Time has come for new rules in Europe’s health claims game

April 30, 2004

7 Min Read
Time has come for new rules in Europe’s health claims game

If the functional foods industry is to continue to grow and gain in credibility, the European Union needs to expand its approvals for regulated health claims, and the accuracy and balance of consumer media coverage has to improve, Tony Miles-Prouten says

The direct link between our health and what we eat is, for most people, increasingly understood. And it is often said that all we need do is eat a balanced diet. But what exactly is a balanced diet? There is no consensus on that.

Differing lifestyles, financial circumstances and preferences immediately dictate that one person?s balanced diet would not be right for someone else. As consumer knowledge increases, people should be able to buy and eat foods they believe will specifically benefit them, and which suit their lifestyle and personal preferences. But how are they to get clear and balanced information about the choices available?

Accurately communicating the facts about functional foods remains a challenge for European manufacturers in the face of two major factors: restrictive health claims controls, which are also inconsistent between member states, and the influence of powerful consumer media. The potential for success is significant—hence the number of new products vying for consumer attention and shelf space.

However, to really develop the opportunities for growth and secure the industry?s continued success, a regulatory framework needs to be developed. To help achieve this, the industry must work together to secure the benefits of communicating health claims in a consistently clear, credible and balanced manner.

Clear legislation
While unregulated or unsubstantiated health claims are damaging to the functional foods industry, the industry?s long-term success is equally jeopardised by the extreme difficulties in making any health claims whatsoever in Europe. Coherent European legislation governing health claims for functional foods is needed to provide manufacturers with labelling options that communicate truthful, reliable and useful guidance, based on sound scientific evidence, in a way that consumers can understand. The EU Food Labelling Directive (2000) does not currently define the conditions for the use of health claims, so they are largely prohibited. Consequently, manufacturers are very limited in what they can communicate to consumers. Although the EC is reviewing the regulations on health claims, proposed changes to existing legislation are still in a consultation phase. As Europe continues to work toward an agreement, are there lessons to be learned from the current leading markets for functional foods: Japan and the US?

The Japanese Food for Specified Health Use (FOSHU) system provides specific functional foods with an officially approved status. Indeed, the positive legislative environment in Japan plays a significant role in the continued popularity of functional foods with Japanese consumers. Since 1991, around 300 functional products have been proposed for approval, of which close to 200 have obtained FOSHU status. However, while the Japanese functional foods market is booming, there may be a risk that the proliferation of products carrying health claims could ultimately cause confusion among consumers. This is a key consideration for European legislators who may wish to focus on the quality, rather than quantity, of health claims.

In contrast to Japan, US legislation does not approve specific functional food products. The Food and Drug Administration has approved 12 generic health claims that meet Significant Scientific Agreement (SSA). The comprehensive SSA process is used by the FDA to evaluate health claims and initially focuses on a review of individual studies. After identifying relevant, good-quality studies and assessing their strengths and weaknesses, the agency conducts a more comprehensive review based on the body of evidence as a whole.

SSA claims that are already approved include calcium and osteoporosis, soy protein and the risk of heart disease, and stanol and sterol esters and the risk of heart disease. The FDA has also established interim procedures whereby lesser or so-called ?qualified? health claims can be made not only for dietary supplements but also for conventional foods. These claims aim to provide guidance to industry on the circumstances under which the FDA will consider exercising its enforcement discretion to permit health claims that do not meet the SSA standard.

The system of generic health claims developed in the US—the current middle ground between Europe and Japan—may prove to be a suitable blueprint for Europe. Indeed, some national governments have already established local codes to provide both manufacturers and consumers with interim guidance for generic claims, for example the Joint Health Claims Initiative in the UK and the Swedish Nutrition Foundation?s self-regulating code. However, for the generic health claims approach to function effectively, there must be harmonisation across Europe to prevent market fragmentation.

The might of the media
While manufacturers are very limited by EU legislation in what they can communicate to consumers about health benefits, the autonomous mass media holds the cards when it comes to influencing public opinion. Health news is big news. And to be successful, a company and its product offering must be credible in the eyes of the consumer—press coverage can make or break reputations.

Recent media coverage in the UK on soy clearly illustrates the dichotomy between balanced scientific argument and its communication to consumers through the press. The general understanding of the potential health benefits of soy consumption has significantly improved in recent year—soy is no longer perceived as an unappetising food just for vegetarians or those with lactose intolerance. There is also greater awareness of specific soy ingredients such as isoflavones, which are now often highlighted positively in health and women?s magazines. Nevertheless, mass media coverage of soy often takes an extreme view, either over-stating it as a ?miracle? food or reporting negative research without placing the findings in a broader scientific context.

BBC News Online, for example, recently reported details of research under way at St Andrews University, Scotland, to develop methods to measure the effects of phyto-estrogens on humans. It was described as a study researching methods to ?beat breast cancer through eating high-fibre foods like strawberries, lentils and soy.? The coverage further stated that ?recent research has reported that breast cancer is less prevalent in Asian women, who have a high-soy diet.? While these positive headlines promote soy, the press report only provided limited information on the ?bigger picture.? Additional information on the quantities of soy involved in achieving the benefits highlighted in the scientific research would have provided a more accurate perspective.

In contrast, a study from Johns Hopkins? Bloomberg School of Public Health in Maryland received negative coverage in the mass media. This study examined the reproductive function in male rats exposed to phytoestrogens while in the womb and achieved such headlines as ?pregnant women warned soy may damage their sons.? In reporting the story, many newspapers did not place the report in context by mentioning the positive research findings about soy consumption or epidemiological evidence from East Asia where soy is a staple of the diet.

Clearly, those involved in manufacturing soy foods and soy-containing dietary supplements must take all research seriously—positive or negative. However, inaccurate or unbalanced reporting of scientific studies by the mass media has long-term repercussions on public opinion. The insinuation sometimes contained in European consumer press coverage that the consumption of soy is potentially harmful is in stark contrast to Japanese consumer attitudes about soy. In Japan, soy is a dietary staple for both men and women. From an early age, children are fed soy-containing products by their parents, with no thought of such issues as maximum daily quantities. For European opinions about soy to change and a more balanced perspective to prevail, it is clear that the attitudes of the press must also change.

Credible science
Manufacturers can play a role in improving press reporting and, in turn, consumer understanding by promoting credible scientific research to support health claims or by reacting to negative press coverage. An industry-wide initiative to promote reliable clinical research to support credible health claims would be extremely beneficial to ingredients and product manufacturers alike. The approved Joint Health Claims Initiative health claim for soy protein in the UK is an example of the impact that manufacturers can have when they work together.

Tony Miles-Prouten is ADM?s vice president of marketing, Europe. Respond: [email protected]. Correspondences will be forwarded to the author.

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