What the FDA Actually Said
On September 9, 2026, the FDA published a clarification after receiving a rising number of inquiries about proof of cosmetic facility registration. The agency noted that ecommerce platforms, naming TikTok Shop specifically, have been asking sellers to provide evidence of FDA registration.
The clarification is short and unambiguous. The FDA does not provide certificates or other documents to verify compliance for cosmetic product facility registration or product listing. It will not issue:
- Certificates of registration
- Verification letters or emails
- Documents confirming that a facility is exempt from registration requirements
The agency also restated a point that gets lost constantly: assignment of a facility registration number or a product listing number does not indicate FDA approval of the facility or its cosmetic products.
So if a platform, a retailer or a distributor has asked you for an FDA certificate, they are asking for a document that does not exist and has never existed.
Why This Is Happening Now
MoCRA introduced mandatory facility registration and product listing for cosmetics. Before that, there was essentially nothing for a platform to ask about. Now there is a registration system, and the existence of a system has been widely misread as the existence of an approval.
Ecommerce platforms are trying to manage their own risk. Faced with sellers making unsupported claims, the intuitive move is to demand paperwork from a regulator. The problem is that the US cosmetics framework was never built on pre-market approval. Registration is a notification obligation, not a licence, and there is no document that turns it into one.
This is a genuinely different model from the one many buyers expect. If you are used to markets where a regulator issues a certificate before you can sell, the American system will feel like something is missing. Nothing is missing. It works differently.
What Actually Exists
When a facility registers or a responsible person lists a product, the FDA assigns a number. Those numbers are the artifact of the process. What does not follow is a signed document from the agency attesting to anything.
Practically, this means the evidence you can assemble comes from your own records and your own submissions, not from an FDA-issued attestation. If a platform will not accept that, the conversation to have is with the platform about what it will accept, not with the FDA about issuing something it has said it does not issue.
Because platform requirements vary and change, confirm what a specific platform will take before you build a launch plan around it.
Who Is Responsible for What
This is where brands sourcing from Korea most often get confused, and the division matters.
Facility registration is an obligation attached to the facility that manufactures or processes the product. For a brand producing in Korea, that is the Korean manufacturer's facility, and registering it is the manufacturer's responsibility.
Product listing is an obligation of the responsible person, defined as the manufacturer, packer or distributor whose name appears on the product label. For most brands importing from Korea, that is you. Your Korean manufacturer does not do this for you, and their facility registration does not cover it.
The responsible person must list each marketed product along with its ingredients, and update that listing annually.
Facility registration renews biennially, every two years from the initial registration date. A registration that was current when you started a project may not be current when you launch.
Note also that some facilities qualify for small business exemptions, but those exemptions never apply to certain product categories, including products that contact the mucous membrane of the eye, products that are injected, products intended for internal use, and products intended to alter appearance for more than 24 hours. If your product falls into one of those categories, exemption is not available regardless of the manufacturer's size. And as the September clarification makes clear, the FDA will not issue a document confirming exemption either.
What to Resolve With Your Korean Manufacturer
None of these questions ask your manufacturer to certify anything. They establish whether the factual basis for your own compliance work is in place.
- Is the facility currently registered with the FDA, and when is its next biennial renewal due?
- If the facility claims an exemption, on what basis, and does your product category permit one?
- Who will be named as the responsible person on the label, and has that been agreed in writing?
- Can the manufacturer supply the full ingredient information you need for your product listing, in the format the listing requires?
- Can they provide the safety substantiation records that sit behind the formula?
- Have they exported to the US before, and can they describe how they supported a previous buyer's filings?
A manufacturer that answers these clearly has done this before. A manufacturer that offers to send you an FDA certificate has not, and that answer should tell you something.
What This Does Not Change
It is worth being precise about the limits of this clarification. It does not change what MoCRA requires. It does not remove the registration or listing obligations. It does not mean registration is optional, and it does not mean platforms will stop asking.
It clarifies one narrow thing: the proof some buyers have been chasing is not a document the FDA produces. The underlying obligations are the same as they were, and they are covered in our FDA and MoCRA import guide.
Planning US Production in Korea
OEMKorea reviews your product brief and matches manufacturers on product capability, realistic production volume, export experience, and their ability to supply the information your US compliance process requires.
To be clear about what that is and is not: we are not a regulatory adviser, we do not make filings on your behalf, and no manufacturer in our network is FDA approved, because no manufacturer anywhere is. Registration is not approval. Your filings, your responsible person obligations and your final compliance remain yours, and a qualified regulatory adviser should review them.
What we can do is make sure the manufacturer you are matched with has genuine US export experience and can produce the documentation your adviser will ask for. Submit an RFQ with your product, target launch date and intended market, and include whether your responsible person arrangement is already settled.
Related Reading
- FDA & MoCRA Cosmetics Import Guide for Korean OEM Buyers: the full registration, listing and responsible person breakdown
- Importing Korean Cosmetics to the USA: labeling, claims, the sunscreen problem and logistics
- MFDS Registration Explained: how the Korean side of the paperwork works
- How to Verify a Korean Cosmetics Manufacturer Is Legitimate: due diligence beyond regulatory filings
Sources: FDA clarification on verification documents, September 9, 2026 and FDA registration and listing guidance. This article is general information, not regulatory advice.