\n<\/p>\n
Robert F Kennedy Jr is sitting stiffly in Joe Rogan\u2019s podcast studio, inside the influencer\u2019s enormous Texas mansion. Atypically for Rogan\u2019s 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 \u201cregenerative wellness\u201d brand Ways2Well.<\/p>\n
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.<\/p>\n
But the interview was building to something. Rogan is a lover of peptides, the cure du jour <\/em>of the \u201cbiohacking\u201d 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 \u201cWolverine stack\u201d \u2013 a reference to the Marvel character who can quickly regenerate lost limbs and heal wounds. The month before Kennedy\u2019s interview, Rogan bragged to his guests Matt Damon and Ben Affleck that a professional footballer once told Rogan that he \u201cshot that shit into [his] hamstring\u201d and \u201cwas right back on the field\u201d after a severe injury.<\/p>\n Finally, Rogan got to the question: <\/strong>\u201cWhere are we at right now on peptides?\u201d \u201cI\u2019m a big fan of peptides,\u201d Kennedy assured him. \u201cI\u2019ve used them myself.\u201d But for years, he explained, lots of peptide devotees had been getting the injectable vials from a legally gray marketplace that sells peptides for \u201clab use only\u201d. Kennedy blamed this lack of availability on an \u201cillegal\u201d action by the Biden-era FDA. (In reality, Biden\u2019s FDA had declared the medications unproven and potentially dangerous, and put a halt on production of many peptides until more research was complete.)<\/p>\n But, Kennedy teased in the February podcast, things may be changing. Soon, he said, he hoped to make several of the most hyped peptides \u2013 including Rogan\u2019s beloved Wolverine stack \u2013 easier to get a hold of. He said he was \u201cvery anxious\u201d to do so.<\/p>\n <\/span>Robert F Kennedy Jr (left) speaks to Joe Rogan in the Oval Office of the White House on 18 April 2026 in Washington DC.<\/span> Photograph: Julia Demaree Nikhinson\/AP<\/p>\n That interview kickstarted a series of announcements that finally came to fruition last week, when a panel within Kennedy\u2019s 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 \u2013 whose members include many people with financial ties to the burgeoning peptide industry \u2013 recommended, by thin margins, that six of the seven peptides in question be made legally available, and not just for \u201clab use\u201d.<\/p>\n But this committee didn\u2019t 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 \u201creclassification\u201d 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.<\/p>\n 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 \u2013 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.<\/p>\n Compounding pharmacies should be boring. They make the personalized or less-common drug compounds that some patients require, but which leading drug manufacturers don\u2019t make: allergen-free formulations, liquid versions of pill medications for patients who have a hard time swallowing, or unusual dosages of existing medications. \u201cIf you think back to 150 years ago, pretty much everything that somebody would take as a medication was compounded in some form \u2013 kind of mixed up with a mortar and pestle by a pharmacist,\u201d 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.<\/p>\n double quotation markCompounding pharmacies were specifically excluded from FDA oversightDr James Watson<\/p>\n 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 \u2013 but the number of prescriptions that required some kind of compounding dropped from 75% in the 1930s to less than 5% by 1960.<\/p>\n Legally 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\u2019s 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. \u201cCompounding pharmacies were specifically excluded from FDA oversight,\u201d Watson says. At a time when huge volumes of drugs were being created in bulk and dispensed across the country, \u201ccompounding for a single person from a single prescription in the back of your corner drugstore didn\u2019t seem relevant\u201d to federal enforcers, he says.<\/p>\n <\/span>A heavily stocked drugstore in 1929.<\/span> Photograph: Bettmann\/Bettmann Archive<\/p>\n 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\u2019t 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.<\/p>\n 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.<\/p>\n But these new compounders weren\u2019t 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 \u201cwe start to see this blurring, this muddying of the waters\u201d between pharmacists and drug manufacturers. Some compounders were scaling up and industrializing \u2013 operating more like small drug production companies. But the regulations didn\u2019t change with them, and compounding pharmacies remained beyond the FDA\u2019s reach. The state pharmacy boards that were supposed to oversee them, meanwhile, had varied track records. When they did<\/em> conduct inspections, it wasn\u2019t uncommon that pharmacies were found to have bad ventilation, improper temperature control and even rodents and bugs.<\/p>\n 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\u2019t 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\u2019t take action, as compounding pharmacies weren\u2019t subject to their scrutiny. (Many of the company\u2019s leaders were later charged with crimes beyond the FDA purview, including involuntary manslaughter and racketeering.)