This study appraises the effectiveness and cost-effectiveness of consumption of plant sterol-enriched margarine-type spreads for the prevention of cardiovascular disease (CVD) in people with hypercholesterolemia in England, compared to a normal diet. A nested Markov model was employed using the perspective of the British National Health Service (NHS). Effectiveness outcomes were the 10-year CVD risk of individuals with mild (4–6 mmol/l) and high (above 6 mmol/l) cholesterol by gender and age groups (45–54, 55–64, 65–74, 75–85 years); CVD events avoided and QALY gains over 20 years. This study found that daily consumption of enriched spread reduces CVD risks more for men and older age groups. Assuming 50% compliance, 69 CVD events per 10,000 men and 40 CVD events per 10,000 women would be saved over 20 years. If the NHS pays the excess cost of enriched spreads, for the high-cholesterol group, the probability of enriched spreads being cost-effective is 100% for men aged over 64 years and women over 74, at £20,000/QALY threshold. Probabilities of cost-effectiveness are lower at younger ages, with mildly elevated cholesterol and over a 10-year time horizon. If consumers bear the full cost of enriched spreads, NHS savings arise from reduced CVD events.
The European Commission has acknowledged the value of sterol-enriched foods for cholesterol lowering through approval of health claims on some products. The findings from this study add weight to calls for the increased use of plant sterol-enriched functional food as a preventive strategy for people with hypercholesterolemia, and suggest that encouraging the consumption of plant sterol-enriched functional food is likely to bring cost savings to health systems, as well as improving patient outcomes. Study findings are detailed in this paper: Yang W, Heather Gage H, Daniel Jackson D, Raats M (in press) The effectiveness and cost-effectiveness of plant sterol or stanol-enriched functional foods as a primary prevention strategy for people with cardiovascular disease risk in England: a modelling study. European Journal of Health Economics. doi.org/10.1007/s10198-017-0934-2
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Background: While functional foods offer promise for public health and innovation in the food industry, the efficiency of such foods should be assured to protect consumers from misleading claims. Globally, many countries regulate the communication of the health effects of such foods to final consumers.
Scope and approach: In the European Union (EU), the use of health claims was harmonized in 2006. All claims need to be scientifically assessed by the European Food Safety Authority (EFSA) and pre-approved. Implementing the regulation has involved a steep learning curve for stakeholders, resulting in many health claims being rejected. The EU-funded REDICLAIM project used existing guidance documents, analyses of Scientific Opinions on new health claim applications, and a series of interviews with experts involved in such applications to identify key points in the process of authorizing new health claims. Key findings and conclusions: Recommendations for the successful substantiation of new health claims in the EU were prepared. The substantiation of health claims is primarily based on human efficacy studies, and greater resources are required to authorize more innovative claims. The reported recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, including the food industry. Study findings are detailed in this paper: Pravst I, Kušar A, Žmitek K, Miklavec K, Lavriša Z, Lähteenmäki L, Kulikovskaja V, Malcolm RN, Hodgkins C, Raats MM, the REDICLAIM Consortium (in press) Recommendations for successful substantiation of new health claims in the European Union. Trends in Food Science & Technology. doi.org/10.1016/j.tifs.2017.10.015 We would like to invite you to participate in our upcoming REDICLAIM webinar about the REDICLAIM project. As the project comes to an end, this webinar will present the project findings and give you the opportunity to ask questions of our expert speakers.
The session will include:
How to join our webinar:
We invite you to participate in our upcoming workshop This multi-disciplinary workshop seeks to initiate the development of a model which can improve regulatory design for nutrition and health needs in food law. It will bring together academics, practitioners and policy-makers from a range of disciplines and locations to explore whether and how public health nutrition research can inform better the design and implementation of European Union (EU) food law. Contributing disciplines will be social sciences, public health nutrition, business studies and law. Much has been written on different styles of regulation but there is very little work which seeks to develop a theoretical approach to integrating scientific research into the design and implementation of regulation in the context of nutrition and health.
