STUTTGART, Germany—The evidence-based medicine approach used to evaluate Article 13.1 claims is an inappropriate way to measure the effects of foods, according to a new paper written by 13 academic experts who attended the 26th Hohenheim Consensus Conference last year (Nutrition. 2011 Oct;27(10 Suppl):S1-S20. DOI 10.1016/j.nut.2011.04.002)
They report the method that European Union’s (EU) Nutrition and Health Regulation uses to approve or deny health claims are designed to evaluate the effects of drugs and not the unique properties of nutrients and the bioactive substances subject to Article 13.1 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 organizes the Hohenheim conferences. “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 health claims on foods and food constituents can be properly justified and scientifically substantiated. The European Food Safety Authority (EFSA), 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.
European Federation of Associations of Health Product Manufacturers (EHPM) came to a similar conclusion in a statement released earlier this year.
At the 26th Hohenheim Consensus 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 antioxidative 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," Biesalski said. “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."
