[Brief Introduction of Seminar]
The Japanese Foods with Function Claims (FFC) system, introduced in 2015, has entered a new phase following major regulatory revisions in 2024–2026 — including mandatory health-hazard reporting, mandatory GMP compliance, extended review periods for new ingredients, and mandatory annual self-inspection. This session reviews these latest regulatory developments and examines the fundamental institutional differences between Korea's government-approved individual-recognition system and Japan's company-responsibility notification system — a distinction Korean health functional food companies must understand before entering the Japanese market. Building on this foundation, the session addresses the practical steps required for successful entry, including defining the functional ingredient, establishing a publication and systematic review (SR) strategy, and designing the notifier structure. It further walks through the full FFC notification process step by step — from product selection and ingredient confirmation through evidence-building, publication, notification, and sales, to post-market management such as health-hazard response, self-inspection, and change management — while highlighting common points Korean companies tend to overlook during market entry, in order to offer more practical preparation strategies.
[Brief Introduction of Speaker]
Dr. Dean Jang yul Kwak is the founder and Chief Executive Officer of Research Mentor, a Korea-based contract research organization specializing in health functional foods, dietary supplements, and functional ingredients. He holds a Ph.D. in Business Management from the United States and is an expert in statistics and research methodology, with extensive experience in clinical research, data analysis, evidence development, and regulatory strategy.
For approximately a decade, he has advised domestic and international companies on the development and commercialization of functional ingredients. His expertise includes clinical trial strategy and design, protocol development, data management and statistical analysis, systematic reviews, scientific publications, regulatory dossier preparation, and global market-entry planning. His primary areas of focus are Korea’s individually recognized functional ingredient system administered by the Ministry of Food and Drug Safety (MFDS) and Japan’s Foods with Function Claims (FFC) system.
Dr. Kwak has led numerous clinical and regulatory projects for ingredient developers, food manufacturers, pharmaceutical companies, and consumer health companies. He has designed, coordinated, and conducted clinical trials in Korea, India, Australia, the United States, and other countries, developing evidence strategies to support regulatory submissions and commercialization across multiple markets.
In recent years, he has focused on integrated evidence-development strategies that consider Korea, Japan, the United States, Canada, India, and Australia from the early stages of ingredient development. In particular, he supports companies in designing clinical studies, publications, and systematic review strategies for entry into Japan’s FFC market.
He also serves as a member of the Industry Division of the Korean Society of Food Science and Nutrition and contributes to discussions on regulatory science, evidence-based functional food development, and the globalization of the Korean health functional food industry.