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MFDS vs FDA — why the same product is regulated so differently

⏱ 2 min read

⚡ Quick answer: Korea's Ministry of Food and Drug Safety allows a class of cosmetic called functional cosmetics to make defined efficacy claims after review or a filed report, sitting above ordinary cosmetics but still inside the cosmetics law. The US FDA has cosmetics and drugs with little between them, and treats sunscreen as an over-the-counter drug — which is why US sunscreen innovation has moved so slowly. The US FDA has cosmetics and drugs with little between them, and treats sunscreen as an over-the-counter drug — which is why US sunscreen innovation moves so slowly.

Korea's Ministry of Food and Drug Safety allows a class of cosmetic called functional cosmetics to make defined efficacy claims after review or a filed report, sitting above ordinary cosmetics but still inside the cosmetics law. The US FDA has cosmetics and drugs with little between them, and treats sunscreen as an over-the-counter drug — which is why US sunscreen innovation has moved so slowly. The US FDA has cosmetics and drugs with little between them, and treats sunscreen as an over-the-counter drug — which is why US sunscreen innovation moves so slowly.

The structural difference

Korea: general cosmetics, functional cosmetics, and pharmaceuticals. The United States: cosmetics and drugs, with anything claiming to affect structure or function landing in the drug category. That middle tier is the whole difference.

The sunscreen consequence

Because sunscreen is a drug in the US, adding a new UV filter requires a drug approval process that has proved extraordinarily slow. The logjam cracked in June 2026, when bemotrizinol (Tinosorb S) became the first new filter added to the US monograph since the 1990s — and it got there through the order pathway created in 2020, not the process that had stalled everything before it. As of writing most of the rest, Tinosorb M, Uvinul A Plus and Uvinul T 150 among them, are still unavailable to American formulators.

The claims consequence

A Korean product may state a reviewed brightening or wrinkle-improvement claim. An American cosmetic making the same claim would risk being treated as an unapproved drug, which is why US packaging leans on vaguer appearance language.

Neither system is simply better

Korea's approach moves faster and gives shoppers more information; the US approach demands more evidence before a claim can be made at all. The practical result for a K-beauty shopper is a market where sunscreen is genuinely more advanced and claims are more specific.

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✍️ Written & reviewed by the KoreaPlus Editorial team — dermatologist-informed, cosmetic-science researched & source-cited. Last reviewed: 2026-08-23.

General educational information using cosmetic structure-function wording — not medical advice. Always patch-test new actives. © KoreaPlus.