Individually Recognized Functional Ingredients of Korean Health Functional Foods: Functional Classification,...

Area of Science:

• Regulatory Science
• Nutritional Science
• Pharmacology

Background:

• The global health functional food (HFF) market is rapidly expanding, driven by consumer interest in preventive healthcare and evidence-based nutrition.
• South Korea's Individually Recognized Functional Ingredient (IRFI) system, established in 2004, is a key regulatory framework for HFFs, accommodating innovative ingredients.
• The IRFI system is recognized as a potential model for evidence-based functional food regulation globally.

Purpose of the Study:

• To examine South Korea's IRFI system within a comparative regulatory context.
• To evaluate the IRFI system's implications for drug-dietary supplement interactions (DDSIs).

Main Methods:

• Defined functional categories based on Ministry of Food and Drug Safety (MFDS) guidelines.
• Collected data on Korean IRFIs from the Food Safety Korea database.
• Conducted a comparative analysis of regulatory frameworks in the US, EU, Japan, and China, alongside a literature review on DDSIs.

Main Results:

• The IRFI system is a hybrid model combining pre-market scientific evaluation (GLP safety testing, clinical evidence) with regulatory incentives.
• It features a stringent authorization process, integrating clinical evidence requirements within pre-market approval.
• Compared to other systems, the IRFI offers a structured approach to evaluating functional foods and potential DDSIs.

Conclusions:

• The IRFI framework sets a high evidentiary standard for functional foods and provides a basis for evaluating DDSIs.
• Its global applicability hinges on mutual recognition of scientific and clinical evaluation criteria across jurisdictions.
• The study reviewed DDSIs based on MFDS-approved IRFIs and existing literature.