An earlier version of this article, published in April, listed tesamorelin, sermorelin, CJC-1295, ipamorelin and AOD-9604 among the peptides covered by the February announcement, and described Category 1 as a list of substances eligible for compounding. Both statements were wrong. This version corrects them and covers what has happened since.
On 27 February 2026, HHS Secretary Robert F. Kennedy Jr. said on a podcast that roughly 14 of 19 restricted peptides would move back to Category 1. That was a statement of intent, not a regulatory action. What the FDA actually did, in late April, was take 12 peptides off Category 2 after their nominations were withdrawn. None was placed in Category 1 and none is on the 503A Bulks List. In July an advisory committee recommended six of them. As of September 2026, none of these peptides can lawfully be compounded on the strength of either the announcement or the vote.
What was said on 27 February, and what it was.
Kennedy made the remarks during an appearance on The Joe Rogan Experience. He said he expected an announcement within weeks, that around 14 of the 19 peptides the FDA had placed in Category 2 would move back to Category 1, and that he hoped people would end up with access through what he called ethical suppliers.
A statement from a cabinet secretary on a podcast carries political weight. It carries no legal weight. It did not amend any list, publish any rule, or change what a pharmacy may lawfully do. The coverage that followed, including a version of this article, treated the number 14 as if it described a regulatory decision. It did not.
What the FDA actually did in April.
On 16 April 2026 the FDA published a Federal Register notice setting dates for its Pharmacy Compounding Advisory Committee to review a group of peptides. Around a week later, twelve peptides came off Category 2: BPC-157, TB-500, KPV, MOTS-c, Epitalon, Semax, emideltide (DSIP), GHK-Cu in injectable form, melanotan II, cathelicidin LL-37, dihexa acetate and PEG-MGF.
They came off because the parties that had nominated them withdrew those nominations, not because the agency concluded they were safe. The FDA said explicitly that removal does not establish that a substance meets the criteria for compounding under Section 503A. And none of the twelve moved into Category 1. The number was twelve, not fourteen, and the destination was not the one announced.
What Category 1 and Category 2 actually are.
This is the part most coverage got wrong, including ours. Section 503A lets a licensed pharmacy compound for an individual patient using a bulk ingredient that has a USP monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List. That list can only be changed by a final rule, and it has admitted six substances since 1997, none of them peptides.
- Category 1 is part of an interim policy for nominated substances the FDA is still evaluating. It describes substances the agency does not currently intend to take action against while it evaluates them. It is not the list, and it is not an authorisation.
- Category 2 covers nominated substances where the FDA identified significant safety risks and would consider enforcement. BPC-157 was placed there in September 2023.
Since 7 January 2025, the FDA no longer assigns interim categories to newly nominated substances at all.
What happened in July.
On 23 and 24 July 2026 the advisory committee voted on seven peptides. BPC-157, KPV and TB-500 passed 8 to 6 with one abstention. MOTS-c passed 7 to 5 with two abstentions. Semax passed 8 to 5 and Epitalon 7 to 4. Emideltide failed. The FDA's own scientific reviewers had argued against the six that passed.
The committee's recommendations do not bind the FDA. Adding any of these peptides to the Bulks List requires formal notice-and-comment rulemaking, and HHS still has to act. The remaining five, including GHK-Cu, are due before the committee by the end of February 2027. We cover the vote in detail in a separate analysis and the list mechanism in our explainer on the 503A Bulks List.
The peptides that were never part of this story.
Several names that circulate alongside the announcement sit in entirely different positions:
- Tesamorelin is an FDA-approved drug (Egrifta, first approved in 2010), indicated only for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. It was never in Category 2.
- Sermorelin was approved as Geref, discontinued in 2008, and in March 2013 the FDA determined it was not withdrawn for safety or effectiveness reasons. It sits on a different legal pathway from the peptides above.
- CJC-1295, ipamorelin and AOD-9604 were reviewed by the same committee in late 2024. It voted against ipamorelin on 29 October 2024 and against CJC-1295 and AOD-9604 on 4 December 2024. They were not part of the April 2026 group.
The announcement said fourteen and Category 1. The agency did twelve and neither. That gap is the whole story of 2026 so far.
So, are peptides legal in 2026?
The accurate answer, as of 23 September 2026: none of the twelve peptides discussed here is on the 503A Bulks List, none is in Category 1, and the July recommendations have not been turned into a rule. Compounding them is not made lawful by the podcast remarks, by the removal from Category 2, or by the committee vote. The FDA retains its enforcement authority.
Products sold online as "research use only" are a separate matter. That label means they are not sold for human consumption, and nothing in 2026 has changed that. Ozemback does not link to, name or evaluate sellers of these products.
What we are tracking.
- Whether the FDA publishes a proposed rule covering any of the six recommended peptides, and when.
- The date and agenda of the committee meeting due before the end of February 2027.
- Any HHS action that changes the interim category policy.
- FTC and FDA enforcement actions against marketing that describes these peptides as approved or legal.
We will update this page when any of those things happens, and date every update.
