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Selling supplements in South Korea

In South Korea, supplements made with functional ingredients are sold as health functional foods under the Health Functional Foods Act, regulated by the Ministry of Food and Drug Safety (MFDS). They use ingredients MFDS has notified or recognised, carry the labelling the Act on Labeling and Advertising of Foods sets, and imports follow the imported food rules.

Updated · Each section links to the official source it comes from

Regulator
Ministry of Food and Drug Safety (MFDS)
Main law
Health Functional Foods Act (건강기능식품에 관한 법률)
Ingredients
Publicly notified by MFDS, or recognised on application
Manufacturing
MFDS permission and good manufacturing practice
Label
A statement that it is not a drug
Adverse events
Reported to MFDS by the business

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a health functional food, or an ordinary food that may not claim to be one? Read more
  2. 2Is each functional ingredient publicly notified, or recognised by MFDS? Read more
  3. 3Does the product meet the MFDS standards and specifications? Read more
  4. 4Does the label carry the particulars for a health functional food? Read more
  5. 5Who holds the manufacturing permission, or the import registration? Read more
  6. 6How are adverse events reported, and is traceability registration required? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What a health functional food is

The category that functional supplements fall into in Korea.

  • A "health functional food" is a food manufactured with functional raw materials or ingredients beneficial to human health (Article 3, Health Functional Foods Act).
  • "Functionality" means controlling nutrients for the structure or functions of the human body, or providing beneficial health effects such as physiological effects.
  • An ordinary food may not be labelled or advertised so as to mislead consumers into believing it is a health functional food (Article 8, Act on Labeling and Advertising of Foods).

How we help: Compliant Always records which category each product is sold under, and keeps the evidence for that choice with it. Ask about this

Ingredients, standards and specifications

What may go into a health functional food, and the standards it is made to.

  • MFDS determines and publicly notifies the raw materials and ingredients that may be used in health functional foods (Article 15(1)).
  • An ingredient not yet notified can be recognised by MFDS after it examines data on its safety and function, submitted by a manufacturer, a registered importer or another person the Ordinance names (Article 15(2)).
  • MFDS sets standards and specifications for the manufacture, use and preservation of health functional foods, with separate standards for food additives in those made for children (Article 14).
  • MFDS may reassess notified or recognised matters and change or cancel them (Article 15-2).

How we help: Compliant Always reads your formula and specifications against the notified ingredients and standards, and keeps each recognition and test report with the product. Ask about this

Labelling and advertising

What a health functional food label has to show.

  • The label shows the product name, net quantity and ingredient names; the business name and location; the use-by date and storage instructions; and dosage, suggested use and warnings (Article 4(1)3, Act on Labeling and Advertising of Foods).
  • It also shows a mark or expression that the product is a health functional food, and a statement that it is not a drug intended to prevent, treat or cure disease.
  • It states the functional information and the content of the ingredients that have the claimed effect.
  • Genetically modified health functional foods are labelled as such (Article 17-2, Health Functional Foods Act).
  • Claims in labels and adverts must be substantiated, and advertising goes through prior review where the Act requires it (Articles 9 and 10, Act on Labeling and Advertising of Foods).

How we help: Compliant Always sets the particulars beside what your label shows, and keeps the evidence behind each functional claim with the label version it supports. Ask about this

Permission, GMP, adverse events and traceability

Who may make and sell health functional foods, and what they keep and report.

  • Manufacturing health functional foods requires permission from MFDS for each place of business (Article 5). Selling them requires a report to the local government (Article 6).
  • Manufacturers follow the good manufacturing practice standards set by Prime Ministerial Ordinance, which MFDS examines and evaluates each year (Article 22).
  • Business entities, including registered importers and pharmacies, report adverse events (unfavourable and unintended signs, symptoms or diseases) to MFDS (Article 10-2).
  • Manufacturers and sellers above a set turnover or store area register traceability of records with MFDS (Article 22-2).
  • Manufacturers inspect their products against the standards and specifications and keep the records (Article 21).

How we help: Compliant Always keeps the permission, GMP evidence and adverse event records with each product, and shows what is due for renewal. Ask about this

Import

How imported health functional foods come into Korea.

  • Health functional foods imported into Korea are imported food under the Special Act on Imported Food Safety Control (Article 2).
  • The foreign facility is registered with MFDS before the import declaration, and each consignment is declared and inspected before customs clearance (Articles 5, 20 and 21).
  • Importers of health functional foods that reach a set amount of sales register imported food traceability with MFDS (Article 23).

How we help: Compliant Always keeps the facility registration, import declarations and inspection reports with the product and lot. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandWhat the label and advertising claim, and the evidence for each functional claim.The label read against the particulars, with the evidence behind each claim kept with it.
ManufacturerMFDS permission, good manufacturing practice and self-quality inspection.GMP and test documents kept with each product and lot.
ImporterFacility registration, import declarations, adverse event reports and traceability where required.Registrations and reports read and dated before the goods arrive.
SellerIts business report, and reporting adverse events it learns of.Product documents ready for the retailer or platform that asks.

National ministries and local government

Product law in South Korea is national. Each Act names the minister in charge, such as the Minister of Food and Drug Safety for food and cosmetics, and the Minister of Trade, Industry and Resources for electrical, consumer and children's products.

Many licences, reports and inspections under those Acts are handled by a Mayor or Do Governor or the head of a Si/Gun/Gu, so the local office named in the Act is often the one a business deals with.

Questions businesses ask

Are supplements regulated as food or as medicine in Korea?
Products made with functional ingredients beneficial to health are health functional foods under the Health Functional Foods Act, regulated by MFDS. Their label states that the product is not a drug intended to prevent, treat or cure disease.
What is a health functional food in Korea?
A food manufactured with functional raw materials or ingredients beneficial to human health, where functionality means controlling nutrients for the body's structure or functions, or beneficial health effects such as physiological effects (Article 3).
Can I use an ingredient MFDS has not listed?
Only after MFDS recognises it. A manufacturer, registered importer or other named person submits data on its safety and function, and MFDS examines it (Article 15, Health Functional Foods Act).
What must a Korean supplement label show?
Name, net quantity, ingredients, business name and location, use-by date and storage, dosage and warnings, a health functional food mark or expression, a not-a-drug statement, and the functional information (Article 4(1)3, Act on Labeling and Advertising of Foods).
Do supplement makers need a licence in Korea?
Manufacturing health functional foods requires permission from MFDS for each place of business. Selling them requires a report to the local government (Articles 5 and 6, Health Functional Foods Act).
Is GMP required for supplements in Korea?
Yes. Manufacturers follow the good manufacturing practice standards set by Prime Ministerial Ordinance, and MFDS examines and evaluates compliance each year (Article 22).
Do I have to report adverse events?
Yes. Business entities, including importers registered under the Special Act on Imported Food Safety Control, report adverse events associated with health functional foods to MFDS (Article 10-2).
Can an ordinary food be sold as a supplement?
No. A food may not be labelled or advertised so as to mislead consumers into believing it is a health functional food (Article 8, Act on Labeling and Advertising of Foods).
How are imported supplements checked?
As imported food: the foreign facility is registered with MFDS, each consignment is declared and inspected before customs clearance, and larger importers register traceability (Special Act on Imported Food Safety Control).
How does Compliant Always help with selling in South Korea?
Our team reads the rules for the markets you sell in, from Korean law and the regulators' own pages. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in South Korea and what your paperwork needs to show.

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