Is MOTS-c legal?
Not as a drug. MOTS-c has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. An FDA advisory committee recommended it for pharmacy compounding in July 2026, but FDA has not acted, so pharmacies still cannot compound it.
DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION
Federal, compounding and sport status
CHECKED 12 OCT 2026Federal status
- Jul 23, 2026 · recommended · 7 yes, 5 no, 2 abstentions (law-firm reports) · SOURCE ↗
Sport-body status
What we couldn’t verify
State rules
1 STATESince 1 Jul 2026 Indiana law (IC 16-42-22.5) bars compounding from research-grade or veterinary-grade bulk ingredients outside an IRB-approved study and requires an FDA-registered source with a certificate of analysis. From 1 Jan 2027 medical spas must register with the state medical board. This matters if FDA later allows pharmacies to compound MOTS-c: in Indiana the ingredient could not be research grade.
- Indiana Senate Enrolled Act 282 (Public Law 136-2026), signed 5 Mar 2026 ↗ · verified Oct 12, 2026
- SEA 282 enrolled text ↗ · verified Oct 12, 2026
In the other states we found nothing that names MOTS-c; federal law applies.
What changed at the last check
6 CHANGES| Date | Field | Was | Now | Why |
|---|---|---|---|---|
| 12 Oct 2026 | 503A Bulks List status | under pcac review | pcac recommended | Not eligible as of 12 Oct 2026. Removed from Category 2 on 15 Apr 2026; the PCAC recommended it (obesity, osteoporosis) in July 2026. source ↗ |
| 12 Oct 2026 | FDA Category 2 (safety risk) | under pcac review | not on list | FDA's Category 2 page lists it under 'nominated but withdrawn', not in Category 2. source ↗ |
| 12 Oct 2026 | WADA 2026 | prohibited (S2) | prohibited (S4.4.1) | Named under S4.4.1 as an AMPK activator (mitochondrial open reading frame of the 12S rRNA-c). Prohibited at all times. source ↗ |
| 12 Oct 2026 | OH state note | Ohio BOP Feb 2026 peptide compounding guidance directs cessation of Category 2 style peptide preparation including MOTS | removed | Removed. The entry described a OH action that does not name MOTS-c; it applied federal-level or class-wide facts by analogy. source ↗ |
| 12 Oct 2026 | IN state note | none | added | Since 1 Jul 2026 Indiana law (IC 16-42-22.5) bars compounding from research-grade or veterinary-grade bulk ingredients outside an IRB-approved study and requires an FDA-registered source with a certificate of analysis. From 1 Jan 2027 medical spas must register with the state medical board. This matters if FDA later allows pharmacies to compound MOTS-c: in Indiana the ingredient could not be research grade. source ↗ |
| 12 Oct 2026 | PCAC review | pending (vote scheduled) | voted yes | PCAC vote on 2026-07-23: 7 yes, 5 no, 2 abstentions (law-firm reports). source ↗ |
Questions
3 ANSWERSIs MOTS-c legal in the US?
Not as a drug. MOTS-c has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. An FDA advisory committee recommended it for pharmacy compounding in July 2026, but FDA has not acted, so pharmacies still cannot compound it.
Can a pharmacy compound MOTS-c?
Not eligible as of 12 Oct 2026. Removed from Category 2 on 15 Apr 2026; the PCAC recommended it (obesity, osteoporosis) in July 2026. No FDA rule or interim decision has followed.
Is MOTS-c banned in sport?
Yes. It is prohibited at all times under WADA 2026 class S4.4.1. Named under S4.4.1 as an AMPK activator (mitochondrial open reading frame of the 12S rRNA-c). Prohibited at all times.