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What FDA and KFDA Certification Actually Require

Aug 17
2 min read

A product built for the Canadian market doesn't automatically qualify for any other market. Every country decides its own bar, and clears its own paperwork, before a product reaches a shelf there. Exporting isn't one extra step, it's a different regulatory system for every country a brand wants to sell into.

CPC manufactures for brands selling in more than 10 markets. Two of the certifications behind that reach are FDA facility registration for the U.S. and KFDA alignment for South Korea, and they don't ask for the same thing.


approved certification

What FDA Registration Actually Requires

Any facility manufacturing, processing, packing, or holding food or dietary supplements for the U.S. market has to register with the FDA under the Food Safety Modernization Act. Registration means submitting facility information and giving the FDA assurance it can inspect the facility, and it has to be renewed every two years, not filed once and forgotten.

Worth being precise about what this registration does and doesn't mean. It is not, by itself, a certification that a facility or its products are safe. It's the gate that makes a facility eligible to sell into the U.S. and subject to inspection, and the FDA can suspend that registration if a facility creates or holds unsafe product. The safety case still has to be made by the manufacturing standard behind it, GMP is what does that work. Registration gets you in the room. GMP is what you do once you're in it.


What KFDA Alignment Actually Requires

South Korea's Ministry of Food and Drug Safety (the agency most people still call KFDA) runs a materially different process for health functional foods. Foreign manufacturing facilities have to register before their products can be imported, every commercial shipment needs an import declaration, and the facility needs a traceability system tracking a product from import through retail.

Products get checked against Korea's Health Functional Food Code or against individually recognized functional ingredients, and verification runs in stages: document review, field inspection, laboratory testing, random sampling, and post-market surveillance of labels and advertising claims after the product is already on shelves.


world export map


Why Holding Both Matters

FDA registration and KFDA alignment aren't the same requirement wearing two names, they're two different regulatory systems for two of the largest supplement markets outside Canada. A brand manufacturing at a facility that already holds both isn't starting that compliance work from zero, which turns into faster, more credible access to two markets at once, and recognition a retailer in either country can actually verify.

Looking to bring a product into the U.S. or South Korean market?


References

U.S. Food and Drug Administration, Registration of Food Facilities and Other Submissions — https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions


ChemLinked, South Korea Health Functional Food Regulation — https://food.chemlinked.com/foodpedia/south-korea-health-functional-food-regulation


 
 
 

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