A labelling fix built on top of a new factory paper trail
Customised health functional foods let a buyer combine several approved health functional food ingredients into one personalised product, sold through pharmacies and specialised outlets after a consultation with a qualified manager. MFDS has run the category as a pilot since 2020, and participants include multinational direct-sellers such as Amway and Herbalife alongside domestic pharmacy chains. The problem MFDS says it is fixing is consumer confusion: because a customised product is assembled to order and can resemble a prescription regimen, the ministry's stated concern is that buyers may mistake it for medicine. The draft's answer is a dedicated visual design so a customised product is recognisable at a glance, plus the "not a medicine" statement and a use-by date on the inner packaging, not just the outer box, closing a gap where a repackaged or subdivided product could lose its date information once removed from its original container.
Three nuances that separate signal from noise
01
The label is the part that photographs well
A new pictogram and a "not a medicine" line are easy to illustrate, which is why nearly every write-up of the draft opened with them. The GMP provisions in the same notice got a fraction of the coverage.
02
Reprocessing records are a new duty, not a stricter old one
Korea's GMP standard for health functional foods already existed under MFDS Notice 2022-25. The draft adds a specific requirement to retain records each time a batch is reprocessed, a documentation duty that did not previously exist in that form.
03
Facility rules loosen at the same time contamination rules tighten
The same draft lets health functional foods be made in quasi-drug manufacturing facilities and allows subdividing products at a buyer's request, easing where and how products are made while adding new documentation for how that process is controlled.
2020
MFDS launches the customised health functional food system as a regulated pilot channel sold through pharmacies and specialised outlets.
11 May 2026
776 businesses are registered to sell customised health functional foods in Korea, according to MFDS figures reported by trade press.
21 Jul 2026
MFDS opens a legislative notice (입법예고) on a partial amendment to the Enforcement Rule of the Health Functional Food Act.
31 Aug 2026
Public comment period on the draft amendment closes.
The numbers behind the draft
One number is how long MFDS gave stakeholders to respond. One is how many registered sellers the label and GMP duties would apply to first. The third places the customised segment inside the market it sits within.
41 days
the public comment window MFDS opened on 21 July 2026, running to 31 August, before the amendment can be finalised
776
businesses registered to sell customised health functional foods in Korea as of 11 May 2026, the sellers the new label and disclosure duties reach first
$3.7B
value of Korea's overall health functional food industry in 2024 (KRW 5.07 trillion), the market the customised segment sits inside, per USDA's Seoul trade office
The real subject: a label rule that also reaches into the factory
Read narrowly, this is a consumer-protection fix: stop shoppers from mistaking a personalised supplement for medicine. Read alongside the GMP provisions in the same draft, it is something broader. MFDS is using a labelling reform as the vehicle to introduce a documentation duty that reaches past the finished pack and into the manufacturing process itself: a written record every time a batch is reprocessed, and periodic verification of the compressed air and lubricants that touch the product line. Neither of those facts appears on a label. Both become part of what a compliant customised health functional food now requires a manufacturer to be able to produce on demand. That is the pattern regulators keep returning to across markets: the front-of-pack claim is only the visible layer, and the harder, less photogenic compliance work sits one step back, in the process data behind it.
Why it matters for brands
For any consumer-goods or wellness brand selling into Korea's customised health functional food channel, directly or through a local partner, three things follow from the 21 July draft. First, the dedicated design and the "not a medicine" statement are per-SKU packaging changes, on both outer and inner packaging, that will need to be reflected in each product's artwork and label file the moment the rule is finalised, not treated as a single company-wide update. Second, the GMP additions fall on whoever holds the manufacturing site, which for many brands is a contract manufacturer rather than the brand itself: a compliance team that has not asked its Korean CMO whether it already logs batch reprocessing and verifies compressed air and lubricants on a schedule will not know its exposure until the amendment is adopted. Third, Korea's move to fold process-level recordkeeping into a labelling reform is not unique to health functional foods; brands that keep manufacturing-process data (reprocessing, utility checks, facility type) in the same system as label and claims data, mapped per market, absorb a change like this as an update to an existing record. Brands that only track what is printed on the pack will find the harder half of the rule sitting with a supplier they have not yet asked the right question.
Two ways to read the 21 July draft
The narrow read
MFDS is adding a clearer label so shoppers stop mistaking a personalised supplement for medicine, and closing a gap where the use-by date disappeared once a product left its outer box.
The structural read
A labelling reform is the wrapper around a new manufacturing-process documentation duty, batch-reprocessing records and utility verification, that has nothing to do with what is printed on the pack: the compliance work brands need to check for sits with their manufacturing sites, not their design files.
Frequently asked questions
What is South Korea proposing for customised health functional foods?
Does the draft only change labelling?
Who does the new rule affect first?
Sources
- Ministry of Food and Drug Safety (MFDS): legislative notice on the partial amendment to the Enforcement Rule of the Health Functional Food Act (건강기능식품에 관한 법률 시행규칙 일부개정령안 입법예고), 21 July 2026
- Ministry of Government Legislation (법제처): legislative notice listing for the Enforcement Rule of the Health Functional Food Act amendment
- NutraIngredients-Asia: "South Korean regulator to tighten GMP controls and labeling of customized health foods" (5 August 2026)
- ChemLinked: "South Korea to Amend the Health Functional Food Labeling Standard"
- ChemLinked: Health Functional Food Good Manufacturing Practice database entry (MFDS Notice No. 2022-25)
- Etoday (이투데이): "식약처, 맞춤형 건기식 '의약품 아님' 표시 의무화 추진"
- Medipharm Health News (메디팜헬스뉴스): "식약처, 건강기능식품법 시행규칙 개정안 입법예고"
- USDA Foreign Agricultural Service (GAIN report KS2026-0003): "Health Functional Food and Supplements - Market Brief for the Republic of Korea", Seoul ATO, April 2026
