Researchers Call for Framework to Assess Totality of Evidence for Health Claims

Researchers have called for a process to define evidence-based nutrition that embraces state-of-the-art nutrition science, and stimulates future academic research.

Sep 28 2011 --- Evidence based medicine is not suitable for the evaluation of the Article 13.1 claims under the of European Union’s (EU) Nutrition and Health Regulation, the 26th Hohenheim Consensus Conference has agreed.

In a document published this month in the academic journal Nutrition, the 13 academic experts who attended the conference last year and who authored the paper said that evidence based medicine is designed to evaluate the effects of drugs and not the unique properties of nutrients and the bioactive substances subject to Article 13.1 of the EU’s Nutrition and Health Claims Regulation.

They called for a process to define evidence-based nutrition that embraces state-of-the-art nutrition science, and stimulates future academic research.

At the conference the experts spent a day presenting and discussing their views and arrived at several consensus statements, which they hope will serve as guidance for bodies performing or taking decisions on the claims assessments, such as the European Commission.

"The scientific knowledge available to date cannot be ignored and should be a starting point for the assessment of the totality of the available data and the strength, consistency and biological plausibility of the evidence," said Professor Hans Biesalski, who heads the University of Hohenheim (Stuttgart, Germany) Department of Biological Chemistry and Nutrition and organises the renowned Hohenheim conferences.

"Evidence based medicine is clearly not appropriate for the evaluation of claims made on foods and what is needed in the process of evaluating Article 13.1 claims is to define evidence-based nutrition, which embraces state-of-the-art nutrition science, and stimulates future academic research. This approach does not mean to have a lower scientific level. Indeed, specific designs should be developed to estimate the effect of ’non-xenobiotics’ on human health“.

Article 13.1 of the EU’s Nutrition and Health Claims Regulation aims to ensure that health claims on foods and food constituents can be properly justified and scientifically substantiated. The European Food Safety Authority, the body entrusted with the evaluations of the claims, has adopted an evaluation process that has been subject to considerable debate amongst leading scientists in the field of human nutrition. It is thought that this process has led to negative opinions on health effects for many food components, which, according to some, could have been recognised had a more holistic approach to the evaluation of the claims been adopted.

The Univeristy of Hohenheim organised the 26th Hohenheim Consensus Conference to gather the views of many academic experts in the field of nutritional research on various aspects of the claims substantiation process and the possibilities and limitations of the different approaches given the debates in this area.

At the conference case studies were addressed, focusing on carotenoids and Vitamin A in relation to age related macular degeneration (AMD); the quality of carbohydrates (as expressed by the glycemic index) in relation to health and wellbeing; probiotics in relation to intestinal and immune functions; micronutrient intake and maintenance of normal body functions; food components with anti-oxidative properties and health benefits, and the nature of evidence supporting the impact of deficient, adequate, and optimal intakes of micronutrients on physiological function.

“We chose these case studies in order to address the extent to which an evidence-based benefit is a reliable endpoint, and the extent to which data from clinical studies of disease states can be used as supportive evidence for health effects,” said Prof Biesalski. “They also enabled us to consider how to assess other factors, such as the different effects of the various dietary nutritional components on systemic parameters, for example, the individual effects of the various types of fatty acids in the diet on blood lipids.”

The university will continue its exploration into issues presented by the EU’s claims regulation and has already touched upon this in two further case-study consensus workshops this summer, which focused on the health relationships of individual substances subject to evaluation under Article 13.1.