Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as pills, tablets, capsules, or liquids in measured doses. They may contain various nutrients and other ingredients, including vitamins, minerals, amino acids, essential fatty acids, fiber, plants, and herbal extracts.
The European Union (EU) regulates food supplements within the foodstuffs frame. Harmonized legislation covers the use of vitamins and minerals and their sources in food supplements; for ingredients other than vitamins and minerals, such as botanicals, the European Commission has established harmonized rules to protect consumers against potential health risks while a harmonized list of plants admitted in food supplements has never been implemented.
In Italy, the use of botanicals in food supplements is regulated by the Decree of the Ministry of Health August 10, 2018, that, under Annex I (amended by the Director’s Decree July 26, 2019), lists the admitted plants and the relevant parts, including some special provisions for their use.