The concept of food is not as simple as it seems. In addition to the foods that we eat day-to-day and take for granted, there are other categories of food. In fact, "foodstuffs" are regulated by European Regulation (EC) No 178 / 2002 (the "Food Regulation"), which provides for the safety of foods circulating in the internal market – controlling and monitoring the production, prevention and management of risks. The Regulation also creates the European Food Safety Authority ("EFSA"), to oversee the control and evaluation of food.

The Food Regulation defines food, or "foodstuff", in Article 2, as follows:

any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

'Food' includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment.

However, the Food Regulation expressly excludes from the definition of food, amongst other things, medicinal products within the meaning of the Community code relating to medicinal products for human use (the "Community code") (Directive 2001/83/EC).

This raises the question in borderline cases, of how some products will be identified, as foodstuffs or medicinal products for the purpose of regulation. To resolve such borderline cases, the "non-cumulation principle" was introduced into Article 2.2 of the Community code. The non-cumulation principle says:

In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.

In cases where the characteristics of a product suggest that it may be either a medicinal product or a foodstuff, by default it must be regulated as a medicinal product. The rationale for this measure is that medicinal products are more strictly regulated than foodstuffs. Hence, in cases of doubt, the protection of the public health is guaranteed.