The Food and Drug Administration is moving toward allowing compounding pharmacies to produce more than a dozen injectable peptides that were banned because of potentially significant safety risks, according to a senior administration official.
In 2023, 14 peptides were removed from a list of products that the F.D.A. allows compounding pharmacies to produce. The pharmacies tailor products for individual patients’ needs. The peptides had not been approved by the F.D.A. as safe or effective and, in recent years, the agency had noted that they were increasingly being marketed with unproved claims that they had cosmetic, anti-aging and disease-fighting benefits.
“It’s 100 percent ‘bro’ science,” said Dr. Noah Raizman, an orthopedic surgeon in the Washington area who said he had also observed a rise in peptide use for a variety of health-related purposes. He added: “Are these specific drugs likely to be dangerous? We don’t know.”
Health Secretary Robert F. Kennedy Jr. has said in recent podcast appearances that he is pushing for the F.D.A. to reverse the prohibition on the peptides, which include some that act as growth-hormone stimulators. On Joe Rogan’s podcast last month, Mr. Kennedy said he has personally used the products to heal injuries “with really good effect.”
Peptides are chains of amino acids in the body that serve many different functions, prompting cells to perform actions like decreasing inflammation or increasing collagen production. Peptides comprise a vast category of compounds. Some, like insulin, have long been used as treatments, but many others have received little study and much remains unknown about their benefits or harms.
Since the agency removed the 14 peptides from the compounding pharmacies’ list, they have been primarily sold online in a kind of “gray” market, under the guise of compounds for research, which are not subject to regulation. The F.D.A. can warn companies against products they deem illicit, seize them or ban them from entering the country.
Within the F.D.A., top leaders have reservations about the change, according to a senior Department of Health and Human Services official who spoke on condition of anonymity because they were not authorized to discuss internal deliberations. If the F.D.A. follows through, it is likely to heighten criticism that the agency is basing its decisions on politics rather than science.
A spokesman for the Health Department did not respond to a request for comment.
The F.D.A. accepts nominations for many products, including the peptides, to add to the list of products compounding pharmacies can make for individual patients. But in 2023, as officials observed a rise in mass telehealth marketing of peptides, claiming that they offered longevity or a fitness boost to otherwise healthy people, the agency effectively banned the compounds.
Dr. Raizman said he had seen some clinicians in the sports medicine field embrace the restricted peptides. One of the products closely resembles drugs that have serious side effects, including a painful, hourslong erection. Another peptide was approved in Eastern Europe but not in the United States. A third is referred to as the “Barbie drug” and is meant to enhance tanning, exposing patients to risk for a limited benefit.
Since 2012, when an outbreak of fungal meningitis caused by an injectable painkiller made by the New England Compounding Center killed at least 64 people and sickened hundreds of others, career agency officials have been particularly wary of small compounding pharmacies. But over the last few years, the pharmacies have experienced a surge in business through selling cheaper, copycat versions of weight loss drugs — a practice the F.D.A. has recently cracked down on.
Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding, a trade group, said the injectable peptides that people are currently purchasing online raise concerns.
“The patients who are getting them are almost certainly getting either unproven, illicit product from overseas or research-grade product,” Mr. Brunner said, “because there’s not a version of these drugs that is pharmaceutical grade from F.D.A-registered manufacturers and eligible for use in humans.”
Some of the most high-profile vendors of peptides include Mr. Kennedy’s supporters and allies. Mr. Kennedy hosted Brigham Buhler, a compounding pharmacy owner, on his podcast in 2023, describing him as someone who left a career in pharmaceutical sales to “provide low-cost preventive wellness” to patients.
Mr. Buhler also runs a company, Ways2Well, that advertises peptides. Asked about the products, Mr. Buhler said his company does not use or sell research-grade peptides. He said that he recalled having at least six conversations about peptides with senior leaders in the Health Department, including Mr. Kennedy.
“The devil’s advocates will say, ‘We have got to stop the Wild West. If the F.D.A. were to do this, this will create the Wild West,’” Mr. Buhler said. “And my rebuttal to that is: We are living in the Wild West.”
Mr. Buhler’s compounding pharmacy, ReviveRX, has in the past run afoul of the F.D.A., which in September warned the company that its products were not sterile and that they “put patients at risk.” The warning referred to an F.D.A. inspection from earlier in 2025 that discovered bacteria and mold in “critical areas” of the pharmacy’s processing suite, records show.
Mr. Buhler said that his pharmacy promptly responded to the warning letter, “implementing comprehensive corrective and preventive actions to fully address the agency’s observations.” He said his company is not compounding peptides that were removed from the F.D.A. list.
Gary Brecka, another supporter of Mr. Kennedy’s and a self-described biohacker, markets vials and nasal sprays of peptides through his website for up to $375. On his popular podcast “The Ultimate Human” and on MAHA Action webcasts, he has pushed for the administration to expand access to peptides.
Mr. Brecka’s website features some peptides that were taken off the F.D.A. list in 2023. But he said that the peptides are prescribed by a doctor and that physicians can still prescribe peptides that are used for research purposes.
Mr. Brecka said in an interview that he takes peptides every day and feels better at 55 than he did at 25, calling them “phenomenal solutions for a lot of people.”
“I think strategically, ethically, this is the right thing to do for Americans,” Mr. Brecka said.
Mr. Kennedy agrees that the restrictions on the peptides should be lifted. He called the peptides sold on the gray market “very substandard” and said he wanted people to have access to “ethical suppliers.”
“We created the black market,” he said, “and it’s a very dangerous black market.”
If the F.D.A. does return peptides to the list of acceptable items for compounding, many of them would continue to be produced in facilities that are not required to follow the so-called good manufacturing rules that apply to makers of approved drugs, said Kalah Auchincloss, a former F.D.A. deputy chief of staff.
Dr. Eric Topol, director of the Scripps Research Translational Institute, said the data on peptides is “just woefully minuscule,” and urged more caution in their use, saying he was worried about serious safety concerns.
“It’s a mess, because we don’t have any data that these work,” he said. “Maybe one of them actually does something good. But right now, we just know that they’re a liability.”
Dr. Raizman said the move to bring back the peptides appeared to reflect Mr. Kennedy’s animus toward mainstream medicine at the cost of risks to safety.
“It seems so shortsighted to me,” he said, “just poor strategy of feeding your base to score meaningless points without accomplishing anything.”
The Health Department official said the F.D.A. planned to aggressively enforce rules against making false or misleading claims about medical benefits.
The F.D.A. is also planning to convene a meeting of its Pharmacy Compounding Advisory Committee. That group is likely to consider whether there is a medical justification for the peptides and vote on whether to add them to a list of products that can be legally used by compounding pharmacies.
Dr. Raizman said Mr. Kennedy should use his authority to commission research on peptides.
Otherwise, Mr. Kennedy appears to be in a role akin to one he has long criticized: A public official acting at the behest of allies with financial motivations, said John W.M. Claud, a lawyer at Nelson Mullins in Washington, who previously worked for the F.D.A. and the Justice Department on cases against compounding pharmacies.
“What I’ve seen are the people who would profit the most from this saying that these drugs are safe,” he said. “And what I haven’t seen is safety data that would tell me that these drugs should be more available.”
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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