Food supplements, supplements, nutrition, nutrient, needs, recommended daily doses, maximum authorised doses , exceeding, recommended dietary intakes, RDIs, safety limit, intake, deficiency, shortage, diet, composition, marketing authorisation

What are food supplements?

The concept of food supplements is relatively recent. It was defined in the European Parliament directive 2002/46/EC, which was transposed by the French 20 March 2006 decree: “Food supplements means foodstuffs the purpose of which is to supplement a normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination”.

The legislation also specifies that they are “marketed in dose form, namely forms such as capsules, pellets, tablets, pills and other similar forms, sachets of powder, liquids in ampoules , drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in small measured doses”.

Governed by the consumer code, food supplements must be declared to the Directorate General for Competition, Consumer Affairs and Fraud Control (DGCCRF), which investigates their composition and carries out inspections similar to those performed for other categories of foodstuffs. The regulations stipulate the gradual establishment of a positive list of ingredients authorised for the manufacturing of food supplements. This list is currently focused on vitamins and minerals in Europe, and in France it also includes maximum permissible daily doses and miscellaneous substances such as plants (1).
There are food supplements made from plants, vitamins, minerals and other substances used for a wide variety of purposes including nutrition, weight-loss, energy, digestion, beauty, the treatment of menopause and the cardiovascular system.

However, unlike medication, the marketing of food supplements does not require an individual marketing authorisation based on the evaluation of an industrial application by an expert assessment body. The manufacturer is responsible for ensuring that the marketed product is safe and compliant with current standards and that it does not mislead the consumer.

The need for enlightened consumption

Over the past few years, consumption of food supplements by the French population has increased and enriched foods now make up a larger percentage of total foods on sale. Nutritional shortages and, a fortiori, deficiencies are extremely rare in the general population and primarily concern specific population groups (e.g. pregnant women, elderly people in homes, very low-income populations with little security). In these specific population groups, additional intake of vitamins, minerals and other nutrients through food supplements or enriched foods may be beneficial, but in these cases, consumers should rely on medical advice rather than making an unenlightened dietary decision for themselves.
For the vast majority of the population, a balanced diet alone can provide all necessary nutrients. Consumption of food supplements therefore has no proven advantages for most people, especially given that we lack studies showing they are safe when taken regularly and for an extended amount of time, and also that severe acute accidents which may be linked to their use have been reported.

In the case of food supplements containing vitamins and minerals, consumers may risk exceeding the tolerable upper intake levels when taking excessive doses. The Agency has brought this message to the attention of European member States through its work on exposure in France.
In the case of food supplements made from plant extracts, the preparation's safety can be demonstrated only if its production and instructions for use are clearly defined. Botanical specificities (species, plant parts), the method used to extract active substances, batch homogeneity and potential contaminants are just some factors that can alter the final product's composition and therefore its properties.

What does the Agency's work on food supplements entail?

The Agency is regularly called upon for advice and it issues opinions on the impact of French and European Commission draft regulations and on substances that may be introduced into food supplements.

In the framework of the second individual and national study of food consumption (INCA 2), the Agency, for the first time in France, gathered detailed information on the use of food supplements and contributing factors.
> INCA 2: spotlight on the consumption of food supplements

In July 2009, the Hospital, Patients, Health and Territories act entrusted the Agency with “the implementation of the 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”.
> A national nutrivigilance system

(1) French decree no. 2006-3524, transposition of directive 2002/46/EC

December 2010