The aim is to improve manufacturing and quality management standards for health functional foods.
The MFDS, for example, will introduce GMP standards when reprocessing – a procedure where repeating an established manufacturing process for semi-finished products that have deviated from predetermined manufacturing or quality-control standards – is involved.
As part of the GMP requirements, all reprocessing procedures, equipment failures and corrective actions should be documented. Approval from the head of the quality management department is also required before reprocessing is commenced.
Manufacturers will also need to periodically verify whether compressed air, lubricants, and related systems affect product quality as part of the regulator’s proposal to tighten GMP controls.
The newly proposed measures would also align the domestic GMP with international GMP norms.
Once approved, the Enforcement Rule of the Health Functional Foods Act will be amended.
“This measure aims to strengthen systematic process management and quality assurance by requiring the retention of records following any reprocessing during manufacturing and mandating periodic management of compressed air and lubricants—elements that pose a risk of cross-contamination,“ the MFDS said in its announcement.
Customized health foods labeling
South Korea’s customized health functional foods market has been expanding since it was introduced as a pilot project in 2020, with major brands such as Amway and Herbalife on board.
As of May 11, 2026, there are 776 registered businesses selling customized health functional foods.
Six years on, the MFDS is now proposing additional labeling requirements, such as printing product expiry dates and the statement “this product is not a medicine intended for the prevention or treatment of diseases” on individual packs.
“Consumers often carry individual daily-dose packets. However, expiry dates are only printed on the outer packaging and once this is discarded, consumers are unable to confirm the products’ expiry dates and individual packs may be mistaken for medicines,” the MFDS wrote in its proposal.
The regulator added that businesses must display precautions for concurrent use of customized health functional foods with pharmaceuticals, including via electronic means or at the location of purchase.
There are also plans to introduce an official symbol for customized health functional food products, which will need to be printed on the product packaging.
Preventing falsification of records
To prevent the alteration or falsification of quality inspection results, the MFDS is also proposing that manufacturers conducting in-house quality testing should install and operate a record management system.
Currently, only tests conducted by third-party institutions will be registered with the MFDS’ Laboratory Information Management System (LIMS).
The MFDS said that the current practice in the health functional foods sector differed from that of similar industries, such as food, livestock product, and sanitary product manufacturers, which are already required to maintain a record management system when quality testing is conducted in-house.
Health functional food businesses may tap into the MFDS-operated LIMS free of charge if they encounter challenges installing their own record management systems, according to the MFDS proposal.
According to the MFDS, there are currently 204 health functional food manufacturers that conduct in-house quality testing or partially outsource testing to third parties.
