A comparative analysis of regulatory frameworks and their market impacts on health functional foods: perspectives from South Korea, Canada, the United States, and China

This review provides a comparative analysis of the regulatory frameworks and market dynamics of health functional foods (HFFs) in South Korea, Canada, the United States (U.S.), and China. The selection of these markets was made with the intention of reflecting a broad spectrum of regulatory approaches, including full pre-market approval, risk-based licensing, post-market monitoring, and dual-track authorization systems. The study examines distinct regulatory approaches, ranging from South Korea's stringent pre-market approval system under the Health Functional Food Act (HFFA) to the U.S. post-market surveillance model governed by the Dietary Supplement Health and Education Act (DSHEA). Canada's Natural Health Products Regulations establish a comprehensive pre-approval framework requiring Natural Product Numbers (NPNs), whereas China operates a dual-pathway system with "Blue Hat" certification. Market analysis reveals significant growth trajectories, with the global HFFs market projected to reach USD 299.3 billion by the year 2030, demonstrating compound annual growth rates (CAGRs) ranging from 5.6% in South Korea to 17.1% in Canada. The review identifies critical regulatory divergences in scientific evidence requirements, health claim substantiation, and enforcement mechanisms that significantly impact international commercialization strategies. This comparative approach highlights key differences and strategic considerations essential for successful product development, market entry, and global harmonization efforts in the expanding HFFs sector.