RFK Jr.’s peptide deregulation threatens the foundations of drug safety

HHS Secretary Kennedy’s peptide push would legitimize unproven injectables while weakening century-old drug safeguards

Spend a few minutes in the wellness economy — at a clinic, on social media or on a biohacking podcast — and you will encounter peptides touted as injectable solutions for everything from chronic pain and inflammation to muscle wasting, cognitive decline, sexual dysfunction, and aging. Sometimes marketed with the backing of physicians, they are often bundled into branded stacks with superhero names like the “Wolverine protocol.”

There is one problem: not one of these claims has been proven in a human clinical trial. The products themselves — known not by recognizable brand names but by alphanumeric codes like BPC-157, CJC-1295, TB-500 and AOD-9604 — are often manufactured in Chinese factories, sold through gray-market online vendors and injected by consumers who have no reliable way to know what is actually in the vial.

In February, HHS Secretary Robert F. Kennedy Jr. announced on The Joe Rogan Experience — without using the formal regulatory process, presenting the move to a scientific advisory committee or, apparently, notifying FDA staff — that he intended to lift federal restrictions on 14 injectable peptides and allow compounding pharmacies to produce and sell them. The announcement was greeted with enthusiasm by wellness influencers and gray-market vendors. It should alarm everyone else.

To understand why, consider what those restrictions were based on. Federal law governing compounding pharmacies — specialized pharmacies that mix custom medications for individual patients — requires FDA to assess whether bulk drug ingredients are safe to use. When FDA formally reviewed these peptides in 2022 and 2023, it placed them on a restricted list for specific reasons: evidence of immune-reaction risk, contamination with dangerous impurities, or insufficient human safety data to support their use. In late 2024, the agency’s independent scientific advisory committee reviewed the evidence and voted against allowing several of the peptides back into compounding. It was a deliberative process grounded in scientific review. Kennedy’s casual announcement bypassed it entirely.

There is a crucial legal distinction here. Under federal law, a product that claims to treat or cure a disease is regulated as a drug and must undergo clinical trials and FDA review, while one that merely claims to “support” an organ or bodily function can be sold as a dietary supplement under a far more permissive standard that requires no premarket proof of safety or efficacy. Peptide marketers have exploited this loophole aggressively, but that framing should not obscure what these products are. Injectable peptides with potentially powerful biological effects are not ordinary supplements, and their safety risks make clear they should be regulated as drugs (or biologics) regardless of the vague claims their marketers choose to emphasize.

The injuries that can be caused by peptides are not hypothetical. In 2025, two women were hospitalized on ventilators after receiving peptide injections at a longevity conference in Las Vegas. Whether the cause was the peptides themselves or contaminants in the vials remains unclear — and that uncertainty is precisely the problem. Independent testing of commercially available peptide products has found significant purity failures across a substantial share of vendors. 

A false cure for the gray market

Kennedy’s central argument — that restricting compounding pharmacy drove consumers to a dangerous gray market, and deregulation will therefore clean it up — is superficially plausible but empirically weak. The gray market predated the 2023 restrictions and is driven largely by social media economics, not regulatory gaps that licensed compounding can close.

Deregulation will not eliminate the gray market; more likely, it will create a second, more seemingly medically legitimized channel alongside it. However, even if some consumers migrate to licensed compounders with higher purity standards, expanding access to unproven injectable peptides would still normalize demand and broaden exposure without generating the human evidence FDA ordinarily requires to ensure products are safe and effective. The result would not be an evidence-based market, but a larger one, with the unregulated online tier continuing alongside it.

The supply chain adds a national security dimension this administration seems content to ignore while invoking Chinese threats in every other context. Many of the raw ingredients in these products appear to come from Chinese manufacturers, flowing through online vendors with no oversight, no required purity documentation, and no accountability when something goes wrong. Sen. Tom Cotton (R-Ark.) urged the FDA to crack down on illegal Chinese peptide shipments even as Kennedy was announcing plans to expand access to the same supply chain.

None of this is new ground. In 1906, Upton Sinclair’s The Jungle and Samuel Hopkins Adams’ The Great American Fraud exposed a marketplace where patent medicines laced with morphine and alcohol were sold to infants and adults alike with no labeling, no purity standards, and fantastical therapeutic claims — a near-perfect preview of today’s peptide market. The public outrage that followed prompted President Theodore Roosevelt to champion the Pure Food and Drugs Act, declaring that such a law “would protect legitimate manufacture and commerce, and would tend to secure the health and welfare of the consuming public.” It was the founding premise of the FDA: that government has a duty to stand between consumers and those who would profit from selling dangerous or fraudulent products. Kennedy is weakening a century of drug safety law built on that premise.

The wellness peptide marketplace today recapitulates everything Roosevelt sought to end: products with mysterious alphanumeric identifiers rather than names, claims untethered from evidence, raw ingredients from unregulated foreign suppliers, and profits flowing to those who have invested nothing in proving their products safe or effective. As researcher Paul Knoepfler of UC Davis has observed, this deregulatory push “would put public health at great risk, while giving compounders and likely wellness influencers a lot more profit.”

Companies that invest many years and billions of dollars in clinical trials to prove that their drugs are safe and effective have a direct stake in this outcome. If injectables can reach consumers without human trial data by executive fiat, the foundation of the drug approval system is eroded.

President Roosevelt said the work of drug safety “must be unflinchingly carried forward in the interest both of the public and of the great body of producers engaged in honest business.” Under this administration, that work is not being carried forward. It is being abandoned — by podcast, at scale, and without process.

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David Beier is managing director of Bay City Capital, a San Francisco-based life science venture capital firm. He previously served as chief domestic policy adviser to Vice President Al Gore and as a senior officer at Genentech and Amgen.

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