Is Melanotan II legal in the US?
No. It is not approved and is sold as an unregulated product.
Not approved by the FDA for any use and sold as an unregulated gray-market product. Melanotan II was nominated for the FDA's list of substances compounding pharmacies may use and placed in Category 2 (significant safety risk); the nomination was withdrawn and the FDA removed it from that category in April 2026, with an advisory committee review planned, which does not make it legal to compound or sell. 1
No. It has never been approved for anything. The FDA listed it as a significant safety risk for compounding. The nomination was withdrawn in 2026. After that, the FDA removed it from that category pending an advisory committee review. None of that permits sale. 1
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Citations
- FDA: Certain bulk drug substances for use in compounding may present significant safety risks fda.gov
- Dorr 1996, Life Sci: Evaluation of melanotan-II in a pilot phase 1 clinical study pubmed.ncbi.nlm.nih.gov
- 2008, Arch Dermatol: Melanotan-associated changes in melanocytic nevi doi.org
- 2009, Br J Dermatol: Melanotan II use and atypical naevi doi.org
- 2014, Dermatology: Melanoma associated with the use of melanotan-II pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Melanotan II article, fact-checked against the cited sources. No dosing anywhere on this site.