Peptide Regulation Watch · Substance File

MOTS-c

Not Permitted STATUS VERIFIED AUGUST 22, 2026 · HAS A SHELF LIFE

A mitochondrial-derived peptide studied in metabolism research — and, as of the date above, not lawful to compound for human use via any pathway.

Also encountered as: MOTS-c · class: mitochondrial / metabolic

Where it actually stands

On July 23–24, 2026, FDA's Pharmacy Compounding Advisory Committee voted to recommend this substance for the 503A compounding bulks list. That vote is the most misread event in this space: PCAC is advisory, FDA staff entered the process recommending against, and no rulemaking has followed. It sits on no permitted category and is not on the 503B bulks list. Removal from Category 2 in April placed it in no category — limbo, not clearance.

The one-sentence version: a committee recommended it; the agency has not acted; it cannot lawfully be compounded for human use today.

The record

APR 15, 2026

FDA removes this substance (among 12 peptides) from Category 2 — placing it in no category. Docket FDA-2025-N-6895.

JUL 23–24, 2026

PCAC votes to recommend it for the 503A bulks list. Advisory, non-binding, over FDA staff objections.

AUG 2026

No FDA rulemaking. Expert timelines put actual rule changes 12–24+ months out; “research use only” marketing remains an enforcement target.

Primary sources

FDA PCAC meeting record, Jul 23–24 2026 · Federal Register doc. 2026-07361 / docket FDA-2025-N-6895 · FDA bulk substances / safety-risk pages (updated 4/22/26) · Holland & Knight client alert, Aug 4 2026. Full citation list available on request.