Achieving an internationally recognised regulatory approach to health claims, which will protect the consumer, promote fair trade and encourage innovation in the food industry, is a long way off, if ever achievable, concluded experts at a recent seminar on health claims.
The meeting, organised by the Northern Ireland Centre for Food and Health (NICHE) and hosted by the College of Agriculture, Food and Rural Enterprise (CAFRE), brought into focus the different approaches of the EU and US to the use of health claims in foods.
Both regions have introduced new proposals for health claims this year, but there remains a significant gap in claim definitions, so that companies will still be required to comply with different standards before marketing a food on both sides of the Atlantic. Ideally, this could be harmonised, but speakers at the meeting discussing the background to their countries' regulatory systems, revealed the extent to which the two approaches differ.
Nancy Childs, professor of food marketing at the Erivan K. Haub School of Business at St Joseph's University in Philadelphia, discussed the impact of regulations on claim use in the US.With the introduction of the Nutrition Labeling & Education Act (NLEA) of 1990, the 'weight of scientific evidence' pendulum swung substantially in favour of less evidence, only to swing back with the Dietary Supplement Health & Education Act (DSHEA) of 1994. However, regulations arising from the DSHEA legislation were subsequently challenged, and Case Law led to the First Amendment Rulings (based on freedom of speech).
"As a result of the Pearson v. Shalala 1999 court case, the FDA is now required to allow appropriately qualified health claims that would be misleading without such qualifications and based on the weight of scientific evidence - more evidence for than against," added Childs.
Qualified Health Claims are still under review, including the newly announced 'weight of scientific evidence' grading system. This system will allow different grades of claims from those with existing health claim status to those with little scientific evidence supporting the claim.
"Claims function as a trigger for industry effort and offer competitive differentiation," said Childs. They also contribute directly - through label information - and indirectly - using expanded product choices and external information sources - to increased consumption of healthier products, she added.
However, the new graded claims will again change the regulatory and marketing environment."Use of qualified health claims will dichotomise, resulting in 'disease prevention/health enhancing' market positionings with documentation, dosage, and endorsement, and 'health halo' market positions, emphasising taste and lacking dosage and documentation," argued Childs.
She also predicted that interested and educated consumers will benefit from information for desired choices while many general consumers may become confused or indifferent. Claims will grow in importance for sustainable differentiation to the consumer through proprietary ingredients, bio-sophistication, product positioning, product sourcing, brand and trust in the food manufacture or retailer.
And there is likely to be a high level of new and improved product activity and integrated marketing in the US, which is encouraged by a shift to self-medication. However, "nutritional claims are not silver bullets for consumer health or for corporate profits", noted Childs.
Gerhard Rechkemmer, chairman of the new department of Biofunctionality of Food at Technische Universität München (TUM), discussed the definition of health claims in Europe, where 'nutrient function claims', (calcium aids in the development of strong bones and teeth) and 'enhanced function claims', such as an ingredient that has cholesterol-lowering effects, are widely recognised.
A third definition, 'reduction of disease risk', can currently be regarded as illegal under the interpretation of food labelling legislation, in the UK, said Rechkemmer. In practice, however, the three categories of claims are part of a continuum, and the third has required the EU regulatory framework to be clarified so that it does not fall under the prohibition of preventive claims.
"It is now generally accepted that foods can reduce the risk of disease over and above the provision of nutrients that they contain," said Rechkemmer.
"Claims may relate to diets, broad food categories, food components including nutrients (generic health claims), or relate to particular food products (product-specific health claims)," he added.
While the scientific standard for the substantiation of both approaches should be the same, there is a clear divergence between the evidence needed for each. Product-specific claims are likely to be based primarily on human intervention studies showing the claimed effect when the product is consumed as part of normal diet, while generic claims are based on well-established, generally accepted evidence in the scientific literature and/or to recommendations from national or international public health bodies and national scientific advisory committees.
The British Nutition Foundation (BNF) has however recently attacked Europe's proposal for health claims, for its plans to evaluate the 'nutritional profiles' of foods. This is designed to restrict the use of claims on some foods with high fat, high salt or high sugar contents, but is likely to categorise foods as good or bad, according to the BNF. Those food items not carrying nutrition claims may be viewed negatively by consumers it claimed.
Rechkemmer, a member of the Steering Committee of the EU-funded 'Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM)' project, co-ordinated by ILSI Europe, also reviewed 'an evidenced-based approach, drawing primarily on well designed human studies', 'weighted evidence according to a predefined hierarchy scheme' and a 'claim based on an evaluation of the totality of evidence'.
The European proposal still has to go to the European Parliament and the Council, with a view to entering into force by 2005.