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A booming wellness market has formed around peptides—mini-proteins that affect various processes inside the body. They help regulate hunger, blood sugar, inflammation, tissue repair, sleep and hormone release, among other bodily functions. Synthetic versions are sold as injections, pills, nasal sprays and creams. Some, including insulin and GLP-1 drugs, have been rigorously tested and approved by the FDA and are sold by prescription. But many wellness peptides lack credible evidence of safety or effectiveness, yet are available online.
"There's so much hype, there's so much fake news out there," said Dr. Julie Chen of Kaiser Permanente, warning that even careful consumers can be taken in by the advertising.
The gray market for experimental peptides has grown from a fringe biohacking trade into a commercial ecosystem of online vendors, medical spas, and compounding pharmacies. Celebrity promotions have helped turn some peptides into social-media sensations. Joe Rogan has said BPC-157 eliminated his elbow tendinitis within two weeks and has repeatedly praised it together with TB-500 as the "Wolverine stack." Actor Josh Duhamel says he uses the same combination. Hailey Bieber has promoted BPC-157 for gut health, muscle repair and recovery, while actor Tony Cavalero credited a BPC-157 injection with ending his recurring elbow pain. Actress Jennifer Aniston, a perennial fixture in the grifter wellness space, touts anti-aging solutions. And of course, there's the high priestess of wellness grifting, Gwyneth Paltrow, hawking her Youth-boost NAD+ Peptide Rich Cream. (The name is somewhat misleading: Only one of the 48 ingredients in the moisturizer is a peptide).
The reach of peptides and the dubious science behind them came into sharper focus on August 12 when Eli Lilly sued six U.S. sellers that it accused of illegally marketing one of them: retatrutide, an experimental weight-loss peptide that the Food and Drug Administration says cannot lawfully be compounded or sold to consumers.
According to Lilly, some sellers labeled their products "for research use only" while offering them for human use—even though FDA says retatrutide cannot lawfully be compounded or sold to consumers. Some marketers don't make that restriction clear.
Growing problem: Bias and conflicts-of-interest
At its July meeting, the RFK, Jr.-reconstructed FDA Pharmacy Compounding Advisory Committee recommended adding six unapproved peptide substances to the Section 503A Bulks List. That would eventually permit state-licensed pharmacies to compound them for individual patients with prescriptions—but only if FDA formally accepts the recommendations through rulemaking. The vote did not make the peptides FDA-approved or immediately authorize their compounding, but that could happen soon.
Compounding is the preparation of customized medications for individual patients, as opposed to the dispensing of conventionally manufactured, FDA-approved drugs. The committee endorsed six of seven substances promoted for conditions ranging from ulcerative colitis and wound healing to obesity, osteoporosis, insomnia and neurological disorders. The only peptide not recommended was emideltide for opioid withdrawal, chronic insomnia, and narcolepsy.
Every affirmative vote was close: 8-6, 8-6, 8-6, 7-5, 7-4 and 8-5. Although close votes do not independently establish bias, in this instance, the uniform margins are suggestive. Shortly before the meeting, eight new members—all appointed by the Kennedy-led HHS—were named to the committee. According to the New York Times, six had sold peptides or were affiliated with clinics, pharmacies or companies operating in the peptide market. Thus, these are not merely scientists with remote "industry ties." Several are active market participants voting on whether to expand the market in which they work.
Dr. Gabriel Alizaidy, for example, promotes peptides on social media and charges $500 for "peptide and hormone" consultations, including advice on "where to safely get each peptide or compound." Dr. Haleem Mohammed runs clinics in Florida that sell injections of peptides, vitamins, testosterone and weight loss medications.
Another appointee, Tennessee state Sen. Bobby Harshbarger, is a pharmacist in his family's compounding business. His mother, Rep. Diana Harshbarger, sent Kennedy a letter last year urging the FDA to permit greater access to six peptides, two of which were approved last month.
HHS responded to criticism by saying all members underwent the standard ethics review and that candidates unable to satisfy its requirements were dropped from consideration. That describes a process, but it does not dispel the conflicts. Formal ethics clearance—especially by this administration—does not resolve the broader question of whether members with ongoing commercial interests should have participated as voting members in decisions that could benefit their businesses.
