UK Gov considers bold new nutraceutical laws
Published last week, the Task Force on Innovation, Growth and Regulatory Reform's (TIGRR) report sets out a new vision for the UK given its newfound legislative freedom, with one section concentrating on the creation of a new regulatory framework for the fast growing category of health foods and supplements.
The report notes the nutraceutical sector is estimated to be worth £275bn globally and £4bn in the UK yet these products have traditionally been viewed with scepticism by the mainstream medical and pharmaceutical establishment. As a result, the regulatory environment has focused on pharmaceutical grade medicines tested through the full clinical RCT process.
"However, science is starting to point the way to a new sector of nutritional products with increasingly explicable and/or verifiable medicinal benefits, which needs to be reflected in our regulatory framework," the report states.
MP George Freeman, one of the authors of the report, says: “We are living through an extraordinary period of technological change – not just in life science but in host of sectors: from AI to robotics to agri-tech, nutraceuticals, nanotechnology, synthetic biology, biofuels, satellites and fusion energy.
“The UK is indeed a ‘science superpower’. But we have traditionally been woeful at commercialising here in the UK. There are many reasons. But, in recent years, the EU’s increasingly slow, bureaucratic and ‘precautionary’ approach – copied in Whitehall – has made the EU and the UK an increasingly poor place to commercialise new technology.”
Currently, where a product like a food or a herbal remedy makes ‘medicinal’ claims (it can help cure or mitigate a disease) it is regulated by the MHRA. Where a food product makes general ‘health’ claims, it is regulated by the DHSC (Department of Health and Social Care) in England, by the FSA in Wales and Northern Ireland, and by Food Standards Scotland in Scotland.
The report says this 'patchwork of regulators' creates additional costs and uncertainty for businesses who would like to see the relevant functions brought together in a central regulatory body and a clearer UK landscape.
It states: "The pace of scientific progress, the rapid growth of the consumer health wellness market, growing consumer demand and health system pressure for increased focus on prevention is creating a number of problems. This has led to confused terminology, inappropriately polarised regulatory silos, a lack of consistency between UK/EU and other international standards, and the lack of a clear regulatory framework for assessing, verifying and authorising medicinal claims."
The report notes that the restrictions caused by regulations are particularly apparent in the probiotics sector where the value globally is forecast to reach about $69.3bn by 2023, yet in the UK the sector currently stands at only around £750m.
It states: "As European regulation of food health claims has tightened, probiotic manufacturers have been required to provide stronger scientific evidence to support health claims.
"In July 2012 the European Food Safety Authority (EFSA) rejected health claims made by the probiotics industry, and made labelling extremely restricted. Despite its current limited size, according to Global Industry Analysts, Europe is the largest and fastest growing probiotics market, with Germany and the UK accounting for around 45% of the total EU market with annual growth rates of 10-12% quoted by various analysts."
The taskforce also proposes that the government establish clear regulatory standards and definitions for nutraceutical products and create a permissive environment for regulation of products with accepted science outcomes, to form a new easier regulation pathway. The team also notes there is no industry-accepted, standard definition for the term ‘nutraceutical’.
"Clear regulatory pathway and accepted, standard terminology needs to be established for foods which claim to perform a specific medicinal role in the prevention and treatment of pathological conditions...
"Currently the lack of official recognition of medicinal foodstuffs limits research, meaning they are in some cases under-scrutinised, which makes the UK an unfavourable destination to pursue development.
"...currently regulation either recognises something as a food or a medicine, but not both. This disconnection causes innovation-stifling uncertainty. The disconnection is currently embedded into the system because food regulations (overseen by the FSA and DHSC) only go as far as officially recognising food supplements with health claims, and the MHRA only officially recognises medicines (which stop being perceived as foodstuffs as soon as they achieve that recognition). This leaves a large, ambiguous grey area between food and pharmaceuticals which is hard to navigate."
In response to the taskforce’s report, Prime Minister Boris Johnson has said that bold and ambitious ideas such as these are needed to encourage growth and innovation.
He said: “The Government, through our Better Regulation Committee, is already hard at work on reform of the UK’s regulatory framework. Your bold proposals provide a valuable template for this, illustrating the sheer level of ambitious thinking needed to usher in a new golden age of growth and innovation right across the UK.
"So we will give your report the detailed consideration it deserves, consult widely across industry and civil society, and publish a response as soon as is practicable.”