Despite major efforts to regulate the status of probiotics and other products containing intentionally added live microorganisms, legislation is not yet harmonised at a global level. Most countries still regulate the marketing of probiotic products in their own way, leading to lower consumer confidence, lack of information and restricting international trade, all while the range of available products with added live bacteria is continuously increasing. Most probiotics are found in foods and dietary supplements, therefore it does not make sense to regulate these products according to the same criteria and guidelines as medicines. International organisations such as the Food and Agriculture Organisation of the United Nations (FAO), the World Health Organisation (WHO) and the International Scientific Association for Probiotics and Prebiotics (ISAPP) are trying to establish general and evidence-based guidelines for quality assurance and product labelling that all countries can follow. This is hampered by the complexity of the mechanisms of action observed in probiotics and poorer availability of newer methods to characterise and ensure the safety of microorganisms in developing countries. In addition, international guidelines are open to interpretation by some countries, as we are seeing today in the European Union. A better understanding of how probiotics work, more high quality clinical studies and cooperation between regulatory authorities in different countries will be needed to achieve a satisfactory state of affairs in this field.
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