U.S. Food and Drug Administration (FDA)
Is MOTS-c legal in United States?
Not approvedNo FDA approval; FDA found no human exposure data, and a July 2026 advisory vote to consider it is non-binding
Not approved as a medicine here.
MOTS-c is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA has no human exposure data for MOTS-c drug products. The Pharmacy Compounding Advisory Committee reviewed it for obesity and osteoporosis on 23 July 2026 and, according to a law-firm report, voted 7 to 5 with two abstentions to recommend it for the 503A bulks list; FDA has not acted. US customs officers reported seizing MOTS-c among unapproved peptide shipments in 2026.
Last verified 2026-09-29 · how we verify
MOTS-c elsewhere
Sources (4)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
- 03Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29
- 04Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.U.S. Customs and Border Protection · 2026-03-31 · accessed 2026-09-29