Icelandic Medicines Agency To Review Melatonin As Medicinal Product

Imports of melatonin-containing supplements, which are banned in Iceland, have steadily increased in the country, reports Fréttablaðið.

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Matvælastofnun, the Icelandic Food and Veterinary Authority, says members of the public do not know they are bringing illegal goods into the country. In Iceland, the substance is classified as a medicine, and therefore the customs authorities must seize all melatonin-containing food supplements that are imported into the country.

Melatonin is an active ingredient in various medicines. It has a naturally calming effect and is produced by the body to make it easier for people to sleep.

The drug is subject to prescription in Iceland, unlike many neighboring countries where melatonin supplements are permitted.

The agency says the fact that melatonin is legally available as a dietary supplement elsewhere in Europe, for example in Spain, Italy, and Poland, has led to a steady increase in imports of melatonin-containing products, which is reflected in the high levels of customs seizures.

Matvælastofnun has now requested the opinion of the Icelandic Medicines Agency on whether melatonin should continue to be classified as a medicine in Iceland or whether there is reason to review those rules. The Icelandic Medicines Agency must decide when there is doubt as to whether individual compounds are considered medicinal products.

Melatonin has a marketing authorization from 1 mg melatonin up to 5 mg in a daily dose, according to RÚV.

In some European countries, however, the substance is marketed as a dietary supplement and can be found in up to greater amounts or about 2 mg per day. In the United States, a melatonin supplement is permitted and appears to be marketed ranging from 0.5 mg to 10 mg of melatonin per daily dose.