Food supplements are foodstuffs aimed at supplementing the normal diet and which are concentrated sources of vitamins, minerals or other substances with a nutritional or physiological effect. They are marketed in dose form, namely forms such as capsules, pastilles, tablets, pills, liquids in measured doses, etc.
A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.
Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic action. Therefore their use is not intended to treat or prevent diseases in humans or to modify physiological functions.
At European Union level, in the EU, food supplements are regulated as foods and are generally subject to the provisions of European food law, including, but not limited to, food labelling, nutrition and health claims, food additives, food hygiene and production, food control.
The Food Supplements Directive 2002/46/EC sets specific marketing requirements for food supplements relating notably to their composition and labelling/advertising. It regulates the vitamins and minerals, and the substances used as their sources, which can be used in the manufacturing of food supplements (in the Annexes to the Directive). The Directive also provides that maximum and minimum amounts of vitamins and minerals in food supplements will be set.
The Food Supplements Directive does not lay down specific rules for the use of substances other than vitamins and minerals (e.g. amino acids, essential fatty acids, fibre, plants and herbal extracts) in food supplements.
The use of these ‘other substances’ can be prohibited, restricted or put under Union scrutiny according to harmonized EU rules (Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods). The European Commission maintains a list of substances which are known or suspected to have adverse effects on health and the use of which is therefore controlled in Annex III of this Regulation.
For the ‘other substances’ for which no EU rules apply, Member States may set their own rules in the area.