A European Commission draft Decision was prompted following concerns raised by a number of competent health authorities in the EU, over the medical device status of products that were once marketed as food supplements.
If the draft Decision is adopted in its current form, cranberry products with PACs which are currently marketed as medical devices to prevent or treat cystitis are likely to be considered by the competent authorities as food supplements. Those producers will, therefore, be subject to more stringent requirements concerning the type of health claims made in relation to the products. In particular, the cranberry products’ producers would not be permitted to make health claims in relation to the treatment or prevention of cystitis. This will require such producers to undergo significant changes to the labelling and marketing of the affected products.
In accordance with the procedure provided in Article 13(1)(d) of the Medical Devices Directive, the European Commission was notified of the marketing by Arkopharma and other producers of cranberry products with PACs as medical devices to prevent or treat cystitis, following an application from the French National Security Agency of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé) (“ANSM”).