The legal requirements for food and foodstuffs are that they are governed by Regulation No. 178/2002 (the “Food Regulation“); medicinal products are specifically excluded under Article 2. The Food Supplements Directive 2002/46/EC defines a food supplement as foodstuffs which supplement a normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physical effect (Article 2).  Nutrients are defined as vitamins and minerals as listed in Annex I in the forms listed in Annex II to the Food Supplements Directive. Cannabidiol does not fall within this list and being categorised as an “other substance” is therefore subject to national law (which must comply with the Food Supplement Directive).  Under Article 6(1) and (2), food supplements must be labelled as such and must not be labelled, presented or advertised as ‘preventing, treating or curing a human disease’.

It is determined by case law that the MHRA is required to apply the multi-factorial test set by the CJEU in HLH Warenvertriebs GmbH (para 30‎, [2005] ECR I-5141) which stated that for the purposes of determining whether a product must be classified as a medicinal product or as a foodstuff, the competent national authority must decide on a case-by-case basis, taking account of all of the characteristics of the product, in particular its composition, its pharmacological properties (to the extent scientifically known), the manner in which it is used, the extent of distribution, its familiarity to consumers and the risks which its use may entail.

The CJEU case law suggested that it was the purpose for which a product was used and/or marketed which was often a critical factor in distinguishing between medicinal and non-medicinal products.  The (functional limb) covered products whose pharmacological properties had been scientifically proven to have physiological effects.  However, such physiological effects were not specific to medicinal products but were also among the criteria recognised within the definition of food supplements.  Thus to fall within the functional limb, the criteria extended beyond mere health benefits, a product must treat or prevent disease.  Products could not be classified as medicinal on a ‘blanket’ basis under the functional definition of medicinal product.  The approach must be proportional.  The fact that some hemp products are classified as medicinal products does not mean that all other hemp products containing an identical substance and mode of action must also be classified in the same way.  The multi-factorial test involved the application of complex factual and scientific considerations by the MHRA, particularly in respect of ‘borderline’ products.

In accordance with the  judgement on Commission of the European Communities v Federal Republic of Germany (C-319/05) .  Hemp products whose effect on physiological functions is no more than the effects which a foodstuff consumed in a reasonable quantity may have on those functions, does not have a significant effect on the metabolism and cannot, therefore, be classified as a product capable of restoring, correcting or modifying physiological functions within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83. Because the mentioned risks and contra-indications related to taking hemp preparations are limited and, more importantly, are no different from those linked to taking hemp as a foodstuff, such a preparation cannot be classified as a medicinal product by function within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83. We accept that defining a given product and the interpretation of the classification rules is a matter for the MHRA. The MHRA guidance on classification focuses on the presentational and functional tests, as set out in the definition of medicinal products and this approach has generally been accepted by the English Courts. However, the classification can be very complicated, based on a detailed assessment of the product and the claims made about it, and is a mixture of factual and scientific considerations. In a recent case, the MHRA emphasised the fact that it assesses each product on a case-by-case basis, taking into account the totality of the factors set out in the guidance, and the Court accepted that products should not be classified as medicinal on a “blanket” basis, or based on one criterion alone. It will also be relevant which “borderline” is being considered (for example, with food, or with medical devices) and the precise definitions of the relevant products. As a result, there is the potential for different determinations to be made for similar products, depending on the precise composition of the product, and the claims made about it.

Several substances contained in foods (such as garlic) have physiological effects, but it is not appropriate to treat all products having such effects at certain doses as medicinal, where the amount absorbed is no different from that which would be absorbed as part of a normal diet.