Marty Makary, his successors, and the FDA on peptides
Makary said little on peptides in public. His FDA said a lot about compounded GLP-1s. He left in May 2026, before the committee met, and the agency has had an acting head since.
Marty Makary, a surgeon and former Johns Hopkins professor, was Commissioner of Food and Drugs from April 2025 to May 2026, the dates FDA itself now gives beside his name. The committee vote on peptides happened after he left. Much of what FDA said about peptides and compounding during his tenure came in agency notices rather than in his own words. This page separates the two.
What Makary said
| Date | Setting | His words |
|---|---|---|
| 9 Sep 2025 | FDA press release on drug advertising | "For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship." "Drug companies spend up to 25% of their budget on advertising." |
| 10 Nov 2025 | Copied on Rep. Harshbarger's letter to Kennedy | No public reply found. |
| 23 Dec 2025 | Podcast with Gary Brecka | "If a therapy has good data, we'd like to see it." On peptides, Undark reports he said FDA would need to review which are "harmless" and which need more study (paraphrase with a quoted word). |
| 6 Feb 2026 | FDA statement on compounded GLP-1s | "Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1" ingredients for mass-marketed compounded drugs. "These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy." "We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act." |
Undark described his December 2025 answers as "open yet non-committal". We found no interview, hearing testimony or post in which Makary commented on BPC-157 or on the April 2026 Category 2 decision by name.
What FDA did while he was commissioner
- September 2025: the advertising crackdown, with "thousands" of letters and about 100 cease-and-desist letters. Warning letters posted that month included telehealth companies marketing compounded GLP-1s.
- 6 February 2026: the GLP-1 ingredient statement, which also said companies "cannot claim that non-FDA-approved compounded products are generic versions" of approved drugs.
- 1 April 2026: a compliance policy on "essentially copies" of approved GLP-1s, with a four-prescriptions-a-month threshold for 503A pharmacies.
- 15 April 2026: the announcement removing 12 peptides from Category 2 and scheduling committee review.
- 30 April 2026: the Commissioner renewed the PCAC charter for two years, to 25 April 2028.
- 1 May 2026: the proposal to keep semaglutide, tirzepatide and liraglutide off the 503B list.
The GLP-1 steps are covered on the GLP-1 compounding policy page and the dated FDA and compounded GLP-1s page.
His resignation
Makary resigned on 12 May 2026. NBC News reported that the departure followed months of friction with the White House, and that a source close to HHS leadership said he opposed the decision to authorise fruit-flavoured e-cigarettes. Reporting at the time did not link his resignation to peptides or compounding. President Trump named Kyle Diamantas, FDA's deputy commissioner for human foods and a lawyer, as acting commissioner.
Since May 2026
Diamantas led the agency through the July committee meeting and remained acting commissioner in October 2026. NBC News reported he declined the permanent job. On 19 August 2026 Trump said he would nominate Dr. Heidi Overton, a White House Domestic Policy Council official. The Senate Health, Education, Labor and Pensions Committee held her confirmation hearing on 24 September 2026. Coverage of the hearing centred on vaccines and mifepristone; we found no report that peptides were raised, and no committee vote had been reported when this was written.
We found no public statement by Diamantas or Overton on peptides. The agency's position since May has come through documents: the July briefing packages, which recommended against all seven peptides, and warning letters to online sellers of "research use only" products in June and August 2026.
What FDA's documents said about the process
The April 2026 action was framed narrowly. Law firms that read the announcement reported that FDA gave the nominators' withdrawals as the reason for removing the 12 peptides from Category 2, not new safety evidence. The July briefing documents opened with a standard caution: "The FDA does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized." It added that "the final determination may be affected by issues not discussed at the advisory committee meeting." In other words, the agency told the committee, in writing, that its vote was one input among several.
Agency staff versus agency leadership
One feature of 2026 is that FDA's written record and its leadership's public direction were not the same. FDA's reviewers concluded, for each of the seven July peptides, that the balance of evidence "weighs against" listing. FDA's leadership had scheduled the meeting after Secretary Kennedy's public comments and after nominators withdrew from Category 2. Both are part of the record. Neither is the final word; that is a rule FDA has not yet proposed.
Where to look next
The Kennedy page covers the Secretary's statements, the committee page the July meeting, and the timeline the full sequence. For background on what the list is, start with the 503A explainer.
Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.
Questions people ask
What did Marty Makary say about peptides?
On a podcast with Gary Brecka on 23 December 2025 he said "If a therapy has good data, we'd like to see it," and, as reported by Undark, that FDA would need to review which peptides are harmless and which need more study.
Is Makary still FDA commissioner?
No. He resigned on 12 May 2026. Kyle Diamantas has been acting commissioner since then.
Who is the nominee for FDA commissioner?
Dr. Heidi Overton, a White House Domestic Policy Council official, announced on 19 August 2026. Her Senate committee hearing was on 24 September 2026.
What did Makary's FDA say about compounded GLP-1s?
On 6 February 2026 FDA said it intended to take "decisive steps to restrict GLP-1" ingredients used in mass-marketed compounded drugs, and that companies cannot call compounded products generic versions of approved drugs.
Sources
- FDA launches crackdown on deceptive drug advertising, U.S. Food and Drug Administration, 9 September 2025
- BPC-157: a MAHA-adjacent peptide, linked to Croatia, Undark, co-published with STAT, 3 February 2026
- FDA intends to take action against non-FDA-approved GLP-1 drugs, U.S. Food and Drug Administration, 6 February 2026
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, U.S. Food and Drug Administration, updated 1 April 2026
- FDA announces removal of 12 peptides from Category 2 and schedules PCAC meetings, Orrick, 16 April 2026
- Pharmacy Compounding Advisory Committee; renewal (91 FR 23275), Federal Register, 30 April 2026
- Dr. Marty Makary is out as FDA commissioner, NBC News, 12 May 2026
- Trump nominates Heidi Overton to lead the FDA, NBC News, 19 August 2026
- FDA nominee faces skepticism on vaccines from Republican senators at confirmation hearing, States Newsroom, 24 September 2026
- Letter from Rep. Diana Harshbarger to HHS Secretary Robert F. Kennedy Jr. on peptides, 10 November 2025
