New device vigilance for nutritional supplements in France

In July 2009, Law Hospital, Patients, Health and Territories told the French Agency for Food Safety (AFSSA) “the implementation of the vigilance system on new foods, food supplements, foods that are subject to the addition of substances for nutritional or physiological as well as products intended for particular nutritional. An implementation decree will set the first half of 2010, the modalities of implementation of this system of care.

The agency began this mission with a pilot phase on the vigilance of nutritional supplements that should help better identify side effects associated with their consumption.

This system includes reporting by health professionals of adverse events among persons who consumed dietary supplements. Starting today, they can access the device vigilance on the site of the AFSSA.

Depending on the code of consumption, dietary supplements are subject to declaration to the Directorate for Competition, Consumption and Fraud Control (DGCCRF) which examines the composition and conducts checks like the other food categories. The regulations provide a positive list of ingredients gradually drawn up into their composition, currently focused on vitamins and minerals at European level, rolled out nationally by the maximum daily dose should not be exceeded and various substances such as plants.

Unlike drugs, the marketing of dietary supplements do not require individual authorization for placing on the market based on the evaluation of a dossier by a body of industrial expertise. The manufacturer is responsible for compliance placed on the market with the standards, security and non-misleading consumers.

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