To ask Her Majesty's Government what criteria they intend to apply to determine whether plant, fungal and algal products are regulated as food or as medicine after 30 April 2011, in the light of advances in nutrigenomic science illuminating how food bioactive components (nutrients and non-nutrients) can influence gene expression.
There is no mention of the term "nutrigenomic" in the medicines directive 2001/83. The decision as to whether a product falls within the definition of a medicinal product is made by the Medicines and Healthcare Products Regulatory Agency (MHRA) on a case-by-case basis using the definition of that term contained in Article 1 of the directive. The criteria that the MHRA takes into account are set out in their document Guidance Note 8: A Guide to What is a Medicinal Product. This can be found on the MHRA website at www.mhra.gov.uk/home/group/is-lic/documents/ publication/co007.pdf.
The criteria include all presentational material and available scientific evidence or information on any pharmacological, metabolic or immunological function of the ingredients. The approach that the MHRA takes is in line with the relevant judgments of the European Court.