Short answer. Appendix B describes enforcement discretion for MOTS-c acetate by subcutaneous or intramuscular injection [2]. The notice does not approve MOTS-c. It does not say MOTS-c causes weight loss. As of Oct 29, 2026.

The identity

MOTS-c acetate is printed with molecular formula C101H152N28O22S2·CH3COOH, molecular weight 2234.64 g/mol, and the sequence Met-Arg-Trp-Gln-Glu-Met-Gly-Tyr-Ile-Phe-Tyr-Pro-Arg-Lys-Leu-Arg as the acetate [2]. Sixteen amino acids. The policy says the substance has to match the identity in Appendix B, including sequence, structure, molecular weight, and formula [2].

It was in Category 2 from September 29, 2023 until April 22, 2026. The policy says that placement and its removal did not change 503A status. CDER recommended against listing either form. The advisory committee voted in favor of both forms [2]. The discretion sentence is about the acetate and two injectable routes [2].

An analogue is not this product

HHS says lot certificates now report impurity, residual solvent, endotoxin, and microbial results, and that most documented use was single-ingredient. It also points to a randomized placebo-controlled trial of a MOTS-c analogue that reported no serious adverse events, and to rodent studies [2].

An analogue is a related molecule, not the compounded product in your hand. A sentence in an enforcement policy is not a label claim. The MOTS-c evidence page still says the FDA briefing did not establish effectiveness for the nominated uses, which included obesity and osteoporosis. Both documents can be true: FDA staff did not find the clinical case made, and HHS later described limited discretion anyway [1][2].

No dose is printed in the discretion sentence. Do not take a number from a group chat and call it the policy. Sommar Club does not prescribe or sell MOTS-c.

FAQ

Does the policy cover oral MOTS-c? The sentence we read names subcutaneous or intramuscular dosage forms [2].

Does the analogue trial mean compounded MOTS-c is safe? The policy cites that trial as part of HHS's justification. It also says compounded drugs are not FDA-approved [1][2].

Sources

1. HHS notice, FR Doc. 2026-22192, filed Oct 28, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf

2. HHS policy, Appendix B, MOTS-c. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf

Education only. Not medical or legal advice. As of Oct 29, 2026.