The European Commission’s recently proposed Directives on products at the borderline between medicines and foods do not go far enough, according to a new report. They could serve only to deepen the current confusion over functional foods.

The report, Harnessing Chaos: Negotiating the borderline between medicines and food, highlights the growing regulatory chaos created by the rapidly expanding dietary supplements and fortified foods markets, and underlines the fact that the Directives proposed by the Commission will only address a fraction of the problem.

Given the wide differences in where countries draw the food/drug borderline – and with both proposed Directives restricted for the time being to vitamins and minerals – the Commission’s ‘lowest common denominator’ approach will also be out of step with the various efforts Australia, Canada, Japan, the US – or the

“Member states have not even been able to agree on how a product’s content should be used to determine whether it is medicinal or not”

global Codex Alimentarius Commission – are making to establish their own coherent legislative frameworks for dietary supplements and functional foods.

One glaring omission from the proposed Directives is the lack of attention to the ‘health claims’ issue. This is central, the report argues, in determining whether a product is a medicine or a drug. The European Commission still clings to a policy formulated over 30 years ago through Directive 65/65, which says that disease-prevention claims, and even risk-reduction claims, are the province of medicines, despite mounting evidence to the contrary from the scientific community. The report also points out, however, that problems with the more liberal US approach to claims for the positive health-benefits of both foodstuffs and dietary supplements have still to be ironed out in the law courts.

But what manufacturers can claim about their products are not even the most pressing issue in Europe. Member states have not even been able to agree on how a product’s content should be used to determine whether it is medicinal or not, according to the report’s author, Peter Mansell. He identifies two schools of thought in Europe. The more common approach, taken by countries like Germany, uses multiples of the recommended daily allowance (RDA) – the measure of minimum levels in the population to avoid deficiency – to draw the borderline between medicines and food.

More liberal countries like the UK, however, regard safety and consumer choice as the paramount criteria, provided unsubstantiated medicinal claims are not being made by the manufacturer.

Meanwhile, amidst all this confusion, both mainstream food and pharmaceutical companies have recognised the enormous market potential and have made determined moves into the dietary supplement, nutraceutical and fortified foods sectors. These categories have already experienced massive growth in recent years as consumers take a more active interest in their health and wellbeing.

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This report doesn’t solve the problems

But with different, and confused, rules in every major market of the world about what can or cannot be sold as food, and what can or cannot be said about its benefits, even the largest multinational food and pharmaceutical companies are having problems establishing their marketing strategies.

Three firms, however, have clear ideas on their strategic direction and these are highlighted by three case studies in the report. Royal Numico of the Netherlands has moved into the dietary supplements market from infant nutrition to become the world’s largest player; while Germany’s Merck KGaA, owner of Seven Seas in the UK, has more of a pharmaceutical perspective. Novartis straddles the whole sector from nutraceuticals to pharmaceuticals.

“This report doesn’t solve the problems,” says Mansell, “but it does provide some of the answers by highlighting the ways companies can harness this chaos to their own advantage.”

By Stephen Blake
Editor of Food Industry News