Is Melatonin legal in Sweden?

Formal status

Melatonin sits outside any EU-harmonised framework for food supplements. Member states set their own rules, and those rules differ considerably from one country to the next.

Sweden sits at the strictest end of that range, and it is one of the clearest national positions in Europe. The Swedish medicines agency states that melatonin is classified as a medicine in Sweden, may not be sold as a food supplement, and may only be sold in pharmacies.

Non-prescription melatonin exists, but within narrow limits. The agency's substance report for over-the-counter melatonin restricts the non-prescription indication to short-term treatment of jet lag in adults over 18, with a maximum daily dose of 5 mg and pack sizes of up to ten tablets. The same report states that sale in non-pharmacy retail is not accepted in Sweden, because of the risk of off-label use. Higher strengths and any use other than jet lag remain prescription-only.

The consequence for a cross-border supplement seller is unambiguous. There is no dose at which melatonin may be sold into Sweden as a food supplement, and there is no retail channel outside pharmacies through which it may be sold at all.

Do we sell here?

No.

No, we do not ship to Sweden.

Melatonin is regulated as a medicine in Sweden rather than as a supplement. It cannot be sold as a food supplement at any dose, and even the non-prescription form is limited to pharmacies, to adults, to short-term jet lag, and to packs of ten tablets. There is no version of our Sleep formula that could lawfully reach a Swedish customer through us.

Sweden has also acted against online sellers based in other EU countries, ordering them to stop supplying Swedish customers with unauthorised medicinal products, and its courts have confirmed that this applies to internet sales from abroad. Both of those point the same way, so Sweden is a market we have ruled out rather than one we are waiting on.

Outlook

Sweden moved melatonin from prescription-only to a limited over-the-counter status in 2020, and non-prescription volumes have grown substantially since. If there is any direction of travel it is toward wider availability, but every step so far has stayed inside the pharmacy channel and inside the jet lag indication.

What we would need before reconsidering Sweden is melatonin becoming available as a food supplement, which would be a change of category rather than of degree. Nothing suggests that is contemplated.

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Förvaltningsrätten i Uppsala upholds Läkemedelsverket's prohibition on a Netherlands company selling CBD products to customers in Sweden, holding that a medicine sold in Sweden must be authorised in Sweden even where the sale is made over the internet, and rejecting the argument that the e-commerce directive exempts cross-border online sellers (mål nr 1702-21).

Sveriges Domstolar