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”).
ANSM requested the European Commission to take a decision on whether the cranberry products fall within the definition of a medical device. This procedure was prompted by a negative classification assessment from ANSM in relation to the data supporting the products’ classification as a medical device. This lead to ANSM requiring Arkopharma to change the status of the company’s cranberry-derived “Cys-Control” product back to a food supplement status in March 2014.
Under Article 1(2)(a) of the Medical Devices Directive, a “medical device” is defined as:
“...any instrument, apparatus, appliance, software, material or other article [..] intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
In a European Commission draft Decision, which was published on 22 February 2016, the European Commission stated that the principal intended action of the cranberry products is to treat cystitis by inhibiting adhesion between P-fimbriated E. coli and mucous membrane cells in the urinary tract. As such, the European Commission found that such action achieves its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
The European Commission is currently analysing comments from the EU Member States after which the draft Decision will be sent to the European Parliament and the Council of the European Union (“Council”) for review, in accordance with the comitology procedure. Following the application of the European Parliament and Council’s right of scrutiny, the draft Decision will be adopted, amended or withdrawn by the European Commission. The draft Decision, if adopted, will enter into force on the 20th day following its publication in the Official Journal of the European Union.