Food or pharma: the name does make a difference

As the body of knowledge on the interaction between the microbiome and its host expands, the industry is taking this opportunity to develop new approaches to improve overall and specific health management. An increasing number of stakeholders are now involved in the development of products containing living microorganisms, aimed at positively influencing health by improving the balance between the microbiome and its host. Many strategies allow studying the microbiome, varying from fecal and vaginal microbiota transplants, the use of synthetic ecosystem, phages, all the way to highly characterized strains (single or in combination) often addressed as “probiotics,” a concept the consumer is familiar with due to the large media coverage. In this chapter, we like to dive a bit deeper than the (social) media normally do, clarifying the legal width of the term “probiotic,” particularly when it is used to “prevent, cure or manage a human disease.” When a product is intended to “prevent, cure or manage a human disease,” it is to be considered a drug in legal terms. The drug status is highly regulated, with multiple requirements for the product to be placed on the market. The first section of this chapter will deal with the drug status, focusing on the importance of the “disease” aspect. The second section will deal with “probiotics” in particular focusing on their different regulatory statuses. In Section 2.3, the regulations in Europe, the United States, Canada, and Japan will be compared for probiotic substances used to promote human health, again with a focus on the intended use. Finally, in this chapter, we will try to objectively describe the borders between the “scientific” and the “regulatory” statuses of probiotics, which, still today, are often not very clear.