An initial reaction to this statement is to question its relevance to hemp products, such as hemp seed oil, that are not intended for therapeutic use. Indeed, at the time of writing no correspondence from MHRA on this matter has been received by hemp producers. The sale and distribution of CBD as a food or foodstuff appear to be governed by regulation no. 178/2002. The Food Supplements Directive 2002/46/EC in outline defines a food supplement as ‘something which supplements a normal diet and is a concentrated sources of nutrients or other substances with a nutritional effect’. CBD can be categorised as an “other substance” and is therefore subject to national laws which must comply with this directive and in particular cannot be labelled, presented, nor advertised as preventing, treating, or curing a human disease. The precise legal issues are complicated and will require a detailed assessment of the claims made about each product. In truth, the MHRA has emphasised the fact that it assesses each product on a case by case basis rather than the application of a blanket ban. It would appear that food supplements can be classified separately from medicines and to date the MHRA has not made any determination in relation to their status. Clearly, this is a situation that requires very careful consideration of all the relevant factors and one would hope that the MHRA would respond positively to representations made to it by producers of CBD intended for use solely as a food supplement (with no claims being made for medical effect). Other issues among others which merit more detailed scrutiny include: CBD’s therapeutic effect and its value; the right to medicines under European Union (EU) law; the free movement of goods within the EU; a reasonable period of time being made available to companies operating in this space so that they can make formal representations to the MHRA; a list of existing licenses granted for the treatment of specific conditions such as arthritis, multiple sclerosis, childhood epilepsy, various forms of cancer and in particular pain management related to such conditions; the origin and nature of the clinical evidence (animal/human) to be provided in support of any application for a licence; the financial cost of applying for a licence.
It is clear that there will be a variety of opportunities available to the industry to enter into a constructive dialogue with the MHRA. The fact that an increasing number of countries and states are envisaging or are enacting legislation around the world to cover the wider use of cannabis for medical purposes adds further weight to the case for detailed discussion with the MHRA, which could usefully include a formal consultation process with all relevant stakeholders. It is to be hoped that such a process can be engaged before the end of the year.
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