Before the meeting, Dr. Peter Lurie, a former FDA associate commissioner and current president and executive director of the Center for Science in the Public Interest, warned that broader compounding would "unleash upon unsuspecting Americans a set of products previously deemed too dangerous to compound by the FDA."
During my 15 years at the FDA—as a medical reviewer, special assistant to the commissioner, and office director—I never witnessed anything remotely comparable.
The votes are especially indefensible because FDA's career scientists had reviewed all seven peptides and recommended they should not be included on the approved list. The newly appointed committee overruled them six times.
A review of the final document found evidence of safety and efficacy scarce or nonexistent. For several peptides, FDA found no human exposure data for the proposed routes of administration. The available evidence consisted largely of laboratory experiments, animal studies, uncontrolled observations and anecdotes—the sort of preliminary material that should prompt further research, not widespread clinical use.
FDA reviewers had also raised concerns about immunogenicity, impurities, aggregation and inadequate characterization of the active ingredients. FDA concluded that chronic, continuous exposure to Epitalon, one of the peptides the panel recommended for approval, could, by increasing telomerase activity and extending telomeres, present a potential carcinogenic risk. Thus, Epitalon's proposed effects on telomeres raised theoretical concerns about causing malignancies.
For data on peptide BPC-157, FDA found only a meeting abstract describing a small two-week ulcerative-colitis trial. Critical details were missing, and the study used an enema rather than the proposed suppository formulation.
Dr. Brian Lee, a USC transplant hepatologist who voted against BPC-157, noted that placebo-response rates can approach 30% and concluded that the evidence presented did not convincingly exceed that benchmark. Cardiologist Eric Topol, who is not a committee member, added: "There is no evidence from randomized trials in humans that any of these peptides provide the benefits that are advocated."
Compounded drugs are not FDA-approved, and their production is overseen primarily by state pharmacy boards. Russell Wesdyk, an FDA pharmaceutical-quality official, told the committee that the agency lacks authority to impose many of the purity-testing and adverse-event-reporting safeguards panelists said they wanted.
The supply chain is also murky. A recent analysis by Chainalysis estimated that the cryptocurrency-based gray-market peptide trade now exceeds $100 million annually. It linked some peptide vendors to Chinese chemical manufacturers that had previously supplied fentanyl and amphetamine precursors. The market relies heavily on cryptocurrency and layered intermediaries, obscuring the identities of sellers and the origin of their products even though blockchain payments themselves can sometimes be traced. Incorrect amino-acid sequences (peptides are small chains of amino acids), degradation, contamination, and dosing errors can be difficult to detect.
Supporters of these products, mostly physicians peddling unapproved peptides online, argue that pharmacy compounding would protect consumers currently buying peptides on the gray market. Here is a list of some of the most followed physicians and other health practitioners (generated by Deep Research):
Secretary Kennedy has said FDA should "do the science" and inform the public; that no government safety or oversight agency should dictate to physicians what they may prescribe or to patients what they may take. That is his philosophy of so-called medical freedom, one of his signature cliches. It is not a scientific standard, however—and it flagrantly disregards the consumer-protection purpose and requirements of the federal drug laws, in particular the Federal Food, Drug, and Cosmetic Act, enacted in 1938.
FDA's implementing criteria for Section 503A require the agency to consider physical and chemical characterization, safety, available evidence of effectiveness, and historical use. Treating access as the controlling principle sidelines the scientific criteria the agency is required to weigh. These hasty approvals legitimize poorly studied substances—no substitute for data providing evidence of safety and efficacy. Nor is inclusion on the compounding list easily distinguished, in the public mind, from an FDA endorsement.
The committee's recommendations are not binding. FDA can reject them, and it should. Expanding lawful access to unapproved drugs on the recommendation of a wellness industry-connected panel that overruled the agency's career scientists six times cannot credibly be called regulatory reform. It is regulatory malpractice.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the Science Literacy Project. He was the founding director of the FDA's Office of Biotechnology. Find Henry on X @henryimiller