Food supplements - borderline between foods and medicines?
Food supplements are foods that differ from other food groups due to their form and intended use. Food supplements can also resemble medicines in appearance and use, in some cases even in composition.
As the list of medicines is conditional and food legislation as such does not prohibit the use of substances included in the list of medicines in foods, foods may contain substances from the list of medicines. Thus, there may be products on the market, which contain the same substances but are manufactured and sold in compliance with different requirements depending on whether they are placed on the market under medicine legislation or food legislation.
Food supplements and medicines have different requirements
Different requirements apply for food supplements and medicines. Medicinal uses may be proposed only for medicinal products. Instead, medicinal marketing of food supplements is prohibited. They shall not be presented as having or refer to features related to the prevention, treatment or cure of human diseases.
A valid marketing authorisation is required for the sale of medicines. The sale of food supplements, on the other hand, does not require a marketing authorisation and therefore foodsupplements are not subject to any advance control procedure. However, the placing on the market of food supplements must be notified to the Finnish Food Authority, but their composition, labelling, efficacy or safety are not assessed in the context of the notifications procedure. The food business operator is responsible for ensuring that the food supplement, when used in accordance with the instructions for use, is suitable for human consumption and harmless to human health.
Classification of medicines is the duty of Fimea
The Finnish Medicines Agency Fimea is responsible for deciding, if necessary, whether a substance or preparation should be considered a medicinal product.The classification decision is made on a product-by-product basis and is based on 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 website.
If a food business operator intends to place on the market a food supplement containing a substance or herbal substance mentioned in the list of medicines, the Finnish Food Authority recommends contacting Fimea to assess the need for classification. Fimea may also classify a product as a medicinal product on its own initiative if it meets the criteria for the definition of a medicinal product.
If a product is classified as a medicinal product, it must not be marketed as food. Marketing authorisation has to be sought for a product classified as a medicinal product before it can be placed on the market.
The operator is responsible for the sales of the product and for the selection of the correct sales channel, as well as for removing the product classified as a medicinal product from the shelves of stores selling food products. Control authorities can intervene in the illegal sale of the product.