MFDS HFF

Korea regulates supplements as Health Functional Food (HFF, 건강기능식품) under the Health Functional Foods Act administered by the Ministry of Food and Drug Safety (MFDS, formerly KFDA). HFF status is mandatory for any product marketed with health-function claims in Korea — products without HFF status cannot claim physiological function regardless of formulation or evidence. Two pathways: Generic HFF uses ingredients on the MFDS Functional Ingredient List (~90+ generic ingredients including vitamins, minerals, omega-3, probiotics, dietary fibre, ginseng/red ginseng, plant sterol esters, glucosamine, CoQ10, lutein, EGCG) with MFDS-specified daily dose ranges and verbatim function-claim wording, ~90-day MFDS review; Individually-Approved HFF (개별인정형) covers novel functional ingredients requiring full safety, function, manufacturing standardisation and analytical method dossier with 6-18 month review and applicant-specific commercial protection. Function claims are categorised across nutrient function, disease risk reduction, and physiological function (immune, antioxidation, blood lipid, blood sugar, cognitive, joint, eye, GI, fatigue, sleep, weight, skin). HFF GMP certification is required for manufacturing facilities — domestic via direct MFDS certification, overseas via MFDS overseas-manufacturer registration with documented GMP equivalence (FDA 21 CFR 111, TGA, EU GMP, Japan FFC, NSF/USP). Imported HFF requires Korean importer of record with MFDS authorisation, per-SKU registration, Korean-language label with HFF mark and MFDS-approved claim wording, allergen declaration per Korean allergen list (differs from US Big-9, including buckwheat, excluding sesame), and adverse reaction reporting via Korea Adverse Event Reporting System for Food.