Kennedy's Peptide Plan Reaches the White House, and Wall Street Is Already Counting the Money

In the autumn of 2012, a mold that normally lives in soil and on grass turned up in the spinal fluid of Americans who had gone to their doctors for back pain. The organism, Exserohilum rostratum, arrived in vials of injectable steroid made by the New England Compounding Center in Framingham, Massachusetts, and by the time the CDC closed its count, 753 people in 20 states had been sickened and 64 had died. Every fight over compounding pharmacies since then has taken place in that outbreak’s shadow, and the newest one comes with a price tag.

On Thursday, Robert F. Kennedy Jr.’s Department of Health and Human Services sent a peptides “interim access policy” to the White House for review, and the companies waiting on the other side of it are easy to find. Hims & Hers and Noom have both announced plans to sell peptides if Washington eases access, and Wall Street analysts put the market at $2 billion to $3 billion. The filing itself, now at the Office of Management and Budget, gives no specifics. Two people familiar with the plan told the Associated Press it would let compounding pharmacies temporarily make some of the most popular peptides, BPC-157 among them, under “enforcement discretion,” meaning the FDA would simply choose not to go after those pharmacies. Formally adding the peptides to the agency’s list of substances eligible for compounding would take federal rulemaking, which could run for years.

NECC left regulators with one question they still ask about every compounded injection: does anyone know what is in the vial? Kennedy has spent months pressing a second one. What happens to the people who buy peptides anyway once the pharmacies are shut out?

From the pharmacy counter to a Queens bodega

The restrictions began in 2023, when the FDA moved BPC-157 and more than a dozen other injectable peptides into Category 2, its list of bulk substances that may present significant safety risks, a classification that effectively bars compounding pharmacies from making them. The agency’s reasons were specific. For BPC-157 it cited a risk of immune reactions by certain routes of administration, peptide-related impurities and trouble characterizing the active ingredient. For TB-500 it flagged possible aggregation and said it had found no human exposure data at all.

The peptides did not go away. As TIME reported, consumers turned to other sources, including suppliers in China. At the July advisory meeting, Anant Vinjamoori, a physician with Hims & Hers, told the committee that a colleague had sent him a photo of peptides for sale in a Queens bodega, which he called “the real alternative” to letting legitimate pharmacies compound them under controlled conditions. He had an obvious commercial stake in saying so. Kennedy, who has none of that kind, has made the same argument from the secretary’s chair, warning that Americans are turning to “gray market” peptides made in China and elsewhere. Before he joined the administration he promised that the “FDA’s war” on peptides and other wellness products would end, and NPR reported that he has used some of them himself.

The agency’s own staff handed Kennedy’s side its sharpest line without meaning to. At the July meeting, Russell Wesdyk of the FDA’s drug center objected to listing the peptides with a question: “If you don’t know what it is and I don’t know what it is, how do I put it on the list?” It is a fair question to put to a pharmacy. It lands much harder on a vial from an unnamed overseas factory sitting on a convenience-store shelf in Queens. NECC was a licensed pharmacy that failed catastrophically, but a licensed pharmacy is something regulators can inspect, trace and shut down, which is how a disaster like 2012 gets counted to the last death. A bodega supplied from abroad is none of those things. The 2023 restrictions left that trade running in places where nobody will ever count the casualties.

In April the FDA said it would take 12 peptides off Category 2 after the people who had nominated them withdrew their nominations. Removal did not make them eligible for compounding, because the agency’s interim leniency covers only Category 1 substances, and one law firm described the twelve as left in limbo. The advisory committee met July 23 and 24 and narrowly recommended 6 of the 7 peptides on its agenda: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. It rejected only emideltide. The BPC-157 vote was 8 to 6, with 1 abstention. None of that is binding, and the FDA would still have to finish rulemaking before any of the six joined the list. The interim policy now at the White House would go around that slow path.

Forty-six patients and an enema

FDA staff scientists unanimously opposed adding every one of the peptides, and their reasons are worth reading closely. For BPC-157, the only trial staff could find was a 46-person meeting abstract on ulcerative colitis, in which the peptide was given as an enema rather than injected. For KPV, none of the studies they found were in humans. None of these peptides is approved for what people actually want from them, bulking up, looking younger or boosting energy, and most of the data come from animal studies. Alexander Weber, chief of sports medicine at the University of Southern California, told NPR: “We just don’t have enough data to support their use.”

Thin evidence argues for collecting data, and that is where the plan, as described so far, looks weakest. Wesdyk told the panel that the FDA lacks the regulatory authority to put in place the guardrails the committee wanted. Even formal listing, ABC News noted, would require pharmacies to confirm where their ingredients come from and test them for contamination, while the products would still skip ongoing tracking of dangerous side effects and clear safety labeling. Enforcement discretion is a lighter instrument than listing, and whatever conditions HHS attaches to it are unknown because the filing does not say.

We have watched a version of this before. During the GLP-1 shortage, compounding pharmacies made their own semaglutide and tirzepatide, and at the July meeting the Partnership for Safe Medicines pointed to a 2025 paper by Kenneth McCall, one of the group’s board members, comparing compounded GLP-1s with non-compounded products from 2018 to 2024. It found higher rates of adverse effects, including more abdominal pain, diarrhea and nausea, and more reported prescribing and preparation errors with the compounded versions. Those findings arrived years after patients had taken the drugs. A peptide policy that requires no reporting would leave researchers even less to work with when the questions come.

A health-populist case for peptides owes the new winners the same scrutiny it gives Pfizer, and they are not hiding. HHS selected the July panel, which included doctors, pharmacists and consultants who work in the peptide field. STAT reported that a majority of the panelists who voted yes have ties to the peptide industry, and ABC News found that six of the eight recently appointed members run clinics that offer peptides. Hims & Hers, whose physician brought the bodega photo, saw its stock rise more than 10 percent after the BPC-157 vote.

A conflicted panel can still reach the right answer, and on access this one may have. But medical freedom that pays off first for a publicly traded telehealth company is not what the MAHA movement promised voters. People spent years rightly furious at the revolving door between captured agencies and the drug giants, and a friendlier door opening onto a different industry has not earned an exemption from that anger. Patients should be able to get peptides from a pharmacy that can be held to account, and the public should get a full count of what happens to them afterward.

The plan now sits with the Office of Management and Budget. When HHS publishes the text, the test of what kind of reform this is will be a single requirement: whether pharmacies dispensing these peptides must test each lot and report adverse events to the FDA. That is our standard, not yet anyone’s rule. The same committee is slated to take up five more peptides, LL-37, GHK-Cu and Melanotan II among them, before the end of February 2027, and by then Kennedy’s HHS should be able to tell Americans what has happened to the people already injecting whatever the interim policy covers.

Sources

1. STAT / Associated Press: Trump administration advances plan for peptide drugs favored by RFK Jr. (Oct. 15, 2026)
2. FDA: Certain bulk drug substances for use in compounding that may present significant safety risks
3. TIME: An FDA committee voted in favor of peptides despite the agency’s opposition (July 23, 2026)
4. ABC News: FDA advisers narrowly vote to add 6 peptides to a drug compounding list
5. STAT: FDA advisory panel narrowly votes to allow compounding of unapproved peptides (July 23, 2026)
6. NPR via OPB: FDA scientists flag concerns with peptides as RFK Jr. tries to ease access (June 30, 2026)
7. Frier Levitt: FDA to remove 12 peptides from the Category 2 list (2026)
8. CDC (archived): Multistate outbreak of fungal meningitis and other infections, final case counts