Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a va riety of ways. Several such products are available commercially, although m arkets in Japan and Europe are more developed than in the USA. Once healthf ul attributes of a probiotic product have been identified, there remain mic robiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic st ability in the product over the course of product manufacture, shelf-life a nd consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containi ng foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provid e the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporat e commitment to marketing.