Health functional foods (HFF) are processed supplemental foods which provide nutritional benefits and act as preventive medicinal products. The historical familiarity and cultural inclination of locals in South Korea towards these foods has led to thriving market for them. To market them locally, they must be notified to/registered with the Ministry of Food and Drug Safety (MFDS), depending upon the product type. But deviation from MFDS listed ingredients, and therapeutic claims can lead to reclassification and approval process extension which are economically non-viable.
Freyr’s Regulatory team conducts ingredient analysis to establish product safety and efficacy. Further, we also extend professional support for claims review and substantiation. With expertise in providing end-to-end product notification and approval services, we guide both types of HFFs mentioned below towards compliance within stipulated timelines.
- Listed Health Functional Food (HFF Type 1)
- Product Specific Health Functional Food (HFF Type 2)
- HFF Product Classification
- Ingredient Assessment
- Label Compliance
- Claims Review and Consultation
- Translation into Korean language
- Labeling Design
- Product Notification for Generic Health Functional Food
- New Ingredient Approval and Novel Food Registration for HFF
- Legal Representation
- Formulation Sample Testing in the MFDS Authorized Labs
- Regulatory Affairs and Regulatory Intelligence
- Strategic Regulatory Consulting
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
- Support for region-specific Regulatory activities
- Extensive partner network across the globe
- Strong relationship with different local Health Authorities (HAs)
- Structured approach to ensure speed to market for products