South Korea's Health Functional Foods Act: what foreign supplement brands need to know

South Korea has one of Asia's most structured and commercially developed health supplement markets. The K-wellness trend has driven strong consumer demand for functional products, and Korean consumers are among the most sophisticated supplement buyers in the region. But the regulatory framework, built around the Health Functional Foods Act administered by the MFDS, is positive-list based and highly specific. Brands can't simply enter with their existing formulations and claims.

The MFDS and the Health Functional Foods Act

The Ministry of Food and Drug Safety (MFDS) administers the Health Functional Foods Act, which governs the registration, labelling, and advertising of health functional foods in South Korea. Under this framework, a 'health functional food' is a product that uses functional ingredients recognised by the MFDS and makes approved health function claims. Products that don't meet this definition can't carry health function claims in Korea.

The positive-list ingredient system

Korea operates a positive list: only ingredients that have been evaluated and approved by the MFDS can be used in health functional foods with associated claims.

Individual recognition ingredients have been individually reviewed and approved by the MFDS through a formal dossier process. Once recognised, other companies can use that ingredient within the approved conditions.

Standards ingredients have established MFDS standards and specifications, effectively a pre-approved list including vitamins, minerals, and a range of functional botanical and nutritional ingredients. These can be used without individual recognition if the product meets the established specifications.

For foreign brands, the practical implication: check whether your functional ingredients are on the Korean approved list before anything else. Ingredients common in Australian, EU, or US supplements, including certain botanical extracts, proprietary blends, and newer functional ingredients, may not be on the Korean list. If they're not, you either reformulate, pursue individual recognition (expensive and slow), or sell the product as ordinary food without health function claims.

Health function claims in Korea

Claims on health functional foods in Korea are tightly controlled. Only approved functional claims associated with recognised ingredients at specified intake levels can appear on product labelling or in advertising. The claim must be approved for that specific ingredient at that specific daily intake. Brands must match their formulation to the approved specification exactly.

Import and registration requirements

Health functional food products sold in Korea must be registered or notified before sale. The process: product must use only approved functional ingredients at approved levels, label must be in Korean and comply with MFDS labelling requirements, registration or notification submitted to MFDS, and a local responsible entity (Korean importer or distributor) is required. For ordinary food imports without health function claims, the process is simpler: import notification to MFDS rather than full registration.

Labelling requirements

Korean health functional food labels must include: health functional food designation and MFDS logo, functional ingredient content per serving, approved health function statement, daily intake and directions for use, precautions and target population restrictions, Korean language throughout, and local importer details.

The advertising framework

Korea has strict advertising rules for health functional foods. Claims in advertising must match approved label claims exactly. Online advertising and social media are covered: brands can't make claims online that they can't make on pack.

Taama's South Korea coverage is on our roadmap, covering MFDS positive-list ingredient screening, Health Functional Food registration, and claims compliance. See our Korea page