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SMi’s Conference on Nutraceuticals and Functional Foods, London, 25-27 October 2010

This report was compiled by Dr Amanda Easey, a solicitor with Innovate Legal.  Dr Easey leads Innovate Legal’s Nutraceuticals and Functional Foods Practice Area.  She chaired an Executive Briefing on the third day of SMi’s conference entitled Protecting Product Innovation, which described in detail the various ways in which intellectual property (IP) rights may be used to protect new products and processes in this sector.

Dr Easey may be contacted by email at amandaeasey@innovatelegal.co.uk.

This conference provided an opportunity for those with interests in the nutraceutical and functional foods market to be brought up to date with current hot topics. The conference covered a wide range of aspects of the global nutraceuticals and functional foods market, including the latest developments in omega-3 fatty acids, probiotics, nanotechnology, health claims and consumer trends.  

Following an introduction by the Chairman, Peter McConville, Vice President of Nutritionals R&D, GlaxoSmithKline, the first speaker was Harry Van Der Hijden, Research Manager, Unilever. Mr Van Der Hijden outlined the challenges ahead for the functional food market and research and development approaches to these challenges, in particular the use of manufacturing techniques to optimise the nutritional benefits of ready-to-eat products. Fruit and vegetables are known to be important components of a healthy diet yet many people do not consume them in sufficient amounts to maintain optimum health and reduce their risk of major illnesses such as cardiovascular disease. Current industrial practice tends to focus on the fortification of food products with vitamins and minerals rather than the enhancement of the bioavailability of natural nutrients contained in the product.  Mr Van Der Hijden discussed some of the technologies developed by Unilever to enhance the nutrient bioavailability of fruit and vegetable-based ready-to-eat products. Such technologies promote the nutritional benefits of food without compromising on the taste, texture and stability of products which are important for consumers.

Aleksandra Wesolowska, Regulatory Advisor, European Advisory Services (EAS) gave an update on the implementation of the Nutrition and Health Claims Regulation (EC No 1924/2006), including an overview of the third batch of opinions published by the European Food Safety Authority (EFSA) on 19 October 2010 under Article 13.1 of the Regulation.  Once again, the majority of health claims were rejected. This recent batch included opinions on health claims regarding the use of Omega-3 fatty acids for a variety of health conditions.  The European Commission has recently confirmed that EFSA’s opinions on health claims will no longer be published in batches but that all further opinions will be published simultaneously in June 2011. In addition, health claims for botanical products will now be considered separately from the 13.1 claims assessment procedure after June 2011.  These procedural changes were introduced in response to concerns raised by representatives of the nutraceutical industry that the issue of opinions in batches was creating a distortion in the market between companies whose health claims had been rejected and competitors whose opinions were still pending. 

Simon Parker, Medicines Classifier, Medicines and Healthcare products Regulatory Agency (“MHRA”) gave an overview of medicines legislation relevant to nutraceuticals and functional food products, including the circumstances where a product may be considered to be a medicine under the UK Medicines Act 1968 and therefore be subject to regulation by the MHRA. Mr Parker advised that it was important to note that health claims on products which state that the product may improve a medical condition or poor health would be likely to be considered to be medical claims and would therefore be considered unacceptable by the MHRA unless the product had a medicines marketing authorisation. Products which do not fall within the medicines legislation are not regulated by the MHRA.

Roberta Re, Nutrition Research Manager, Leatherhead Food Research, set out guidelines for how to design a clinical trial to obtain evidence to support health claims for functional foods. The Nutrition and Health Claims Regulation requires that the substantiation of health claims should be based on human data primarily from intervention studies. It is desirable that at least one of the intervention studies demonstrates the effect claimed.  Common criticisms by EFSA of dossiers submitted under the Article 13 procedure have included insufficient characterisation of active ingredients (for example, identification of bacterial strains), product compositions different to the composition used in studies, study populations not representative of the target population, small sample sizes and lack of appropriate controls. Clinical trial data submitted to EFSA in support of a health claim is therefore likely to be rejected unless it is scientifically rigorous and of high quality.

The influence of the Nutrition and Health Claims Regulation on the nutraceuticals and functional foods industry, in particular the potential to inhibit innovation, was discussed in a subsequent panel discussion with Ann Godsell, Managing Director, Ann Godsell Regulatory, Aleksandra Wesolowska, Simon Parker and Roberta Re.

Beat Mollet, IP Manager, Nestlé Research Centre discussed prospects for the functional food market and future trends, in particular consumers’ increasing interest in achieving and maintaining optimal health and fitness.  The Chairman, Peter McConville, then gave a presentation on the challenges and opportunities in the functional beverages market with particular emphasis on the sport and energy “shot” drinks market which, although currently more developed in the US, is expected to grow in Europe.

