In Washington the documents that matter most sometimes say almost nothing. In mid-October a notice went up on a website of the Office of Management and Budget, the White House office that federal rules must pass through. It recorded that the Food and Drug Administration had submitted an “Interim Access Policy” on peptides for review. It did not say what the policy contained. As Beth Mole reported for Ars Technica, the posting gives no information about the proposal itself.
What it means came from people who knew. They told the Associated Press that it would give the FDA “enforcement discretion” over certain peptide drugs. The agency could decline to enforce restrictions that are still on the books, and specialty pharmacies eager to start making these substances would be assured that they would not be targeted. According to the AP report carried by NBC News, the aim is to let pharmacies temporarily compound some of the most popular peptides, BPC-157 among them, which is promoted for building muscle and healing injuries.
The Department of Health and Human Services, which oversees the FDA and is run by Robert F. Kennedy Jr., did not respond to Ars Technica’s request for comment.
The rule and the shrug
Enforcement discretion is one of the state’s oldest instruments, and one of its quietest. The rule stays where it is. The authority simply chooses not to use it. One could put it this way: a government that wants something done without changing the law can rewrite the law or stop reading it, and the second is faster.
Speed matters here because the formal road is long. Adding peptides to the 503A Bulks List, the roster of substances compounding pharmacies may use, would take federal rulemaking with several rounds of public comment, a process that could run for years. The AP reported that it was not immediately clear whether the administration still intends to take that road. In a note to wellness providers, the law firm Holland & Knight observed that a policy of this kind would approve no product, would not reach research-use-only, supplement or 503B outsourcing channels, and could be withdrawn without formal rulemaking. The firm also noted that since August 2026 the FDA has stepped up enforcement against research-use-only peptide sellers and high-volume compounders. So the agency closes one door and gets ready to prop open another.
What the scientists found
Compounding pharmacies make customised formulations of drugs. In 2023, FDA staff scientists looked at a dozen popular injectable peptides and found that the data on their safety and efficacy were lacking and that they posed risks. The substances were removed from the list of drugs such pharmacies may make. The AP listed the concerns the agency had cited: possible contamination, allergic reactions, tumour growth. The FDA is now reviewing those same peptides again.
In July, at a two-day meeting of the agency’s Pharmacy Compounding Advisory Committee, outside advisers recommended lifting restrictions on six peptides, against the conclusion of the FDA’s own staff scientists. STAT reported that BPC-157 and KPV were among them, a win for Kennedy. The votes are not binding. An analysis in Health Affairs found that all of the supporting votes came from the eight members with ties to businesses or clinics in the peptide trade.
A big fan
None of this has dented demand. Sellers claim, without evidence, that the drugs improve appearance, raise energy and help heal injuries. They are especially popular in Kennedy’s Make America Healthy Again movement, and many of its prominent figures sell peptide products. Kennedy calls himself a “big fan” of peptides. When he took office he promised to end what he called “FDA’s war” on them. The enthusiasm has spread as far as shots for the family dog.
Usually it is an industry that comes to the state asking for leniency. In this case the movement’s figures sell the products, the movement’s champion runs the department, and the department’s own scientists are the ones left arguing that nobody has shown the drugs are safe.
The people who would inject these substances are not in the room. They are customers of pharmacies and clinics, trusting that what is sold to them has been checked by someone. Under the proposed policy, someone will have checked and found the evidence missing, and the government will have decided not to act on that finding.
The law firm Buchanan Ingersoll & Rooney, writing on what pharmacies should know, pointed out that the public record does not disclose the policy’s text, which substances it covers, or its conditions. The filing sits at the White House pending review.
For now, only the title is public.