<\/p>\n After that incident, the FDA finally took action. They announced that they would make two different classifications for compounding pharmacies: \u201coutsourcing facilities\u201d, which made drugs in bulk, could now be inspected by the FDA. Smaller, \u201ctraditional\u201d compounding pharmacies remained unregulated at the federal level.<\/p>\n Safety has improved since the FDA got oversight over bulk compounders. But these large compounding pharmacies still don\u2019t 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\u2019t 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.<\/p>\n 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. \u201c\u200aWe\u2019ve seen cases of young children who are supposed to get a low dose of a sedative every day \u2026 accidentally being given a tenfold dosing error by their parents not realizing it, because they just are giving what was dispensed by the pharmacy,\u201d he says. \u201c\u200aAn error like this happening at the level of a pharmaceutical manufacturer is unheard of.\u201d<\/p>\n 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.<\/p>\n <\/span>A village worker cuts blister packs of human-grade capsules of ivermectin in Quezon City, Philippines.<\/span> Photograph: Rolex dela Pe\u00f1a\/EPA<\/p>\n 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 \u201cmedical freedom\u201d, wellness and Maha movements. \u201c\u200aIt\u2019s the peptides, it\u2019s the bioidentical hormones, it\u2019s the biohacking, it\u2019s all of that,\u201d Madison says. \u201c\u200aIt doesn\u2019t start off as being a conversation around compounding pharmacies \u2026 it\u2019s like, \u2018These are the things I\u2019m trying to get. Where do I get those products from?\u2019\u201d<\/p>\n Commenters in online forums repeatedly say they\u2019re drawn to peptide treatments specifically because<\/em> the FDA has not necessarily approved them. Some compounders are cashing in on that skepticism: Last year on Rogan\u2019s show, the right-leaning wellness personality Brigham Buhler, who runs a compounding pharmacy called ReviveRx, said: \u201cIf you go to your doctor and they will not prescribe you a medication, you have to understand \u2026 that is not your doctor\u2019s decision,\u201d he said. \u201cSo when your doctor says, \u2018I\u2019m not going to let you go to a compounding pharmacy,\u2019 you need to fire that fucking doctor.\u201d (Buhler also runs the wellness company Ways2Well, whose shirt Rogan wore in his February interview with Kennedy.)<\/p>\n 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. \u201cAs much as it seems like a great marriage,\u201d she says, compounding pharmacies \u201cstill have regulatory and legal guidelines that they have to follow\u201d. For example, though compounding pharmacies can sell drugs that haven\u2019t been approved by the FDA, they cannot make and sell compounds that have been deemed potentially dangerous.<\/p>\n This distinction lies at the heart of last week\u2019s reclassification recommendation. Kennedy\u2019s pharmacy compounding advisory committee, which passes along official recommendation to the broader FDA for approval, suggested that several peptides be moved out of the \u201csignificant safety risk\u201d category, and into one that would allow compounding companies to legally make injectable peptides \u2013 without backing, and sometimes even without an inspection.<\/p>\n 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 before last week\u2019s 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.)<\/p>\n <\/span>\u2018Follow the money \u2026 You\u2019re definitely seeing these strategic alliances [between the peptide industry and Kennedy].\u2019<\/span> Composite: The Guardian\/Getty Images<\/p>\n 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. \u201cFollow the money,\u201d says Madison. \u201cYou\u2019re definitely seeing these strategic alliances.\u201d<\/p>\n The FDA told the Guardian that they were considering the pharmacy compounding advisory committee\u2019s recommendations and would make a final decision about peptides reclassification after consulting with the United States Pharmacopeia, \u201calong with other information available to the agency\u201d.<\/p>\n Maha moneymakers and biohacking influencers aren\u2019t 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 \u201csignaling molecules\u201d, encouraging the body to do things such as regulate blood sugar to help patients with diabetes. Some peptides, like insulin and GLP-1s (literally \u201cglucagon-like peptide\u201d), have been proven safe and extremely effective.<\/p>\n The FDA, too, has spent years getting serious about the treatments\u2019 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\u2019s known as \u201ccategory two\u201d 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.<\/p>\n double quotation markThis is a way to get the peptides in the market and produce revenue off them without having the FDA legality behind itMohammed Chammout<\/p>\n This move, which Kennedy referred to as \u201cillegal\u201d 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 \u201ccategory one\u201d. 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.