An integrated systems-based model for substantiation of health claims in functional food development

•There is a need for innovative models to boost the functional NPD processes.•Regulatory demands for substantiation of health claims are increasing.•Food industry can take advantage of valuable experiences of the pharma industry.•Systems-based technologies can support substantiation of health claims.•An integrated systems-based NPD model for functional food development is proposed.

There is a pressing need for new innovative models to boost functional food production processes. However, it is not clear how the food industry can technologically transform its traditional NPD model into a modern, integrated NPD pipeline that can satisfy regulatory and consumer demands, on one hand, and enhance the capacity for innovation and competition, on the other hand.We provide a new perspective on how systems-based approaches may practically enable the food industry to support substantiation of health claims for their innovative functional products and to reduce the time and cost of risky decisions associated with clinical trials.