At a ViaJiin garden party this month I ran a trivia round. One question tripped up almost the entire room.
True or false: Korea's cosmetics approval process is easier than the United States'.
Almost everyone said true. It is false, and the reason it is false says something useful about how to shop for Korean skincare.
First, the uncomfortable part: no cosmetic is FDA approved
Not Korean skincare. Not the American moisturizer on your shelf. Not the prestige serum at the department store.
The FDA does not approve cosmetics. It never has. There is no application, no review, no clearance number. A company in the United States can formulate a face cream on Monday and sell it on Friday without ever telling the FDA it exists.
So when a product page says "FDA approved," it is either describing a color additive, which genuinely does require FDA approval, or it is marketing language that means nothing. Be a little suspicious of the brands that use it.
What the FDA does have is authority after the fact. If a product turns out to be adulterated or misbranded, the agency can act. That is a fundamentally different posture than deciding in advance whether something should be sold.
What MoCRA changed, and what it did not
The Modernization of Cosmetics Regulation Act passed in December 2022, and it was the biggest update to US cosmetics law in more than eighty years. Enforcement of the main registration requirements began July 1, 2024.
It added real obligations:
- Facility registration. Manufacturers and processors register their facilities with the FDA and renew every two years.
- Product listing. A named Responsible Person lists each product, with its full ingredient list, and updates annually.
- Safety substantiation. The Responsible Person must hold adequate evidence that the product is safe.
- Adverse event reporting. Serious adverse events go to the FDA within 15 business days.
- Labeling. A US-reachable contact for adverse events has to appear on the label.
That is a meaningful floor, and it is more than the US had before. But notice what is not on the list. There is still no pre-market approval. Nobody at the FDA reads your formula and decides whether it can go on sale. The obligations are about registration, documentation and accountability, not permission.
There is also a small business exemption. Companies averaging under $1 million in US cosmetic sales over the prior three years are exempt from facility registration and product listing, though not from safety substantiation or adverse event reporting. The exemption falls away entirely for certain product types, including anything that regularly contacts the mucous membrane of the eye, anything injected, anything for internal use, and anything that changes appearance for more than 24 hours.
How Korea actually works
Korea gatekeeps at the front end, in three layers.
Layer one: the company. Before selling a single product, a company has to register with the Ministry of Food and Drug Safety as a responsible distributor. Manufacturing is a separate registration. There is no version of Korea where you formulate something in a rented kitchen and put it on the market next week.
Layer two: the ingredients. Korea runs positive lists. For preservatives, UV filters and colorants, only what appears on the permitted list may be used, at the permitted concentration. Everything not listed is prohibited by default. Alongside that sits a prohibited-ingredient list running to over a thousand entries. The FDA's prohibited and restricted list is roughly a dozen.
That difference in architecture matters more than the numbers. A positive list means the default answer is no. A prohibited list means the default answer is yes.
Layer three: functional cosmetics. Korea has a regulated category, 기능성화장품, covering products that make specific claims about things like tone, firmness, UV protection, hair loss and blemish relief. Products in that category require data submitted to the MFDS and cleared before launch. A claim of that kind is not something a Korean brand can simply decide to print.
Put together: Korea gates before. The US gates after.
Side by side
| Korea | United States | |
|---|---|---|
| Pre-market approval | None for ordinary cosmetics, but functional cosmetics need data cleared before launch | None at all |
| Company registration | Required before selling, with manufacturing registered separately | Facility registration under MoCRA since July 2024, with a small business exemption |
| Ingredient control | Positive lists for preservatives, UV filters and colorants. Default is no | A prohibited list of roughly a dozen entries. Default is yes |
| Claims | Regulated category with a data package | No pre-clearance |
| Sunscreen | A functional cosmetic, reformulated as the science moves | An over-the-counter drug under a monograph |
The one place the US is stricter: sunscreen
This is the honest exception, and it is a big one.
In Korea, sunscreen is a functional cosmetic. Brands can reformulate as the science moves, which is why Korean sunscreens are famously light, cosmetically elegant and pleasant enough to wear every day.
In the United States, sunscreen is regulated as an over-the-counter drug under a monograph. The list of permitted UV filters has barely changed in decades, and filters that have been standard in Korea, Japan and the EU for years are still not approved here. Adding one requires a drug-level data package.
That is why your favorite Korean sunscreen may not be legally sold as sunscreen in the US, and why some sellers quietly relabel them. It is also why there is no SPF in any ViaJiin kit. Importing a sunscreen means importing a drug, and we are not going to blur that line to make a kit look more complete.
What this means when you buy Korean skincare
Here is the practical translation, and it is the part most articles skip.
Korean regulation follows the Korean product. It does not follow it across the Pacific. A product that fully complies in Seoul still has to satisfy US requirements once it lands here, and the party responsible for that is whoever imports and distributes it.
This is exactly where the gray market breaks down. When you buy Korean skincare from an unnamed reseller, three things are often true at once: nobody has taken on the Responsible Person role, no safety file exists on the US side, and the label has no US-reachable contact for adverse events. It is not that the product is unsafe. It is that no one is accountable for it here.
So the useful question is not "is this FDA approved." Nothing is. The useful questions are:
- Who is the named Responsible Person for this product in the United States?
- Is there a US contact on the label if something goes wrong?
- Is the full ingredient list in English available before you buy, not after?
- Does the seller know where the product was manufactured?
A serious importer can answer all four. A drop-shipper cannot answer any of them.
How ViaJiin handles this
We source directly from boutique Korean brands, which means most of them have never sold into the US before. That is the whole point of the curation, and it is also the reason this work exists.
For every product in a kit, we determine who holds the Responsible Person role. Where a supplier already holds it and has filed its listings, we stay out of the way and add importer and distributor language only. Where nobody holds it, we take it, and only against a safety file we have actually read. We collect full INCI in English and verify it against the manufacturer's own statement before a single product card goes to print. Anything with an unresolved allergen or fragrance question gets a note on the page rather than a quiet omission.
None of that is visible in a $179 kit. It is most of the reason the kit can exist.
Frequently asked questions
Is Korean skincare FDA approved?
No, and neither is American skincare. The FDA does not approve cosmetics of any origin. It regulates them after they are on the market, and since 2024 it requires facility registration, product listing and safety substantiation under MoCRA.
Is Korean skincare safe?
Korea's system controls ingredients through positive lists, meaning only expressly permitted preservatives, UV filters and colorants may be used. In that specific respect it is tighter than the US. The larger variable is not the country, it is whether the specific product suits your skin.
What does MFDS approval mean?
The MFDS is Korea's Ministry of Food and Drug Safety. Companies register with it before selling, and functional cosmetics require review of supporting data before launch.
Why can I not buy some Korean sunscreens in the US?
Because sunscreen is an over-the-counter drug here, and several UV filters that are standard in Korea are not approved by the FDA.
Does MoCRA apply to imported Korean products?
Yes. Products sold in the US must meet US requirements regardless of where they were made, and someone in the chain has to be the named Responsible Person.
Not sure what your skin actually needs?
Regulation tells you whether a product is accountable. It does not tell you whether it is right for you. The ViaJiin skin quiz takes three minutes and matches you to a kit built around your skin type, concerns and how much time you actually have. Every product in it is sourced directly from Korea, with INCI verified in English before it ever reaches you.