Regulating your Product: Borderline Medicine or a Food for a Specific Group?
Manufacturers whose products fall outside of the FSG (Food for a Specific Group) Regulation criteria are increasingly considering registration of their functional food products as "medicinal products"

Foods fortified with nutritional and disease-preventing qualities such as omega-3 fats and pre/probiotics are invigorating the world food industry. Health-conscious consumers are driving the demand for products that aim to promote better health, increase longevity and prevent the onset of chronic diseases. Increasingly we are seeing product innovation trends led by the food and pharmaceutical industries focussing heavily on the development of products targeting health promotion and not just health cure.

The functional food market is rapidly emerging as a distinct food category. Hovering somewhere between food and medicine, functional foods – sometimes known as nutraceuticals – are being used, distributed and regulated differently from medical foods and drugs. The primary distinction is that functional foods may be consumed freely as part of everyday life, whereas medical foods and drugs are used in specific cases, under medical supervision, to treat or manage a health condition. Although, “functional food” is not defined under EU or Irish food legislation it is currently regulated through existing general food law[1]. Therefore, prior to placing a new food on the EU market, specific authorisation must be obtained through the process outlined in the EU Novel Food Regulation (2015/2283).

Further, July 2016 saw the application of the Foods for Specific Groups (FSG) Regulation[2], which abolishes the concept of 'dietetic foods', and repeals the existing legislation that sets the framework for these products, (PARNUTS[3]). It also requires specific compositional and labelling rules to be established for certain food products that are created for and marketed to specific vulnerable groups of consumers (infants and young children, people with specific medical conditions and people undertaking energy-restricted diets to lose weight). Manufacturers whose products fall outside of the FSG criteria have increasingly been considering registration of their functional food products as "medicinal products"; that is: substances containing properties for preventing or treating disease in human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis. 

Before deciding on registration, manufacturers should consider the additional regulatory and compliance obligations associated with such an authorisation. Further, as recent case-law has demonstrated, the registration of one food product as a medicinal product could potentially force an entire category of significantly similar products into regulation under the medicinal products regime.

In R (Blue Bio Pharmaceuticals Ltd and Abba Pharma Ltd) v Secretary of State for Health (2016) EWCA Civ 554 the Court of Appeal required the UK Medicines Healthcare Products Regulatory Authority (MHRA) to re-consider whether some glucosamine products, which are marketed as food supplements, should be treated as medicinal products. The court found that glucosamine-containing products sharing the same dosage and form as licensed medicinal products should be classified in the same way unless some significant characteristic took them outside the "medicinal product" legal definition. Whilst method of use may be a significant characteristic, the MHRA had to establish the position through proper investigation and inquiry, but had failed to do so.

The requirement to hold a medicinal product manufacturer and/or marketing authorisation places a greater burden on the manufacturer to adhere to stricter controls than those required for food products. Therefore the decision to define a product as a food or medicine should be informedly made to ensure all legal and regulatory matters are complied with.

Contributed by Cliodhna McDonough

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[1] Regulation (EC) 178/2002

[2] Regulation (EU) 609/2013

[3] Directive 2009/39/EC

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