The operation of much regulatory law is frequently described as a barrier to innovation and development. This is arguably because it often fails to incorporate domain specific knowledge, e.g. in the area of food and health, into the design stage of regulation. This workshop will seek to initiate the development of a regulatory design model in respect of food law so as to promote public health, taking account of the interdisciplinary approach necessary to design good regulation. Dates: 8-9 June 2015 Location: University of Surrey, Guildford, UK Details: http://www.ias.surrey.ac.uk/workshops/nutrition/index.php Deadline for submitting abstracts: 11 May 2015 Fee: £80 (£30 for PhD students). The registration fee includes workshop materials and refreshments and lunch on both days. WORKSHOP FORMAT Three themed sessions each with a keynote speaker and 2-3 shorter related presentations (sourced from contributors responding to an open call) followed by chaired round table discussions focussing on key workshop themes, including a final session which will integrate the theme discussions. THEMES Styles of regulation for nutrition and health Designing effective regulation is of primary concern in achieving the public health objective. Whether the law is risk-based, prohibitory, procedural or reflexive are all questions which need to be considered in relation to the particular form of law which is adopted and its ability to achieve the public health objective which is its purpose. Much legislation in the food arena is reactive and, in relation to the EU, is increasingly emerging in the form of Regulations which are directly applicable and leave no discretion to Member States. Concern to ensure harmonisation at the highest level in the face of increasing threats relating to the safety of food is leading to this result. But is that reactive approach the most effective way to design legislation which is aimed at promoting public health? This session will reflect on whether the current legislation adequately supports public health nutrition. Round table discussions will focus on the following questions:
Domain-specific science underpinning nutrition-related legislation Within the fields of food and nutrition, research abounds across scientific, technical and behavioural areas but this leaves the question as to how effectively such research is being incorporated into legislation in terms of its design and style. Further, lack of scientific consensus is not operating as a barrier to legislation and the precautionary principle is frequently invoked as a legitimate and ethical basis for new EU Regulations. This session will reflect on the link between public health nutrition research and the associated legislation. Round table discussions will focus on questions such as:
Behavioural aspects for nutrition and health The process whereby people make decisions about their choices of food represents a complex decision-making process and behavioural sciences are increasingly important in determining the framework for this cognitive process. Examples of the abundance of scientific research include, for example, the impact of behavioural patterns around nutrition on health, quality of life and longevity. Behavioural research is extensive and shows that individuals may not function in predictable and rational ways. With legislation increasingly used as the main driver for influencing human behaviour in respect of the food choices they make it becomes imperative to examine the efficacy of different approaches to regulation to achieve good public health outcomes. This session will reflect on what the behavioural sciences offer legislators developing food law that promotes nutrition and health. Round table discussions will focus on:
PROCEDURE FOR SUBMITTING ABSTRACTS AND/OR ATTENDING WORKSHOP Contributions are welcomed from a wide range of disciplines, and from both academics and practitioners. Individual contributions will be around 10 – 15 minutes, and potential contributors should send a 250 word abstract by using the submission form below by 11 May 2015. Attendance will be confirmed by 18 May 2015. The number of participants in the workshop will be strictly limited to facilitate creative discussion, and there is an attendance fee payable by speakers and attendees of £80 (£30 for PhD students). The registration fee includes workshop materials and refreshments and lunch on both days. The UK Association for the Study of Obesity (ASO), in conjunction with SATIN and Full4Health, held a meeting focusing on food based solutions for appetite control and weight management in the context of health claims. Monique Raats presented a poster entitled "Understanding the impact of European regulation on the substantiation and use of claims on food & drinks" and took part in a debate entitled "Is there any Future in Satiety-based Health Claims?"
Project partners met in Budapest for their 4th consortium meeting. One of the highlights of the meeting was Amanda Cleary's (University of Surrey) presentation on her work mapping the regulatory framework and decision-making processes at EU level. Liisa Lähteenmäki (Aarhus University) presented results from the desk research on the role of EU-funded research on substantiating risk reduction and new evidence based claims.
Živa Korošec and Igor Pravst of the Nutrition Institute in Slovenia published a paper entitled "Assessing the Average Sodium Content of Prepacked Foods with Nutrition Declarations: The Importance of Sales Data" in the journal Nutrients. The primary objective was to test a new approach for assessing the sales-weighted average sodium content of pre-packed foods on the market. They show that a combination of 12-month food sales data provided by food retailers covering the majority of the national market and a comprehensive food composition database compiled using food labelling data represent a robust and cost-effective approach to assessing the sales-weighted average sodium content of pre-packed foods. Food categories with the highest sodium content were processed meats (particularly dry cured meat), ready meals (especially frozen pizza) and cheese. The results show that in most investigated food categories, market leaders in the Slovenian market have lower sodium contents than the category average. The proposed method represents an excellent tool for monitoring sodium content in the food supply. Analyses of the use of salt-related claims on foods on the market showed that only 1% of the investigated food products (whole sample) were labelled with sodium-related nutrition claims, and no sodium-related health claims were found. The sodium-related claims most frequently observed were low sodium and no added sodium, mainly found on products in the category of breakfast cereals.
Igor Pravst presented REDICLAIM at the conference "Labelling of foods and food supplements – are we ready for changes?" held on the 3rd of June 2014 in Ljubljana, Slovenia. The conference brought together policymakers, competent authorities, food and ingredient manufacturers and NGOs to gain in-depth insights into the food labelling regulation and its implementation; examine the future of the EU's food labelling plans and how they will influence business; share the experiences; and learn about consumers' expectations of food labelling.
Igor Pravst presented REDICLAIM at the TAIEX Workshop on nutrition and health claims made on foods in Skopje, the former Yugoslav Republic of Macedonia, 26 to 27 May 2014. TAIEX is the Technical Assistance and Information Exchange instrument managed by the Directorate-General Enlargement of the European Commission. TAIEX supports partner countries with regard to the approximation, application and enforcement of EU legislation.
Project partners met at the University of Surrey to embark on the programme of work. Discussions focused on the development of the protocols for the different strands of work.
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