What are the Options for the Industry to Promote Probiotic Benefits?

Probiotics have been considered a healthy food for more than a century, especially in Asian countries. Research on their health benefits was mainly structured as food research. In the nineties probiotics gained interest in Europe and the USA, mainly because of their extensive commercialization. This evolution increased the pressure to supply scientific support for the claimed health benefits. In parallel there was an evolution in the USA and Europe to better regulate health claims for food, in order to protect the consumer. In Europe this resulted in the nutrition and health claims Regulation 1924/2006, which today has approved only one health claim in the probiotics area. While there might be several reasons for this, it is clear that current and future research efforts to sustain health benefits will need to be of very high quality, approaching what is generally requested for drugs. Current technological developments involving –omics technologies will largely assist in improving the quality and profoundness of this health claim supporting research. Depending on the target population, the nature (species designation) of the strains used, the quality of the supporting science and the expected commercial margins, probiotic products can be put on the market as foods or drugs. If the food was not used for human consumption to a significant degree within the EU before 15 May 1997, it could be considered as a Novel food. This will be especially the case for the ‘new type’ of probiotics that are the result of extensive metagenomics research, resulting in non-QPS probiotic candidates. Alternative categories for probiotics might be foods for special medical purpose, medical devices, or medicinal products. According to the European Directorate for the Quality of Medicines and Healthcare, the latter is considered as live biotherapeutic products, Biological medicinal products containing living microorganisms (bacteria or yeast).