<\/p>\n Kennedy\u2019s proposal has some scientists sounding the alarm. Reclassification is not \u201csupposed to be a route for unapproved drugs to get into the market\u201d, 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. \u201cIt 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.\u201d<\/p>\n 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\u2019 stock prices have soared 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 \u2013 and companies like Hims & Hers stand to take a large cut.<\/p>\n <\/span>The Hers app displays a marketplace of GLP-1 injections and other supplements. <\/span> Photograph: Bloomberg\/Getty Images<\/p>\n 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 \u2013 who will order the prescription through the Hims & Hers compounding pharmacy. (Patients, though, will probably pay out of pocket, as the medications won\u2019t 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 \u201csenior medical advisers see meaningful potential in several peptide therapies, and we welcome the FDA\u2019s move to evaluate regulated access to certain peptides for compounding\u201d, adding that they manufacture all peptides in-house, ensuring direct control over safety and quality control.<\/em><\/p>\n Some companies, though, didn\u2019t even wait for last week\u2019s meeting. This April \u2013 long before the formal review meeting that recommended these several influencer-favorite peptides be placed in the more lenient category one \u2013 Kennedy made a sweeping, unilateral decision: while he couldn\u2019t personally place these drugs in category one, he did remove them from the FDA\u2019s 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\u2019t accept the recommendation of the pharmacy compounding advisory committee and officially reassign these peptides to category one, Kennedy\u2019s agency could still decide not to come after those who choose to compound and sell those peptides.<\/p>\n Modern compounding pharmacies began as a legal carve-out to ensure that people who can\u2019t 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.<\/p>\n 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.<\/p>\n <\/span>A person uses a prefilled injection pen of Mounjaro, a brand-name prescription of the weight-loss drug tirzepatide.<\/span> Photograph: Niall Carson\/PA<\/p>\n 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 probably won\u2019t realize that what is commonly assumed to be one of the last remaining maxims of the US healthcare industry \u2013 that a drug prescribed by a doctor has been deemed safe and effective \u2013 won\u2019t 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.<\/p>\n 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 \u2013 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\u2019t 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\u2019t licensed to practice 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.<\/p>\n 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\u2019t have a consistent doctor or anywhere near adequate medical coverage, it\u2019s 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\u2019t have robust medical support networks. Immediately after Kennedy\u2019s appearance on Rogan in February, he started to get questions. \u201cPeople every day ask[ed] me, \u2018Can I get this peptide? How do I buy it?\u2019\u201d The inquiring patients ranged in age and abilities \u2013 from young athletes hoping to make faster recoveries to older adults living with musical dystrophy. \u201cThey come to me and they show me their phone and say, \u2018I want this,\u2019\u201d Chammout says. \u201cTikTok,\u201d patients repeatedly told him, \u201ctold me that these are all legal.\u201d His patients, he says, barely got to see their doctors thanks to high costs and scheduling issues. In that vacuum, he says, \u201cthey see these things online [and think], \u2018Oh my God, I can reverse my ageing.\u2019\u201d<\/p>\n Kennedy\u2019s 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\u2019 pockets. \u201c\u200aThis is a way to get the peptides in the market and produce revenue off them without having the FDA legality behind it,\u201d says Chammout. \u201cIt\u2019s like the wild west right now.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":" Robert F Kennedy Jr is sitting stiffly in Joe Rogan\u2019s podcast studio, inside the influencer\u2019s enormous Texas mansion. Atypically for Rogan\u2019s 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<\/p>\n","protected":false},"author":1,"featured_media":51546,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[18679,542,306,150,23849,789,25101,2187,1714],"class_list":{"0":"post-51545","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-clearing","9":"tag-drugs","10":"tag-market","11":"tag-news","12":"tag-peptide","13":"tag-rfk","14":"tag-untested","15":"tag-west","16":"tag-wild"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/51545","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=51545"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/51545\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/51546"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=51545"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=51545"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=51545"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}