RFK Jr. is a 'big fan' of this treatment and plans to widen access
He indicated that the FDA will soon take action on peptides, the mini-proteins biohackers tout as therapies for a range of ills.
By Lauren Gardner
Health Secretary Robert F. Kennedy Jr. is poised to declare victory on widening access to one of the country’s biggest wellness fads: peptides, the building blocks of proteins that biohackers claim help quickly heal injuries and promote muscle growth and fat loss.
Kennedy — a self-declared “big fan” of the treatments for injuries for which he reports “good results — has accused the Food and Drug Administration of aggressively suppressing peptides’ use.
Last month, on Joe Rogan’s podcast, the Health Secretary signaled imminent action by the FDA to allow “about 14” peptides to be “more accessible” for domestic compounding pharmacies.
Kennedy didn’t specify what the FDA will do, referring vaguely to “some kind of new action” after the agency reviews the science around the peptides in question.
But there are other signs that new regulations are likely afoot. Last summer, a group of compounding pharmacies that had sued the FDA over its restrictive peptide stance agreed to stand down when the agency said it “expects to submit” a final rule by next February addressing four peptides the companies want to produce.
At minimum, the FDA could exercise leniency in enforcing against U.S.-based peptide makers unless they identified safety issues.
An HHS spokesperson did not answer POLITICO’s questions about how and when the FDA plans to act on peptides.
“The FDA’s goal is to ensure that patients can obtain FDA approved products, and when those aren’t available or can’t work because of a patient’s unique situation, [that they] are made by licensed U.S. pharmacies, prescribed by a physician, and produced under appropriate quality standards — not products from unregulated or foreign sources that may pose safety risks,” spokesperson Emily Hilliard said in an email.
Kennedy’s supporters in the Make America Healthy Again Movement, which include social media influencers selling popular peptide treatments, and his pharmacist allies have applauded his remarks and say they expect bold action from him any day now.
Brigham Buhler, a compounding pharmacy and wellness clinic owner who’s close to Kennedy, told Trump- and MAHA-friendly podcaster Rogan on an episode Wednesday that senior HHS officials “are aligned” on widening access to peptides.
“It’s just a matter of when,” he added.
‘One of the biggest medical experiments’ in history
Yet some pharmacists and doctors warn that any move by the FDA to loosen current regulations around peptides could pose serious health risks because of the lack of scientific data to support many of them.
Peptides, which are usually injected under the skin, include the FDA-approved diabetes therapy insulin and GLP-1 weight-loss drugs, like Ozempic and Wegovy. The global market for the mini-proteins is projected to reach $100 billion in the next decade as pharma companies chase the spectacular success of the GLP-1s and growing demand for precision medicine.
But Kennedy and the biohacking corner of the MAHA movement hype dubiously legal chemicals known by alphanumeric names — like BPC-157 and CJC-1295 — for their health benefits, despite questions around their efficacy and FDA safety approval. These products are now often manufactured in China and sold on the black market. Consumers are also seeking out peptides for purported anti-aging and sleep-promoting qualities, in addition to possible benefits for injuries and body composition.
Many wellness-focused Americans, skeptical of mainstream medicine and wary of “Big Pharma,” find these peptide treatments through social media influencers, some of whom offer links to products of dubious quality. They can also be found through peptide clinics that are popping up across the country.
“We’re about to unleash one of the biggest medical experiments in the history of America onto Americans as the test subjects,” Alec Ginsberg, chief operating officer at C.O. Bigelow, the country’s oldest pharmacy, said, referring to the lack of clinical data on peptide use.
In Kennedy’s telling, the FDA under President Joe Biden “illegally” reclassified more than a dozen peptides, including BPC-157, in 2023 to a category of substances considered potentially unsafe on its so-called bulks list for compounded drug ingredients. That made them illegal for specialized pharmacies to make.
Sellers found a loophole by marking these peptide products for research use only — a label that hasn’t stopped consumers from injecting themselves, anyway.
The FDA “did not shut down accessibility,” Buhler told POLITICO, and instead routed people to the gray market, where legal products labeled for research are diverted for human use, and the black market, where illegal products are sold.
Buhler, whose brother died of opioids, often invokes the FDA’s role in fueling the opioid crisis by approving new pain drugs when describing the allure of alternative therapies.
“Just because something is FDA-approved does not make it safe,” he said, adding that, by restricting peptides, the agency has “created an opioid crisis all over again.”
Skeptics of unleashing peptides puzzle over the MAHA movement’s enthusiasm for unproven therapies and rejection of FDA-approved treatments backed by reams of evidence.
“These are the same people that won’t take a vaccine that’s been shown to work in millions of people,” said Eric Topol, director of the Scripps Research Translational Institute who studies personalized medicine.
