A change to European rules regulating the sale of ‘medicinal’ foods could prove to be a major headache for the functional food industry, a legal expert has claimed.
Under a recent amendment to the European Directive on medicinal products for human use, ‘borderline’ functional foods that could be described as foods or medicines will be reclassified as medicines when the Directive hits UK statute books later this year, said Craig Simpson at law firm Steptoe & Johnson, which advises several multinational food and beverage companies.
Speaking at an Agra Informa conference on functional drinks in London, he said: “This is putting some manufacturers between a rock and a hard place. Take herbs. The Commission has drawn up a list of those deemed to be ‘medicinal’ at certain concentrations. Food manufacturers don’t want to go through all the clinical trials and other things you have to do to get a medicine licence, so they are thinking about using less of the herb. But if they use such low amounts, it may be that they can’t make any claims about it at all.”
Foods claiming to stimulate the metabolic system, boost the immune system or generally restore, correct or modify these kinds of physiological functions, would be reclassified as medicines unless they changed their marketing, he said.
Separately, a draft proposal drawn up by the European Commission to regulate the market for sports drinks was also sending shockwaves around the industry, he claimed. In its current form, this would prevent companies from marketing products as sports drinks if they did not contain certain levels of carbohydrate or protein, he said. “This represents yet another potential restriction on the functional foods market.”