Nutraceuticals, a new product sector for the UK?
Last month, the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report was published, giving its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit.
The report was wide-ranging, from space and satellites, digital health, clinical trials, energy, transport, agriculture, environment, and Nutraceuticals.
Many of the recommendations in the report won’t come as a surprise, the aim was to explore ways to remove the “unnecessary red tape” stemming from EU regulations. This would then in theory facilitate innovation, promote competition, and accelerate development of new technologies.
In regard to Nutraceuticals, the proposal is to create a new regulatory framework for a branch of novel health enhancing foods. The question is, what significance would this have for our life-sciences market?
The concept of Nutraceuticals is not new but operates within a grey area. It comprises foods and food supplements that have known physiological benefits or can provide protection against chronic diseases.
Under the current framework, there is a fixed border between foods (including food supplements) and medicines. Currently promotion of foods relates to the maintenance and support of normal health functions, mention of improvement of physiological functions or prevention/treatment of a disease, the conversation resides under the medicinal framework, consequently the product needs authorisation and evidence from clinical trials. Borderline products including nutraceuticals, by their very nature require careful navigation.
The proposed approach within TIGRR is to create a new regulatory framework for Nutraceuticals is to get the separate regulatory bodies in the UK, FSA (Food Standards Agency), MHRA (Medicines and Healthcare Products Regulatory Agency) and DHSC (Department of Health and Social Care), to work together to create a clear pathway for this new sector. It is not clear in the report what burden of evidence there would be for Nutraceuticals and whether there would need to be an authorisation to market these products, but it certainly suggests that there would be opportunity for better product claims based on scientific evidence rather than clinical data.
This approach would be welcome for marketeers of foods and food supplements who are always searching for new product claims to gain a competitive edge, but there is a risk that if the goalposts shift, it could just result in weakening the food supplement and pharmaceutical sector, causing more confusion for consumers and patients alike. It remains a dynamic area and something we will be keeping a close eye on.
Our team is comprised of leading experts in the borderline area of foods and medicine, so we can help you navigate this maze. We are used to working in this area to help drive your strategy and ensure compliance against the product claims you may wish to make.
Find out how we can help you by getting in touch with us today.