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Practical experience with Health and Nutrition Claims: a "moving target"

International Fresenius-Conference discussed legal framework, research results and implementation problems

Dortmund, Mainz, 01.06.2011

When it comes to Health and Nutrition Claims many practitioners from the food industry find inconsistencies regarding the legal demands, detect further need for governmental regulation or become confronted with implementation problems in practice. To discuss current questions the industry met from 30th to 31st May 2011 in Cologne (Germany) at the 3rd International Conference "Health and Nutrition Claims" by Akademie Fresenius and SGS Institut Fresenius.

Martin Holle, Unilever Great Britain, saw the main problem not primarily in the legal requirements but in their practical implementation. The current policies are neither based on a coherent interpretation nor is there a consistent handling of the issue, Holle made clear. Even if a Health Claim was authorized, this would not guarantee a smooth use in the market. According to Holle, especially a lack of awareness of the legal situation in some member states, differences in national product classification, the high complexity of the statements relevant to personal health cause numerous stumbling blocks for the food industry. On top of that, Holle highlighted the insufficient protection of data and findings. Without adequate protection mechanisms for this data the industrial nutrition research with external partners like universities would dramatically decline, Holle predicted.

Herbal ingredients in medicine and nutrition

Exemplary for the classification problems and different national approaches within the European Union, Patrick Coppens (European Advisory Services) criticized the inconsistent handling of herbal ingredients. Medical products and over the counter dietary supplements would often consist of the same ingredients but face a completely different legal treatment, Coppens explained. While medicine is strongly regulated by provisions, the food market suffers from missing harmonization, different national constraints and concerns regarding the security of its products. Because of that, a rule for harmonization in both areas is actually being discussed, Coppens concluded.

Different approaches in the EU and the USA

Analogue to the European Union’s complex shape of regulations, the US-implementation of the Health Claims topic is likewise confusing. Unlike the EU, the USA have two authorities which handle the classification and regulation of Health Claims: the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), John E. Villafranco (Kelley Drye & Warren) explained for companies that think about product launches in the United States. Villafranco pointed out that product launches in the USA would require accurate knowledge about the governmental competence, the associated regulations and requirements for a specific Health Claim, because not every claim would be in need of an official acknowledgement by the authorities. For example, dietary references would not belong to the regulatory objects, Villafranco specified.

Product benefit often overrated

Hans-Dieter Orzechowski (analyze & realize ag) reminded the audience of not overestimating the effect their products can have on the consumer’s health. A correct clinical study in the field of nutrition would always require healthy subjects who have no current diseases. Just a risk for the tested disease would be tolerable, Orzechowski made clear. According to Orzechowski, these requirements would often lead to a limited potential for the tested product, because a healthy group of probands could not get significantly healthier over the use of a special product. To clarify the actual potential, Orzechowski suggested the inclusion of risk factors and their decline to determine the efficiency of a product.

Risk factors would also play an important role in the formulation of Health Claims, confirmed Henk van Loveren, member of the EFSA NDA Panel. Because the application of Claims requires in all cases a substantial scientific base, the EFSA would use just the highest possible scientific standards while assessing a product to preclude an endangerment or a misguidance of the consumers, van Loveren told the audience. The high standards would cause the EFSA not to approve of Claims that promise a cardinal prevention, treatment or cure for specific diseases. Merely the reduction of risk factors leading to certain diseases could be a subject matter in a Claim, van Loveren summed up the position of the EU-authority. In this context, Lawyer Christian Ballke (meyer//meisterernst) suggested that, in spite of high standards, the rules of the regulation would often prove themselves as too generic and cause therewith numerous questions for national courts like the German Bundesverwaltungsgericht.

Iacopo Berti (Italian Antitrust Authority) pointed out that not just the general benefits but the use of advertising slogans for Health Claims would be a big problem, too. Overrating and claiming a generic product benefit were common, Berti specified. The consumer would get no details at all in which specific situations, for whom or to which degree a product could be of use.

Research backs up sales impact

Unlike the product impact, the effect of Health Claims on sales figures counts as significant. The presence of a Claim would definitely increase the likelihood of buying because products with Claim would be seen as more healthy in comparison to products without one, stated Jessica Aschemann-Witzel, MAPP-Centre for Research on customer relations in the food sector (Aarhus School of Business & Social Sciences). Furthermore, the familiarity with a product’s ingredients as well as a natural relation between product and Claim would have the biggest impact on the consumer’s buying decision, Aschemann-Witzel explained. On the other hand, the exact wording of a Claim could be classified as irrelevant regarding the question of purchase and therewith overrated in its importance.

The complete Fresenius conference documentation including scripts from all the presentations can be purchased at the Akademie Fresenius for 295,00 € (plus VAT) or here.

Contact details:

Die Akademie Fresenius GmbH
Monika Stratmann

Alter Hellweg 46
44379 Dortmund

Phone  +49 231 75896-48
Fax  +49 231 75896-53

Titel Health Claims Produkt

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