The global functional food market is expanding rapidly, with probiotics leading this growth due to consumer demand for health-promoting products. These live microorganisms are increasingly incorporated into diverse food matrices, from yogurts to cereals and meats. However, their use as food additives faces significant regulatory complexity. This review provides a comprehensive analysis of the scientific and legal frameworks governing probiotics as food additives. It first outlines the scientific basis for probiotics, including their mechanisms of action and the critical importance of strain-specificity and viability. The core of the paper presents a comparative analysis of regulatory approaches by major bodies like the U.S. FDA, the European EFSA, Health Canada, and Japan's MHLW. Key distinctions are made between pathways such as the GRAS notification in the U.S., the QPS approach in the EU, and novel food approvals. A central challenge is the approval of health claims, with the review contrasting EFSA's stringent evidence-based process with the U.S. structure/function system and Japan's FOSHU system. It also discusses challenges in quality control, labeling accuracy, and the lack of global harmonization. The conclusion emphasizes that fragmented legal frameworks act as a bottleneck for innovation. Future progress depends on generating robust clinical evidence and fostering international cooperation to harmonize safety and efficacy guidelines, ensuring consumer confidence and access to beneficial probiotic foods.
Nwakoby et al. (2025) studied this question.