Compounders’ push on peptides
For years, compounding pharmacies urged the FDA to relax its stance on peptides — well before the MAHA movement elevated their profile.
In its 2024 lawsuit against the agency, the group of compounding pharmacies claimed the FDA under Biden illegally used the reclassification of peptides to put off final rules on what substances may and may not be legally compounded.
Independent advisers supported FDA proposals to prohibit the compounding of several peptides later that year, but the agency never finalized them.
The four peptides that are the subject of the lawsuit are used to treat conditions ranging from impaired immune responses to vaccines and transplants to a rare genetic disorder causing insatiable appetite. They’re currently listed on the FDA website as substances that “may present significant safety risks.”
An FDA employee who works on compounded drug issues said the description encompasses known safety concerns, such as adverse event reports from peptide users, as well as the lack of long-term studies of the treatments in humans. Scientists have flagged certain growth hormone-related peptides as posing theoretical cancer risks.
“We don’t know what we don’t know,” said the employee, who was granted anonymity to speak freely about one of Kennedy’s political priorities.
Compounders say the FDA has been too heavy-handed in its approach to peptides, some of which are approved in other countries. They argue its safety concerns are ill-defined and that regulators are too focused on efficacy for products that are intended for use only on a case-by-case basis.
“Commissioner Makary has an opportunity to build a pathway that provides the proper checks and balances — that provides patients with accessible and affordable care,” Buhler said.
Makary was circumspect in December when wellness influencer Gary Brecka pressed him on how the FDA views peptides.
“We have to use some common sense, and the peptide world is a very large bucket, so we have to … ask ourselves what is harmless, been out there for a long time, and already has an established safety profile,” Makary said on Brecka’s podcast.
Compounding businesses and providers who prescribe peptide treatments pushed back against drugmakers’ criticisms late last year during two FDA advisory committee meetings scheduled as part of the agreement between the government and the compounders suing the agency.
A representative for Eli Lilly, one of two major GLP-1 manufacturers, testified against adding a fat-burning peptide known as AOD-9604 to the agency’s bulks list.
“False and misleading advertising by compounding pharmacies touting the effectiveness of this molecule for weight management and tissue repair is being used to deceive patients,” Brad Jordan, Lilly’s associate vice president of regulatory policy, said at the Dec. 4, 2024, meeting.
Buhler and others say Lilly and GLP-1 competitor Novo Nordisk are trying to sully legitimate compounders’ reputations — and their potential for competition — by conflating them with rogue actors and claiming safety concerns. Novo and Lilly declined to comment on potential FDA action on compounded peptides.
The two companies and Buhler’s compounding pharmacy, ReviveRX, all have received warnings from the FDA about safety or misleading claims — or both.
Novo was recently chastised for failing to report serious adverse events that included deaths of patients taking GLP-1s, and an agency inspection found the company released drug batches with “mammalian hair contamination” from one of its manufacturing facilities.
An FDA inspection of ReviveRX in early 2025 observed sanitary concerns, including “microbial contamination” in rooms that were supposed to be sterile; the facility received a warning letter in September describing responses that “appear deficient.”
Buhler said Revive “promptly” responded to the FDA’s warning and has finished implementing protocols to correct the identified issues and prevent them from recurring.
Peptide curiosity
Meanwhile, wooed by the success of weight-loss injections, Americans are increasingly curious about what other peptides can do for them.
If the FDA creates more access, “this peptide craze is going to be just as big as GLP-1s, and we saw how quickly GLP-1s became a household term,” Ginsberg predicted.
Jessica Duncan, an obesity medicine doctor at telehealth platform Ivim Health, said more patients are inquiring about peptides beyond GLP-1s. If the FDA allows some to be compounded, she said, she’ll evaluate their potential use on an individual basis.
“The decision to take anything — any drug — is not something you can make flat out for every population,” Duncan said.
Duncan and some pharmacists warn that any FDA action won’t mean peptides are immediately available. It could take months for the supply chain to pivot from research- to human-grade chemicals.
If consumers do find them immediately, Duncan said, “you can rest assured that’s probably not coming from a source you want to get it from.”
Still, plenty of telehealth companies and wellness clinics are preparing for a change. Hims acquired a California peptide facility in early 2025 in a move the company said would position it to “explore exciting advances in peptide innovation” in areas like “preventive health, metabolic optimization, cognitive performance” with consumer interest.
Ginsberg said he’ll be eyeing how those purveyors describe peptide products online. He wonders whether they will make hard claims about their effects or stick to vague language about potential benefits akin to how supplements are marketed.
The prospect of a company like Hims entering the peptide market and showing proof of its products’ purity is “definitely an improvement over the current situation we have” with the gray market, Ginsberg said.
“That doesn’t mean that it’s good for you,” he added. “It just means it’s better for you than what you were doing before.”
