Foods and medicines - borderline?
As the List of medicinal substances is conditional and food laws do not prohibit the substances included in the List of medicinal substances being used in foods (?), products that contain substances included in the medicines list can be sold as food. This means that there may products on the market, which contain the same substances but are manufactured and sold in compliance with different requirements depending on whether they are entered into the market pursuant to medicine laws or food laws.
Medicinal uses can only be presented for medicinal substances, however. A valid marketing authorisation is required for selling medicinal substances, while no authorisation is required for selling foods and therefore foods are not subject to any advance control procedure. A notification procedure applies to food supplements, but their composition, labelling, effectiveness or safety are not assessed prior to the introduction of the product into the market. The operator is responsible for maintaining an in-house control procedure, which ensures that when used in the amount defined in the instructions for use, the product is suitable for use as food and has no adverse effects on human health.
The decision on whether a substance or a product is to be considered to be a medicinal product is taken, if necessary, by the Finnish Medicines Agency Fimea. The classification decision is made separately on each product on the basis of both the composition and the intended use of the product. More information on classification as well as Fimea's classification decisions can be found on Fimea's web site.
A product classified as a medicinal product may not be marketed as food. Marketing authorisation has to be sought for a product classified as a medicinal product before it can be introduced into the market. The operator is responsible for the sales of the product and for the selection of the correct marketing channel, as well as for a product classified as a medicinal product being removed from stores that sell foods. Control authorities can take action if a product is marketed in violation of regulations.