Selling food: retailing or medicine?

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Bert Schwitters, of the International Nutrition Company, believes that the EU is confused in its definitions of food. Here he explains why.

The International Nutrition Company

Yoghurt is a food product that has been around for millenia, but today it runs the risk of being classified as a medicine. Recent EU Directives and proposed Directives dealing with foods and medicines now define yoghurt as a food and as a medicine. So which is it?

Yoghurt is a food when it sustains, assists and maintains physiological functions. It’s a medicine when it ‘restores, corrects or modifies physiological functions.’ In simpler words, yoghurt is food when taken by healthy consumers. It is a medicine for those who suffer from a gastro-intestinal problem.

Logical consequences

Retailers who sell yoghurt to people suffering from a gastro-intestinal ailment are violating EU 2004/27 because they are selling an unlicensed medicine. Food retailers will have to check whether in each individual consumer the yoghurt they sell may restore, correct or modify physiological functions. They must establish this to avoid being prosecuted for selling yoghurt as an unlicensed medicine and/or for practising medicine without a license.

To purchase yoghurt at their supermarket, consumers will have to present a ‘Certificate of Perfect Health’. If they cannot, they will be refused their yoghurt and they'll have to go to a nearby pharmacy to buy pharmaceutically registered yoghurt. This is how the retailer must try to avoid violation of Directive 2004/27. He or she may also decide to stop the sales of yoghurt and of all other foods that could possibly restore, correct or modify physiological functions, raising the prospect of a lot of empty shelf-space.

Manufacturers will have to state on their products: ‘We’re sorry, but when this product will or may restore, correct or modify one or more of your physiological functions, please do not use it. If you do, we will be prosecuted for violating EU Directive 2004/27 and illegally practising medicine.’ Such disclaimers will make sure that manufacturers won’t be prosecuted for selling unregistered medicines.

Food supplements

The analogy with food supplements is evident. EU Directive 2002/46/EC classifies food supplements as foods. However, according to Directive 2004/47 food supplements are medicines when taken by unhealthy consumers. Retailers who sell food supplements to people who are not in perfect health violate EU 2004/27 because they sell an unregistered medicine. They may also be prosecuted for practising medicine without a license because they had to diagnose the consumer’s health condition trying to establish whether a food supplement may or may not ‘restore, correct or modify physiological functions’ in the client who comes for a bottle of vitamin C tablets.

The problem is that Directive 2004/27 introduces the condition of the individual consumer as the determining factor by bluntly stating that a product is a medicine when it ‘restores, corrects or modifies physiological functions by exerting a pharmacological, immunological or metabolic action.’ Such a Directive means the end of food in Europe, because all foods (even Coca-Cola) have a metabolic action and modify physiological functions. As a logical consequence, the distinction between food and medicine must then be made by objectively checking whether, in an individual consumer, a food does what a medicine does. Unless the consumer has been found in perfect health, all foods retroactively become drugs and all Directives relating to foods are rendered null and void.

This is a confusing situation indeed.

Readers are invited to type ‘EU Directive 2004/27/EC’ into Google, open the Directive and look under Article 1,1)’2(b).

Further information

The International Nutrition Company BV

Website: www.inc-opc.com

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