There were two informative presentations on the status of research on omega-3 fatty acids. Philip Calder, Professor of Nutritional Immunology, University of Southampton, discussed the future directions for nutritional and therapeutic research in omega-3 fatty acids.  The evidence for the positive health impact of increased intake of long chain omega-3 fatty acids was reviewed, in particular evidence of reduction in cardiovascular disease. These fatty acids are also believed to be important in the development and function of brain, neural and eye tissue and in the regulation of a variety of physiological mechanisms including platelet function, inflammation, immune response, bone health and insulin sensitivity.  Professor Calder argued that consumers should be educated about the need to increase their intake of omega-3 fatty acids to optimal levels for health, probably to at least 0.75g/day. The challenge for the functional food industry is to deliver adequate amounts of these fatty acids in products in order to benefit health without compromising on taste and other sensory qualities important to consumers.

Andrew Salter, Professor of Nutritional Biochemistry, University of Nottingham, gave a presentation on omega-3 fatty acids, cardiovascular disease and the metabolic syndrome.  Professor Salter considered the importance of the omega-6/omega-3 dietary fatty acid ratio and the potential role of a variety of polyunsaturated fatty acids. He also gave a review of metabolic syndrome, a combination of medical disorders that increases the risk of developing cardiovascular disease and diabetes and is associated with non-alcoholic fatty liver disease (NAFLD). There is evidence that treatment with fish oils may have a positive effect on NAFLD in humans.  Parveen Yaqoob, Reader in Cellular & Molecular Nutrition, University of Reading, gave an overview of the relationship between diet and immunity and the ways in which nutrients affect immune function.  Professor Yaqoob also considered EFSA’s approach to reviewing health claims relating to immune function.

Dora Pereira, Research Scientist, MRC Human Nutrition Research, discussed nanotechnology in foods. “Nano” foods, which contain engineered particles of 1-100nm in size that have been deliberately introduced into the food, are a developing market in the US but are not currently marketed in Europe.  Nutrients which are “nano” size appear to be more readily absorbed by the gut and have high bioavailability. Nutrients and nutraceuticals may also be encapsulated by nano particles for better absorption, stability or targeted delivery.  Nanoencapsulation may also enable food fortification, for example of fish oils, without affecting the taste and appearance of the food. EFSA is expected to adopt a new guidance document on the risk assessment of engineered nanomaterials during 2011.

There were further presentations on the treatment of iron and iodine deficiencies globally and new developments in micronutrients and other ingredients for functional foods.

Executive Briefing

The powerpoint slides from Innovate Legal’s Executive Briefing are available upon request by emailing Simon Barnham at simonbarnham@innovatelegal.co.uk.

The Executive Briefing offered an opportunity for delegates to discuss with Innovate Legal’s IP experts the options available for the legal protection of nutraceuticals and functional foods.  Following an introduction by Dr Amanda Easey to the basics of IP protection and the different types of IP right, a detailed presentation was given by Garry Mills (Head of Trademarks and Brands, Innovate Legal) on developing and supporting a brand, including how to register logos, colours, shapes and packaging designs as trademarks.  Duncan Curley (Head of Patents, Innovate Legal) then explained how to build a patent estate, using lessons learned from experience in the pharmaceutical sector, focussing in particular on ‘method of use’ claims.  Finally, Dr Easey concluded the Executive Briefing with some case studies, including the recent English Ajinomoto v Asda Stores case on product claims.     

 Related links

The Foods that Make Billions, BBC iPlayer (clips from 2010 series)
http://www.bbc.co.uk/programmes/b00wdf5t/episodes/2010

Nutrition labels give Brussels indigestion, Financial Times, 15 March 2010
http://www.ft.com/cms/s/0/a0b3f988-3063-11df-bc4a-00144feabdc0.html#axzz1A50lvUUI

Food and pharma prove a rich mix, Financial Times, 12 October 2010
http://www.ft.com/cms/s/0/1f41bf6c-d62f-11df-81f0-00144feabdc0.html#axzz1A51RjlHd

Yoghurt and the functional food revolution, www.bbc.co.uk, 6 December 2010
http://www.bbc.co.uk/news/business-11926609

DSM buys baby food group Martek, Financial Times, 21 December 2010
http://www.ft.com/cms/s/0/67cdc37c-0d0f-11e0-ace7-00144feabdc0.html#axzz1A52CZ4CY

 
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