On 21 July, South Korea's food and drug regulator proposed a mandatory warning label for every customised health supplement sold there: the label is what made the trade headlines, but the same draft is the country's first rule requiring supplement makers to write down every time they reprocess a batch

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.

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.

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