the FDA doesn’t accept the recommendation of the pharmacy compounding advisory committee and officially reassign these peptides to category one, Kennedy’s agency could still decide not to come after those who choose to compound and sell those peptides.

Modern compounding pharmacies began as a legal carve-out to ensure that people who can’t swallow pills or who need special doses of medications could get the drugs they need. Now, that industry has been transformed into an underregulated business opportunity, through which a multibillion-dollar peptide industry may be about to explode.

This compounded peptide boom may be brief. The FDA may eventually pull unsafe peptides after testing and approve others, prompting big pharma to mass-produce a version that they can patent and sell. This boom-and-bust cycle is familiar to compounding companies; many did the same thing with GLP-1s, selling them before patented manufacturers took control of the market. Compounding companies are likely to do the same with peptides: capitalize on a moment, however liminal, when a drug is available to be compounded.

Consumers, in the meantime, will be sold a story of peptide success in which the truth will be hard to suss out. They will see slickly produced ads on television, or conversations on podcasts, that push miracle cures. Many likely won’t realize that what is commonly assumed to be one of the last remaining maxims of the US healthcare industry – that a drug prescribed by a doctor has been deemed safe and effective – won’t necessarily be true. And without mandatory preliminary inspections of compounding pharmacies, the dangerous and even sometimes deadly errors that have put these pharmacies in the historic spotlight may make headlines again.

Fans of the reclassification say that allowing compounding pharmacies to make these drugs will allow some degree of FDA oversight, and will therefore protect customers – some of whom may already be injecting themselves with unproven peptides that are not intended for human use. They point to examples in which some users have already fallen ill from gray-market drugs. But the mere possibility of FDA inspection hasn’t historically guaranteed safety: earlier in July, a 27-year-old New York woman died after a botched injection of what was supposed to be an anti-ageing peptide, administered by a proprietor who wasn’t licensed to practise in New York. For years, that particular peptide has been legal to compound. Despite that, a hidden market of practitioners administering these products has flourished anyway.

If the current obsession with peptides is any indication, many patients will probably take the chance on these unproven products. And in a medical climate in which many people don’t have a consistent doctor or anywhere near adequate medical coverage, it’s hard to blame them. Pharmacists such as Mohammed Chammout, who works in the Detroit area, see this first-hand. Like many people in the US, many of his patients don’t have robust medical support networks. Immediately after Kennedy’s appearance on Rogan in February, he started to get questions. “People every day ask[ed] me, ‘Can I get this peptide? How do I buy it?’” The inquiring patients ranged in age and abilities – from young athletes hoping to make faster recoveries to older adults living with musical dystrophy. “They come to me and they show me their phone and say, ‘I want this,’” Chammout says. “TikTok,” patients repeatedly told him, “told me that these are all legal.” His patients, he says, barely got to see their doctors thanks to high costs and scheduling issues. In that vacuum, he says, “they see these things online [and think], ‘Oh my God, I can reverse my ageing.’”

Kennedy’s FDA is now closer than ever to opening up a huge market for compounders and telehealth companies to sell products that the FDA itself may ultimately find have no benefit. Patients, primed on the rhetoric of wellness influencers and a broken healthcare system, will be the ones padding these corporations’ pockets. “ This is a way to get the peptides in the market and produce revenue off them without having the FDA legality behind it,” says Chammout. “It’s like the wild west right now.”