New system for regulating probiotics is necessary

In order to better inform American and European consumers about probiotics, a Category Tree system should be implemented, states Dr. Gregor Reid, Director of the Canadian R&D Center for Probiotics at Lawson Health Research Institute and a scientist at the Western University, in the scientific journal Nature. More than $30 billion is spent on probiotics (beneficial microorganisms) worldwide, although it is difficult for consumers to tell what these products do for health and whether they have been tested in clinical trials. According to the regulatory system in the United States, all products that claim to affect disease must be classified as a drug. As a result, researchers are unable to determine whether a probiotic yogurt relieves individuals with inflammatory bowel disease without registering the yogurt as a drug beforehand. Dr. Reid argues that this regulation has stopped a considerable amount of research on probiotics in North America. In addition, this regulation also has ramifications for probiotic research and development in Europe. Dr. Reid explained: "In Europe, bureaucrats have set up a system that has so far refused to acknowledge results of excellent clinical studies. The net result is an impasse, reduced R&D, and consumers left in limbo." According to Dr. Reid, a system should be set up in which all probiotics must pass a set of minimum requirements in order to be called a probiotic. This system would force manufactures to conduct trials on their products, or label them something else. In order to receive a product stamp, companies would have to conduct a series of well-defined experiments on their product. Once these experiments are completed, the product could then receive a Category 1 or 2 stamp. Dr. Reid said: "This, regulators could quickly and easily determine whether or not the product met the standard and approve the stamp, and consumers would be able to understand the the extent to which the product had been tested. With collective discussion amongst probiotic experts and regulatory agencies, this could be a universal stamp across the globe." For food and supplement products, Dr. Reid suggests that documentation requirements would be higher and an expert panel or process might be required in order to conclude whether this Category 3 level was reached. Professor Glenn Gibson, an international expert in probiotics at the University of Reading, UK, explained: "This is long overdue given the intransigence of European Food Safety Authority and US Food & Drug Association at present. The idea clearly has merit given the current confusing situation for consumers, but will regulators have the courage to even consider implementing something so sensible? Sadly I doubt it, although given the high profile of the publication in Nature, and sincerity of the idea, I can only live in hope."