Is Melatonin legal in Finland?

Formal status

There is no EU-harmonised rule on melatonin in food supplements. It is governed nationally, and member states differ widely - from open sale at several milligrams to prescription-only status.

Finland draws a clear line, and it is one of the better-defined in Europe. Melatonin is named in Annex 1 of Fimea's medicines list 230/2025, but that decision states in its own terms that the list is not exhaustive and that not every product containing a listed substance meets the definition of a medicine. The operative boundary is dose. A daily dose of 2 mg or more makes the product a medicine requiring a marketing authorisation; below that it is a food supplement.

Both sides of that line have been settled by decision rather than by assertion. In April 2014 the Supreme Administrative Court upheld the regulator's finding that a 2 mg melatonin product was a medicine. In 2018 the regulator issued four decisions holding 1.9 mg melatonin preparations not to be medicines; all four are final.

The Finnish market has organised itself around that boundary. Pharmacy chains sell melatonin food supplements at 1.0 to 1.95 mg as ordinary retail products. Higher strengths exist in Finland as licensed medicines.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Yes, and this one is straightforward.

Finland draws a clear line at 2 mg: at or above that a melatonin product is a medicine requiring authorisation, and below it a food supplement. Our Sleep formula contains 1 mg, half the threshold. Finnish courts and the medicines regulator have tested that boundary from both directions, and Finnish pharmacies openly sell melatonin supplements at up to 1.95 mg.

So there is no grey area for melatonin in Finland. We sit comfortably inside a published national limit, in a market where products at nearly twice our dose are sold as ordinary supplements.

Outlook

This is a settled position with a decade of decisions behind it on both sides of the boundary, and an established retail market operating just under the line. We do not expect it to move.

The only thing that would change it is Finland revisiting the 2 mg boundary itself, for which there is no current indication. If that happened it would most likely be announced as a classification change by the medicines regulator rather than as legislation.

Timeline

April 2014

Korkein hallinto-oikeus upholds Fimea's decision that a melatonin product dosed at 2 mg per tablet is a medicinal product which may not be marketed without a marketing authorisation (muu päätös 1394/2014).

Korkein hallinto-oikeus

August 2018

Fimea decides that a 1.9 mg extended-release melatonin product is not a medicinal product, the last of four decisions in 2018 clearing 1.9 mg melatonin preparations as food supplements. All four are final.

Fimea, luokittelupäätökset 2018-2025

May 2025

Fimea's decision on the medicines list, 230/2025, enters into force and repeals the 2022 list. Cannabidiol and melatonin are both named in Annex 1; cannabinol is not. The decision states in its own terms that the list is not exhaustive and that not every product containing a listed substance meets the definition of a medicine.

Suomen säädöskokoelma 230/2025