The concept of food supplement is relatively new. It has been defined by the European Parliament in Directive 2002/46/EC and in France by the Decree of 20 March 2006: “Food supplements means foodstuffs, the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination…”
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Updated on 04/08/2016
What are Food Supplements ?
Definition and the Agency’s role
The legislation also states that they are "marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.”
Depending on consumer protection law, food supplements may be subject to registration with the French General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), which will examine their composition and conduct tests similar to those for other categories of foodstuffs. The regulation calls for a positive list of ingredients that can make up their composition to be gradually established. This list currently focuses on vitamins and minerals at the European level, while in France it also includes setting maximum allowed daily doses, and various substances such as plants (1).
Food supplements can contain plants, vitamins and minerals, or other substances, and are used in various sectors such as: nutrition, weight loss, energy boosters, digestion, beauty, menopause, and cardiovascular disorders.
However, unlike drugs, food supplements do not require a marketing authorization for each product, following an assessment by a body of experts of an application submitted by the manufacturer seeking to market them. For food supplements placed on the market, the manufacturer is responsible for the product’s compliance with the regulations in force, both in terms of safety and of consumer information (no misleading claims).
The need for informed consumers
In recent years, there has been an increase in the consumption of food supplements by the French population (as well as fortified foods). Deficits are very rare in the general population (and nutrient deficiencies even rarer) and mainly concern specific substances (such as Vitamin D) or specific population groups (pregnant women, the elderly living in institutions, or people living in extreme poverty, for example). In these specific population groups, additional intake of vitamins, minerals and other nutrients through food supplements may be beneficial. In such cases, consumers should consult a healthcare professional.
For a large majority of the population, a balanced diet provides the essential nutrients needed to meet their requirements.
When taking food supplements containing vitamins and minerals (especially in combination with fortified foods), consumers may run the risk of exceeding safe limits, a message that the Agency has brought to the attention of European institutions; this message is based on its work on exposure in France.
In addition, the nutrition and health claims that may be indicated on product packaging are strictly regulated by European legislation. To date, a limited number of health claims have been approved, and the list (in English) can be found on the website of the European Commission. By definition, a food supplement cannot have or claim that it has therapeutic effects.
In general, it is important:
- to avoid taking food supplements for prolonged, repeated or multiple periods in one year without the advice of a health professional;
- to carefully follow the instructions for use as stated by the manufacturer, who is responsible for the safety of the products sold;
- to report any adverse effects resulting from the use of a food supplement to a health professional.
What is the Agency doing about food supplements?
The Agency is regularly called upon for advice and it issues opinions on assessment of substances which are being considered for inclusion in dietary supplements. It also issues opinions on the impact of proposed national and European Commission regulations on food supplements.
As part of the second National Individual Survey on Food Consumption (INCA 2), for the first time in France, the Agency has gathered detailed information on the consumption of food supplements and contributing factors.
- INCA 2 spotlight on the consumption of food supplements
In July 2009, the French Hospital, Patients, Health and Territories Act entrusted the Agency with “the implementation of a vigilance system for new foods, food supplements, foods to which substances have been added for nutritional or physiological purposes, and products intended for particular nutritional uses.”
After a pilot phase of vigilance focused on food supplements in 2009 and 2010, the Agency extended this scheme to all related products.
(1) Decree n. 2006-3524, transposing European Directive 2002/46/EC