Food suplements
Food supplements are a very diverse group of products intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or 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. Such food supplements can be marketed in “dose” form, such as pills, tablets, capsules, liquids in measured doses, etc.
These types of products are considered food products in the European Union and are regulated by Directive 2002/46/EC. The objective of rules on those products in Directive 2002/46/EC is to:
- protect consumers against potential health risks from those products, and
- to ensure that they are not provided with misleading information.
In the context of food supplements, EFSA (European Food Safety Authority) should be mentioned. Most of EFSA’s work is undertaken in response to requests for scientific advice from the European Commission, the European Parliament and EU Member States. Based on EFSA’s work, the European Commission reviews and updates the list of vitamins or mineral substances that may be used in food supplements. For all substances added to foods, including food supplements, that are claimed to have an effect on the nutritional or health status of consumers, EFSA carries out an assessment in line with Regulation (EC) No 1924/2006 on nutrition and health claims.
If you need support in notification procedure, scientific advice or labeling consultancy in the European Union, contact SciencePharma.
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We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
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Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
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Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.